Trial ChiCTR2000030054
Publication Chen L, medRxiv, 2020 (preprint)
Dates: 2/18/2020 to 3/30/2020
Funding: Public (Medical and Health Key project of Xiamen, a project of the Xiamen Science and Technology Bureau)
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Single center / China Follow-up duration (days): 28 | |
| Inclusion criteria | 1. Aged 18-75 years old; 2. RT-PCR positive for 2019-nCoV or Confirmed lung involvement with chest imaging; 3. The clinical symptoms are slight, and there is no obvious manifestation of pneumonia (mild disease) or clinical symptoms such as fever and respiratory tract in imaging. The manifestation of pneumonia (common type) can be seen in imaging; 4. <=7 days since onset of the disease; 5. Willingness of study participant to accept randomization to any assigned treatment arm; 6. Must agree not to enroll in another study of an investigational agent prior to completion of Day 28 of study. |
| Exclusion criteria | 1. Investigator makes a decision that trial participation is not in patients' best interest, or any condition that does not allow the protocol to be followed safely; 2. As judged by investigator historic or current diseases that may have impact on the subjects participation of the study or the study outcome. These diseases include but not limited to cardiac disease and arrhythmia and QT prolongation), neurological disease psychiatric disease,active bleeding, serious malnutrition and endocrine disease; currently complicated with serious respiratory disease or that seriously affect immune system, such as flu, COPD, asthma, HIV infection, blood system disease, or splenectomy, organ transplantation etc.; 3. Severe liver disease (AST>3 ULN); 4. Patients with known severe renal impairment (estimated glomerular filtration rate <=60 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis; 5. QT elongation; 6. Allergic to chloroquine or hydroxychloroquine; 7. Pregnant or breastfeeding, or positive pregnancy test in a predose examination; 8. Will be transferred to another hospital within 72 hours; 9. Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within the 14 days prior to the time of the screening evaluation. |
| Interventions | |
| Treatment 1 Hydroxychloroquine (200mg) Co-Intervention: Standard care Duration : 10 days | |
| Control Chloroquine (1000mg ini) Co-Intervention: Standard care Duration : 10 days | |
| Control Standard care | |
| Participants | |
| Randomized 67 participants n1=25/ n2=28/ n3=14 | |
| Characteristics of participants N=67 Mean age : 50 22 males Severity : Mild: n=0 / Moderate: n=48/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register Clinical recovery time | |
| In the report The primary outcome measurement for this study was time to clinical recovery (TTCR), defined as the number of days from randomization to clinical recovery. | |
| Documents available |
Protocol Yes 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 |
High |
| 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 did not achieve the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. The initial inclusion criteria included mild patients who were then removed after randomization. Table 1 reported characteristics for moderate patients only. 5 additional patients excluded before outcome analysis because they were asymptomatic. No pre-specified statistical analysis plan. Statistical measures (OR, RR, HR) were not reported; PO reported as median days (IQR). Data analysis is pending required information on outcomes |