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

Fundacion Clinica Valle del Lili3,217 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

3,217

Conditions

Covid19

Interventions

ChloroquineDRUG

250mg tablet (150mg base chloroquine)

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Fundacion Valle del Lili

Cali, Valle del Cauca Department, Colombia