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

• Status: Active, not recruiting
• Trial end date: 2020-08-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Respiratory Diseases, Mexico
• Collaborator: Sanofi
• Treatments: Hydroxychloroquine

Criteria

Inclusion Criteria:

1. Signed informed consent

2. negative pregnancy test in women

3. COVID-19 confirmed by rtPCR in any respiratory sample.

4. Severe COVID-19 disease defined as any from the following:

1. Pulse oximetry less than 91% or a 3% drop from base pulse oximetry or need to increase supplementary oxygen in chronic hypoxia

2. Need for mechanical ventilation (invasive or non invasive )

3. Sepsis/septic shock.

Exclusion Criteria:

1. history of anaphylactic shock to hydroxychloroquine.

2. History of previous administration of chloroquine or hydroxychloroquine (within 1 month)

3. decision of attending physician by any reason.

4. History of chronic hepatic disease (Child-Pugh B or C)

5. History of Chronic renal disease (GFR less than 30)