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

Primary Purpose

Covid19

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tempol
Placebo
Sponsored by
Adamis Pharmaceuticals Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pinnacle Research Group
  • LA Universal Research
  • Doral medical Research
  • Sarkis Clinical Trials
  • Omega Research Orlando, LLC
  • Sunrise Research Institute
  • Center for Respiratory and Sleep Medicine
  • Tandem Clinical Research GI, LLC.
  • Barrett Clinical
  • Monroe Biomedical Research
  • Dayton Clinical Research
  • Clinical Trials Center of Middle Tennessee, LLC
  • Vilo Research Group
  • United Memorial Medical Center
  • R&H Clinical Research
  • Meridian Clinical Research
  • Eastside Research Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active Treatment

Placebo

Arm Description

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

Placebo (n=124)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.

Full Information

First Posted
January 25, 2021
Last Updated
December 5, 2022
Sponsor
Adamis Pharmaceuticals Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04729595
Brief Title
Study to Evaluate the Effects of Tempol (MBM-02) in COVID-19 Patients.
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Study did not demonstrate statistical significance of its primary endpoint of clinical resolution of COVID-19 symptoms at day 14 versus placebo
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
September 21, 2022 (Actual)
Study Completion Date
September 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adamis Pharmaceuticals Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Double-blind, placebo-controlled enrolling high risk subjects with early COVID19 infection.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Randomized, Double-blind, Placebo-Controlled
Allocation
Randomized
Enrollment
248 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment
Arm Type
Active Comparator
Arm Description
Tempol (MMB-02) 800 mg per Day (n=124)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (n=124)
Intervention Type
Drug
Intervention Name(s)
Tempol
Intervention Description
Tempol 800 mg capsule will be administered at 400mg (2 capsules) two times daily for fourteen (14) consecutive days.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules will be administered orally (2 capsules) two times daily for fourteen (14) consecutive days.
Primary Outcome Measure Information:
Title
Difference in the rate of sustained clinical resolution1 of symptoms of COVID-19
Description
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.
Time Frame
14 Days from the date Randomization/First Dosing.
Secondary Outcome Measure Information:
Title
Safety of Tempol + SOC vs placebo + SOC: Occurrence of Adverse Events/All cause of mortality
Description
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).
Time Frame
60 Days from Randomization/First Dosing.
Title
Efficacy of Tempol on preventing hospitalization: Odds ratio of the rate of hospitalization
Description
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.
Time Frame
14 Days from the date Randomization/First Dosing.
Title
Changes in functional status: Post COVID Functional Scale (PCFS)
Description
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.
Time Frame
7,14 and 21 Days from the date Randomization/First Dosing.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald B Moss, MD
Organizational Affiliation
Adamis Pharmaceutical Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
LA Universal Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Doral medical Research
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Omega Research Orlando, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Facility Name
Sunrise Research Institute
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33325
Country
United States
Facility Name
Center for Respiratory and Sleep Medicine
City
Greenwood
State/Province
Indiana
ZIP/Postal Code
46143
Country
United States
Facility Name
Tandem Clinical Research GI, LLC.
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Barrett Clinical
City
La Vista
State/Province
Nebraska
ZIP/Postal Code
68128
Country
United States
Facility Name
Monroe Biomedical Research
City
Monroe
State/Province
North Carolina
ZIP/Postal Code
28112
Country
United States
Facility Name
Dayton Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
Clinical Trials Center of Middle Tennessee, LLC
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Vilo Research Group
City
Houston
State/Province
Texas
ZIP/Postal Code
77017
Country
United States
Facility Name
United Memorial Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77091
Country
United States
Facility Name
R&H Clinical Research
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Facility Name
Meridian Clinical Research
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23707
Country
United States
Facility Name
Eastside Research Associates
City
Redmond
State/Province
Washington
ZIP/Postal Code
98052
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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