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

Completed
COVID-19
Severe Acute Respiratory Syndrome

Drug: Hydroxychloroquine

hydroxychloroquine 400mg day for 10 days

Drug: Placebo oral tablet

Placebo oral tablet

Eligibility 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)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 80 Years
Countries
Mexico
Locations

Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"
Mexico, City, Mexico

National Institute of Respiratory Diseases, Mexico
NCT Number
Keywords
Covid-19
Severe acute respiratory syndrome
MeSH Terms
COVID-19
Severe Acute Respiratory Syndrome
Hydroxychloroquine