Hydroxychloroquine to Prevent SARS-CoV-2 Infection/COVID-19

Sponsor

Universidad Peruana Cayetano Heredia (Other)

Overall Status

Completed

CT.gov ID

NCT04414241

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

22.7

Patients Per Site

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2	Drug: Hydroxychloroquine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Hydroxychloroquine to Prevent SARS-CoV-2 Infection Among Healthcare Workers: Randomized Controlled, Open-label, Phase 3 Clinical Trial

Actual Study Start Date :

Jun 25, 2020

Actual Primary Completion Date :

Nov 23, 2020

Actual Study Completion Date :

Nov 23, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hydroxychloroquine Hydroxychloroquine prophylaxis plus standard measures of personal protection.	Drug: Hydroxychloroquine A loading dose of 600mg of hydroxychloroquine orally on the first day, followed by 400mg of hydroxychloroquine orally every-other-day and use of standard measures of personal protection provided from the hospital for 8 weeks.
No Intervention: Control Standard measures of personal protection.

Arm

Intervention/Treatment

Experimental: Hydroxychloroquine

Hydroxychloroquine prophylaxis plus standard measures of personal protection.

Drug: Hydroxychloroquine

A loading dose of 600mg of hydroxychloroquine orally on the first day, followed by 400mg of hydroxychloroquine orally every-other-day and use of standard measures of personal protection provided from the hospital for 8 weeks.

No Intervention: Control

Standard measures of personal protection.

Outcome Measures

Primary Outcome Measures

Efficacy: Proportion of participants with positive molecular or serologic testing for SARS-CoV-2 [Eight weeks]
Safety: Proportion of participants with grade 3 or more adverse events [Eight weeks]

Secondary Outcome Measures

Tolerability: Proportion of participants that discontinue prophylactic treatment due to grade 1 or 2 adverse events [Eight weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Presents COVID-19 symptoms including cough, fever, myalgias, headaches, loss of smell, and taste.
Prior (last 30 days), current or planned use (during study period) of hydroxychloroquine, chloroquine sulfate, or azithromycin.
Known cardiac disease or a history of prolonged QT syndrome.
Known allergy or intolerance to hydroxychloroquine and/or chloroquine sulfate.
Use of concomitant medications that are contraindicated with the use of hydroxychloroquine.
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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centro Médico Naval "Cirujano Mayor Santiago Távara"	Callao	Peru	07006
2	Hospital Nacional Arzobispo Loayza	Lima	Peru	15082
3	Hospital Cayetano Heredia	Lima	Peru	15102

Sponsors and Collaborators

Universidad Peruana Cayetano Heredia

Investigators

Principal Investigator: Alejandro Llanos, MD, PhD, Universidad Peruana Cayetano Heredia
Study Chair: Eduardo Gotuzzo, MD, Universidad Peruana Cayetano Heredia
Study Chair: Max Grogl, PhD, U.S. Naval Medical Research Unit Six
Study Chair: Patricia García, MD, MPH, PhD, Universidad Peruana Cayetano Heredia
Study Chair: Manuel Espinoza, MD, Instituto de Nacional de Salud