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)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / Taiwan
Follow-up duration (days): 14
Inclusion criteriaEnrolled 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 criteriaParticipants 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
Definition of Standard care: supportive treatment for subjects with mild clinical COVID-19 symptoms and antimicrobial therapy for subjects presenting with moderate clinical COVID-19 symptoms. The treatment consisted of:
(1) ceftriaxone 2 g daily for 7 days +/- azithromycin 500 mg on day 1 and 250 mg on days 2-5; or
(2) levofloxacin 750 mg daily for 5 d; or
(3) levofloxacin 500 mg daily; or
(4) moxifloxacin 400 mg daily for 7-14 days for subjects allergic to ceftriaxone or azithromycin or according to physician discretion.
Oseltamivir 75 mg b.i.d. will be administered for 5 days to subjects presenting with concomitant influenza A or B infection.
Participants
Randomized
33 participants (n1=21 / n2= 12)
Characteristics of participants
N=33
Mean age : 32.9
19 males
Severity : Mild: n=29 / Moderate: n=4/ Severe: n=0 Critical: n=0
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 stated

Yes
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.