Clinical trial: Efficacy and Tolerability of Hydroxychloroquine in Adult Patients With COVID-19 (NCT04384380)

Eligibility 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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 79 Years

Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Entailment