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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04729595
Recruitment Status : Recruiting
First Posted : January 28, 2021
Last Update Posted : April 5, 2022
Sponsor:
Information provided by (Responsible Party):
Adamis Pharmaceuticals Corporation

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

Condition or disease Intervention/treatment Phase
Covid19 Drug: Tempol Other: Placebo 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : September 1, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Difference in the rate of sustained clinical resolution1 of symptoms of COVID-19 [ Time Frame: 14 Days from the date Randomization/First Dosing. ]
    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 :
  1. Safety of Tempol + SOC vs placebo + SOC: Occurrence of Adverse Events/All cause of mortality [ Time Frame: 60 Days from Randomization/First Dosing. ]

    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).

  2. Efficacy of Tempol on preventing hospitalization: Odds ratio of the rate of hospitalization [ Time Frame: 14 Days from the date Randomization/First Dosing. ]
    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.

  3. Changes in functional status: Post COVID Functional Scale (PCFS) [ Time Frame: 7,14 and 21 Days from the date Randomization/First Dosing. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04729595


Contacts
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Contact: Ronald B Moss, MD 619-742-6035 rmoss@adamispharma.com

Locations
Show Show 22 study locations
Sponsors and Collaborators
Adamis Pharmaceuticals Corporation
Investigators
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Study Director: Ronald B Moss, MD Adamis Pharmaceutical Corporation
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Responsible Party: Adamis Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT04729595    
Other Study ID Numbers: APC400-03
First Posted: January 28, 2021    Key Record Dates
Last Update Posted: April 5, 2022
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Tempol
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Protein Synthesis Inhibitors
Enzyme Inhibitors
Radiation-Protective Agents
Neuroprotective Agents