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Open Multicentre Study of the Safety and Efficacy Against COVID-19 of Nirmatrelvir/Ritonavir in the Adult Population

NCT05601167 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2023-04-10

No results posted yet for this study

Summary

This is open-labe randomized multicenter comparative Phase III study conducted in 11 medical facilities. The objective of the study is to evaluate efficacy and safety of the drug JTBC00201, tablets in the setting of pathogenetic and symptomatic therapy as compared to standard therapy in outpatients with COVID-19.

Conditions

Interventions

DRUG

nirmatrelvir/ritonavir

Tablets 300/100mg, 2 times a day with 12 ±2 hours interval for 5 days

DRUG

Standard of care

The administration of 'Standard of care' drugs was done according to the regimen recommended in the 'COVID-19 TreatmentGuidelines' validated at the time of the study

Sponsors & Collaborators

  • Sponsor GmbH

    collaborator OTHER

  • Promomed, LLC

    lead OTHER

Principal Investigators

  • Dmitriy Pushkar, Academician · Moscow State Clinical Hospital №50

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-02-17
Primary Completion
2022-06-01
Completion
2022-06-01

Countries

  • Russia

Study Locations

More Related Trials

Entities

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 NCT05601167 on ClinicalTrials.gov