NCT04335305

Checkpoint Blockade in COVID-19 Pandemic

A Randomized, Controlled, Open-Label, Phase II Trial to Evaluate the Efficacy and Safety of Tocilizumab Combined With Pembrolizumab (MK-3475) in Patients With Coronavirus Disease 2019 (COVID-19)-Pneumonia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: MedSIR · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, randomized, controlled, open-label, phase 2 clinical trial

Detailed description

The aim of this study is to assess the efficacy -as determined by the proportion of patients with normalization of SpO2 ≥96% on room air- of continued standard care together with tocilizumab plus pembrolizumab (MK- 3475) in patients with COVID-19 pneumonia

Conditions

• COVID-19
• Pneumonia, Viral

Interventions

Type	Name	Description
DRUG	Tocilizumab	IV infusion over 60 minutes; 8 mg/kg (up to a maximum of 800 mg per dose); single dose
BIOLOGICAL	Pembrolizumab (MK-3475)	IV infusion over 30 minutes, 200 mg; single dose

Timeline

• Start date: 2020-04-09
• Primary completion: 2021-03-08
• Completion: 2021-06-21
• First posted: 2020-04-06
• Last updated: 2022-06-21

Locations

7 sites across 1 country: Spain