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

NCT04414241 | Completed Phase 3 DMC

• 2 other identifiers: 20208720923
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 3

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.

Conditions

SARS-CoV-2

Keywords

SARS-CoV-2 infection; Hydroxychloroquine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  Eight weeks

Study Arms (2)

Hydroxychloroquine

EXPERIMENTAL

Hydroxychloroquine prophylaxis plus standard measures of personal protection.

Drug: Hydroxychloroquine

Control

NO INTERVENTION

Standard measures of personal protection.

Interventions

Hydroxychloroquine 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.

Hydroxychloroquine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Peruana Cayetano Heredia: lead

Study Sites (3)

Centro Médico Naval "Cirujano Mayor Santiago Távara"

Callao, 07006, Peru

Location

Hospital Nacional Arzobispo Loayza

Lima, 15082, Peru

Location

Hospital Cayetano Heredia

Lima, 15102, Peru

Location

Related Publications (1)

• 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.

  PMID: 36849996 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Alejandro Llanos, MD, PhD

  Universidad Peruana Cayetano Heredia

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: June 25, 2020
• Primary Completion: November 23, 2020
• Study Completion: November 23, 2020
• Last Updated: October 28, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

PE (3)