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Triple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) aiming to prove hydroxychloroquine's security and efficacy as prophylaxis treatment for healthcare personnel exposed to COVID-19 patients.
Healthcare personnel infection with COVID-19 is a major setback in epidemiological emergencies. Hydroxychloroquine has proven to inhibit coronavirus in-vitro but no data to date has proven in-vivo effects. Nevertheless, hydroxychloroquine is a low cost, limited toxicity and broadly used agent. Since there is currently no treatment for COVID-19 exposure prophylaxis, the investigators will implement a triple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) for 60 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-risk Treatment | Experimental | Hydroxychloroquine 200mg per day for 60 days. |
|
| High-risk Placebo | Placebo Comparator | Placebo tablet per day for 60 days. |
|
| Low-risk Treatment | Experimental | Hydroxychloroquine 200mg per day for 60 days |
|
| Low-risk Placebo | Placebo Comparator | Placebo tablet per day for 60 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine | Drug | All treatment will be administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic COVID-19 infection rate | Symptomatic infection rate by COVID-19 defined as cough, dyspnea, fever, myalgia, arthralgias or rhinorrhea along with a positive COVID-19 real-time polymerase chain reaction test. | From date of randomization until the appearance of symptoms or study completion 60 days after treatment start |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic non-COVID viral infection rate | Symptomatic infection rate by other non-COVID-19 viral etiologies defined as cough, dyspnea, fever, myalgia, arthralgias or rhinorrhea along with a positive viral real time polymerase chain reaction test. | From date of randomization until the appearance of symptoms or study completion 60 days after treatment start |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorge Rojas-Serrano, MD, PhD. | National Institute of Respiratory Diseases - México | Principal Investigator |
| Rogelio Perez-Padilla, MD | National Institute of Respiratory Diseases - México | Study Director |
| Felipe Jurado-Camacho, MD. MSc | National Institute of Respiratory Diseases - México | Study Director |
| Ireri Thirion-Romero, MD, MSc | National Institute of Respiratory Diseases - México | Study Chair |
| Sebastian RodrÃguez-Llamazares, MD, MPH | National Institute of Respiratory Diseases - México | Study Chair |
| Carmen Hernandez Cárdenas, MD, MSc | National Institute of Respiratory Diseases - México | Study Chair |
| Cristobal Guadarrama-Pérez, MD | National Institute of Respiratory Diseases - México | Study Chair |
| Alejandra RamÃrez-Venegas, MD, MSc | 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 |
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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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Triple blinded, randomized controlled trial
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Randomization will happen after previous assignment of recruited individual to high-risk or low-risk exposure according to he or her activities. An independent member of the team will randomly assign treatment or placebo following a computer based program. Blinding will end in case elimination criteria are met.
| Placebo oral tablet | Drug | All placebo will be administered orally |
|
|
| Days of labor absenteeism | Number of days absent from labor due to COVID-19 symptomatic infection | From date of randomization until study completion 60 days after treatment start |
| Rate of labor absenteeism | Absenteeism from labor rate due to COVID-19 symptomatic infection | From date of randomization until study completion 60 days after treatment start |
| Rate of severe respiratory COVID-19 disease in healthcare personnel | Rate of severe respiratory COVID-19 disease in healthcare personnel | From date of randomization until the appearance of symptoms or study completion 60 days after treatment start |
| 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 |