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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)

NCT04380519 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2022-01-24

Study results available
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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.

Conditions

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

Sponsors & Collaborators

  • Data Management 365

    collaborator INDUSTRY

  • K-Research, LLC

    collaborator INDUSTRY

  • R-Pharm International, LLC

    lead INDUSTRY

Principal Investigators

  • Mikhail Samsonov · Chief Medical Officer, R-Pharm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-23
Primary Completion
2020-07-10
Completion
2020-07-24

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04380519 on ClinicalTrials.gov