COVID-19, Severe Acute Respiratory Syndrome
Conditions
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.
Interventions
DRUGHydroxychloroquine
All treatment will be administered orally.
DRUGPlacebo oral tablet
All placebo will be administered orally
Sponsors
National Institute of Respiratory Diseases, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Triple blinded, randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic COVID-19 infection rate | From date of randomization until the appearance of symptoms or study completion 60 days after treatment start | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic non-COVID viral infection rate | From date of randomization until the appearance of symptoms or study completion 60 days after treatment start | 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. |
| Days of labor absenteeism | From date of randomization until study completion 60 days after treatment start | Number of days absent from labor due to COVID-19 symptomatic infection |
| Rate of labor absenteeism | From date of randomization until study completion 60 days after treatment start | Absenteeism from labor rate due to COVID-19 symptomatic infection |
| 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 | Rate of severe respiratory COVID-19 disease in healthcare personnel |
Countries
Mexico
Outcome results
None listed