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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04384380
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : May 12, 2020
Sponsor:
Collaborators:
Center for Drug Evaluation, Taiwan
Centers for Disease Control, Taiwan
Taiwan Food and Drug Administration
National Health Research Institutes, Taiwan
Information provided by (Responsible Party):
Taoyuan General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Coronavirus Infection Drug: Hydroxychloroquine Sulfate 200 MG [Plaquenil] Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study will employ an open-label parallel design, to evaluate the efficacy and safety between hydroxychloroquine sulfate (plaquenil) and controlled standard of care treatment. The administration plan of HCQ is 400 mg bid on Day 1 and 200 mg bid for 6 days on Day 2-7. All of the enrolled subjects will receive standard of care. The comparison group will receive standard of care, i.e., supportive treatment for subjects with mild COVID-19 clinical illness.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : September 30, 2020


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 Name: 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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Virologic assessment [ Time Frame: 14 days ]
    To evaluate the efficacy of HCQ in the aspect of virologic assessments in COVID-19 patients

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04384380


Contacts
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Contact: Shu-Hsing Cheng, Dr. +886-3-3699721 ext 8364 shcheng@mail.tygh.gov.tw

Locations
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Taiwan
Taoyuan General Hospital, Ministry of Health and Welfare Recruiting
Taoyuan City, Taiwan, 320
Contact: YUNG-NIEN HSU, Dean    +886-3-3699721 ext 4572    hsu5003@mail.tygh.gov.tw   
Principal Investigator: Shu-Hsing Cheng, Dr.         
Sub-Investigator: Chien-Yu Cheng, Dr.         
Sub-Investigator: Yi-Chun Lin, Dr.         
Sub-Investigator: Jang-bin Chen, Dr.         
Sponsors and Collaborators
Taoyuan General Hospital
Center for Drug Evaluation, Taiwan
Centers for Disease Control, Taiwan
Taiwan Food and Drug Administration
National Health Research Institutes, Taiwan
Investigators
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Principal Investigator: Shu-Hsing Cheng, Dr. Taoyuan General Hospital, Ministry of Health and Welfare
  Study Documents (Full-Text)

Documents provided by Taoyuan General Hospital:
Study Protocol  [PDF] March 29, 2020

Publications of Results:

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Responsible Party: Taoyuan General Hospital
ClinicalTrials.gov Identifier: NCT04384380    
Other Study ID Numbers: TYGH109014
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The study outcome will be shared with the experts and persons interested in this field.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taoyuan General Hospital:
COVID-19
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents