Study to Evaluate the Effects of Tempol (MBM-02) in COVID-19 Patients.
NCT ID: NCT04729595
Last Updated: 2022-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2/PHASE3
248 participants
INTERVENTIONAL
2021-09-01
2022-09-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Trial of Remdesivir in Adults With Severe COVID-19
NCT04257656
Efficacy of Amantadine Treatment in COVID-19 Patients
NCT04952519
A Trial of Remdesivir in Adults With Mild and Moderate COVID-19
NCT04252664
A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacodynamics for the Treatment of COVID-19.
NCT04847544
Efficacy and Safety of Molnupiravir (MK-4482) in Hospitalized Adult Participants With COVID-19 (MK-4482-001)
NCT04575584
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active Treatment
Tempol (MMB-02) 800 mg per Day (n=124)
Tempol
Tempol 800 mg capsule will be administered at 400mg (2 capsules) two times daily for fourteen (14) consecutive days.
Placebo
Placebo (n=124)
Placebo
Placebo capsules will be administered orally (2 capsules) two times daily for fourteen (14) consecutive days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tempol
Tempol 800 mg capsule will be administered at 400mg (2 capsules) two times daily for fourteen (14) consecutive days.
Placebo
Placebo capsules will be administered orally (2 capsules) two times daily for fourteen (14) consecutive days.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Adamis Pharmaceuticals Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ronald B Moss, MD
Role: STUDY_DIRECTOR
Adamis Pharmaceutical Corporation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
APC400-03
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.