Trial ChiCTR2000030016
Publication Lin YR, J Aerosol Med Pulm Drug Deliv, 2021 (published paper)
Dates: 2020-01-22 to 2020-02-17
Funding: Public/non profit (National Natural Science Foundation of China, the Guangxi Natural Science Foundation and Integrated
Innovation, Application and Popularization of Standardized Technology of Prehospital First Aid for Acute and Critical Diseases of Guangxi)
Conflict of interest: No
| Methods | |
| RCT Blinding: double blinding | |
| Location :
Single center / China Follow-up duration (days): * | |
| Inclusion criteria | Patients aged ≥ 18 years; diagnosis of moderate COVID-19 (combined with epidemic history, with fever, respiratory symptoms, nucleic acid test positive, radiological findings of pneumonia, but did not match severe or critical diagnosis); agreed to collect oropharyngeal swabs and venous blood. |
| Exclusion criteria | Received systemic antiviral and immune regulation within 3 months; viral RNA nucleic acid test has turned negative after diagnosis; allergic to M. vaccae; had other severe diseases such as severe heart disease, myocardial damage, significant vascular sclerosis, endocarditis, extremely weak, and severe anemia; pregnant women. |
| Interventions | |
| Treatment
Mycobacterium vaccae 45 mcg by inhalation once a day for 10 days. |
|
| Control
Standard care ( / ) Definition of Standard care: Guidelines of standard care: according to the updated "Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 4 and Version 5)" issued by Chinese government, main medication is lopinavir/ritonavir plus a-IFN nebulization. | |
| Participants | |
| Randomized 31 participants (n1=16 / n2= 15) | |
| Characteristics of participants N=31 Mean age : NR 16 males Severity : Mild: n=0 / Moderate: n=31/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register Viral negative-transforming time; 30-day cause-specific mortality; 30-day cause-adverse events; 30-day all-cause mortality; co-infections; Time from severe and critical patients to clinical improvement; Others (liver function, kidney function, myocardial enzyme). | |
| In the report Time interval from admission to viral RNA negative conversion | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated
|
| 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 the published article, the trial registry was used in data extraction and assessment of the risk of bias. Neither protocol nor statistical analysis plan was available. The study did not achieve the target sample size specified in the trial registry (i.e. 30 participants in each study arm). There is no change from the trial registration in the intervention and control treatments. There may be some differences between the outcomes in the registry and the report (e.g. co-infections; Time from severe and critical patients to clinical improvement; liver function, kidney function, myocardial enzyme), though no deaths were registered and some laboratory outcomes were reported as supplementary material as before and after treatment. |