Drug studies often look at the effect one or two drugs have on a medical condition, and involve one company. There is currently an urgent need for one study to efficiently test multiple drugs from more than one company, in people who have tested positive for COVID-19 but who do not currently need hospitalization. This could help prevent disease progression to more serious symptoms and complications, and spread of COVID-19 in the community. This study looks at the safety and effectiveness of different drugs in treating COVID-19 in outpatients. In Phase II, participants in the study will be treated with either a study drug or with placebo. In protocol version 7.0, participants in Phase III of the study will be treated with either a study drug or active comparator drug. Participants assigned to the bamlanivimab agent/placebo arm and will have 28 days of intensive follow-up following study drug administration, followed by limited follow-up through 24 weeks in phase II and in phase III. All other investigational agents and their corresponding placebo arms will involve 28 days of intensive follow-up, followed by limited follow-up through 72 weeks in phase II and phase III. Additional study visits may be required, depending on the agent.
This is a master protocol to evaluate the safety and efficacy of multiple investigational
agents aimed at modifying the host immune response to SARS-CoV-2 infection, or directly
enhancing viral control in order to limit disease progression.
The study includes both infused and non-infused agents and is a randomized controlled
platform that allows agents to be added and dropped during the course of the study for
efficient phase II and phase III testing of new agents within the same trial infrastructure.
Version 7 of the protocol provided for blinded phase II evaluation of an investigational
agent for superiority to placebo among participants at lower risk of progression to
hospitalization or death, regardless of the mode of administration of the agent.
Agents that graduate to phase III after initiation of the protocol version will be evaluated
in persons at higher risk for progression to hospitalization or death for non-inferiority to
an active comparator (monocolonal antibody cocktail of casirivimab plus imdevimab (REGEN-COV,
Regeneron). This active comparator has been shown to be effective in this population in
preventing hospitalization or death. When two or more agents are being evaluated in the same
phase of the study, the trial design includes sharing of the control group (placebo in phase
II and active comparator in phase III) for efficient evaluation of each agent.
Investigational agents will be approved by the Trial Oversight Committee (TOC) for phase II
evaluation based on the presence of in vitro data demonstrating promise as anti-SARS-CoV-2
therapeutics in pre-clinical testing, and for which there are suitable pharmacokinetics and
safety data from phase I testing, or through clinical or research testing for a different
indication, and agent availability. Investigational agents will be included in phase III
evaluation based on agent entry criteria for phase III as outlined in the protocol (or by TOC
approval based on data available outside ACTIV-2).
Biological: bamlanivimab 7000mg
Administered by single IV infusion. Participants are no longer being randomized to this intervention.
Other Name: LY3819253
Biological: BRII-196+BRII-198
1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
Biological: AZD7442 (IV)
300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
Other Name: AZD8895 + AZD1061
Biological: AZD7442 (IM)
Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
Other Name: AZD8895 + AZD1061
Drug: SNG001
1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
Drug: Camostat
200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
Other Name: Array
Biological: BMS-986414 + BMS-986413
Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
Other Name: C135-LS + C144-LS
Biological: SAB-185 (3,840 Units/kg)
Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
Other Name: Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived)
Biological: SAB-185 (10,240 Units/kg)
Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
Other Name: Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived)
Drug: CASIRIVIMAB + IMDEVIMAB
600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
Other Name: Array
Drug: Placebo for Bamlanivimab 7000mg
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Drug: Placebo for Bamlanivimab 700mg
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Drug: Placebo for BRII-196+BRII-198
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Drug: Placebo for SNG001
Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
Drug: Placebo for Camostat
200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
Drug: Placebo for SAB-185 (low dose)
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Drug: Placebo for BMS-986414 + BMS-986413
Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
Drug: Placebo for AZD7442 (IV)
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Drug: Placebo for AZD7442 (IM)
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Drug: Placebo for SAB-185 (high dose)
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Biological: bamlanivimab 700mg
Administered by single IV infusion. Participants are no longer being randomized to this intervention.
Other Name: LY3819253
Inclusion Criteria:
- Signed informed consent.
- Documentation of laboratory-confirmed SARS-CoV-2 infection, as determined by a
molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g.
oropharyngeal, nasopharyngeal (NP), or nasal swab, or saliva) collected ≤240 hours (10
days) prior to study entry. Laboratory-confirmed SARS-CoV-2 infection outside the US
must be conducted at a DAIDS-approved laboratory.
- Able to begin study treatment no later than 7 days from self-reported onset of
COVID-19 related symptom(s) or measured fever, where the first day of symptoms is
considered symptom day 0 and defined by the self-reported date of first reported
sign/symptom from the following list:
- subjective fever or feeling feverish
- cough
- shortness of breath or difficulty breathing at rest or with activity
- sore throat
- body pain or muscle pain/aches
- fatigue
- headache
- chills
- nasal obstruction or congestion
- nasal discharge
- loss of taste or smell
- nausea or vomiting
- diarrhea
- temperature > 38°C (100.4°F)
- One or more of the following signs/symptoms within 24 hours of participating in the
study:
- subjective fever or feeling feverish
- cough
- shortness of breath or difficulty breathing at rest or with activity
- sore throat
- body pain or muscle pain/aches
- fatigue
- headache
- chills
- nasal obstruction or congestion
- nasal discharge
- loss of taste or smell
- nausea or vomiting
- diarrhea
- temperature > 38°C (100.4°F)
- Oxygen levels of ≥92% obtained at rest (adjusted as needed for altitude) by study
staff within 24 hours of study entry. For a potential participant who regularly
receives chronic supplementary oxygen for an underlying lung condition, their oxygen
saturation should be measured while on their standard home oxygen supplementation
level.
- Participant must agree not to participate in another clinical trial for the treatment
of COVID-19 or SARS-CoV-2 during the study period until hospitalization or 28 days
after the start of the study, whichever occurs first.
- Meet the protocol definition of being at "higher" risk of progression to
hospitalization or death (BRII-196/BRII-198).
- In Phase III, meeting the protocol definition of being at "higher" risk of progression
to hospitalization or death (SNG001, SAB-185, BMS 986414+BMS 986413)
- For participants of reproductive potential, negative serum or urine pregnancy test
within 48 hours prior to study entry by any clinic or laboratory that has a CLIA
certification or its equivalent, or by a point of care (POC)/CLIA-waived test. Note:
Participants not of reproductive potential are eligible without requiring the use of a
contraceptive method (BRII-196/BRII-198. AZD7442 [IV], AZD7442 [IM], SNG001, Camostat,
SAB-185, BMS 986414+BMS 986413).
- Participants that engage in sexual activity that may lead to pregnancy in their
partner must agree to either remain abstinent or use male contraceptives. They are
strongly advised to inform their non-pregnant sexual partners of reproductive
potential to use effective contraceptives for 24 weeks after investigational product
is administered. Participants with pregnant partners should use condoms during vaginal
intercourse through 24 weeks after investigational agent administration. Participants
should refrain from sperm donation for 24 weeks after investigational agent
administration (BRII-196/BRII-198, AZD7442 [IV], AZD7442 [IM], SAB-185).
- Participants that engage in sexual activity that may lead to pregnancy in their
partner must agree to either remain abstinent or use male contraceptives for 30 days
after investigational agent administration. They are also strongly advised to inform
their non-pregnant sexual partners of reproductive potential to sue effective
contraceptives for 30 days after investigational agent is administered to the
participant. Participants with pregnant partners should use condoms during vaginal
intercourse through 30 days after last dose of investigational agent administration.
Participants should refrain from sperm donation for 30 days after investigational
agent administration (SNG001).
- Participants that engage in sexual activity that may lead to pregnancy in their
partner must agree to either remain abstinent or use male contraceptives. They are
also strongly advised to inform their non-regnant sexual partners of reproductive
potential to use effective contraceptives from study entry through 90 days after study
treatment. Participants with pregnant partners should use condoms during vaginal
intercourse from study entry through 90 days after the last dose of the study
treatment. Participants should refrain from sperm donation from study entry through 90
days after the last dose of study treatment (Camostat).
- If participating in sexual activity that could lead to pregnancy, participants who are
of reproductive potential must agree to use effective contraception for 24 weeks after
investigational agent is administered. This would include oral contraceptives,
implanted contraceptives, implanted contraceptives, intrauterine devices, and barrier
methods.
- If participating in sexual activity that could lead to pregnancy, participants who are
of reproductive potential must agree to use highly effective contraception for 24
weeks after investigational agent is administered (AZD7442 [IV], AZD7442 [IM],
SAB-185).
- If participating in sexual activity that could lead to pregnancy, participants who are
of reproductive potential must agree to use effective contraception for 30 days after
investigational agent is administered (SNG001).
- If participating in sexual activity that could lead to pregnancy, participants who are
of reproductive potential must agree to use effective contraception for 90 days after
the last dose of treatment (Camostat).
- If participating in sexual activity that could lead to pregnancy, participants who are
of reproductive potential must agree to use highly effective contraception for at
least 48 weeks after the investigational agent is administered (BMS 986414+BMS
986413).
Exclusion Criteria:
- History of or current hospitalization for COVID-19.
- For the current SARS-CoV-2 infection, any positive SARS-CoV-2 nucleic acid or antigen
tests from any respiratory tract specimen collected > 240 hours prior to study entry.
- Current need for hospitalization or immediate medical attention.
- Use of any prohibited medication listed in the protocol and/or use of systemic or
inhaled steroids for the purpose of COVID-19 treatment (new or increased dose from
chronic baseline) within 30 days prior to study.
- Receipt of convalescent COVID-19 plasma or other antibody-based anti-SARS-CoV-2
treatment or prophylaxis at any time prior to study entry.
- Receipt of other investigational treatments for SARS-CoV-2 any time before
participating in the study (not including drugs approved and taken for other
conditions/diseases or COVID-19 vaccines).
- Known allergy/sensitivity or hypersensitivity to study drug or placebo.
- Any condition requiring surgery up to 7 days before participating in the study, or
that is considered life threatening up to 30 days before participating in the study.
- Currently pregnant or breastfeeding (BRII-196/BRII-198, AZD7442 [IV], AZD7442 [IM],
SNG001, Camostat, SAB-185, BMS 986414+BMS 986413).
- In phase II, meeting the protocol definition of being at "higher" risk of progression
to hospitalization or death (AZD7442 [IV], AZD7442 [IM], SNG001, Camostat, SAB-185,
BMS 986414+BMS 986413).
- Inflammatory skin conditions that compromise the safety of intramuscular (IM)
injections, or other overlying skin conditions or tattoos that would preclude the
assessment of injection site reactions, per the discretion of the investigator
(AZD7442 [IM]).
- Inflammatory skin conditions that compromise the safety of subcutaneous (SC)
injections, or other overlying skin conditions or tattoos that would preclude the
assessment of infection site reactions, per the discretion of the investigator (BMS
986414+BMS 986413).
- History of coagulopathy which, in the opinion of the investigator, would preclude IM
injection, or use of oral or injectable anticoagulants (protocol provides more
information on prohibited medications) (AZD7442 [IM]).
- Use of or need for chronic supplemental oxygen (SNG001).
- Known severe liver disease prior to enrollment (defined as ALT or AST > 5 times upper
limit of normal or end stage liver disease with Child-Pugh Class C or
Child-Pugh-Turcotte score ≥ 10) (Camostat).
- Known severe kidney disease prior to enrollment (defined as estimated glomerular
filtration rate (eGFR) <30 ml/min/1.73m² or on renal-replacement therapy such as
peritoneal dialysis or hemodialysis (Camostat)
Other investigational drug protocol-defined inclusion/exclusion criteria may apply.
Pinnacle Research Group (Site 1082), 321 E. 10th Street
Anniston, Alabama, United States
North Alabama Research Center LLC (Site 1194), 721 W. Market St., Ste. B
Athens, Alabama, United States
University of Alabama at Birmingham (Site 1005), 908 20th Street South
Birmingham, Alabama, United States
Cullman Clinical Trials (Site 1140), 501 Clark St. NE.
Cullman, Alabama, United States
Jasper Summit Research, LLC. (Site 1056), 1280 Summit
Jasper, Alabama, United States
Absolute Clinical Research, LLC. (Site 1186), 7725 North 43rd Avenue, Ste. 211
Phoenix, Arizona, United States
University of Arizona (Site 1043), 1501 N. Campbell Ave., Rm. 6410
Tucson, Arizona, United States
Omnibus Clinical Research (Site 1253), 3340 W. Ball Road, Ste. I
Anaheim, California, United States
Franco A. Felizarta MD (Site 1174), 3535 San Dimas St.
Bakersfield, California, United States
Clearview Medical Research LLC. (Site 1251), 2714 Hidaway Ave., Ste. 103
Canyon Country, California, United States
St. Jude Heritage Medical Group (Site 1093), 2151 N. Harbor Blvd.
Fullerton, California, United States
University of California San Diego (Site 1160), 9350 Campus Point Drive, Perlman Cancer Cancer
La Jolla, California, United States
Fadi A. Haddad, MD, Inc. (Site 1146), 8860 Center Dr., Ste. 320
La Mesa, California, United States
Atella Clinical Research (Site 1111), 5451 La Palma Avenue
La Palma, California, United States
Loma Linda University Health (Site 1110), 11374 Mountain View, Dover Bldg, Ste. C
Loma Linda, California, United States
University of Southern California (Site 1057), 1300 N. Mission Rd., Rm 349
Los Angeles, California, United States
UCLA CARE Center (Site 1003), 11075 Santa Monica Blvd., Suite 100
Los Angeles, California, United States
Science 37, Inc. (Site 1124), 12121 Bluff Creek Dr., Ste. 100
Los Angeles, California, United States
VA Northern California Health Care System (NAVREF) (Site 1137), 10535 Hospital Way
Mather, California, United States
Central Valley Research, LLC (Site 1085), 400 E. Orangeburg Ave., Ste. 5
Modesto, California, United States
Hoag Memorial Hospital Presbyterian (Site 1200), 1 Hoag Dr.
Newport Beach, California, United States
Valley Clinical Research, Inc. (Site 1059), 18433 Roscoe Blvd., Ste 210
Northridge, California, United States
University of California Irvine (Site 1083), 843 Health Sciences Road
Orange, California, United States
FOMAT Medical Research (Site 1136), 300 South A Street
Oxnard, California, United States
Eisenhower Medical Center (Site 1040), 39000 Bob Hope Drive
Rancho Mirage, California, United States
Paradigm Research (Site 1150), 3652 Eureka Way
Redding, California, United States
Riverside Medical Clinic (Site 1232), 7117 Brockton Ave.
Riverside, California, United States
University of California Davis Medical Center (Site 1097), 2315 Stockton Blvd.
Sacramento, California, United States
Premier Urgent Care Centers of California, Inc. (Site 1176), 284 E. Highland Ave.
San Bernardino, California, United States
University of California San Diego (Site 1002), 220 Dickinson Street
San Diego, California, United States
Zion Medical Center (Site 1063), 4647 Zion Avenue
San Diego, California, United States
VA San Diego Health System (Stie 1127), 3350 La Jolla
San Diego, California, United States
University of California San Francisco (Site 1009), 995 Potrero Ave., Building 80, Ward 84
San Francisco, California, United States
San Francisco Research Institute (Site 1210), 2435 Ocean Ave.
San Francisco, California, United States
Stanford University (Site 1213), 1201 Welch Road
Stanford, California, United States
Millennium Clinical Trials (Site 1260), 550 Saint Charles Dr., Ste. 208
Thousand Oaks, California, United States
Office of Ramesh V. Nathan, MD (Site 1073), 2220 Lynn Rd., Ste. 301
Thousand Oaks, California, United States
Harbor UCLA (Site 1022), 1124 West Carson Street
Torrance, California, United States
Allianz Research Institute Inc. (Site 1159), 14120 Beach Blvd., Ste. 101
Westminster, California, United States
University of Colorado (Site 1007), 12401 East 17th Avenue
Aurora, Colorado, United States
UConn - Institute for Collaboration on Health (Site 1169), 2006 Hillside Rd., Unit 1248
Storrs, Connecticut, United States
Whitman-Walker Health (Site 1027), 1337 R Street NW.
Washington, District of Columbia, United States
Imagine Research of Palm Beach County (Site 1157), 709 S. Federal Hwy., Ste. 2
Boynton Beach, Florida, United States
Bradenton Research Center Inc. (Site 1109), 3924 9th Ave. W
Bradenton, Florida, United States
Synergy Healthcare (Site 1099), 300 Riverside Drive E., Ste. 1350
Bradenton, Florida, United States
Cardiology Physicians, P.A. (Site 1180), 305 Memorial Medical Pkwy., Ste. 301
Daytona Beach, Florida, United States
Midland Florida Clinical Research Center LLC (Site 1130), 665 Peachwood Drive
DeLand, Florida, United States
Integrity Clinical Research (Site 1214), 3901 NW 79th Ave.
Doral, Florida, United States
Universal Axon Clinical Research (Site 1077), 3650 NW 82nd Ave.
Doral, Florida, United States
EMINAT Research (Site 1202), 2500 E. Commercial Blvd.
Fort Lauderdale, Florida, United States
Holy Cross Health (Site 1072), 4725 North Federal Highway
Fort Lauderdale, Florida, United States
North Florida / South Georgia Veterans Health System (Site 1133), 1601 SW Archer Rd.
Gainesville, Florida, United States
University of Florida (Site 1047), 1600 SW. Archer Rd.
Gainesville, Florida, United States
NW FL Clinical Research Group, LLC. (Site 1046), 400 Gulf Breeze Parkway
Gulf Breeze, Florida, United States
Indago Research and Health Center (Site 1050), 3700 W. 12th Ave., Ste. 300
Hialeah, Florida, United States
AGA Clinical Trials (Site 1026), 900 West 49th Street
Hialeah, Florida, United States
Community Research of South Florida (Site 1197), 7100 W. 20th Ave., Ste. 403
Hialeah, Florida, United States
New Generation Medical Research (Site 1204), 7600 W. 20th Ave., Ste. 106
Hialeah, Florida, United States
Best Quality Research, Inc. (Site 1237), 2387 W. 68th St., Ste. 403
Hialeah, Florida, United States
Innovative Health Medical Center (Site 1222), 6750 Taft Street
Hollywood, Florida, United States
University of Florida Jacksonville (Site 1039), 655 West 8th Street
Jacksonville, Florida, United States
Mayo Clinic Jacksonville (Site 1149), 4500 San Pablo Rd. S.
Jacksonville, Florida, United States
QC Trials (Site 1117), 300 W. 41st Street, Ste. 203
Miami Beach, Florida, United States
Lakes Research (Site 1037), 5801 NW 151 Street
Miami Lakes, Florida, United States
Savin Medical Group, LLC. (Site 1212), 5789B NW. 151st Street
Miami Lakes, Florida, United States
Amber Clinical Research, LLC. (Site 1206), 9000 NE. 2nd Avenue
Miami Shores, Florida, United States
Gonzalez MD & Aswad MD Health Services (Site 1238), 3401 NW. 7th Street
Miami, Florida, United States
Clintex Research Group, Inc. (Site 1231), 590 SW. 27th Ave.
Miami, Florida, United States
Advance Medical Research Center (Site 1193) 330 SW. 27th Ave., Ste. 701
Miami, Florida, United States
University of Miami Miller School of Medicine CoVID Unit (Site 1068), 1425 NW. 10th Ave.
Miami, Florida, United States
Florida International Medical Research (Site 1239), 1890 S. Red Rd., Ste. 103
Miami, Florida, United States
D&H National Research Centers (Site 1205), 8485 Bird Road
Miami, Florida, United States
Allied Biomedical Research Institute (Site 1227), 7100 SW. 47th St., Ste. 220
Miami, Florida, United States
Miami Clinical Research (Site 1089), 2400 SW. 69th Ave.
Miami, Florida, United States
Research Institute of South Florida, Inc. (Site 1201), 9835 SW. 72nd Street, Ste. 201
Miami, Florida, United States
RM Medical Research, Inc. (Site 1230), 10346 W. Flagler St.
Miami, Florida, United States
Pro Live Medical Research Corp (Site 1219), 12781 SW. 42nd Street
Miami, Florida, United States
Miami Dade Medical Research Institute, LLC (Site 1223), 8955 SW. 87th Ct.
Miami, Florida, United States
Bravo Health Care Center (Site 1221), 1440 79 Street
North Bay Village, Florida, United States
Orlando Immunology Center (Site 1045), 1707 North Mills Avenue
Orlando, Florida, United States
Clintheory (Site 1203), 7350 Sandlake Commons Blvd.
Orlando, Florida, United States
IMIC, Inc. (Site 1141), 18320 Franjo Rd
Palmetto Bay, Florida, United States
Family Clinical Trials (Site 1236), 1601 N. Palm Ave., Ste. 102
Pembroke Pines, Florida, United States
Physician Care Clinical Research, LLC. (Site 1242), 1617 S. Tuttle Ave., Ste. 1A
Sarasota, Florida, United States
Bassetti Medical Research, Inc. (Site 1158), 5825 US Highway 27 N.
Sebring, Florida, United States
DBC Research (Site 1188), 7707 N. University Dr., Ste. 106
Tamarac, Florida, United States
ETNA Medical Center (Site 1225), 7401 N. University Drive
Tamarac, Florida, United States
Moore Clinical Research, Inc. (Site 1164), 4257 W. Kennedy Blvd.
Tampa, Florida, United States
Tampa General Hospital Family Care Center Healthpark (Site 1088), 5802 N. 30th Street
Tampa, Florida, United States
Infectious Disease Consultants of the Treasure Coast (Site 1171), 3735 11th Cir., Ste. 201
Vero Beach, Florida, United States
AIDS Research and Treatment Center of the Treasure Coast (Site 1095), 981 37th Place
Vero Beach, Florida, United States
Triple O Research Institute PA (Site 1121), 2580 Metrocentre Blvd., Ste. 4
West Palm Beach, Florida, United States
The Ponce de Leon Center (site 1015), 341 Ponce De Leon Avenue Northeast
Atlanta, Georgia, United States
Rare Disease Research, LLC. (Site 1248), 1891 Howell Mill Rd.NW, Ste. B
Atlanta, Georgia, United States
Agile Clinical Rsearch Trials, LLC (Site 1051), 750 Hammond Drive
Atlanta, Georgia, United States
Balanced Life Health Care Solutions/SKYCRNG (Site 1191), 2033 Buford Hwy., Ste. 109
Buford, Georgia, United States
IACT Health (Site 1035), 800 Talbotton Road
Columbus, Georgia, United States
Clintheory (Site 1254), 4300 Pleasant Hill Road
Duluth, Georgia, United States
One Health Research Clinic, Inc. (Site 1250), 5880 Live Oak Pkwy, Ste. 160
Norcross, Georgia, United States
Renew Health Clinical Research, LLC. (Site 1161), 1550 Janmar Rd.
Snellville, Georgia, United States
John A. Burns School of Medicine UH Clinics at Kakaako (Site 1177), 651 Ilalo St.
Honolulu, Hawaii, United States
Snake River Research, PLLC (Site 1120), 2900 Cortez Ave.
Idaho Falls, Idaho, United States
Metro Infectious Disease Consultants (Site 1106), 901 McClintock Dr., Ste. 201
Burr Ridge, Illinois, United States
Chicago Clinical Research Institute (Site 1132), 611 W. Roosevelt Rd.
Chicago, Illinois, United States
Northwestern University (Site 1025), 645 North Michigan Ave
Chicago, Illinois, United States
Rush University Medical Center (Site 1017), 600 Paulina St.
Chicago, Illinois, United States
University of Illinois at Chicago (Site 1147), 835 South Wood Street
Chicago, Illinois, United States
University of Chicago (Site 1064), 5841 S. Maryland Ave.
Chicago, Illinois, United States
Great Lakes Clinical Trials (Site 1049), 5149 N. Ashland Ave.
Chicago, Illinois, United States
Investigators Research Group, LLC. (Site 1170), 321 E. Northfield Dr., Ste. 100
Brownsburg, Indiana, United States
Roudebush VA Medical Center (Site 1217), 550 University Blvd
Indianapolis, Indiana, United States
University of Kansas Medical Center (Site 1042), 3901 Rainbow Boulevard
Kansas City, Kansas, United States
MedPharmics (Site 1065), 3800 Houma Blvd.
Metairie, Louisiana, United States
Clinical Trials of America, LLC. (Site 1245) 3201 Armand Street
Monroe, Louisiana, United States
New Orleans Adolescent Trials Unit (Site 1028), 1440 Canal St., Suite 904
New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center (Site 1153), 2000 Canal Street
New Orleans, Louisiana, United States
Ochsner Clinic Foundation (Site 1218), 1514 Jefferson Highway
New Orleans, Louisiana, United States
Baltimore VA Medical Center (Site 1258), 10 N. Greene St.
Baltimore, Maryland, United States
Johns Hopkins University (Site 1006), 1830 East Monument Street
Baltimore, Maryland, United States
Walter Reed Army Institute of Research (Site 1118), 503 Robert Grant Ave.
Silver Spring, Maryland, United States
Massachusetts General Hospital (Site 1016), 55 Fruit Street
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center (Site 1166), 110 Francis Street
Boston, Massachusetts, United States
Brigham and Women's Hospital - Therapeutics Clinical Research Site (Site 1023), 75 Francis Street
Boston, Massachusetts, United States
University of Massachusetts Medical School (Site 1054), 55 Lake Avenue N.
Worcester, Massachusetts, United States
Vida Clinical Studies (Site 1244), 3815 Pelham Street
Dearborn, Michigan, United States
Revive Research Institute (Site 1257), 32255 Northwestern Hwy.
Farmington Hills, Michigan, United States
Revival Research Corporation (Site 1256), 13409 East 14 Mile Road
Sterling Heights, Michigan, United States
Memorial Hospital at Gulfport (Site 1104), 4500 13th Street
Gulfport, Mississippi, United States
MedPharmics, LLC. (Site 1032), 15190 Community Rd.
Gulfport, Mississippi, United States
University of Missouri Health Care System (Site 1224), 1 Hospital Drive
Columbia, Missouri, United States
Hannibal Clinic (Site 1129), 100 Medical Drive
Hannibal, Missouri, United States
Washington University School of Medicine (Site 1008), 620 South Taylor, Suite 200
Saint Louis, Missouri, United States
Bozeman Health Deaconess Hospital (Site 1115), 931 Highland Blvd, Ste. 3103
Bozeman, Montana, United States
Mercury Street Medical Group (Site 1074), 300 W. Mercury St.
Butte, Montana, United States
Quality Clinical Research (Site 1112), 10040 Regency Circle
Omaha, Nebraska, United States
Las Vegas Medical Research (Site 1048), 8530 W. Sunset Rd.
Las Vegas, Nevada, United States
AXCES Research Group (Site 1152), 531 Harkle Road
Santa Fe, New Mexico, United States
Bronx Prevention Research Center (Site 1108), 390 East 158th Street
Bronx, New York, United States
Lincoln Hospital (Site 1092), 249 East 149th Street
Bronx, New York, United States
Urban Health Plan, Inc. (Site 1243), 1065 Southern Blvd
Bronx, New York, United States
Jacobi Medical Center (Site 1105), 1400 Pelham Parkway South
Bronx, New York, United States
James J. Peters VA Medical Center (Site 1053), 130 West Kingsbridge Road
Bronx, New York, United States
Maimonides Medical Center (Site 1138), 4802 10th Avenue
Brooklyn, New York, United States
University at Buffalo, Emergency Medicine (Site 1172), 77 Goodell Street
Buffalo, New York, United States
Flushing Hospital Medical Center (Site 1067), 4500 Parsons Blvd
Flushing, New York, United States
Jamaica Hospital Medical Center (Site 1066), 8900 Van Wyck Expressway
Jamaica, New York, United States
Columbia Partnership for Prevention and Control of HIV/AIDS CTU (Site 1019), Columbia University Irving Medical Center, Department of Medicine - Division of Infectious Diseases, 180 Fort Washington Avenue, HP6 - Rm 604
New York, New York, United States
Cornell Clinical Trials Unit (Site 1011), NewYork-Presbyterian Hospital-Weill Cornell Medical Center, 525 East 68th Street
New York, New York, United States
Canton-Potsdam Hospital (Site 1076), 50 Leroy Street
Potsdam, New York, United States
University of Rochester (Site 1010), 601 Elmwood Ave
Rochester, New York, United States
SUNY Stony Brook NICHD (Site 1094), HSC L-02, Rm. 142 C
Stony Brook, New York, United States
University of North Carolina at Chapel Hill (Site 1001), 130 Mason Farm Rd., Bioinformatics Bldg, 2nd Floor
Chapel Hill, North Carolina, United States
Carolina Clinical Research (Site 1167), 9040 Nations Ford Rd.
Charlotte, North Carolina, United States
Research Carolina Elite (Site 1247), 7480 Waterside Loop Road, Suite 201
Denver, North Carolina, United States
Duke University Medical Center (Site 1041), 40 Duke Medicine Circle
Durham, North Carolina, United States
Carteret Medical Group, LLC. (Site 1249), 302 Medical Park Ct.
Morehead City, North Carolina, United States
Wake Forest University Health Sciences (Site 1038), 1 Medical Center Boulevard
Winston-Salem, North Carolina, United States
Sanford Health (Site 1084), 801 Broadway N.
Fargo, North Dakota, United States
The Christ Hospital (Site 1119), 2123 Auburn Avenue
Cincinnati, Ohio, United States
Case Western Reserve University (Site 1033), 2061 Cornell Road
Cleveland, Ohio, United States
MetroHealth Medical Center (Site 1195), 2500 Metrohealth Dr.
Cleveland, Ohio, United States
Ohio State University Medical Center (Site 1020), 480 Medical Center Drive
Columbus, Ohio, United States
Cincinnati CRS (Site 1004), University of Cincinnati, University Hospital, 200 Albert Sabin Way
Ohio City, Ohio, United States
STAT Research (Site 1107), 66 Remick Blvd.
Springboro, Ohio, United States
Ascension St. John Clinical Research Institute (Site 1090), 1725 East 19th Street
Tulsa, Oklahoma, United States
Providence Portland Medical Center (Site 1098), 4805 NE. Glisan Street
Portland, Oregon, United States
Kaiser Permanente Center for Health Research (Site 1079), 3800 N. Interstate Ave.
Portland, Oregon, United States
Portland VA Medical Center (Site 1131), 3710 SW US Veterans Hospital Rd.
Portland, Oregon, United States
Oregon Health and Science University (Site 1259), 3181 SW. 10th Avenue
Portland, Oregon, United States
Doylestown Hospital (Site 1122), 595 W. State Street
Doylestown, Pennsylvania, United States
University of Pennsylvania (Site 1031), 3400 Spruce Street
Philadelphia, Pennsylvania, United States
The University of Pittsburgh (Site 1018), 3471 5th Ave.
Pittsburgh, Pennsylvania, United States
Veterans Affairs Pittsburgh Healthcare System (Site 1070), University Drive C.
Pittsburgh, Pennsylvania, United States
The Miriam Hospital Clinical Research Site (1142), 164 Summit Avenue
Providence, Rhode Island, United States
Medtrial, LLC (Site 1134), 1718 Saint Julian Pl., Ste. 2
Columbia, South Carolina, United States
Clinovacare Medical Clinical Research Center (Site 1211), 160 Medical Circle Suite D
West Columbia, South Carolina, United States
American Indian Clinical Trials Research Network (Site 1148), 717 Meade Street
Rapid City, South Dakota, United States
Sanford USD Medical Center (Site 1078), 1305 W. 18th St.
Sioux Falls, South Dakota, United States
Clinical Trials Center of Middle Tennessee (Site 1183), 100 Covey Drive
Franklin, Tennessee, United States
Vanderbilt Therapeutics Clinical Research (Site 1013), Vanderbilt Health One Hundred Oaks, 719 Thompson Ln., Ste 47183
Nashville, Tennessee, United States
Saint Hope Foundation Inc. (Site 1100), 6800 West Loop Street, Ste. 560
Bellaire, Texas, United States
South Texas Medical Research Institute, Inc./TTS Research (Site 1198), 1420 River Road
Boerne, Texas, United States
PanAmerican Clinical Research, LLC. (Site 1069), 1416 Palm Blvd.
Brownsville, Texas, United States
Trinity Health and Wellness Center (Site 1030), 219 Sunset Avenue
Dallas, Texas, United States
UT Southwestern HIV/ID Clinical Trials Unit (Site 1208), 1936 Amelia Court
Dallas, Texas, United States
Doctors Hospital at Renaissance Health Institute for Research and Development (Site 1145), 5323 S. McColl Rd.
Edinburg, Texas, United States
Sealy Institute for Vaccine Sciences Clincial Trials Program (Site 1044), 400 Harborside Drive
Galveston, Texas, United States
Rheumatology Center of Houston (Site 1252), 1200 Binz St., Ste. 1495
Houston, Texas, United States
Lyndon B. Johnson Hospital (Site 1014), 5656 Kelley Street
Houston, Texas, United States
University of Texas Health Science Center at Houston (Site 1055), 6431 Fannin Street, Ste. 2.112
Houston, Texas, United States
Houston Methodist Hospital (Site 1123), 6565 Fannin Street
Houston, Texas, United States
Dynamic Medical Research Group (Site 1081), 8314 Southwest Fwy
Houston, Texas, United States
Fairway Medical Clinic (Site 1156), 4910 Telephone Road
Houston, Texas, United States
Houston Heart and Vascular Associates (Site 1215), 1485 FM 1960 Bypass R. E., Ste. 100
Humble, Texas, United States
SMS Clincial Research, LLC. (Site 1060), 1210 N. Galloway Ave.
Mesquite, Texas, United States
Epic Medical Research, LLC (Site 1233), 106 Plaza Drive
Red Oak, Texas, United States
San Antonio Military Medical Center (Site 1173), 3551 Roger Brooke Dr.
San Antonio, Texas, United States
Inova Fairfax Medical Campus (Site 1029), 3300 Gallows Road
Falls Church, Virginia, United States
Clinical Research Partners LLC (Site 1196), 7110 Forest Ave., Ste. 201
Richmond, Virginia, United States
EvergreenHealth (Site 1080), 12040 NE 128th Street, Ste MS-77
Kirkland, Washington, United States
University of Washington ACTU (Site 1012), Harborview Medical Center, 325 9th Ave.
Seattle, Washington, United States
Providence Medical Research Center (Site 1075), 105 W. 8th Ave., Ste. 6050W
Spokane, Washington, United States
Hershel Woody Williams VA Medical Center (Site 1128), 1540 Spring Valley Drive
Huntington, West Virginia, United States
West VA University, Mary Babb Randolph Cancer Center (Site 1178), 1 Medical Center Drive
Morgantown, West Virginia, United States
Vida Clinical Studies (Site 1246), 5757 West Oklahoma Avenue
Milwaukee, Wisconsin, United States
Medical College of Wisconsin, Inc. (Site 1036), 8701 Watertown Plank Road
Milwaukee, Wisconsin, United States
Allegiance Research Specialists (Site 1162), 2645 N. Mayfair Rd., Ste. 200
Wauwatosa, Wisconsin, United States
Instituto Médico Platense (Site 3011), Avenida 51 335
La Plata, Buenos Aires, Argentina
Fundación Sanatorio Güemes (Site 3001), Francisco Acuña de Figueroa 1240
Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Instituto Médico Río Cuarto (Site 3005), Hipólito Yrigoyen 1020
Río Cuarto, Córdoba, Argentina
Instituto Médico de la Fundación Estudios Clínicos (Site 3009), Italia 428
Rosario, Santa Fe, Argentina
Clínica Adventista Belgrano (Site 3007), Estomba 1710
Ciudad Autonoma de Buenos Aires, Argentina
Instituto Ave Pulmo (Site 3006), Carlos M. Alvear 3345
Mar Del Plata, Argentina
Hospital Universitario Austral (Site 3004), Av. Juan Domingo Peron, Derqui
Pilar, Argentina
L2 Ip - Instituto de Pesquisas Clinicas Ltda (Site 4008), SGAS 613, Conjunto E, Lote 95, Sala 6
Brasília, Distrito Federal, Brazil
Hospital Das Clinicas Da Universidade Federal de Minas Gerais (Site 4001), Avenida Alfredo Balena 190
Belo Horizonte, Minas Gerais, Brazil
SOM Federal University Minas Gerais Brazil (Site 4002), Avenida Alfredo Balena 190
Belo Horizonte, Minas Gerais, Brazil
Hospital Nossa Senhora da Conceicao (Site 4004), Avenida Francisco Trein 596
Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Dia do Pulmão (Site 4007), Rua Engenheiro Paul Werner, 1141
Blumenau, Santa Catarina, Brazil
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto (Site 4003), Avenida Bandeirantes 3900, Campus Universitário
Ribeirão Preto, São Paulo, Brazil
Instituto de Pesquisa Clínica Evandro Chagas (Site 4005), Avenida Brasil, 4365
Rio De Janeiro, Brazil
Hospital E Maternidade Celso Pierro (Site 4006), Avenue John Boyd Dunlop S/n
São Paulo, Brazil
Centro Medico Militar (Site 9401), Finca El Palomar, Acatan, Sta. Rosita Zona 16
Ciudad De Guatemala, Guatemala
CIMAB SA de CV (Site 6002), Francisco I Madero 270 Sur
Torreon, Coahuila, Mexico
Oaxaca Site Management Organization (Site 6004), Calle Humboldt 302, Colonia Centro
Oaxaca, Distrito Federal, Mexico
Instituto Jalisciense de Investigacion Clinica SA de CV (Site 6005), Penitenciaria Numero 20, Colonia Centro
Guadalajara, Jalisco, Mexico
Centro de Investigación Farmacéutica Especializada de Occidente (Site 6006), Av. Vallarta 1670, Piso 2 PH1, Colonia Americana
Guadalajara, Jalisco, Mexico
Neurociencias Estudios Clinicos S.C. (Site 6008), Boulevard Alfonso G. Calderon, 2193 int 2 A desarrollo urbano 3 rios
Culiacán, Sinaloa, Mexico
Hospital Civil De Culiacan (Site 6011), Avenida Álvaro Obregón 1422
Culiacán, Sinaloa, Mexico
Eme Red Hospitalaria (Site 6010), Calle 33 No. 496
Mérida, Yucatán, Mexico
Kohler and Milstein Research (Site 6013), Avenida Colón 197, García Ginerés
Mérida, Yucatán, Mexico
De La Salle Health Sciences Institute (Site 9504), Gov. Mangubat Avenue
Cavite City, Cavite, Philippines
Makati Medical Center (Site 9502), No. 2 Amorsolo Street, Legaspi Village
Makati City, National Capital Region, Philippines
Asian Hospital and Medical Center (Site 9503), 2205 Civic Drive
Muntinlupa, National Capital Region, Philippines
Puerto Rico AIDS Clinical Trials Unit (Site 1024), Proyecto ACTU Biomedical Building II
San Juan, Puerto Rico
Peermed Clinical Trial Center (Site 9215), Corner of Voortrekker and Monument Roads
Kempton Park, Ekurhuleni, Gauteng, South Africa
Worthwhile Clinical Trials (Site 9214), No. 1 Mowbray Avenue
Benoni, Gauteng, South Africa
The Aurum Institute Tembisa Clinical Research Site (Site 9217), Cnr Flint Mazibuko / Rev RTJ Namane Drive
Johannesburg, Gauteng, South Africa
Roodepoort Medicross (Site 9220), 54 Ontdekkers Road
Johannesburg, Gauteng, South Africa
Soweto ACTG CRS (Site 9203), Chris Hani Road
Johannesburg, Gauteng, South Africa
Helen Joseph Hospital (Site 9201), Perth Road
Johannesburg, Gauteng, South Africa
Setshaba Research Centre (Site 9205), 2088 Block H
Pretoria, Gauteng, South Africa
Into Research (Site 9210), Totius Street
Tshwane, Gauteng, South Africa
Durban International Clinical Research Site (Site 9208), Sidmouth Avenue
Durban, Kwazulu - Natal, South Africa
Welkom Clinical Trial Centre (Site 9211), 189 Power Road
Welkom, Matjhabeng, Free State, South Africa
The Aurum Institute Klerksdorp Clinical Research Center (Site 9204), Corner Margaretha Prinsloo St. and O.R. Tambo St.
Klerksdorp, North-West, South Africa
The Aurum Institute Rustenburg Clinical Research Site (Site 9202), 50 Steen St., c/o Pretorius St.
Rustenburg, North-West, South Africa
TASK Eden (Site 9218), G, 4 Victoria St.
George, South Africa
CLINRESCO, ARWYP Medical Suites (Site 9209), 22 Pine Avenue
Johannesburg, South Africa
Mzansi Ethical Research Centre (Site 9212), 184 Cowen Ntuli Street, Steve Tschwete
Mpumalanga, South Africa
Global Clinical Trials Sunnyside (Site 9216), 175 Steve Biko Street
Pretoria, South Africa
David Smith, MD, MAS, Study Chair
University of California, San Diego