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

Primary Purpose

SARS-CoV-2

Status

Completed

Phase

Phase 3

Locations

Peru

Study Type

Interventional

Intervention

Hydroxychloroquine

About this trial

This is an interventional prevention trial for SARS-CoV-2 focused on measuring SARS-CoV-2 infection, Hydroxychloroquine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Centro Médico Naval "Cirujano Mayor Santiago Távara"
Hospital Nacional Arzobispo Loayza
Hospital Cayetano Heredia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hydroxychloroquine

Control

Arm Description

Hydroxychloroquine prophylaxis plus standard measures of personal protection.

Standard measures of personal protection.

Outcomes

Primary Outcome Measures

Efficacy: Proportion of participants with positive molecular or serologic testing for SARS-CoV-2

Safety: Proportion of participants with grade 3 or more adverse events

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04414241

First Posted

June 1, 2020

Last Updated

October 20, 2021

Sponsor

Universidad Peruana Cayetano Heredia

1. Study Identification

Unique Protocol Identification Number

NCT04414241

Brief Title

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

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

June 25, 2020 (Actual)

Primary Completion Date

November 23, 2020 (Actual)

Study Completion Date

November 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universidad Peruana Cayetano Heredia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

SARS-CoV-2

Keywords

SARS-CoV-2 infection, Hydroxychloroquine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hydroxychloroquine

Arm Type

Experimental

Arm Description

Hydroxychloroquine prophylaxis plus standard measures of personal protection.

Arm Title

Control

Arm Type

No Intervention

Arm Description

Standard measures of personal protection.

Intervention Type

Drug

Intervention Name(s)

Hydroxychloroquine

Intervention Description

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.

Primary Outcome Measure Information:

Title

Efficacy: Proportion of participants with positive molecular or serologic testing for SARS-CoV-2

Time Frame

Eight weeks

Title

Safety: Proportion of participants with grade 3 or more adverse events

Time Frame

Eight weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

Eight weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: