NCT04315896

Hydroxychloroquine Treatment for Severe COVID-19 Pulmonary Infection (HYDRA Trial)

Hydroxychloroquine Treatment for Severe COVID-19 Respiratory Disease: Randomised Clinical Trial (HYDRA Trial)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: National Institute of Respiratory Diseases, Mexico · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Double blinded randomized clinical trial designed to evaluate the security and efficacy of hydroxychloroquine as treatment for COVID-19 severe respiratory disease. The investigators hypothesize that a 400mg per day dose of hydroxychloroquine for 10 days will reduce all-cause hospital mortality in patients with severe respiratory COVID-19 disease.

Detailed description

Since hydroxychloroquine is a low cost and safe anti-malaria drug that has proven effects against COVID-19 in vitro. The investigators aim to study the security and efficacy of this drug in trough a double blinded randomized clinical trial. Recruited patients with severe respiratory disease from COVID-19 will be randomized to an intervention group (400mg per day dose of hydroxychloroquine) and placebo. The investigators' main outcome will be all cause hospital mortality. The investigators hypothesize that a 400mg per day dose of hydroxychloroquine for 10 days will reduce all-cause hospital mortality in patients with severe respiratory COVID-19 disease. Results will be compared in an intention to treat analysis. All clinical, analysis and data team members will be blinded to treatment assignment.

Conditions

• COVID-19
• Severe Acute Respiratory Syndrome

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine	hydroxychloroquine 400mg day for 10 days
DRUG	Placebo oral tablet	Placebo oral tablet

Timeline

• Start date: 2020-04-14
• Primary completion: 2020-07-01
• Completion: 2020-08-15
• First posted: 2020-03-20
• Last updated: 2022-02-01

Locations

1 site across 1 country: Mexico