NCT05595824

Open Multicenter Study for Assessment of Efficacy and Safety of Molnupiravir in Adult Patients With COVID-19

Open Multicenter Study for Assessment of Efficacy and Safety of the Drug JCBC00101, Capsules (PROMOMED RUS LLC, Russia) in Relation to COVID-19 in Adult Population

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (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 12 medical facilities. The objective of the study is to evaluate efficacy and safety of the drug JCBC00101, capsules 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, 240 eligible outpatients with mild or moderate COVID-19 were randomized at a 1:1 ratio to receive either molnupiravir capsules, 800 mg, 2 times a day with 12 ±2 hours interval for 5 days, or SOC

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Molnupiravir (Esperavir)	Capsules 800 mg, 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'(Version 14 of 27.12.2021), or inforce at the time of the study

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-03-11
• Completion: 2022-03-11
• First posted: 2022-10-27
• Last updated: 2022-10-27

Locations

12 sites across 1 country: Russia