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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 : Active, not recruiting
First Posted : November 13, 2020
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Fundacion Clinica Valle del Lili

Tracking Information
First Submitted Date  ICMJE October 30, 2020
First Posted Date  ICMJE November 13, 2020
Last Update Posted Date April 6, 2021
Actual Study Start Date  ICMJE March 28, 2020
Actual Primary Completion Date July 9, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2020)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2020)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 11, 2020)
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Prevention With Chloroquine in Health Personnel Exposed to Infection With Coronavirus Disease 2019 (COVID-19) (TS-COVID)
Official Title  ICMJE Prophylaxis With Chloroquine in Health Personnel Exposed to Infection With Coronavirus Disease 2019 (COVID-19)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Covid19
Intervention  ICMJE Drug: Chloroquine
250mg tablet (150mg base chloroquine)
Study Arms  ICMJE Experimental: Chloroquine 150mg base
Volunteers received chloroquine tablets orally at days 0, 15, 30, 45, 60 and 75.
Intervention: Drug: Chloroquine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 11, 2020)
3217
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Actual Primary Completion Date July 9, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04627467
Other Study ID Numbers  ICMJE FVL-1567
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Fundacion Clinica Valle del Lili
Study Sponsor  ICMJE Fundacion Clinica Valle del Lili
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Juan D Velez, MD Fundacion Clinica Valle del Lili
PRS Account Fundacion Clinica Valle del Lili
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP