drugset
drugset / Trial / NCT05601167

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

NCT05601167 ↗

Phase 3 Completed 264 enrolled Promomed, LLC Sponsor GmbH · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Publications

  • Background L.A. Balykova, N.M. Selezneva, E.I. Gorshenina, O.I. Shepeleva, N.V. Kirichenko, E.N. Simakina, K.B. Kolontarev, D.Yu. Pushkar, D.N. Zemskov, K.Ya. Zaslavskaya, S.M. Noskov, A.V. Taganov, P.A. Bely. modern directed antiviral COVID-19 therapy: results of multicenter clinical effectiveness and safety study of fixed nirmatrelvir+ritonavir combination. Pharmacy & Pharmacology. 2022;10(4):. DOI: 10.19163/2307-9266- 2022-10-4-

Drugs

EvaluationDrugModalityDoseRoute
Subject Nirmatrelvir Small molecule 300 mg —
Subject Ritonavir Other / unclassified 100 mg —

Indications

COVID-19