Trial ChiCTR2000030007
Publication Cheng L, JAMA Intern Med, 2020 (published paper)
Dates: 2020-02-18 to 2020-04-10
Funding: Mixed (Grants related to the prevention and management of coronavirus disease 2019; Guangzhou Institute for Respiratory Health; Kyowa Hakko Kirin China Pharmaceutical Co Ltd)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Multicenter / China Follow-up duration (days): 60 | |
| Inclusion criteria | Patients 18 years or older who had positive test results with re- verse-transcription polymerase chain reaction (RT-PCR) assay for severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) in oropharyngeal samples were eligible if they had pneumonia as confirmed by chest imaging and a PBL cell count of 800 per μL (to convert to ×109/L, multiply by 0.001) or lower. |
| Exclusion criteria | Patients were excluded if they had a peripheral blood leukocyte cell count greater than 15 000 per μL, any comorbidity (eg, chronic obstructive pulmonary disease, hypertension, diabetes, coronary heart disease, and/or malignancy), required invasive ventilation, developed shock or other organ failure that required admission to an intensive care unit, had an allergy to rhG-CSF, or were breastfeeding or pregnant. |
| Interventions | |
| Treatment
rhG-CSF 5 mcg/kg subcutaneously once a day from days 0 to 2 |
|
| Control
Standard care Definition of Standard care: Standard of care treatment, based on the Protocol for the Diagnosis and Treatment of Coronavirus Disease (Trial version 5) by the National Health Commission, comprised resting, supportive treatment (supplemental oxygen, non invasive ventilation, or intravenous antibiotics), supplementation of nutrition and energy, water and electrolyte equilibrium, and maintenance of homeostasis. | |
| Participants | |
| Randomized 200 participants (n1=100 / n2= 100) | |
| Characteristics of participants N=200 Mean age : NR 112 males Severity : Mild: n=0 / Moderate: n=146/ Severe: n=54 Critical: n=0 | |
| Primary outcome | |
| In the register Clinical symptoms, Blood routine, the viral load of 2019-nCOV of throat swab, TBNK cell subsets, TH1/TH2 Cytokine, Chest CT | |
| In the report Time to clinical improvement, ie, the duration from randomization to the improvement of at least 1 point on a 7-category ordinal scale (adopted from a scale for hospitalized patients with severe influenza) or discharge from hospital, whichever occurr | |
| Documents available |
Protocol Yes. In English Statistical plan Yes 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 |
Some concerns |
| General comment | In addition to all available versions of the published article, the study registry, statistical analysis plan and protocol were used in data extraction and risk of bias assessment. Overall, the published study report reflects the protocol in methods and in results published. There are some small inconsistencies in the trial registry (recorded as "prospectively registered", but recruitment data already passed and between the registration and the published report (the primary outcome in the protocol and the report is not included in detail in the registration), but it is possible that these relate to the data entry interface or structure of the registry. The study achieved the target sample size specified in the registry. |