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Hydroxychloroquine Chemoprophylaxis for COVID-19 Infection in High-risk Healthcare Workers.

NCT04370015 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 374

Last updated 2020-05-06

No results posted yet for this study

Summary

Healthcare personnel are at an increased risk of exposure to SARS-CoV-2 infection while handling such patients. Currently, there is no treatment available for SARS-CoV-2 and stringent preventive measures are advised to avoid or minimize risk of exposure to healthcare workers. There are in vitro studies available which show inhibition of corona virus by hydroxychloroquine, a widely-used agent against malaria and certain autoimmune conditions and of low-cost and limited toxicity. However, evidence regarding its effects in patients is limited. We plan to conduct a randomized controlled trial to evaluate the safety and potential prophylactic efficacy of hydroxychloroquine in preventing secondary SARS-CoV-2 infection among healthcare workers at high-risk of exposure while managing such patients.

Conditions

Interventions

DRUG

Hydroxychloroquine

Health care workers at high risk of contracting SARS-CoV-2 randomized to this arm will be treated with oral hydroxychloroquine 400 mg twice a day (four 200 mg tablets) on day 1 followed by 400mg (two 200 mg tablets) once a week for 11 weeks.

DRUG

Placebo oral tablet

• Health care workers at high risk of contracting SARS-CoV-2 randomized to this arm will be treated with placebo twice a day (four tablets) on day 1 followed by 2 tablets once a week for 11weeks.

Sponsors & Collaborators

  • Services Institute of Medical Sciences, Pakistan

    lead OTHER_GOV

Principal Investigators

  • Saira Burney, FRCP (Edin) · SIMS

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-15
Primary Completion
2020-06-30
Completion
2020-10-15

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04370015 on ClinicalTrials.gov