Trial | NCT04414241  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    68
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 Started
Jun 25
2020
Primary Completion
Nov 23
2020
Study Completion
Nov 23
2020
Last Update
Oct 28
2021

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.

Hydroxychloroquine Experimental

Hydroxychloroquine prophylaxis plus standard measures of personal protection.

Control No Intervention

Standard measures of personal protection.

Criteria 

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.
No Results Posted