Status:
COMPLETED
Hydroxychloroquine Treatment for Severe COVID-19 Pulmonary Infection (HYDRA Trial)
Lead Sponsor:
National Institute of Respiratory Diseases, Mexico
Conditions:
COVID-19
Severe Acute Respiratory Syndrome
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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...
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 d...
Eligibility Criteria
Inclusion
- Signed informed consent
- negative pregnancy test in women
- COVID-19 confirmed by rtPCR in any respiratory sample.
- Severe COVID-19 disease defined as any from the following:
- Pulse oximetry less than 91% or a 3% drop from base pulse oximetry or need to increase supplementary oxygen in chronic hypoxia
- Need for mechanical ventilation (invasive or non invasive )
- Sepsis/septic shock.
Exclusion
- history of anaphylactic shock to hydroxychloroquine.
- History of previous administration of chloroquine or hydroxychloroquine (within 1 month)
- decision of attending physician by any reason.
- History of chronic hepatic disease (Child-Pugh B or C)
- History of Chronic renal disease (GFR less than 30)
Key Trial Info
Start Date :
April 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2020
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT04315896
Start Date
April 14 2020
End Date
August 15 2020
Last Update
February 1 2022
Active Locations (1)
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1
Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"
Mexico City, Mexico, 14080