Clinical trial NCT04318015: Hydroxychloroquine Chemoprophylaxis in Healthcare Personnel in Contact With COVID-19 Patients (PHYDRA Trial)
Official title: Chemoprophylaxis With Hydroxychloroquine in Healthcare Personnel in Contact With COVID-19 Patients: A Randomized Controlled Trial (PHYDRA Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
Severe Acute Respiratory Syndrome
Lead sponsor: National Institute of Respiratory Diseases, Mexico
Sponsor class: OTHER_GOV
First posted: 2020-03-23
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Triple blinded, randomized controlled trial
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Symptomatic COVID-19 infection rate
timeFrame: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start
Secondary outcomes:
measure: Symptomatic non-COVID viral infection rate
timeFrame: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start
measure: Days of labor absenteeism
timeFrame: From date of randomization until study completion 60 days after treatment start
measure: Rate of labor absenteeism
timeFrame: From date of randomization until study completion 60 days after treatment start
measure: Rate of severe respiratory COVID-19 disease in healthcare personnel
timeFrame: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start
Other outcomes:
Locations:
city: Mexico, City
country: Mexico
facility: Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"
Study officials:
affiliation: National Institute of Respiratory Diseases - México
name: Jorge Rojas-Serrano, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Respiratory Diseases - México
name: Rogelio Perez-Padilla, MD
role: STUDY_DIRECTOR
affiliation: National Institute of Respiratory Diseases - México
name: Felipe Jurado-Camacho, MD. MSc
role: STUDY_DIRECTOR
affiliation: National Institute of Respiratory Diseases - México
name: Ireri Thirion-Romero, MD, MSc
role: STUDY_CHAIR
affiliation: National Institute of Respiratory Diseases - México
name: Sebastian Rodríguez-Llamazares, MD, MPH
role: STUDY_CHAIR
affiliation: National Institute of Respiratory Diseases - México
name: Carmen Hernandez Cárdenas, MD, MSc
role: STUDY_CHAIR
affiliation: National Institute of Respiratory Diseases - México
name: Cristobal Guadarrama-Pérez, MD
role: STUDY_CHAIR
affiliation: National Institute of Respiratory Diseases - México
name: Alejandra Ramírez-Venegas, MD, MSc
role: STUDY_CHAIR
References: