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Clinical Trial of Efficacy and Safety of Raphamin in the Treatment of Coronavirus Disease 2019 in Outpatients

NCT05364671 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 771

Last updated 2025-01-06

Study results available
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Summary

Multicenter double-blind placebo-controlled parallel-group randomized clinical trial of efficacy and safety of Raphamin in the treatment of coronavirus disease 2019 in outpatients.

Conditions

  • Coronavirus Disease 2019 (COVID-19)

Interventions

DRUG

Raphamin

Tablet for oral use. The drug is administered not during meals. The tablet should be held in mouth until complete dissolution. On the first day, 8 tablets should be administered using the following regimen: 1 tablet every 30 minutes in the first 2 hours (5 tablets in total within 2 hours), then additionally one tablet 3 times with regular time intervals. From day 2 onwards, 1 tablet taken 3 times daily. The treatment period is 5 days.

DRUG

Placebo

Tablet for oral use. The drug is administered not during meals. The tablet should be held in mouth until complete dissolution. Placebo is administered according to the Raphamin regimen.

Sponsors & Collaborators

  • Materia Medica Holding

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-29
Primary Completion
2023-08-18
Completion
2023-08-18

Countries

  • Russia

Study Locations

More Related Trials

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 NCT05364671 on ClinicalTrials.gov