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)

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.

Timeline

Start

2020-04-23

Primary completion

2020-07-10

Completion

2020-07-24

Outcome

Missed primary endpoint

registry analysis (superiority test); RPH -104 80 mg vs Placebo; p = 0.434; Risk Ratio (RR) 1.012; Maximal Likelihood Estimator (MLE) model; note: Hochberg adjustment was applied for p-values NCT04380519 ↗

registry analysis (superiority test); Olokizumab 64 mg vs Placebo; p = 0.073; Risk Ratio (RR) 1.125; Maximal Likelihood Estimator (MLE) model; note: Hochberg adjustment was applied for p-values NCT04380519 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Goflikicept	Monoclonal antibody	80 mg	Subcutaneous
Subject	Olokizumab	Monoclonal antibody	64 mg	Subcutaneous

Indications