COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04384380

Shu-Hsing Cheng

shcheng@mail.tygh.gov.tw

2020-05-12

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: 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

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

2

Taoyuan General Hospital

20

79

Taiwan

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

33

Time to negatively RT-PCR

None

Not reported

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]