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

A Phase 2/3, Adaptive, Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of Tempol (MBM-02) in Subjects With COVID-19 Infection

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

Study Overview

• Status: Terminated
• Conditions: Covid19
• Intervention / Treatment: Drug: Tempol; Other: Placebo

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 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.

• Study Type: Interventional
• Enrollment (Actual): 248
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Pinnacle Research Group
  • California
    • Los Angeles, California, United States, 90057
      • LA Universal Research
  • Florida
    • Doral, Florida, United States, 33166
      • Doral Medical Research
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • Orlando, Florida, United States, 32808
      • Omega Research Orlando, LLC
    • Sunrise, Florida, United States, 33325
      • Sunrise Research Institute
  • Indiana
    • Greenwood, Indiana, United States, 46143
      • Center for Respiratory and Sleep Medicine
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Tandem Clinical Research GI, LLC.
  • Nebraska
    • La Vista, Nebraska, United States, 68128
      • Barrett Clinical
  • North Carolina
    • Monroe, North Carolina, United States, 28112
      • Monroe Biomedical Research
  • Ohio
    • Dayton, Ohio, United States, 45406
      • Dayton Clinical Research
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Clinical Trials Center of Middle Tennessee, LLC
  • Texas
    • Houston, Texas, United States, 77017
      • Vilo Research Group
    • Houston, Texas, United States, 77091
      • United Memorial Medical Center
    • Katy, Texas, United States, 77494
      • R&H Clinical Research
  • Virginia
    • Portsmouth, Virginia, United States, 23707
      • Meridian Clinical Research
  • Washington
    • Redmond, Washington, United States, 98052
      • Eastside Research Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Treatment; Tempol (MMB-02) 800 mg per Day (n=124)	Drug: Tempol; Tempol 800 mg capsule will be administered at 400mg (2 capsules) two times daily for fourteen (14) consecutive days.
Placebo Comparator: Placebo; Placebo (n=124)	Other: Placebo; Placebo capsules will be administered orally (2 capsules) two times daily for fourteen (14) consecutive days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Tempol + SOC vs placebo + SOC: Occurrence of Adverse Events/All cause of mortality	To evaluate the safety of Tempol + SOC vs placebo + SOC from Baseline/Day 1 through Day 60 For: Occurrence of treatment-emergent adverse events (TEAEs).; Occurrence of TEAEs leading to withdrawal of study treatment or premature study discontinuation.; All cause of mortality (death of the patient, from any cause).	60 Days from Randomization/First Dosing.
Efficacy of Tempol on preventing hospitalization: Odds ratio of the rate of hospitalization	To evaluate the efficacy of Tempol on preventing hospitalization at Day 14 in subjects with COVID-19 by evaluating the odds ratio of the rate of hospitalization in subjects with COVID-at Day 14 between treatment arms.	14 Days from the date Randomization/First Dosing.
Changes in functional status: Post COVID Functional Scale (PCFS)	To evaluate the changes in functional status measured by Post COVID Functional Scale (PCFS) at Baseline/Day1 to Day7, Day 14 and Day 21 by evaluating the difference in the Post COVID Functional Scale (PCFS) measurement between Tempol + SOC vs. placebo + SOC. The scale is measured from 0 - 10, with a higher score being worse.	7,14 and 21 Days from the date Randomization/First Dosing.

Collaborators and Investigators

• Sponsor: Adamis Pharmaceuticals Corporation
• Investigators: Study Director: Ronald B Moss, MD, Adamis Pharmaceutical Corporation

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): September 21, 2022
• Study Completion (Actual): September 21, 2022

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Neuroprotective Agents; Protective Agents; Protein Synthesis Inhibitors; Antioxidants; Radiation-Protective Agents; Tempol
• Other Study ID Numbers: APC400-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No