NCT04441385

Study to Evaluate the Efficacy and Safety of Maraviroc in SARS-CoV-2 Infection (COVID-19).

Bicentric, Phase 2, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Maraviroc Associated With Standard Treatment in Hospitalized Patients With Pulmonary SARS-CoV-2 Infection (COVID-19).

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Hospital Universitario Infanta Leonor · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a bicentric, phase 2, randomized, open-label study to evaluate the efficacy and safety of maraviroc associated with standard treatment in hospitalized patients with pulmonary SARS-CoV-2 infection (COVID-19).

Detailed description

This is a bicentric, phase 2, randomized, open-label study to evaluate the efficacy and safety of maraviroc associated with standard treatment in hospitalized patients with pulmonary SARS-CoV-2 infection (COVID-19), to prevent disease progression to severe Acute Respiratory Distress Syndrome (ARDS). Patients will be randomized to receive maraviroc (300 mg BID for 14 days) plus standard treatment, or standard treatment alone. 200 subjects will be enrolled and randomized 1:1 in this study.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Maraviroc 300 mg	Patients will receive maraviroc 300 mg twice daily for 14 days
OTHER	Standard care therapy	Subjects randomized to control group will be on standard care treatment according to the Ministry of Health and Local Guidelines and Protocols.

Timeline

• Start date: 2020-06-26
• Primary completion: 2021-02-08
• Completion: 2021-02-08
• First posted: 2020-06-22
• Last updated: 2022-03-11

Locations

2 sites across 1 country: Spain