A Phase 2 interventional study of Chloroquine in Covid19, sponsored by Fundacion Clinica Valle del Lili. Completed at 1 site in Colombia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-07.
Sponsored by Fundacion Clinica Valle del Lili · Phase 2, Interventional, and Prevention
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)
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.
7,641 studies on the registry are indexed under COVID-19; 487 are open to participants now.
This study's enrollment of 3,217 is above the median of 100 across 4,100 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Fundacion Clinica Valle del Lili is the lead sponsor of 23 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Volunteers received chloroquine tablets orally at days 0, 15, 30, 45, 60 and 75.
Drug: Chloroquine
250mg tablet (150mg base chloroquine)
COVID-19 infection
Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
Time frame: Day 15
COVID-19 infection
Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
Time frame: Day 30
COVID-19 infection
Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
Time frame: Day 45
COVID-19 infection
Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
Time frame: Day 60
COVID-19 infection
Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
Time frame: Day 75
COVID-19 infection
Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
Time frame: Day 90
IgG antibodies seropositivity against SARS-CoV-2
Number of participants with IgG antibodies seropositivity against SARS-CoV-2 in the final sample.
Time frame: Day 90
Adverse drug event
Number of participants with at least one adverse drug event
Time frame: Day 15, day 30, day 45, day 60, day 75 and day 90
Unexpected adverse events
Number of participants with unexpected adverse events
Time frame: Day 15, day 30, day 45, day 60, day 75 and day 90
Participant drop-out
Number of participants who did not completed prophylaxis because of discontinuing medication, withdrawal of consent, or lost to follow-up
Time frame: Baseline and day 90
Non-adherence
Number of participants who were not-adherent to the medication scheme
Time frame: Baseline and day 90
Plan to share: No — We do not plan to share IPD, since we are not allowed to share information concerning medical history of our patients or health workers.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fundacion Clinica Valle del Lili