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

National Institute of Respiratory Diseases, Mexico

Status and phase: Completed; Phase 3

Conditions: COVID-19; Severe Acute Respiratory Syndrome

Treatments: Drug: Placebo oral tablet; Drug: Hydroxychloroquine

Study type: Interventional

Funder types: Other

Identifiers

NCT04315896

HidroxycloroquinaCOVID19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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320 participants in 2 patient groups, including a placebo group

treatment

Active Comparator group

Description:

Hydroxychloroquine tablet 200mg every 12 hours for 10 days.

Treatment:

Drug: Hydroxychloroquine

placebo

Placebo Comparator group

Description:

identical placebo, one tablet every 12 hours for 10 days

Treatment:

Drug: Placebo oral tablet