NCT05601167

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

Open Multicentre Study for Assessment of the Safety and Efficacy Against COVID-19 of the Drug JTBC00201 (PROMOMED RUS LLC, Russia) in the Adult Population

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 264 (actual)
• Sponsor: Promomed, LLC · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Upon signing the informed consent form and screening, 264 eligible outpatients with mild or moderate COVID-19 were randomized at a 1:1 ratio to receive either nirmatrelvir/ritonavir tablets, 300/100 mg, 2 times a day with 12 ±2 hours interval for 5 days, or SOC

Conditions

• COVID-19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-02-17
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2022-11-01
• Last updated: 2023-04-10

Locations

11 sites across 1 country: Russia