COVID-19, Severe Acute Respiratory Syndrome
Conditions
Keywords
COVID-19, Severe acute respiratory syndrome
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.
Interventions
DRUGHydroxychloroquine
hydroxychloroquine 400mg day for 10 days
DRUGPlacebo oral tablet
Placebo oral tablet
Sponsors
National Institute of Respiratory Diseases, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Double blinded, randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Mexico
Outcome results
None listed