Study to Evaluate the Effects of Tempol (MBM-02) in COVID-19 Patients.

• Status: Recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

Summary

An Adaptive, Randomized, Double-blind, Placebo-controlled study to examine the Effects of Tempol in subjects with COVID-19 infection.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adamis Pharmaceuticals Corporation
• Treatments: Tempol

Criteria

Inclusion Criteria:

• Subjects 18 years of age and older with at least one comorbidity (i.e., hypertension, diabetes, obesity, cancer, chronic renal disease, immunodeficiency and in the opinion of the investigator the comorbidity is not acutely life-threatening).

• Laboratory confirmed infection of SAR-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.

• 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 od Baseline/Day 1.

• Lactating females.

• Evidence of any known chronic liver or kidney disease.

• Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 within 14 days of Baseline.

• Serum AST/ALT/Total bilirubin levels greater than 2 times upper limit of normal within 14 days of baseline.

• Prior COVID-19 vaccination or prior recovery from documented COVID-19 infection.