Trial ChiCTR2000029559
Publication Chen Z, medRxiv, 2020 (preprint)
Dates: 04feb2020 to 28feb2020
Funding: Public/non profit (Epidemiological Study of COVID-19 Pneumonia to Science and Technology Department of Hubei Province)
Conflict of interest: No

Methods
RCT
Blinding: double blinding
Location : Single center / China
Follow-up duration (days): 6
Inclusion criteria1. Age >/= 18 years;
2. Laboratory (RT-PCR) positive of SARS-CoV-2;
3. Chest CT with pneumonia;
4. SaO2/SPO2 ratio > 93% or PaO2/FIO2 ratio > 300 mmHg under the condition in the hospital room (mild illness);
5. Willing to receive a random assignment to any designated treatment group and not participating in another study at the same time.
Exclusion criteria1. Severe/Critical illness patients or participating in the trial does not meet the patient's maximum benefit or does not meet any criteria for safe follow-up in the protocol after a doctor’s evaluation;
2. Retinopathy and other retinal diseases;
3. Conduction block and other arrhythmias;
4. Severe liver disease (e.g., Child-Pugh score >/= C or AST> twice the upper limit);
5. Pregnant or breastfeeding;
6. Severe renal failure [estimated glomerular filtration rate (eGFR) 7. Possibility of being transferred to another hospital within 72 h;
8. Received any trial treatment for COVID-19 within 30 days before this research
Interventions
Treatment
Hydroxychloroquine
200 mg orally twice a day for 5 days
Control
Standard care
Definition of Standard care: "All received the standard treatment (oxygen therapy, antiviral agents, antibacterial agents, and immunoglobulin, with or without corticosteroids), patients in the HCQ treatment group received additional oral HCQ (hydroxychloroquine sulfate tablets, Shanghai Pharma) 4** mg/d (2** mg/bid) between days 1 and 5 (Figure 1), patients in the control group with the standard treatment only. "
Duration : 5 days
Participants
Randomized
62 participants (n1=31 / n2= 31)
Characteristics of participants
N=62
Mean age : 44.7
29 males
Severity : Mild: n=0 / Moderate: n=62/ Severe: n=0 Critical: n=0
Primary outcome
In the register
The time when the nucleic acid of the novel coronavirus turns negative and T cell recovery time
In the report
NR
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing stated

No
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/pre-print article, the study registry was used in data extraction and risk of bias assessment. The study was initially registered as a 3-arm RCT, with a placebo-control arm and two arms receiving hydrochloroquine. It did not achieve the target sample size specified in the trial registry. Neither of the outcomes specified in the registry as primary is reported in the paper. Some outcomes (time to recovery, pulmonary recovery base on chest CT scan improvement, adverse events) are reported in the paper, but was not pre-specified in the trial registry/protocol.