Prevention With Chloroquine in Health Personnel Exposed to Infection With Coronavirus Disease 2019 (COVID-19) (TS-COVID) (TS-COVID)
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ClinicalTrials.gov Identifier: NCT04627467 |
Recruitment Status :
Completed
First Posted : November 13, 2020
Last Update Posted : October 7, 2021
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Condition or disease | Intervention/treatment | Phase |
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Covid19 | Drug: Chloroquine | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
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. |
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 : | March 28, 2020 |
Actual Primary Completion Date : | July 9, 2020 |
Actual Study Completion Date : | September 30, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Chloroquine 150mg base
Volunteers received chloroquine tablets orally at days 0, 15, 30, 45, 60 and 75.
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Drug: Chloroquine
250mg tablet (150mg base chloroquine) |
- COVID-19 infection [ Time Frame: Day 15 ]Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
- COVID-19 infection [ Time Frame: Day 30 ]Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
- COVID-19 infection [ Time Frame: Day 45 ]Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
- COVID-19 infection [ Time Frame: Day 60 ]Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
- COVID-19 infection [ Time Frame: Day 75 ]Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
- COVID-19 infection [ Time Frame: Day 90 ]Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
- IgG antibodies seropositivity against SARS-CoV-2 [ Time Frame: Day 90 ]Number of participants with IgG antibodies seropositivity against SARS-CoV-2 in the final sample.
- Adverse drug event [ Time Frame: 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 [ Time Frame: Day 15, day 30, day 45, day 60, day 75 and day 90 ]Number of participants with unexpected adverse events
- Participant drop-out [ Time Frame: 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 [ Time Frame: Baseline and day 90 ]Number of participants who were not-adherent to the medication scheme

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04627467
Colombia | |
Fundacion Valle del Lili | |
Cali, Valle Del Cauca, Colombia, 760032 |
Principal Investigator: | Juan D Velez, MD | Fundacion Clinica Valle del Lili |
Responsible Party: | Fundacion Clinica Valle del Lili |
ClinicalTrials.gov Identifier: | NCT04627467 |
Other Study ID Numbers: |
FVL-1567 |
First Posted: | November 13, 2020 Key Record Dates |
Last Update Posted: | October 7, 2021 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Chloroquine COVID-19 SARS-CoV-2 |
Antibodies Prophylaxis Healthcare workers |
COVID-19 Infections Respiratory Tract Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections |
Lung Diseases Respiratory Tract Diseases Chloroquine Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Antimalarials Antirheumatic Agents |