Overview

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

Status:
Completed
Trial end date:
2020-05-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Taoyuan General Hospital
Collaborators:
Center for Drug Evaluation, Taiwan
Centers for Disease Control, Taiwan
National Health Research Institutes, Taiwan
Taiwan Food and Drug Administration
Treatments:
Hydroxychloroquine
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