Study to Evaluate the Effects of Tempol (MBM-02) in COVID-19 Patients.
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|ClinicalTrials.gov Identifier: NCT04729595|
Recruitment Status : Recruiting
First Posted : January 28, 2021
Last Update Posted : April 5, 2022
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Drug: Tempol Other: Placebo||Phase 2 Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||248 participants|
|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|
|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|
Active Comparator: Active Treatment
Tempol (MMB-02) 800 mg per Day (n=124)
Tempol 800 mg capsule will be administered at 400mg (2 capsules) two times daily for fourteen (14) consecutive days.
Placebo Comparator: Placebo
Placebo capsules will be administered orally (2 capsules) two times daily for fourteen (14) consecutive days.
- 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.
- 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.
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
|Contact: Ronald B Moss, MDfirstname.lastname@example.org|
|Study Director:||Ronald B Moss, MD||Adamis Pharmaceutical Corporation|