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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)

NCT05451654 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-10-26

No results posted yet for this study

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.

Conditions

  • COVID-19 Pandemic

Interventions

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

Sponsors & Collaborators

  • Medesis Pharma SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-04
Primary Completion
2022-10-04
Completion
2022-12-01

Countries

  • Brazil

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05451654 on ClinicalTrials.gov