Chemoprophylaxis with chloroquine in a high-risk population for the prevention of SARS-CoV-2 infections severity of infection.

Chloroquine chemoprophylaxis in a high-risk population for the prevention of SARS-CoV-2 infections severity of infection. Randomized clinical trial of phase III

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-7bxhrt

Enrollment

Unknown

Registered

2020-07-14

Start date

2020-05-25

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus

Interventions

Experimental study. Randomized in 3 arms: 1 standard care group (with n = 200) and 2 possible chloroquine regimens, with doses of: • 150 mg / day for 120 days (weekend medication break)(with n = 400)

Drug

D03.633.100.810.050.180

E02.319.162

Eligibility

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Health professionals attending patients with suspected SARS-CoV-2 infection. sign the informed consent. Willing to adhere to the study protocol.

Exclusion criteria

Exclusion criteria: Known allergy to the study drug (aminoquinolines). flu-related symptoms at the time of inclusion. Previous or current SARS-Cov2 infection confirmed. Known pregnancy (no pregnancy test required). History of retinopathy. ECG changes with enlargement of the QT interval. Weight less than 40 kg Participant with any immunosuppressive condition or hematological disease. Treatment with drugs that can prolong the QT interval or increase the number of adverse events in the last month before randomization for more than 7 days, including: azithromycin, chlorpromazine, cisapride, clarithromycin, domperidone, droperidol, erythromycin, halofantrine, haloperidol, lumefantrine, mefloquine, methadone, pentamidine, procainamide, cimetidine, quinidine, quinine, sotalol, sparfloxacin, thioridazine, amiodarone, Dapsone

Design outcomes

Primary

Measure	Time frame
The incidence of COVID-19 cases confirmed by PCR during the first month.	—

Secondary

Measure	Time frame
Kinetics of viral load in infected patients.;Incidence and severity of adverse events referred through a self-reported questionnaire;Incidence of adverse events that lead to discontinuation of treatment.;Qualitative studies (well-being, acceptability, adherence to recommended prevention measures).;Incidence of cases confirmed by COVID-19 PCR during the second month and at the end of the study (3M).;Clinical severity of COVID-19 cases during follow-up (clinical score to be confirmed).;Proportion of patients with seroconversion at the end of the follow-up.;Duration of clinical parameters (The Influenza Intensity and Impact Questionnaire (FluiiQ ™).;Number of hospitalizations required during follow-up.	—

Measure

Time frame

Kinetics of viral load in infected patients.;Incidence and severity of adverse events referred through a self-reported questionnaire;Incidence of adverse events that lead to discontinuation of treatment.;Qualitative studies (well-being, acceptability, adherence to recommended prevention measures).;Incidence of cases confirmed by COVID-19 PCR during the second month and at the end of the study (3M).;Clinical severity of COVID-19 cases during follow-up (clinical score to be confirmed).;Proportion of patients with seroconversion at the end of the follow-up.;Duration of clinical parameters (The Influenza Intensity and Impact Questionnaire (FluiiQ ™).;Number of hospitalizations required during follow-up.

—

Countries

Brazil

Contacts

Public ContactNínive Pinto

Fundação Oswaldo Cruz

ninive.upc.uff@gmail.com21989953416

Outcome results

None listed

Source: REBEC (via WHO ICTRP)