Status:
COMPLETED
Efficacy and Tolerability of Hydroxychloroquine in Adult Patients With COVID-19
Lead Sponsor:
Taoyuan General Hospital
Collaborating Sponsors:
Center for Drug Evaluation, Taiwan
Centers for Disease Control, Taiwan
Conditions:
Coronavirus Infection
Eligibility:
All Genders
20-79 years
Phase:
NA
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 stu...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
- Willing and able to comply with the study procedure and sign a written informed consent
Exclusion
- Patients with the medical history of hypersensitivity to chloroquine, chloroquinine, or hydroxychloroquine
- Patients with retinal disease, hearing loss, severe neurological and mental illness
- Patients with pancreatitis
- 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
- 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
- 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)
- 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
- Patients with concomitant use of medications that alter the absorption or excretion of hydroxychloroquine
- Patients were considered to be unable to complete the study, or not suitable for the study judged by Investigators
- Pregnant or breast-feeding women
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2020
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04384380
Start Date
April 1 2020
End Date
May 31 2020
Last Update
August 4 2020
Active Locations (1)
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1
Taoyuan General Hospital, Ministry of Health and Welfare
Taoyuan, Taiwan, 320