Covid-19 Living Data

Trial NCT04384380
Publication Chen CP, Plos one (2020) (published paper)
Dates: 01/04/2020 to 31/05/2020
Funding: Mixed (Hospital and Social Welfare Organizations Administration Commission, Ministry of Health and Welfare, Taiwan biotec donation of investigational products)
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / Taiwan Follow-up duration (days): 14
Inclusion criteria	Enrolled patients were aged 20-79 y and confirmed positive for SARS-CoV-2 infection by real-time reverse transcription polymerase chain reaction (rRT-PCR). They provided signed informed consent. Patients with mild and moderate illness.
Exclusion criteria	Participants presenting with severe illness were excluded from this study. The following patients were excluded from the trial: (a) documented history of hypersensitivity to quinine derivatives (b) retinal disease (c) hearing loss (d) severe neurological or mental illness (e) pancreatitis (f) lung disease (g) liver disease (alanine aminotransferase (ALT)/aspartate aminotransferase (AST) > 3x the normal upper limit) (h) kidney disease (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2 according to MDRD or CKD-EPI) (i) hematological disease (j) cardiac conduction abnormalities at electrocardiographic (ECG) screening with long QT syndrome or QTcF interval > 450 msec for males and > 470 msec for females according to Fridericias correction at screening (k) known HIV infection (l) active hepatitis B or C without concurrent treatment (positive for hepatitis B [HBsAg and HBeAg] or hepatitis C ribonucleic acid [RNA] titer > 800,000 IU/mL) (m) G6PD (n) psychiatric disorders and alcohol/substance dependence/abuse that may jeopardize patient safety and (o) pregnant or breast-feeding women.
Interventions
	Treatment Hydroxychloroquine 200 mg orally twice daily on day 1 or 200 mg twice daily for 6 days
	Control Standard care
Participants
	Randomized participants : Hydroxychloroquine=21 Standard care=12
	Characteristics of participants N= 33 Mean age : NR 19 males Severity : Mild: n=29 / Moderate: n=4 / Severe: n=0 Critical: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register Time to negatively RT-PCR [ Time Frame: 14 days ]
	In the report Time to negative rRT-PCR assessments from randomization up to 14 days
Documents available	Protocol Yes. In English Statistical plan NR Data-sharing willing stated in the publication:
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to all available versions of the published article, pre-print article, the study registry, protocol and data from direct contact to authors were used in data extraction and risk of bias assessment. The study achieved the target sample size reported in the registry. There is no change from the trial registration in the intervention and control treatments. No pre-specified statistical analysis plan is available. There is no change from the trial registration in the primary outcome. Some secondary outcomes in the report are not present in the registry. One secondary outcome stated in the paper, 'the proportion of discharge by day 14', was not reported. This study was updated on August 12th with data from contact with authors. This study was updated on December 9th with data from the published manuscript.