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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-14

Study Completion Date

2020-08-15

Brief Summary

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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.

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Detailed Description

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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

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COVID-19 Severe Acute Respiratory Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blinded, randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Clinical practitioners and data analysts will remain blinded all through the study. Blinding will end in case the attending physician considers the patient should abandon the study or some of the exclusion/elimination criteria apply.

Study Groups

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treatment

Hydroxychloroquine tablet 200mg every 12 hours for 10 days.

Group Type ACTIVE_COMPARATOR

Hydroxychloroquine

Intervention Type DRUG

hydroxychloroquine 400mg day for 10 days

placebo

identical placebo, one tablet every 12 hours for 10 days

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

Placebo oral tablet

Interventions

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Hydroxychloroquine

hydroxychloroquine 400mg day for 10 days

Intervention Type DRUG

Placebo oral tablet

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No