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

Sponsor

Fundacion Clinica Valle del Lili (Other)

Overall Status

Completed

CT.gov ID

NCT04627467

Collaborator

(none)

3,217

Enrollment

Location

Arm

18.1

Actual Duration (Months)

177.7

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: Chloroquine	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

3217 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single arm study in which healthcare workers were actively invited to participate. After verifying volunteer's eligibility through a survey that evaluated the presence of COVID-19 symptoms (primary efficacy outcome), 150 mg chloroquine base was dispensed in site by a pharmaceutical chemist at days 0, 15, 30, 45, 60, and 75. Questions regarding adverse drugs reactions (safety outcome) were included in the survey after the first dose was administered. Participants who discontinued chloroquine were followed up until study completion.Single arm study in which healthcare workers were actively invited to participate. After verifying volunteer's eligibility through a survey that evaluated the presence of COVID-19 symptoms (primary efficacy outcome), 150 mg chloroquine base was dispensed in site by a pharmaceutical chemist at days 0, 15, 30, 45, 60, and 75. Questions regarding adverse drugs reactions (safety outcome) were included in the survey after the first dose was administered. Participants who discontinued chloroquine were followed up until study completion.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 28, 2020

Actual Primary Completion Date :

Jul 9, 2020

Actual Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chloroquine 150mg base Volunteers received chloroquine tablets orally at days 0, 15, 30, 45, 60 and 75.	Drug: Chloroquine 250mg tablet (150mg base chloroquine)

Arm

Intervention/Treatment

Experimental: Chloroquine 150mg base

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

Drug: Chloroquine

250mg tablet (150mg base chloroquine)

Outcome Measures

Primary Outcome Measures

COVID-19 infection [Day 15]
Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
COVID-19 infection [Day 30]
Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
COVID-19 infection [Day 45]
Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
COVID-19 infection [Day 60]
Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
COVID-19 infection [Day 75]
Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
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

IgG antibodies seropositivity against SARS-CoV-2 [Day 90]
Number of participants with IgG antibodies seropositivity against SARS-CoV-2 in the final sample.

Other Outcome Measures

Adverse drug event [Day 15, day 30, day 45, day 60, day 75 and day 90]
Number of participants with at least one adverse drug event
Unexpected adverse events [Day 15, day 30, day 45, day 60, day 75 and day 90]
Number of participants with unexpected adverse events
Participant drop-out [Baseline and day 90]
Number of participants who did not completed prophylaxis because of discontinuing medication, withdrawal of consent, or lost to follow-up
Non-adherence [Baseline and day 90]
Number of participants who were not-adherent to the medication scheme

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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