Trial ChiCTR2000029542
Publication Huang M, J Mol Cell Biol, 2020
Dates: 27jan2020 to 15feb2020
| Methods | |
| Non-randomized study | |
| Location :
Single center / China Follow-up duration (days): 14 | |
| Inclusion criteria | 1. Aged ?18 years old; 2. Patients had been been diagnosed with COVID19 according to WHO interim guidance: Clinical management of severe acute respiratory infection when novel coronavirus (2019 -nCoV) infection is suspected (Interim guidance, 28 January 2020). |
| Exclusion criteria | 1 Pregnant woman patients, 2 documented allergic history to Chloroquine, 3 documented history of haematological system diseases, 4 documented history of chronic liver and kidney diseases, 5 documented history of cardiac arrythmia or chronic heart diseases, 6 documented history of retina or hearing dysfunction, 7 documented history of mental illness, 8 use of digitalis due to the previous disease |
| Type of analysis | Missing Data |
| Interventions | |
| Treatment
Chloroquine (500 mg) Co-Intervention: SC Duration : 10 days |
|
| Control
Lopinavir-Ritonavir (500 mg) Duration : 10 days | |
| Participants | |
| N analyzed 22 participants (n1=10 / n2= 12) | |
| Characteristics of participants N=22 Mean age : NR 13 males Severity : Mild: n=0 / Moderate: n=14/ Severe: n=8 Critical: n=0 | |
| Primary outcome | |
| In the register No | |
| In the report Viral negative negative-transforming time and the negative conversion rate of SARS-CoV -2 RT -PCR at day 10, 14. | |
| Documents avalaible |
Protocol Yes. In English Statistical plan NR Data-sharing stated NR |
| 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 |
* |
| Notes | In addition to the published article, the study registry was used in data extraction and risk of bias assessment. Whether randomization occured or not, and other information relevant to randomization (i.e., how the random sequence was generated, whether random allocation was concealed), is unclear. The study achieved the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. Mortality was a primary outcome in the registry, but not in the protocol, and is not reported in the paper. Some outcomes from the registry are not reported in the paper (e.g., length of ICU stay). The time points at which some outcomes were assessed were not pre-specified in the registry, and it is unclear whether all measurements (i.e., at all follow-up time points) of each outcome have been reported in the paper. The timing of the registered primary outcome (30 day mortality) does not reflect the follow-up of the study. |