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

Sponsor
Adamis Pharmaceuticals Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04729595
Collaborator
(none)
248
Enrollment
8
Locations
2
Arms
12.9
Anticipated Duration (Months)
31
Patients Per Site
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase
Phase 2/Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
248 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, Double-blind, placebo-controlled enrolling high risk subjects with early COVID19 infection.Randomized, Double-blind, placebo-controlled enrolling high risk subjects with early COVID19 infection.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Randomized, Double-blind, Placebo-Controlled
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. Primary Outcome Measure [21 Days from the date Randomization/First Dosing.]

    The rate of hospitalization in the treated (Tempol) vs. placebo participant population.

Secondary Outcome Measures

  1. Secondary Outcome Measure [28 Days from Randomization/First Dosing]

    Time sustained clinical resolution of COVID-19 symptoms in the treated (Tempol) vs. placebo participant population.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Doral medical ResearchDoralFloridaUnited States33166
2Sarkis Clinical TrialsGainesvilleFloridaUnited States32607
3Omega Research Orlando, LLCOrlandoFloridaUnited States32808
4IMA Clinical Research, PCSaint PetersburgFloridaUnited States33709
5Tandem Clinical Research GI, LLC.MarreroLouisianaUnited States70072
6IMA Clinical Research, PCSaint LouisMissouriUnited States63117
7Monroe Biomedical ResearchMonroeNorth CarolinaUnited States28112
8Clinical Trials Center of Middle Tennessee, LLCFranklinTennesseeUnited States37067

Sponsors and Collaborators

  • Adamis Pharmaceuticals Corporation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Adamis Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT04729595
Other Study ID Numbers:
  • APC400-03
First Posted:
Jan 28, 2021
Last Update Posted:
Nov 18, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2021