Covid19
Conditions
Keywords
Chloroquine, COVID-19, SARS-CoV-2, Antibodies, Prophylaxis, Healthcare workers
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.
Interventions
DRUGChloroquine
250mg tablet (150mg base chloroquine)
Sponsors
Fundacion Clinica Valle del Lili
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 infection | Day 15 | Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IgG antibodies seropositivity against SARS-CoV-2 | Day 90 | Number of participants with IgG antibodies seropositivity against SARS-CoV-2 in the final sample. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse drug event | 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 | Day 15, day 30, day 45, day 60, day 75 and day 90 | Number of participants with unexpected adverse events |
| Participant drop-out | 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 | Baseline and day 90 | Number of participants who were not-adherent to the medication scheme |
Countries
Colombia
Outcome results
None listed