Status:
TERMINATED
Study to Evaluate the Effects of Tempol (MBM-02) in COVID-19 Patients.
Lead Sponsor:
Adamis Pharmaceuticals Corporation
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
An Adaptive, Randomized, Double-blind, Placebo-controlled study to examine the Effects of Tempol in subjects with COVID-19 infection.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2022
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT04729595
Start Date
September 1 2021
End Date
September 21 2022
Last Update
December 6 2022
Active Locations (17)
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1
Pinnacle Research Group
Anniston, Alabama, United States, 36207
2
LA Universal Research
Los Angeles, California, United States, 90057
3
Doral medical Research
Doral, Florida, United States, 33166
4
Sarkis Clinical Trials
Gainesville, Florida, United States, 32607