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

COVID-19 Clinical Trial

— PHYDRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04318015
• Other study ID #: ProfilaxisCOVID
• Status: Completed
• Phase: Phase 3
• Start date: April 14, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2020
• Source: National Institute of Respiratory Diseases, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: March 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• Hydroxychloroquine
All treatment will be administered orally.
• Placebo oral tablet
All placebo will be administered orally

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"	Mexico, City

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Respiratory Diseases, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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