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

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Covid19

In brief

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

Key facts

Study ID

NCT04729595

Run by

Adamis Pharmaceuticals Corporation

People needed

248

Starts

2021-09-01

Expected to finish

2022-09-21

Last updated by the study team

2022-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.