Trial intelligence / Profile preview

Nivolumab in COVID-19

NCT04356508Phase 2

Key facts

Status: Unknown
Start: Apr 2020
Primary completion: Jun 2020
Modality: Monoclonal Antibodies

Drugs: nivolumab
Conditions: coronavirus disease 2019 (COVID-19)

Overview

Phase 2, open-label trial of nivolumab in coronavirus disease 2019 (COVID-19) (2 arms). Primary endpoint: Viral clearance kinetics up to 6 months. Status: unknown.

Design

2 arms

Study design: Non-randomizedOpen-label

Intervention
Nivolumab + best supportive care
Non-intervention
Best supportive care

Who it enrols

Adult patients with mild to moderate COVID-19, excluding those with active cancer, autoimmune conditions, or severe disease requiring mechanical ventilation.

Endpoints

Primary

Viral clearance kineticsup to 6 months

Secondary

Treatment-related adverse events of nivolumabup to 1 year
Lymphocyte kineticsDay 28
Cytokine kineticsDay 10
Length of inpatient stay due to COVID-19up to 6 months

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