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

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

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2
• Intervention / Treatment: Drug: Hydroxychloroquine

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 3

Contacts and Locations

Study Locations

• Peru
  • Callao, Peru, 07006
    • Centro Médico Naval "Cirujano Mayor Santiago Távara"
  • Lima, Peru, 15102
    • Hospital Cayetano Heredia
  • Lima, Peru, 15082
    • Hospital Nacional Arzobispo Loayza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Tolerability: Proportion of participants that discontinue prophylactic treatment due to grade 1 or 2 adverse events	Eight weeks

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2020
• Primary Completion (Actual): November 23, 2020
• Study Completion (Actual): November 23, 2020

Study Registration Dates

• First Submitted: June 1, 2020
• First Submitted That Met QC Criteria: June 1, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Hydroxychloroquine; SARS-CoV-2 infection
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Hydroxychloroquine
• Other Study ID Numbers: 202087; 20923 (OGITT-INS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No