NCT05451654

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)

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)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Medesis Pharma SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

120 patients will be enrolled in this study, they will be randomly assigned in 2 arms on a 3:1 ratio, 90 patients in the NanoManganese® \+ Standard of Care group and 30 patients in the placebo + Standard of Care group. This study will be conducted in Brazil and will be conducted in around 8 investigational sites The investigational products are : Manganese sulfate monohydrate, MnSO4, H2O (NanoManganese®) will be administered using the microemulsion AONYS® technology. The product is mucoadhesive, it sticks to the mucosa of the cheeks on which it will be deposited and will not be swallowed. The placebo (Pharmacopoeia soybean oil) will be administered using the same protocol and the same bottle. Treatments : NanoManganese® + standard of care group: * NanoManganese®: administration of 2 mL twice a day (morning and evening) by depositing 1 mL in the gingivo-jugal groove of each cheek with the graduated pipette. * Standard of care Placebo + standard of care group: * Placebo: administration of 2 mL twice a day (morning and evening) by depositing 1 mL in the gingivo-jugal groove of each cheek with the graduated pipette. * Standard of care The treatments will be administered by the nurse. Duration of treatment: 10 days or until hospital discharge or until death.

Conditions

• COVID-19 Pandemic

Interventions

Type	Name	Description
DRUG	Placebo	The administration of the treatment consists in a deposit in the gingivo-jugal groove of each cheek with a graduated pipette
DRUG	Experimental drug	The administration of the treatment consists in a deposit in the gingivo-jugal groove of each cheek with a graduated pipette

Timeline

• Start date: 2022-02-04
• Primary completion: 2022-10-04
• Completion: 2022-12-01
• First posted: 2022-07-11
• Last updated: 2023-10-26

Locations

1 site across 1 country: Brazil