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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 : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Fundacion Clinica Valle del Lili

Study Description
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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
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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
Estimated Study Completion Date : February 14, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Colombia
Fundacion Valle del Lili
Cali, Valle Del Cauca, Colombia, 760032
Sponsors and Collaborators
Fundacion Clinica Valle del Lili
Investigators
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Principal Investigator: Juan D Velez, MD Fundacion Clinica Valle del Lili
More Information
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Publications of Results:
WHO. Coronavirus disease 2019 (COVID-19). Situation Report - 43 2020 [Available from: https://www.who.int/emergencies/diseases/novel-coronavirus2019/technicalguidance/laboratoryguidance
Wang M, Su S, Lv J, Zhou G, Wang Q, Guo C. Analysis of clinical features and prognostic factors in Chinese patients with rheumatic diseases in an intensive care unit. The Egyptian Rheumatologist. 2018;40(1):63-6.
Su A. Doctors and nurses fighting coronavirus in China die of both infection and fatigue. Los Angeles Times. 2020.
Hydroxychloroquine Chemoprophylaxis in Healthcare Personnel in Contact With COVID-19 Patients (PHYDRA Trial) - Full Text View. ClinicalTrials.gov.
Chloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting - Full Text View. ClinicalTrials.gov
Treatment of COVID-19 Cases and Chemoprophylaxis of Contacts as Prevention - Full Text View. ClinicalTrials.gov
IDOATE A, IDOIPE Á. 2.4. Investigación y ensayos clínicos.

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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: November 13, 2020
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundacion Clinica Valle del Lili:
Chloroquine
COVID-19
SARS-CoV-2
 Antibodies
Prophylaxis
Healthcare workers
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Chloroquine
 Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antirheumatic Agents