Hydroxychloroquine Treatment for Severe COVID-19 Pulmonary Infection (HYDRA Trial)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: treatment Hydroxychloroquine tablet 200mg every 12 hours for 10 days. |
Drug: Hydroxychloroquine
hydroxychloroquine 400mg day for 10 days
|
| Placebo Comparator: placebo identical placebo, one tablet every 12 hours for 10 days |
Drug: Placebo oral tablet
Placebo oral tablet
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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 Criteria:
-
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas" | Mexico, City | Mexico | 14080 |
Sponsors and Collaborators
- National Institute of Respiratory Diseases, Mexico
Investigators
- Principal Investigator: Carmen Hernandez-Cárdenas, MD. MSc., National Institute of Respiratory Diseases - México
- Study Director: Luis-Felipe Jurado-Camacho, MD, National Institute of Respiratory Diseases - México
- Study Chair: Ireri Thirion-Romero, MD. MSc, National Institute of Respiratory Diseases - México
- Study Chair: Sebastian Rodriguez-Llamazares, MD.MPH, National Institute of Respiratory Diseases - México
- Study Director: Rogelio Perez-Padilla, MD. PhD, National Institute of Respiratory Diseases - México
- Study Chair: Cristobal Guadarrama, MD MSc, National Institute of Respiratory Diseases - México
- Study Chair: Joel Vasquez-Pérez, MD, National Institute of Respiratory Diseases - México
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HidroxycloroquinaCOVID19