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

• ClinicalTrials.gov Identifier: NCT04729595
• Recruitment Status: Recruiting
• First Posted: January 28, 2021
• Last Update Posted: April 5, 2022
• Sponsor: Adamis Pharmaceuticals Corporation
• Information provided by (Responsible Party): Adamis Pharmaceuticals Corporation

Tracking Information

• First Submitted Date: January 25, 2021
• First Posted Date: January 28, 2021
• Last Update Posted Date: April 5, 2022
• Actual Study Start Date: September 1, 2021
• Estimated Primary Completion Date: June 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 24, 2022)

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.

Original Primary Outcome Measures (submitted: January 26, 2021)

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.

Current Secondary Outcome Measures (submitted: March 24, 2022)

• 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).
• 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.
• 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.

Original Secondary Outcome Measures (submitted: January 26, 2021)

Secondary Outcome Measure [ Time Frame: 28 Days from Randomization/First Dosing ]

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 in the treated (Tempol) vs. placebo population.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 2; Phase 3

Study Design

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

• Condition: Covid19

Intervention

• Drug: Tempol
  Tempol 800 mg capsule will be administered at 400mg (2 capsules) two times daily for fourteen (14) consecutive days.
• Other: Placebo
  Placebo capsules will be administered orally (2 capsules) two times daily for fourteen (14) consecutive days.

Study Arms

• Active Comparator: Active Treatment
  Tempol (MMB-02) 800 mg per Day (n=124)
  Intervention: Drug: Tempol
• Placebo Comparator: Placebo
  Placebo (n=124)
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 24, 2021): 248
• Original Estimated Enrollment (submitted: January 26, 2021): 310
• Estimated Study Completion Date: September 30, 2022
• Estimated Primary Completion Date: June 30, 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04729595
• Other Study ID Numbers: APC400-03
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Adamis Pharmaceuticals Corporation
• Study Sponsor: Adamis Pharmaceuticals Corporation
• Collaborators: Not Provided

Investigators

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

• PRS Account: Adamis Pharmaceuticals Corporation
• Verification Date: October 2021