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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
320
hydroxychloroquine 400mg day for 10 days
Placebo oral tablet
Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"
Mexico City, Mexico
All-cause hospital mortality
incidence of all-cause mortality
Time frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days
Length of hospital stay
Days from ER admission to hospital discharge
Time frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days
Need of mechanical ventilation
need of invasive or non invasive mechanical ventilation
Time frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days
Ventilator free days
28 minus days without invasive ventilation support in patients with invasive mechanical ventilation at randomization
Time frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days
Grade 3-4 adverse reaction
Adverse Reactions
Time frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days
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