Prevention With Chloroquine in Health Personnel Exposed to Infection With Coronavirus Disease 2019 (COVID-19) (TS-COVID)
- 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
- Asymptomatic healthcare workers and contractors who work in Fundacion Valle del Lili
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chloroquine 150mg base Chloroquine Volunteers received chloroquine tablets orally at days 0, 15, 30, 45, 60 and 75.
- Primary Outcome Measures
Name Time Method COVID-19 infection Day 90 Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
- Secondary Outcome Measures
Name Time Method IgG antibodies seropositivity against SARS-CoV-2 Day 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