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

NCT04627467 | Completed Phase 2 DMC

• 1 other identifier: FVL-1567
• Study Type: interventional
• Target: 3,217
• Locations: 1 country
• Sites: 1

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)

Conditions

Covid19

Keywords

Chloroquine; COVID-19; SARS-CoV-2; Antibodies; Prophylaxis; Healthcare workers

Outcome Measures

Primary Outcomes (6)

• COVID-19 infection

  Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample

  Day 15

• COVID-19 infection

  Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample

  Day 30

• COVID-19 infection

  Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample

  Day 45

• COVID-19 infection

  Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample

  Day 60

• COVID-19 infection

  Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample

  Day 75

• COVID-19 infection

  Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample

  Day 90

Secondary Outcomes (1)

• IgG antibodies seropositivity against SARS-CoV-2

  Day 90

Other Outcomes (4)

• Adverse drug event

  Day 15, day 30, day 45, day 60, day 75 and day 90

• Unexpected adverse events

  Day 15, day 30, day 45, day 60, day 75 and day 90

• Participant drop-out

  Baseline and day 90

Study Arms (1)

Chloroquine 150mg base

EXPERIMENTAL

Volunteers received chloroquine tablets orally at days 0, 15, 30, 45, 60 and 75.

Drug: Chloroquine

Interventions

Chloroquine DRUG

250mg tablet (150mg base chloroquine)

Chloroquine 150mg base

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Asymptomatic healthcare workers and contractors who work in Fundacion Valle del Lili

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Fundacion Clinica Valle del Lili: lead

Study Sites (1)

Fundacion Valle del Lili

Cali, Valle del Cauca Department, 760032, Colombia

Location

Related Publications (28)

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MeSH Terms

Conditions

COVID-19

Interventions

Chloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Juan D Velez, MD

  Fundacion Clinica Valle del Lili

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 13, 2020
• Study Start: March 28, 2020
• Primary Completion: July 9, 2020
• Study Completion: September 30, 2021
• Last Updated: October 7, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)