Skip to content

HYDROXYCHLOROQUINE TO PREVENT SARS-COV-2 INFECTION

HYDROXYCHLOROQUINE TO PREVENT SARS-COV-2 INFECTION AMONG HEALTHCARE WORKERS: RANDOMIZED CONTROLLED, OPEN-LABEL, PHASE 3 CLINICAL TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-011-20
Enrollment
320
Registered
2020-05-14
Start date
2020-05-11
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

None listed

Interventions

Loading dose of 600mg of hydroxychloroquine orally, followed by 400mg of hydroxychloroquine every other day for 8 weeks and use of measures of personal protection. Group name:Arm 2 Type of group
Use of measures of personal protection.

Sponsors

UNIVERSIDAD PERUANA CAYETANO HEREDIA,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: A. Healthcare workers in service during the COVID-19 outbreak including medical, nurse, technical and auxiliary staff. B. Negative rapid serologic and molecular testing for SARS-CoV-2. C. Written informed consent.

Exclusion criteria

Exclusion criteria: A. Presents COVID-19 symptoms including cough, fever, myalgias, headaches, loss of smell and taste B. Prior (last 30 days) or current (or planned use during the study period) use of hydroxychloroquine, chloroquine sulfate or azithromycin. C. Known history of prolonged QT syndrome. D. Known allergy or intolerance to hydroxychloroquine. E. Use of concomitant medications that are contraindicated with the use of hydroxychloroquine. F. Participation might not be beneficial, by investigator judgement.

Design outcomes

Primary

MeasureTime frame
Outcome name:Positive confirmatory or serologic testing for SARS-CoV-2 Measure:Efficacy Timepoints:4 and 8 weeks ; Outcome name:Proportion of patients with grade 3 or more adverse events Measure:Safety Timepoints:4 and 8 weeks

Secondary

MeasureTime frame
Outcome name:Proportion of participants that discontinue prophylactic treatment due to grade 1 o 2 adverse events Measure:Tolerability Timepoints:4 and 8 weeks

Countries

Peru

Contacts

Public ContactAlvaro Schwalb

UNIVERSIDAD PERUANA CAYETANO HEREDIA

alvaro.schwalb@upch.pe988054875

Outcome results

None listed

Source: REPEC (via WHO ICTRP)