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

SARS-CoV-2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04414241
• Other study ID #: 202087
• Secondary ID: 20923
• Status: Completed
• Phase: Phase 3
• Start date: June 25, 2020
• Est. completion date: November 23, 2020

Study information

• Verified date: June 2020
• Source: Universidad Peruana Cayetano Heredia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: November 23, 2020
• Est. primary completion date: November 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Infections
• SARS-CoV-2

Intervention

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.

Locations

Country	Name	City	State
Peru	Centro Médico Naval "Cirujano Mayor Santiago Távara"	Callao
Peru	Hospital Cayetano Heredia	Lima
Peru	Hospital Nacional Arzobispo Loayza	Lima

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Peruana Cayetano Heredia

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Proportion of participants with positive molecular or serologic testing for SARS-CoV-2		Eight weeks
Primary	Safety: Proportion of participants with grade 3 or more adverse events		Eight weeks
Secondary	Tolerability: Proportion of participants that discontinue prophylactic treatment due to grade 1 or 2 adverse events		Eight weeks