Prophylactic Benefit of Hydroxychloroquine in COVID-19 Cases With Mild to Moderate Symptoms and in Healthcare Workers With High Exposure Risk

Prophylactic Benefit of Hydroxychloroquine in COVID-19 Cases With Mild to Moderate Symptoms and in Healthcare Workers With High Exposure Risk (PREVENT)

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04371926

Acronym

PREVENT

Enrollment

Registered

2020-05-01

Start date

2020-06-30

Completion date

2021-07-31

Last updated

2020-06-04

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

Conditions

COVID-19

Brief summary

Few studies have reported the efficacy of HCQ in reducing the viral load and improving the severity of symptoms in hospitalized COVID-19 cases with serious respiratory infection. However, the prophylactic benefits of HCQ has not been clearly defined yet.

Detailed description

This study is designed to evaluate the prophylactic efficacy of HCQ in COVID-19 cases with mild to moderate symptoms and in the hospital staff engaged in attending infected patients.

Interventions

DRUGHydroxychloroquine Sulfate

Patients will receive hydroxychloroquine sulfate 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course. Staff will receive HCQ sulfate 400mg/week for 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Intervention model description

Symptomatic patients will be randomized to hydroxychloroquine (HCQ) vs no-HCQ group. Similarly, hospital staff with high risk of exposure will be randomized to HCQ vs no-HCQ group

Eligibility

Sex/Gender

ALL

Age

18 Months to 85 Years

Healthy volunteers

Inclusion criteria

* Male or female over 18 years of age at the time of enrollment * COVID-19 test positive patients with mild-moderate symptoms including fever \>37.50 F * Consecutive consenting staff at ICU, ER and COVID-19 unit that have never been diagnosed with COVID-19

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Time to reach normal body temperature	1 month	Time to reach normal body temperature (TNBT), ≤37.50 C
Development of COVID-19 symptoms during HCQ preventive therapy in staff	1 month	Development of fever and/or other symptoms of COVID-19 during the 1 month of the HCQ therapy

Secondary

Measure	Time frame	Description
COVID-19 test result at follow-up in patients	6 days	Viral RNA test results at day 6 will be compared between the HCQ vs no-HCQ group
Worsening of symptoms in COVID-19 patients	1 month	Worsening of symptoms in COVID-19 patients requiring artificial ventilation during the study period

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026