Hydroxychloroquine Treatment for Severe COVID-19 Pulmonary Infection (HYDRA Trial)
- Conditions
- COVID-19Severe Acute Respiratory Syndrome
- Interventions
- Drug: Placebo oral tablet
- Registration Number
- NCT04315896
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 320
-
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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo Placebo oral tablet identical placebo, one tablet every 12 hours for 10 days treatment Hydroxychloroquine Hydroxychloroquine tablet 200mg every 12 hours for 10 days.
- Primary Outcome Measures
Name Time Method All-cause hospital mortality From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days incidence of all-cause mortality
- Secondary Outcome Measures
Name Time Method Length of hospital stay From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days Days from ER admission to hospital discharge
Need of mechanical ventilation 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 invasive or non invasive mechanical ventilation
Ventilator free days From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days 28 minus days without invasive ventilation support in patients with invasive mechanical ventilation at randomization
Grade 3-4 adverse reaction From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days Adverse Reactions
Trial Locations
- Locations (1)
Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"
🇲🇽Mexico, City, Mexico