Trial intelligence / Profile preview

Inhaled CT-P63 and CT-P66 in Symptomatic COVID-19

NCT05224856Phase 3

Key facts

Status
Withdrawn
Start
Apr 2022
Primary completion
Nov 2022
Sponsor
Celltrion
Modality
Monoclonal Antibodies
Conditions
coronavirus disease 2019 (COVID-19)
01

Overview

Phase 3, randomised, double-blind trial in coronavirus disease 2019 (COVID-19) comparing CT-P63 and CT-P66 with Placebo (2 arms). Primary endpoint: Time to clinical recovery at Day 14. Planned start Apr 2022; status: withdrawn.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • CT-P63 and CT-P66

    Inhaled CT-P63 and CT-P66 combination therapy

  • Placebo

    Inhaled Placebo

03

Who it enrols

Adult patients with confirmed SARS-CoV-2 infection, oxygen saturation ≥ 94% on room air, not requiring supplemental oxygen, and symptom onset within 7 days. Excludes patients with severe pneumonia, requiring hospitalization or supplemental oxygen, or recent use of prohibited antivirals or immunomodulators.

04

Endpoints

Primary

  • Time to clinical recovery

Secondary

  • Overall safety

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