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A Study to Assess the Efficacy and Safety of XC221 in Patients With Mild COVID-19

NCT04940182 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2023-07-27

No results posted yet for this study

Summary

The innovative drug XC221 100 mg tablet is designed for the treatment of COVID-19 (SARS-CoV-2 infection). A multicenter, adaptive, randomized, double-blind, placebo-controlled Phase III clinical study is aimed to assess the efficacy and safety of XC221 100 mg tablet, in mild COVID-19 patients during a 14-days treatment.

The primary objective of the study is to demonstrate the efficacy of XC221 100 mg tablet (200 mg daily dose) in achieving clinical improvement of mild COVID-19 symptoms.

The secondary objective of the study is to evaluate the safety of XC221 100 mg tablet (200 mg daily dose) in mild COVID-19 patients.

Conditions

Interventions

DRUG

XC221

Participants will receive XC221 100 mg 2 times a day during 14 full days

DRUG

Placebo

Participants will receive Placebo 2 times a day during 14 full days

Sponsors & Collaborators

  • RSV Therapeutics LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-06-26
Primary Completion
2022-08-26
Completion
2022-11-14

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

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 NCT04940182 on ClinicalTrials.gov