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OpenTrials
Completed

NCT Number: NCT04627467

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

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)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fundacion Valle del Lili

Cali, Valle del Cauca Department, 760032, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chloroquine

Drug

250mg tablet (150mg base chloroquine)

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. 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.

Other outcomes

  1. 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

  2. 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

  3. 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

  4. Non-adherence

    Time frame: Baseline and day 90

    Number of participants who were not-adherent to the medication scheme

Sponsors and collaborators

Lead sponsor

Fundacion Clinica Valle del Lili

Other

Registry information

Official study title

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

Acronym: TS-COVID

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Nov 13, 2020
Registry last updated
Oct 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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