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Completed

NCT Number: NCT04414241

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

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.

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Key information

Conditions

SARS-CoV-2 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro Médico Naval "Cirujano Mayor Santiago Távara", Callao, Peru

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Eight weeks

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

    Time frame: Eight weeks

Secondary outcomes

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

    Time frame: Eight weeks

Sponsors and collaborators

Lead sponsor

Universidad Peruana Cayetano Heredia

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 4, 2020
Registry last updated
Oct 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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