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

Covid19 Clinical Trial

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

Status Terminated

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• COVID-19
• Covid19

• NCT number: NCT04729595
• Study type: Interventional
• Source: Adamis Pharmaceuticals Corporation
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: September 1, 2021
• Completion date: September 21, 2022