NanoMn®_COVID-19 A Prospective, Multicenter, Randomized, Placebo-controlled, Parallel-group, Double-blind Trial to Evaluate the Clinical Efficacy of NanoManganese® on Top of Standard of Care, in Adult Patients With Moderate to Severe Coronavirus Disease 2019 (COVID-19)

Summary

This is a prospective, multicenter, randomized (3:1), placebo- controlled, parallel-group, double-blind trial. Patients will be randomized into two arms of treatment: * Placebo + SoC (N=30) * NanoManganese® + SoC (N=90) Patients will be treated and followed-up for 10 days: * Arterial oxygen partial pressure (PaO2) will be measured at baseline and at days 3, 5 and 10, * Oxygen saturation, vital signs including respiration rate, pulse rate, blood pressure and body temperature, disease severity (7-point ordinal scale and NEWS2 score) will be measured at baseline and daily, * Hematology and biochemistry measurements will be done at baseline and at day 3, 5 and 10, * Pharmacokinetic (Blood Mn concentration) measurements will be done at baseline and at day 3, 5 and 10, * Biomarkers will be measured at baseline and at day 3, 5 and 10. At the end of the 10-day treatment period, a follow-up visit will be planned between day 15 and day 22. The following. assessments/examinations will be performed: oxygen saturation, vital signs including respiration rate and body temperature, disease severity (7-point ordinal scale and NEWS2 score), electrocardiogram (ECG), hematology, biochemistry, concomitant therapies, and adverse events.

Timeline

Start

2022-02-04

Primary completion

2022-10-04

Completion

2022-12-01

Drugs

Indications