Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : January 11, 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.

Layout table for study information
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. Primary Outcome Measure [ Time Frame: 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 [ Time Frame: 28 Days from Randomization/First Dosing ]
    Time sustained clinical resolution of COVID-19 symptoms in the treated (Tempol) vs. placebo participant population.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 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.

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
Layout table for location contacts
Contact: Ronald B Moss, MD 619-742-6035 rmoss@adamispharma.com

Locations
Layout table for location information
United States, Alabama
Pinnacle Research Group Recruiting
Anniston, Alabama, United States, 36207
Contact: Almena Free, MD         
United States, Florida
Doral medical Research Recruiting
Doral, Florida, United States, 33166
Contact: Jorge Diaz, DO         
Sarkis Clinical Trials Recruiting
Gainesville, Florida, United States, 32607
Contact: Elias Sarkis, MD         
Omega Research Orlando, LLC Recruiting
Orlando, Florida, United States, 32808
Contact: Kwabena Ayesu, MD         
IMA Clinical Research, PC Recruiting
Saint Petersburg, Florida, United States, 33709
Contact: Howard Chipman, MD         
Sunrise Research Institute Not yet recruiting
Sunrise, Florida, United States, 33325
Contact: Miguel Aponte, MD         
United States, Louisiana
Tandem Clinical Research GI, LLC. Recruiting
Marrero, Louisiana, United States, 70072
Contact: Adil Fatakia, MD         
United States, Missouri
IMA Clinical Research, PC Recruiting
Saint Louis, Missouri, United States, 63117
Contact: Bernard Miller, MD         
United States, Nebraska
Barrett Clinical Recruiting
La Vista, Nebraska, United States, 68128
Contact: Kevin Ahlers, MD         
United States, North Carolina
Monroe Biomedical Research Recruiting
Monroe, North Carolina, United States, 28112
Contact: Awawu Igbinadolor, MD         
United States, Tennessee
Clinical Trials Center of Middle Tennessee, LLC Recruiting
Franklin, Tennessee, United States, 37067
Contact: Alex Slandzicki, MD         
United States, Texas
Sweetwater Medical Associates Withdrawn
Sugar Land, Texas, United States, 77479
United States, Washington
Eastside Research Associates Recruiting
Redmond, Washington, United States, 98052
Contact: Chad Crystal, MD         
Sponsors and Collaborators
Adamis Pharmaceuticals Corporation
Investigators
Layout table for investigator information
Study Director: Ronald B Moss, MD Adamis Pharmaceutical Corporation
Layout table for additonal information
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: January 11, 2022
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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