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

Phase 2
Completed
Conditions
Covid19
Interventions
Registration Number
NCT04627467
Lead Sponsor
Fundacion Clinica Valle del Lili
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
3217
Inclusion Criteria
  • Asymptomatic healthcare workers and contractors who work in Fundacion Valle del Lili
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Chloroquine 150mg baseChloroquineVolunteers received chloroquine tablets orally at days 0, 15, 30, 45, 60 and 75.
Primary Outcome Measures
NameTimeMethod
COVID-19 infectionDay 90

Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample

Secondary Outcome Measures
NameTimeMethod
IgG antibodies seropositivity against SARS-CoV-2Day 90

Number of participants with IgG antibodies seropositivity against SARS-CoV-2 in the final sample.

Trial Locations

Locations (1)

Fundacion Valle del Lili

🇨🇴

Cali, Valle Del Cauca, Colombia

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