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Efficacy and Tolerability of Hydroxychloroquine in Adult Patients With COVID-19

NCT04384380 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2020-08-04

No results posted yet for this study

Summary

The effective medical treatment against COVID-19 infection is still unknown. Chloroquine phosphate is a well-known antimalarial drug which has been on the market for many years. Recently, in vitro study shown that Chloroquine is effective at both entry and at post-entry stages of the COVID-19 infection of Vero E6 cells with promising results. Chloroquine is also an immune-modifier and could distribute to the whole body including lung. Also, chloroquine is cheap and safe, and could be a promising agent against COVID-19 infection. However, only hydroxychloroquine (HCQ) with the extra hydroxyl group is available in Taiwan. Therefore, hydroxychloroquine instead become the best choice for the treatment candidate, since it shows higher in vitro potency (EC50) against COVID-19 with lower toxicity while retaining the original effect which compared with chloroquine.

Conditions

  • Coronavirus Infection

Interventions

DRUG

Hydroxychloroquine Sulfate 200 MG [Plaquenil]

Hydroxychloroquine Sulfate is 400 mg bid on Day 1 and 200 mg bid for 6 days on Day 2-7.

Sponsors & Collaborators

  • Center for Drug Evaluation, Taiwan

    collaborator UNKNOWN

  • Centers for Disease Control, Taiwan

    collaborator OTHER_GOV

  • Taiwan Food and Drug Administration

    collaborator UNKNOWN

  • National Health Research Institutes, Taiwan

    collaborator OTHER

  • Taoyuan General Hospital

    lead OTHER_GOV

Principal Investigators

  • Shu-Hsing Cheng, Dr. · Taoyuan General Hospital, Ministry of Health and Welfare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2020-05-31
Completion
2020-05-31

Countries

  • Taiwan

Study Locations

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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 NCT04384380 on ClinicalTrials.gov