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

NCT ID: NCT04414241

Last Updated: 2021-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-25

Study Completion Date

2020-11-23

Brief Summary

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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.

Detailed Description

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Conditions

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SARS-CoV-2

Keywords

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SARS-CoV-2 infection Hydroxychloroquine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Hydroxychloroquine

Hydroxychloroquine prophylaxis plus standard measures of personal protection.

Group Type EXPERIMENTAL

Hydroxychloroquine

Intervention Type DRUG

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.

Control

Standard measures of personal protection.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Peruana Cayetano Heredia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alejandro Llanos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Peruana Cayetano Heredia

Eduardo Gotuzzo, MD

Role: STUDY_CHAIR

Universidad Peruana Cayetano Heredia

Max Grogl, PhD

Role: STUDY_CHAIR

U.S. Naval Medical Research Unit Six

Patricia García, MD, MPH, PhD

Role: STUDY_CHAIR

Universidad Peruana Cayetano Heredia

Manuel Espinoza, MD

Role: STUDY_CHAIR

Instituto de Nacional de Salud

Locations

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Centro Médico Naval "Cirujano Mayor Santiago Távara"

Callao, , Peru

Site Status

Hospital Nacional Arzobispo Loayza

Lima, , Peru

Site Status

Hospital Cayetano Heredia

Lima, , Peru

Site Status

Countries

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Peru

References

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Llanos-Cuentas A, Schwalb A, Quintana JL, Delfin B, Alvarez F, Ugarte-Gil C, Guerra Gronerth RI, Lucchetti A, Grogl M, Gotuzzo E. Hydroxychloroquine to prevent SARS-CoV-2 infection among healthcare workers: early termination of a phase 3, randomised, open-label, controlled clinical trial. BMC Res Notes. 2023 Feb 28;16(1):22. doi: 10.1186/s13104-023-06281-7.

Reference Type DERIVED
PMID: 36849996 (View on PubMed)

Other Identifiers

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20923

Identifier Type: OTHER

Identifier Source: secondary_id

202087

Identifier Type: -

Identifier Source: org_study_id