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

July 31, 2020 updated by: Taoyuan General Hospital

A Multi-center, Randomized, Open-label, Controlled Trial to Evaluate the Efficacy and Tolerability of Hydroxychloroquine (HCQ) in Adult Patients With Mild to Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

On December 31, 2019, an outbreak of respiratory illness later proved to be caused by a novel coronavirus, officially named Coronavirus Disease 2019 (COVID-19), was notified first in Wuhan, a city of Hubei province, People's Republic of China (PRC). COVID-19 rapidly spreads in China and to other parts of the world. Currently more than 370,000 laboratory-confirmed cases have been reported worldwide, and the case count has been rising daily, and caused a global health emergency. As of March 29, 2020, there were 298 confirmed cases in Taiwan.

This is a multi-center, randomized, open-label, controlled trial to evaluate the efficacy and tolerability of Hydroxychloroquine Sulfate (HCQ) in adult Patients with mild to moderate coronavirus disease (COVID-19) compared to standard of care treatment (SOC). The primary endpoint for the study is to evaluate the efficacy of HCQ, with respect to the time to negatively rRT-PCR assessments from the randomization date up to 14 days. The secondary endpoint is to evaluate the efficacy of HCQ in the aspect of virological assessments and the change of clinical symptoms. In addition, the safety and tolerability of HCQ will be evaluated during treatment period in COVID-19 patients.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan City, Taiwan, 320
        • Taoyuan General Hospital, Ministry of Health and Welfare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients who had fever (central temperature ≥38°C) or acute upper respiratory symptoms and laboratory confirmation (rRT-PCR) for COVID-19, with available same type of upper respiratory tract specimens from screening evaluation to the initial testing within 4 days of initial testing

  2. Patients have mild (no pneumonia) to moderate disease (pneumonia without respiratory distress) according to the following World Health Organization (WHO) definition of COVID-19 clinical syndromes:

    • Mild (Mild illness):

    Patients with uncomplicated upper respiratory tract viral infection, may have non-specific symptoms such as fever, fatigue, cough (with or without sputum production), anorexia, malaise, muscle pain, sore throat, dyspnea, nasal congestion, or headache. Rarely, patients may also present with diarrhoea, nausea and vomiting.

    • Moderate (Pneumonia):

    Adult with pneumonia but no signs of severe pneumonia and no need for supplemental oxygen.

  3. Willing and able to comply with the study procedure and sign a written informed consent

Exclusion Criteria:

  1. Patients with the medical history of hypersensitivity to chloroquine, chloroquinine, or hydroxychloroquine
  2. Patients with retinal disease, hearing loss, severe neurological and mental illness
  3. Patients with pancreatitis
  4. Patients with severe lung, liver (alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevation more than 3 times the normal upper limit), kidney (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73m2, using the MDRD or CKD-EPI methods), brain, haematological diseases or other important systemic diseases
  5. Medical history of uncontrolled but clinically significant abnormal cardiac conduction abnormalities at electrocardiogram (ECG) at screening, any history or evidence of long QT syndrome or QTcF interval >450 msec for males and >470 msec for females (according to Fridericia's correction) at screening
  6. Known HIV infection; active hepatitis B or C without concurrent treatment (positive tests for hepatitis B [both HBsAg and HBeAg], or high titer of hepatitis C ribonucleic acid [RNA] >800,000 IU/ml)
  7. Uncontrolled and unstable concurrent medical condition including psychiatric disorders and alcohol/substance dependence/abuse that will jeopardize the safety of the patient, interfere with the objectives of the study, or affect the patient compliance with study requirements, as determined by the Investigator
  8. Patients with concomitant use of medications that alter the absorption or excretion of hydroxychloroquine
  9. Patients were considered to be unable to complete the study, or not suitable for the study judged by Investigators
  10. Pregnant or breast-feeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HCQ in adult Patients with COVID-19
The administration plan of HCQ is 400 mg bid on Day 1 and 200 mg bid for 6 days on Day 2-7.
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.
Other Names:
  • Plaquenil
No Intervention: standard of care treatment (SOC)
The comparison group will receive standard of care, i.e., supportive treatment for subjects with mild COVID-19 clinical illness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to negatively RT-PCR
Time Frame: 14 days
To evaluate the efficacy of HCQ, with respect to the time to negatively RT-PCR assessments in COVID-19 patients.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Virologic assessment
Time Frame: 14 days
To evaluate the efficacy of HCQ in the aspect of virologic assessments in COVID-19 patients
14 days
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 28 days
To evaluate the safety and tolerability of HCQ
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taoyuan General Hospital

Collaborators

National Health Research Institutes, Taiwan
Centers for Disease Control, Taiwan
Center for Drug Evaluation, Taiwan
Taiwan Food and Drug Administration

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

May 31, 2020

Study Completion (Actual)

May 31, 2020

Study Registration Dates

First Submitted

April 7, 2020

First Submitted That Met QC Criteria

May 10, 2020

First Posted (Actual)

May 12, 2020

Study Record Updates

Last Update Posted (Actual)

August 4, 2020

Last Update Submitted That Met QC Criteria

July 31, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TYGH109014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study outcome will be shared with the experts and persons interested in this field.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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