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

NCT04729595 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: APC400-03
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 17

Brief Summary

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

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Difference in the rate of sustained clinical resolution1 of symptoms of COVID-19

  To evaluate the difference in the rate of sustained clinical resolution1 of symptoms of COVID-19 at Day 14 by evaluating the odds ratio of the rate of sustained clinical resolution1 of symptoms of COVID-19 between Tempol + SOC vs placebo + SOC at Day 14.

  14 Days from the date Randomization/First Dosing.

Secondary Outcomes (3)

• Safety of Tempol + SOC vs placebo + SOC: Occurrence of Adverse Events/All cause of mortality

  60 Days from Randomization/First Dosing.

• Efficacy of Tempol on preventing hospitalization: Odds ratio of the rate of hospitalization

  14 Days from the date Randomization/First Dosing.

• Changes in functional status: Post COVID Functional Scale (PCFS)

  7,14 and 21 Days from the date Randomization/First Dosing.

Study Arms (2)

Active Treatment

ACTIVE COMPARATOR

Tempol (MMB-02) 800 mg per Day (n=124)

Drug: Tempol

Placebo

PLACEBO COMPARATOR

Placebo (n=124)

Other: Placebo

Interventions

Tempol DRUG

Tempol 800 mg capsule will be administered at 400mg (2 capsules) two times daily for fourteen (14) consecutive days.

Active Treatment

Placebo OTHER

Placebo capsules will be administered orally (2 capsules) two times daily for fourteen (14) consecutive days.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Adamis Pharmaceuticals Corporation: lead

Study Sites (17)

Pinnacle Research Group

Anniston, Alabama, 36207, United States

Location

LA Universal Research

Los Angeles, California, 90057, United States

Location

Doral medical Research

Doral, Florida, 33166, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

Omega Research Orlando, LLC

Orlando, Florida, 32808, United States

Location

Sunrise Research Institute

Sunrise, Florida, 33325, United States

Location

Center for Respiratory and Sleep Medicine

Greenwood, Indiana, 46143, United States

Location

Tandem Clinical Research GI, LLC.

Marrero, Louisiana, 70072, United States

Location

Barrett Clinical

La Vista, Nebraska, 68128, United States

Location

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

Location

Dayton Clinical Research

Dayton, Ohio, 45406, United States

Location

Clinical Trials Center of Middle Tennessee, LLC

Franklin, Tennessee, 37067, United States

Location

Vilo Research Group

Houston, Texas, 77017, United States

Location

United Memorial Medical Center

Houston, Texas, 77091, United States

Location

R&H Clinical Research

Katy, Texas, 77494, United States

Location

Meridian Clinical Research

Portsmouth, Virginia, 23707, United States

Location

Eastside Research Associates

Redmond, Washington, 98052, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

tempol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ronald B Moss, MD

  Adamis Pharmaceutical Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomized, Double-blind, Placebo-Controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-blind, placebo-controlled enrolling high risk subjects with early COVID19 infection.

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 28, 2021
• Study Start: September 1, 2021
• Primary Completion: September 21, 2022
• Study Completion: September 21, 2022
• Last Updated: December 6, 2022

Record last verified: 2022-12

Locations

US (17)