Clinical trial NCT04414241: Hydroxychloroquine to Prevent SARS-CoV-2 Infection/COVID-19
Official title: Hydroxychloroquine to Prevent SARS-CoV-2 Infection Among Healthcare Workers: Randomized Controlled, Open-label, Phase 3 Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: SARS-CoV-2
Keywords: SARS-CoV-2 infection
Hydroxychloroquine
Lead sponsor: Universidad Peruana Cayetano Heredia
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether hydroxychloroquine is an effective prophylactic regimen to prevent SARS-CoV-2 infection among healthcare workers. Participants will be randomized into two parallel groups. The first arm will evaluate the use of hydroxychloroquine every-other-day plus standard measures of protection for the prevention of SARS-CoV-2. The second arm will evaluate the use of standard measures of protection for the prevention of SARS-CoV-2. The target enrollment is 320 participants. Each study participant will be monitored for SARS-CoV-2 seroconversion in weekly visits or for the development of COVID-19 symptoms for 8 weeks.


Eligibility criteria: Inclusion Criteria:

1. Healthcare workers in service during the COVID-19 outbreak including medical, nurse, technical, and auxiliary staff.
2. Negative rapid serologic and molecular testing for SARS-CoV-2.
3. Written informed consent.

Exclusion Criteria:

1. Presents COVID-19 symptoms including cough, fever, myalgias, headaches, loss of smell, and taste.
2. Prior (last 30 days), current or planned use (during study period) of hydroxychloroquine, chloroquine sulfate, or azithromycin.
3. Known cardiac disease or a history of prolonged QT syndrome.
4. Known allergy or intolerance to hydroxychloroquine and/or chloroquine sulfate.
5. Use of concomitant medications that are contraindicated with the use of hydroxychloroquine.
6. Other reported medical conditions, such as glucose-6-phosphate dehydrogenase deficiency, hepatic or renal insufficiency, or visual acuity or field disturbances, that make study participation not in the individual's best interest.

Primary outcomes:
measure: Efficacy: Proportion of participants with positive molecular or serologic testing for SARS-CoV-2
timeFrame: Eight weeks
measure: Safety: Proportion of participants with grade 3 or more adverse events
timeFrame: Eight weeks
Secondary outcomes:
measure: Tolerability: Proportion of participants that discontinue prophylactic treatment due to grade 1 or 2 adverse events
timeFrame: Eight weeks
Other outcomes:
Locations:
city: Callao
country: Peru
facility: Centro Médico Naval "Cirujano Mayor Santiago Távara"
city: Lima
country: Peru
facility: Hospital Nacional Arzobispo Loayza
city: Lima
country: Peru
facility: Hospital Cayetano Heredia
Study officials:
affiliation: Universidad Peruana Cayetano Heredia
name: Alejandro Llanos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Peruana Cayetano Heredia
name: Eduardo Gotuzzo, MD
role: STUDY_CHAIR
affiliation: U.S. Naval Medical Research Unit Six
name: Max Grogl, PhD
role: STUDY_CHAIR
affiliation: Universidad Peruana Cayetano Heredia
name: Patricia García, MD, MPH, PhD
role: STUDY_CHAIR
affiliation: Instituto de Nacional de Salud
name: Manuel Espinoza, MD
role: STUDY_CHAIR
References: