Study of the Efficacy and Safety of a Single Administration of Olokizumab and RPH-104 With Standard Therapy in Patients With Severe Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection (COVID-19)

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

372

Participants

Timeline

Start Date

April 23, 2020

Primary Completion Date

July 10, 2020

Study Completion Date

July 24, 2020

Conditions
COVID-19
Interventions
DRUG

RPH-104 80 mg

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

DRUG

Olokizumab 64 mg

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

DRUG

Placebo

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

Trial Locations (16)

109386

"Private healthcare institution Clinical Hospital Russian Railways-Medicine named after N. A. Semashko", Moscow

111539

"State Budget Healthcare Institution City Clinical Hospital № 15 named after O.M. Filatov of Moscow City Healthcare Department", Moscow

117997

"Federal State Budgetary Institution Federal Center for Cerebrovascular Pathology and Stroke of the Ministry of Health of the Russian Federation", Moscow

119991

Federal State Autonomous Education Insitution of High Education the First Moscow State Medical University named after I.M. Sechenov of Ministry of Healthcare of Russian Federation (Sechenov University), Moscow

Federal State Autonomous Education Institution of High Education the First Moscow State Medical University named after I.M. Sechenov of Ministry of Healthcare of the Russian Federation (Sechenov University), Moscow

121359

"Federal State Budgetary Institution Central Clinical Hospital with Polyclinic of Administrative Directorate of the President of the Russian Federation", Moscow

121552

"Federal State Budget Institution National Medicine Research Center on Cardiology By Ministry of Healthcare of Russian Federation", Moscow

123182

"State Budget Institution of Healthcare City Clinical Hospital #52, Moscow City Healthcare Department", Moscow

127206

State budgetary healthcare institution City Clinical Hospital named after S.I. Spasokukotsky Department of Health of the city of Moscow City Clinical Hospital No. 50, Moscow

129090

"Moscow State Budget Institution of Healthcare Scientific Research Institute of Emergency Medicine named after N.V. Sklifosovsky of Moscow Department of Healthcare", Moscow

143442

"АО State Company Medsi based on Clinical Hospital №1", Moscow

150047

"State Budget Healthcare Institution of Yaroslavl Region Yaroslavl Region Clinical Hospital of War Veterans", Yaroslavl

197341

"Federal Budgetary State Healthcare Institution National Medical Research Center named after B.A. Almazov", Saint Petersburg

197706

"Saint-Petersburg State Budget Institution of Healthcare City Hospital №40", Saint Petersburg

394066

Budgetary Health Institution Voronezh Regional Clinical Hospital №1, Voronezh

603950

"Federal State Budgetary Educational Institution of Higher Education Volga Research Medical University of the Ministry of Health of the Russian Federation", Nizhny Novgorod

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Data Management 365

INDUSTRY

collaborator

K-Research, LLC

INDUSTRY

lead

R-Pharm International, LLC

INDUSTRY

NCT04380519 - Study of the Efficacy and Safety of a Single Administration of Olokizumab and RPH-104 With Standard Therapy in Patients With Severe Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection (COVID-19) | Biotech Hunter | Biotech Hunter