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

Fundacion Clinica Valle del Lili

Status and phase

Completed

Phase 2

Conditions

Covid19

Treatments

Drug: Chloroquine

Study type

Interventional

Funder types

Other

Identifiers

NCT04627467

FVL-1567

Details and patient eligibility

About

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)

Full 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.

Enrollment

3,217 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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