: Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2). SAB Biotherapeutics has developedSAB-185, an Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (transchromosomic [Tc]bovine-derived), as a potential therapeutic to treat COVID-19. This study will evaluatethe safety, immunogenicity, and pharmacokinetics of SAB-185 in ambulatory participantswith COVID-19.
Biological: SAB-185
SAB-185 is a purified human immunoglobulin G (hIgG) designed to specifically bind to
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) viruses. SAB-185 is purified
from the plasma of immunized Tc bovines that were immunized initially (vaccinations 1 and
2) with a plasmid DNA (pDNA) vaccine that expresses wild-type SARS-CoV-2 spike protein,
followed by additional immunizations (vaccinations 3 and beyond) with a recombinant spike
protein from SARS-CoV-2 produced in insect cells. The purified hIgG is a sterile liquid
formulated in 10 mM glutamic acid monosodium salt, 262 mM D-sorbitol, 0.05 mg/mL Tween
80, pH 5.5. The drug product will be administered intravenously and will be diluted in
saline per the clinical protocol.
Other Name: Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived)
Other: Normal Saline
Normal (0.9%) saline in approximately the same volume as each cohort in the experimental
drug arm.
Inclusion Criteria:
Subjects must meet all of the following criteria for inclusion:
1. 18-60 years of age
2. Positive for presence of SARS-CoV-2 on NP or OP swab by FDA-authorized RT-PCR test
within seven days prior to infusion
3. At least one current symptom of COVID-19, onset within seven days prior to infusion:
- Fever or chills
- Cough
- Shortness of breath or difficulty breathing
- Fatigue
- Muscle or body aches
- Headache
- New loss of taste or smell
- Sore throat
- Congestion or runny nose
- Nausea or vomiting
- Diarrhea
4. Able to understand the study and comply with all study procedures
5. Agrees not to participate in any other trial of an investigational product during
the study period
6. Willing and able to provide written informed consent prior to the start of any study
related activities
7. If female, meets at least one of the following reproductive risk criteria
- Post-menopausal for at least 12 months
- Use of one or more of the following highly effective contraceptive methods for
at least 90 days following the last dose of study product: combined estrogen
and progestogen containing or progestogen-only hormonal contraception,
intrauterine device (IUD), intrauterine hormone-releasing system, surgical
bilateral tubal occlusion
- Vasectomized sole sexual partner who has received medical assessment of the
surgical success
8. Male and female subjects agree to sexual abstinence (refraining from heterosexual
intercourse for at least 90 days following the last dose of study product) if not
using birth control or condoms for males.
Exclusion Criteria:
Subjects who meet any of the criteria of severe or higher COVID-19 will be excluded from
the study:
- Dyspnea at rest
- Respiratory rate > 30 breaths per minute
- SpO2 ≤ 93% on room air
- Heart rate ≥ 125 beats per minute
- Respiratory distress or respiratory failure.
- Evidence of critical illness
1. Female subjects with positive pregnancy test, breastfeeding, or planning to
become pregnant/breastfeed during the study period.
2. Hospitalization or need for hospitalization for any cause
3. Treatment or participation in another clinical trial of any other
investigational agent within 30 days prior to enrollment.
4. Use of other drugs that, in the opinion of the investigator, could complicate
analysis of SAB-185.
5. Subjects with the following risk factors:
- Compromised immune system including confirmed diagnosis of current cancer under
treatment, inherited deficiencies of the immune system, immune suppressing
medication, or other conditions causing leukopenia or neutropenia
- Known autoimmune condition requiring therapy more intensive than intermittent
non-steroidal anti-inflammatories in the prior 6 months (for example: rheumatoid
arthritis, lupus, inflammatory bowel disease)
- Chronic respiratory disease including COPD, emphysema, cystic fibrosis, pulmonary
hypertension, or other chronic condition that requires the routine use of
supplemental oxygen
- Chronic asthma requiring the use of oral steroids or hospitalization in the last six
months
- Renal failure or renal insufficiency requiring dialysis
- Congestive heart failure or significant atherosclerotic disease (coronary artery
disease or peripheral vascular disease) 6. Receipt of pooled immunoglobulin or
plasma in past 30 days 7. Any other underlying medical (cardiac, liver, renal,
neurological, respiratory) or psychiatric condition that in the view of the
investigator would preclude use of SAB-185 8. Known IgA deficiency or previous
allergic reaction to intravenous immunoglobin (IVIG)/subcutaneous immunoglobin
(SCIG) 9. Positive for hepatitis B virus surface antigen, hepatitis C virus
antibody, or HIV antibody by medical history 10. History of allergy, anaphylaxis, or
severe reaction to beef products (including milk and gelatin).
Quantum Clinical Trials
Miami Beach, Florida, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Sanford Health
Sioux Falls, South Dakota, United States
David Hoover, MD, Principal Investigator
ICON GPHS