Hydroxychloroquine Chemoprophylaxis in Healthcare Personnel in Contact With COVID-19 Patients (PHYDRA Trial)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Chemoprophylaxis With Hydroxychloroquine in Healthcare Personnel in Contact With COVID-19 Patients: A Randomized Controlled Trial (PHYDRA Trial)

Conditions
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COVID-19, Severe Acute Respiratory Syndrome

Intervention / Treatment
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* Drug: Hydroxychloroquine
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old upon study start Healthcare personnel exposed to patients with COVID-19 respiratory disease: physicians, nurses, chemists, pharmacists, janitors, stretcher-bearer, administrative and respiratory therapists. Signed consent for randomization to any study arm. Exclusion Criteria: Known hypersensitivity to hydroxychloroquine manifested as anaphylaxis Current treatment to chloroquine or hydroxychloroquine Women with last menstruation date farther than a month without negative pregnancy test. Women with positive pregnancy test Breastfeeding women Chronic hepatic disease history (Child-Pugh B or C) Chronic renal disease (GFR less or equal to 30)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Triple blinded, randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-risk Treatment<br>Hydroxychloroquine 200mg per day for 60 days. | Drug: Hydroxychloroquine<br>* All treatment will be administered orally.<br>* Other names: Plaquenil;|
| Placebo Comparator: High-risk Placebo<br>Placebo tablet per day for 60 days. | Drug: Placebo oral tablet<br>* All placebo will be administered orally<br>* Other names: Placebo;|
| Experimental: Low-risk Treatment<br>Hydroxychloroquine 200mg per day for 60 days | Drug: Hydroxychloroquine<br>* All treatment will be administered orally.<br>* Other names: Plaquenil;|
| Placebo Comparator: Low-risk Placebo<br>Placebo tablet per day for 60 days. | Drug: Placebo oral tablet<br>* All placebo will be administered orally<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |