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

Covid19 Clinical Trial

— TS-COVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04627467
• Other study ID #: FVL-1567
• Status: Completed
• Phase: Phase 2
• Start date: March 28, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: September 2020
• Source: Fundacion Clinica Valle del Lili
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3217
• Est. completion date: September 30, 2021
• Est. primary completion date: July 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Chloroquine
250mg tablet (150mg base chloroquine)

Locations

Country	Name	City	State
Colombia	Fundacion Valle del Lili	Cali	Valle Del Cauca

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Clinica Valle del Lili

Country where clinical trial is conducted

Colombia, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse drug event	Number of participants with at least one adverse drug event	Day 15, day 30, day 45, day 60, day 75 and day 90
Other	Unexpected adverse events	Number of participants with unexpected adverse events	Day 15, day 30, day 45, day 60, day 75 and day 90
Other	Participant drop-out	Number of participants who did not completed prophylaxis because of discontinuing medication, withdrawal of consent, or lost to follow-up	Baseline and day 90
Other	Non-adherence	Number of participants who were not-adherent to the medication scheme	Baseline and day 90
Primary	COVID-19 infection	Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample	Day 15
Primary	COVID-19 infection	Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample	Day 30
Primary	COVID-19 infection	Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample	Day 45
Primary	COVID-19 infection	Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample	Day 60
Primary	COVID-19 infection	Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample	Day 75
Primary	COVID-19 infection	Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample	Day 90
Secondary	IgG antibodies seropositivity against SARS-CoV-2	Number of participants with IgG antibodies seropositivity against SARS-CoV-2 in the final sample.	Day 90