Trial ChiCTR2000029431
Publication Yuan, medRxiv, 2020 (preprint)
Dates: 2020-02-01 to 2020-03-30
Funding: Public/non profit (Affiliated Zhongshan Hospital of Dalian University)
Conflict of interest: No
| Methods | |
| RCT Blinding: * | |
| Location :
Multicenter / China Follow-up duration (days): 14 | |
| Inclusion criteria | Registry:
1. 2019-nCoV infected patients 2. nCoV nucleic acid positive 3. Aged >=18 years 4. Patients understand the purpose of the trial, voluntarily sign informed consent, and agree to complete the rectification research process |
| Exclusion criteria | 1. Those with allergies; 2. Patients with a history of severe cardio-cerebral vascular disease, diabetes, mental and neurological diseases, severe liver and renal insufficiency; 3. History of hip or knee trauma or surgery; 4. Patients who abuse drugs; 5. Those who are in the acute phase of chronic diseases; 6. Patients with other malignant diseases and a survival time of less than 12 months; 7. pregnancy, lactating women; 8. Poor compliance and unable to follow up on time; 9. Participants in clinical trials of other drugs or devices within the past 3 months. |
| Interventions | |
| Treatment
Tc-MDP (5 ml) Co-Intervention: Standard care Duration : 7 days |
|
| Control
Standard care Definition of Standard care: Routine treatment according to Diagnostic of COVID-19 criteria issued by National Health Commission of China. | |
| Participants | |
| Randomized 21 participants (n1=10 / n2= 11) | |
| Characteristics of participants N=21 Mean age : NR 9 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=* | |
| Primary outcome | |
| In the register Yes | |
| In the report The primary end point was the CT-based radiological pulmonary changes from baseline to 7 days | |
| Documents avalaible |
Protocol NR 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 |
* |
| General comment |
This study is pending author reply. No outcome data (relevant to this review) were reported.
In addition to all available versions of the pre-print, the study registry was used in data extraction and risk of bias assessment. The study as reported in the pre-print article differed from its registration in several regards: the proposed sample size was not reached; two study arms are reported whereas there were three in the registration; a treatment(methylprednisolone) recorded in the registration as being co-administered with Tc-MDP in the treatment arm is not reported in the article; one of two primary outcomes recorded in the registration is not reported, while an outcome not recorded in the registration is reported. |