CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 372 enrolled
Drug / intervention
RPH-104 80 mg +2 moredrug
Likely dose
RPH-104 80 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04380519
NCT04380519Phase 3Completed
CompareCT.gov

An International, Multicenter, Randomized, Double-blind, Adaptive Placebo-controlled Study of the Efficacy and Safety of a Single Administration of Olokizumab and RPH-104 With Standard Therapy in Patients With Severe SARS-CoV-2 Infection (COVID-19)

R-Pharm International, LLC·interventional·Posted May 8, 2020·Updated Jan 24, 2022

In Brief

A Phase 3 clinical trial evaluating RPH-104 80 mg, Olokizumab 64 mg, and 1 other intervention for COVID-19. Completed, enrolled 372 participants across 16 sites.

Detailed Summary

The primary objective of the study was to evaluate the efficacy and safety of a single dose of RPH-104 (80 mg) or OKZ (64 mg) compared to placebo in addition to standard therapy in patients with severe SARS-CoV-2 infection (COVID-19) at Day 15 of the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesRussia
CollaboratorsData Management 365, K-Research, LLC

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedMay 8, 2020
Enrollment StartApr 23, 2020
Primary CompletionJul 10, 2020
Study CompletionJul 24, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.1 years ago

Interventions

RPH-104 80 mgdrug

solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL glass vial

Olokizumab 64 mgdrug

solution for subcutaneous administration 160 mg/mL, in the 2-mL glass vial (target volume 0,4 ml)

Placebodrug

Normal Saline (0.9% Sodium Chloride solution for Injection), in the market package