An Adaptive, Randomized, Double-blind, Placebo-controlled study to examine the Effects of Tempol in subjects with COVID-19 infection.
Phase 2/3 Adaptive, Randomized, Double-blind, placebo-controlled enrolling high risk subjects
with early COVID19 infection with a primary endpoint of limiting hospitalization.
As part of the initial phase 2 portion of the study, 50 COVID positive subjects with
comorbidities will be enrolled. Eligible subjects positively diagnosed COVID-19 infection
will be randomized 1:1 to receive either Tempol or placebo.
An interim analysis by a DSMB will examine safety and markers of systemic inflammation during
a Stage 1 interim analysis. Based on the DSMB adjudication, the Phase 3 portion of the trial
will begin with a second interim analysis after enrollment of 124 subjects
This protocol will seek to enroll approximately 248 subjects > 18 years of age diagnosed with
COVID-19 infection. All subjects will receive standard of care. As standard of care can vary
between institution over time for the treatment of COVID-19; Off label medication use,
therapies, devices, and interventions used in standard of care practice for COVID-19 is
allowed.
Drug: Tempol
Tempol 800 mg capsule will be administered at 400mg (2 capsules) two times daily for fourteen (14) consecutive days.
Other: Placebo
Placebo capsules will be administered orally (2 capsules) two times daily for fourteen (14) consecutive days.
Inclusion Criteria:
- Subjects 18 years of age and above with at least one risk factor for disease
progression (i.e., age≥ 65, hypertension, diabetes, obesity (BMI ≥30 as defined by
CDC), cancer, immunodeficiency and in the opinion of the investigator the risk factor
is not acutely life-threatening).
- Laboratory confirmed infection of SARS-CoV-2 within 5 days of Baseline/day 1.
- Subjects must meet the severity score of Moderate or greater for two of the first ten
symptoms listed in the Patient Reported Outcomes (PRO) at screening.
- Ability to travel to clinic.
- Ability to understand and sign an informed consent form.
- Female subjects of child-bearing potential who are capable of conception must be:
post- menopausal (one year or greater without menses), surgically incapable of
childbearing, or practicing two effective methods of birth control. Acceptable methods
include abstinence, intrauterine device, spermicide, barrier, male partner surgical
sterilization and hormonal contraception. A female subject ≥18 years of age and of
child bearing potential must agree to practice two acceptable methods of birth control
during the study period.
- Ability to swallow a capsule.
- Ability to complete an electronic diary via smartphone or web.
Exclusion Criteria:
- Need for hospitalization based on severe or critical symptoms based on CDC guidance.
- Subject in long-term care facility.
- Known hypersensitivity or contra-indication to Tempol.
- Subjects taking STRONG CYP inhibitors (e.g. fluoxetine, itraconazole, quinidine,
clarithromycin).
- In the opinion of the investigator, any reason that would make the follow up of the
subject impossible during the study treatment and follow up period. Any reason the
subject cannot comply with study and study procedures.
- Subjects receiving any other investigational agent within 4 weeks of Baseline/Day 1.
- Use of non-FDA approved (EUA or full approval)/off label treatments for COVID-19.
- Lactating females.
- History of any known chronic liver or kidney disease.
- Subjects taking drugs with a Narrow Therapeutic Index such as Cyclosporine Digoxin
Flecainide Lithium Phenytoin Sirolimus Theophylline, and Warfarin.
Pinnacle Research Group
Anniston, Alabama, United States
LA Universal Research
Los Angeles, California, United States
Doral medical Research
Doral, Florida, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Omega Research Orlando, LLC
Orlando, Florida, United States
Sunrise Research Institute
Sunrise, Florida, United States
Center for Respiratory and Sleep Medicine
Greenwood, Indiana, United States
Tandem Clinical Research GI, LLC.
Marrero, Louisiana, United States
Barrett Clinical
La Vista, Nebraska, United States
Monroe Biomedical Research
Monroe, North Carolina, United States
Dayton Clinical Research
Dayton, Ohio, United States
Clinical Trials Center of Middle Tennessee, LLC
Franklin, Tennessee, United States
Vilo Research Group
Houston, Texas, United States
United Memorial Medical Center
Houston, Texas, United States
R&H Clinical Research
Katy, Texas, United States
Meridian Clinical Research
Portsmouth, Virginia, United States
Eastside Research Associates
Redmond, Washington, United States
Ronald B Moss, MD, Study Director
Adamis Pharmaceutical Corporation