Prevention With Chloroquine in Health Personnel Exposed to Infection With Coronavirus Disease 2019 (COVID-19) (TS-COVID)

NCT ID: NCT04627467

Last Updated: 2021-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 3217 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-28
• Study Completion Date: 2021-09-30

Brief Summary

The purpose of this study is to assess the efficacy and safety of chloroquine prophylaxis on the incidence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infections in healthcare workers exposed to patients with confirmed Coronavirus Disease 2019 (COVID-19)

Detailed Description

Single arm study in which healthcare workers were actively invited to participate. Possible participants were asked to complete a questionnaire to determine eligibility for study entry and to identify risk factors for infection, severe infection, or adverse events associated with chloroquine use.

Volunteers who meet the eligibility requirements received chloroquine 150mg base at days 0, 15, 30, 45, 60, 75. Cumulative incidence and incidence rate of COVID-19 at days 30,60 and 90 were calculated. Presence of Immunoglobulin G (IgG) antibodies against SARS-Cov-2 was evaluated at the beginning, at the end and at any moment if they become infected with this virus.

In addition, patients were asked to complete a survey evaluating adverse effects and COVID-19 symptoms at day 0 and weeks 2,4,6,8,10, and 12.

Conditions

Covid19

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Chloroquine 150mg base

Volunteers received chloroquine tablets orally at days 0, 15, 30, 45, 60 and 75.

Group Type: EXPERIMENTAL

Chloroquine

Intervention Type: DRUG

250mg tablet (150mg base chloroquine)

Interventions

Chloroquine

250mg tablet (150mg base chloroquine)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Asymptomatic healthcare workers and contractors who work in Fundacion Valle del Lili

Exclusion Criteria

• To have two or more of the following symptoms 14 days previous to the initial assessment: cough, dyspnea, odynophagia, fatigue, weakness, fever >38 degrees °C
• History of close contact (less than two meters) with a person with probable or confirmed COVID-19 without adequate protection during the last 14 days
• History of one the following diseases in treatment at inclusion in the study: cardiac arrhythmias, epilepsy, kidney disease, seizures
• Treatment with concomitant medications: tamoxifen, quinine, cyclosporine, amiodarone, digoxine, anticonvulsivants
• Having recently taken chloroquine or hydroxychloroquine in the last two weeks
• Known hypersensitivity to chloroquine or hydroxychloroquine

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundacion Clinica Valle del Lili

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan D Velez, MD

Role: PRINCIPAL_INVESTIGATOR

Fundacion Clinica Valle del Lili

Locations

Fundacion Valle del Lili

Cali, Valle del Cauca Department, Colombia

Countries

Colombia

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Other Identifiers

FVL-1567

Identifier Type: -

Identifier Source: org_study_id