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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Active Comparator | Hydroxychloroquine tablet 200mg every 12 hours for 10 days. |
|
| placebo | Placebo Comparator | identical placebo, one tablet every 12 hours for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine | Drug | hydroxychloroquine 400mg day for 10 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause hospital mortality | incidence of all-cause 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Days from ER admission to hospital discharge | 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 |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmen Hernandez-Cárdenas, MD. MSc. | National Institute of Respiratory Diseases - México | Principal Investigator |
| Luis-Felipe Jurado-Camacho, MD | National Institute of Respiratory Diseases - México | Study Director |
| 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 Chair |
| Rogelio Perez-Padilla, MD. PhD | National Institute of Respiratory Diseases - México | Study Director |
| Cristobal Guadarrama, MD MSc | National Institute of Respiratory Diseases - México | Study Chair |
| Joel Vasquez-Pérez, MD | National Institute of Respiratory Diseases - México | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Enfermedades Respiratorias, "Ismael CosÃo Villegas" | Mexico City | 14080 | Mexico |
As requested by other investigators.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D045169 | Severe Acute Respiratory Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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Double blinded, randomized controlled trial
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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.
| Placebo oral tablet |
| Drug |
Placebo oral tablet |
|
need of invasive or non invasive 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 |
| Ventilator free days | 28 minus days without invasive ventilation support in patients with invasive mechanical ventilation at randomization | 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 | From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |