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Clinical Study in the Treatment of Patients With Moderate Course of COVID-19

COVID-19 Clinical Trial

Official title:
To Study the Efficacy, Safety and Pharmacokinetics of COVID-globulin, in Addition to Standard Therapy for the Treatment of Patients With a Moderate COVID-19 Form

Clinical Trial Summary

Study of safety, efficacy and pharmacokinetics, dose selection

Clinical Trial Description

Objective: To study the efficacy, safety and pharmacokinetics of COVID-globulin, in addition to standard therapy for the treatment of patients with a moderate COVID-19 form. Study Objectives: The study comprises two stages, 1 and 2. Stage 1 tasks 1. to determine and compare the safety parameters of COVID-globulin after a single infusion at doses of 1 mL/kg, 2 mL/kg, 4 mL/kg and placebo in addition to standard therapy in the treatment of patients with COVID-19; 2. to determine and compare the efficacy parameters of COVID-globulin after a single infusion at doses of 1 mL/kg, 2 mL/kg, 4 mL/kg and placebo in addition to standard therapy in the treatment of patients with COVID-19; 3. to determine the optimal therapeutic dose of COVID-globulin for the treatment of patients with moderate COVID-19 by comparing the safety and efficacy parameters of doses of 1 mL/kg, 2 mL/kg, 4 mL/kg and placebo; 4. to study the pharmacokinetic parameters of COVID-globulin in the blood plasma of patients after a single infusion at a dose of 1 mL/kg, 2 mL/kg, 4 mL/kg, in addition to standard therapy for the treatment of patients with moderate COVID-19. Stage 2 tasks 1. to study the efficacy of COVID-globulin in addition to standard therapy for the treatment of patients with moderate COVID-19; 2. to study the safety of COVID-globulin in addition to standard therapy for the treatment of patients with moderate COVID-19; 3. to conduct a comparative analysis of the efficacy and safety of a group of patients with moderate COVID-19 who receive COVID-globulin in addition to the standard therapy, and a group of patients who receive placebo in addition to standard therapy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04842435
Study type Interventional
Source Microgen
Contact Ekaterina Andreevna Bykova
Phone +7 (495) 790-77-73
Email e.a.bykova@microgen.ru
Status Recruiting
Phase Phase 2/Phase 3
Start date April 12, 2021
Completion date October 5, 2021
View Details
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