Back to resultsPrevention With Chloroquine in Health Personnel Exposed to Infection With Coronavirus Disease 2019 (COVID-19) (TS-COVID) (TS-COVID)
Primary Purpose
Covid19
Status
Completed
Phase
Phase 2
Locations
Colombia
Study Type
Interventional
Intervention
Chloroquine
Sponsored by
About this trial
This is an interventional prevention trial for Covid19 focused on measuring Chloroquine, COVID-19, SARS-CoV-2, Antibodies, Prophylaxis, Healthcare workers
Eligibility Criteria
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
Sites / Locations
- Fundacion Valle del Lili
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chloroquine 150mg base
Arm Description
Volunteers received chloroquine tablets orally at days 0, 15, 30, 45, 60 and 75.
Outcomes
Primary Outcome Measures
COVID-19 infection
Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
COVID-19 infection
Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
COVID-19 infection
Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
COVID-19 infection
Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
COVID-19 infection
Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
COVID-19 infection
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
Number of participants with IgG antibodies seropositivity against SARS-CoV-2 in the final sample.
Full Information
NCT ID
NCT04627467
First Posted
October 30, 2020
Last Updated
October 5, 2021
Sponsor
Fundacion Clinica Valle del Lili
1. Study Identification
Unique Protocol Identification Number
NCT04627467
Brief Title
Prevention With Chloroquine in Health Personnel Exposed to Infection With Coronavirus Disease 2019 (COVID-19) (TS-COVID)
Acronym
TS-COVID
Official Title
Prophylaxis With Chloroquine in Health Personnel Exposed to Infection With Coronavirus Disease 2019 (COVID-19)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 28, 2020 (Actual)
Primary Completion Date
July 9, 2020 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion Clinica Valle del Lili
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Chloroquine, COVID-19, SARS-CoV-2, Antibodies, Prophylaxis, Healthcare workers
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
3217 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chloroquine 150mg base
Arm Type
Experimental
Arm Description
Volunteers received chloroquine tablets orally at days 0, 15, 30, 45, 60 and 75.
Intervention Type
Drug
Intervention Name(s)
Chloroquine
Intervention Description
250mg tablet (150mg base chloroquine)
Primary Outcome Measure Information:
Title
COVID-19 infection
Description
Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
Time Frame
Day 15
Title
COVID-19 infection
Description
Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
Time Frame
Day 30
Title
COVID-19 infection
Description
Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
Time Frame
Day 45
Title
COVID-19 infection
Description
Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
Time Frame
Day 60
Title
COVID-19 infection
Description
Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
Time Frame
Day 75
Title
COVID-19 infection
Description
Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
Time Frame
Day 90
Secondary Outcome Measure Information:
Title
IgG antibodies seropositivity against SARS-CoV-2
Description
Number of participants with IgG antibodies seropositivity against SARS-CoV-2 in the final sample.
Time Frame
Day 90
Other Pre-specified Outcome Measures:
Title
Adverse drug event
Description
Number of participants with at least one adverse drug event
Time Frame
Day 15, day 30, day 45, day 60, day 75 and day 90
Title
Unexpected adverse events
Description
Number of participants with unexpected adverse events
Time Frame
Day 15, day 30, day 45, day 60, day 75 and day 90
Title
Participant drop-out
Description
Number of participants who did not completed prophylaxis because of discontinuing medication, withdrawal of consent, or lost to follow-up
Time Frame
Baseline and day 90
Title
Non-adherence
Description
Number of participants who were not-adherent to the medication scheme
Time Frame
Baseline and day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan D Velez, MD
Organizational Affiliation
Fundacion Clinica Valle del Lili
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundacion Valle del Lili
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760032
Country
Colombia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan to share IPD, since we are not allowed to share information concerning medical history of our patients or health workers.
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Prevention With Chloroquine in Health Personnel Exposed to Infection With Coronavirus Disease 2019 (COVID-19) (TS-COVID)
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