NCT04729595

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

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: Adamis Pharmaceuticals Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-09-21
• Completion: 2022-09-21
• First posted: 2021-01-28
• Last updated: 2022-12-06

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study