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  • Adamis Pharmaceuticals doses first patients in pha...

Adamis Pharmaceuticals doses first patients in phase II/III clinical trial for Tempol in the treatment of COVID-19.

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Published:3rd Sep 2021

Shyam Kottilil, MBBS, Ph.D., Professor of Medicine at the University of Maryland School of Medicine (UMSOM), Chief of the Division of Clinical Care and Research at UMSOM’s Institute of Human Virology, and Principal Investigator for the trial, commented: “The timing for this trial could not be more important as the delta variant spreads and breakthrough infections in vaccinated individuals occur in the U.S. and worldwide. Tempol as an oral antiviral and anti-inflammatory may be an important countermeasure if proven safe and effective in this trial.”

Recently, the National Institutes of Health (NIH) highlighted Tempol as a potential home treatment for COVID-19 (NIH Study) The NIH news stated that, “This treatment would likely prevent severe disease.” Recent studies conducted by NIH researchers suggested that Tempol had potent antiviral activity against the virus that causes COVID-19 in laboratory studies. The NIH news article further describes how Tempol could possibly reduce COVID-19 symptoms by calming inflammation, protecting organs from damage, and decreasing the clumping of platelets.

About the Phase II/III Clinical Trial: This Phase II/III adaptive, randomized, double-blind, placebo-controlled clinical trial is designed to enroll approximately 248 high risk unvaccinated subjects with early COVID-19 infection age 18 years of age and older. The primary endpoint is the rate of hospitalization for patients receiving Tempol, versus those receiving placebo. Eligible subjects with positive COVID-19 infection within five days of study entry plus at least one co-morbidity will be randomized 1:1 to receive either Tempol or placebo. Co-morbidities include hypertension, diabetes, obesity, cancer, chronic renal disease, and immunodeficiency, and in the opinion of the investigator, the co-morbidity is not acutely life threatening. Patients randomized to Tempol (n=124), will receive 800mg daily in two divided doses of 400mg for up to 21 days. Similarly, placebo capsules will be administered twice daily to subjects in the placebo group (n=124) for up to 21 days.

As part of the initial Phase II portion of the study, 50 COVID positive subjects will be enrolled and randomized 1:1 to receive either Tempol or placebo. An interim analysis by the data and safety monitoring board (DSMB) will examine safety and markers of systemic inflammation during a Stage 1 interim analysis. Based on the DSMB analysis, the Phase III portion of the trial designed to enroll 198 patients may begin, with a second interim analysis planned after enrollment of 124 patients. A thorough safety assessment will be conducted, and all treatment related adverse events will be recorded, evaluated and compared for the treated and placebo groups.

Condition: Coronavirus/COVID-19 Infection
Type: drug

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