376
Participants
Start Date
April 12, 2021
Primary Completion Date
September 30, 2021
Study Completion Date
October 5, 2021
COVID-globulin
"In a Stage 1 study, COVID globulin is administered to clinical study subjects randomized to groups 1, 2, or 3 by intravenous drip in one of three doses of 1 mL/kg, 2 mL/kg, or 4 mL/kg The initial drug administration rate is from 0.01 mL/kg to 0.02 mL/kg of body weight per minute for 30 minutes. If the drug is well tolerated, the rate of administration can be gradually increased to a maximum of 0.12 mL/kg of body weight per minute. In order to control the drug administration rate, infusion shall be performed with an infusion pump.~In a Stage 2 study, COVID globulin is administered to clinical study subjects randomized to group 1 by intravenous drip at a dose found optimal based on the results of Stage 1 study."
Placebo
"In a Stage 1 study, Placebo is administered to clinical study subjects randomized to groups 4 by intravenous drip at a dose of 1 mL/kg.~The initial drug administration rate is from 0.01 mL/kg to 0.02 mL/kg of body weight per minute for 30 minutes. If the drug is well tolerated, the rate of administration can be gradually increased to a maximum of 0.12 mL/kg of body weight per minute. In order to control the drug administration rate, infusion shall be performed with an infusion pump.~In a Stage 2 study, placebo is administered to clinical study subjects randomized to group 2 by intravenous drip at a dose equal to the study drug dose."
RECRUITING
"9. State Autonomous Healthcare Institution Professor A. F. Agafonov Republican Clinical Infectious Hospital", Kazan'
RECRUITING
"13. State Budgetary Healthcare Institution Specialized Clinical Infectious Diseases Hospital of the Ministry of Health of the Krasnodar Territory", Krasnodar
TERMINATED
"6. State Budgetary Healthcare Institution Scientific and Research Institute Professor S. V. Ochapovskiy Territorial Clinical Hospital of the Ministry of Health of the Krasnodar Territory", Krasnodar
RECRUITING
"1. State Budgetary Institution of Healthcare of Moscow City Clinical Hospital No. 40 of the Moscow Department of Health", Moscow
RECRUITING
"14. State Budgetary Institution of Healthcare of Moscow Infectious Clinical Hospital No. 2 of the Moscow Department of Health", Moscow
RECRUITING
"16. State Budgetary Institution of Healthcare of Moscow Infectious Clinical Hospital No. 1 of the Moscow Department of Health", Moscow
RECRUITING
"18. State Budgetary Institution of Healthcare of Moscow City Clinical Hospital No. 52 of the Moscow Department of Health", Moscow
RECRUITING
"19. State Budgetary Institution of Healthcare of Moscow City Clinical Hospital of V.P. Demikhova of the Moscow Department of Health", Moscow
RECRUITING
"20. State Budgetary Institution of Healthcare of Moscow Scientific and Research Institute of N.V. Sklifosovskiy of the Moscow Department of Health", Moscow
RECRUITING
"21. State Budgetary Institution of Healthcare of Moscow City Clinical Hospital No. 4 of the Moscow Department of Health", Moscow
RECRUITING
"3. State Budgetary Healthcare Institution of Moscow City Clinical Hospital No. 24 of the Moscow Department of Health", Moscow
TERMINATED
"7. Federal State Budgetary Institution Central Clinical Hospital with an Outpatient Facility of the Administrative Directorate of the President of the Russian Federation", Moscow
RECRUITING
"4. Federal State Budgetary Educational Institution of Higher Education Orenburg State Medical University of the Ministry of Health of the Russian Federation", Orenburg
RECRUITING
"10. Federal State Budgetary Educational Institution of Higher Education Academician I. P. Pavlov Ryazan State Medical University of the Ministry of Health of the Russian Federation", Ryazan
TERMINATED
"5. Saint Petersburg State Budgetary Healthcare Institution City Hospital No. 40 of the Kurortny Region", Saint Petersburg
RECRUITING
"12. Federal State Budgetary Educational Institution of Higher Education Samara State Medical University of the Ministry of Health of the Russian Federation", Samara
RECRUITING
"11. Regional State Budgetary Healthcare Institution Clinical Hospital No. 1", Smolensk
SUSPENDED
"17. Federal State Budgetary Educational Institution of Higher Education Bashkiria State Medical University of the Ministry of Health of the Russian Federation", Ufa
SUSPENDED
"8. State Budgetary Healthcare Institution of the Yaroslavl Region Yaroslavl Regional Clinical Hospital of War Veterans - International Center for Problems of the Elderly Zdorovoye Dolgoletiye", Yaroslavl
SUSPENDED
"15. Municipal Autonomous Institution Central City Clinical Hospital No. 24", Yekaterinburg
RECRUITING
"2. State Budgetary Institution of Healthcare of the Moscow Region Zhukovskiy City Clinical Hospital", Zhukovskiy
Lead Sponsor
Microgen
OTHER