Trial ChiCTR2000029496
Publication Zheng F, 2020 (published paper)
Dates: 1-Feb-20 to 20-Feb-20
Funding: Public/non profit (National Science and Technology Major Project (2017ZX10202201, 2017ZX10202203), the National Key Research and Development Program of China (Nos. 2016YFD0500301), and Specialized Science and Technology Project of Hunan Province (2020SK3013))
Conflict of interest: No
Methods | |
RCT Blinding: Unblinded | |
Location :
Single center / China Follow-up duration (days): 9 | |
Inclusion criteria | Hospitalized COVID-19 patients with confirmed SARS-CoV-2 detection, clinically classified as moderate or severe, at the age over 18 years, and without comorbidity of severe heart, lung, brain diseases, were eligible for enrolling into this study. |
Exclusion criteria | Patients are not eligible to participate in this study if they: 1. suffer from a situation where the protocol cannot be carried out safely; 2. have allergic constitution. 3. have severe underlying diseases that affect survival, including: uncontrolled metastatic malignant tumors that cannot be removed, hematologic diseases, cachexia, active bleeding, severe malnutrition and HIV; suffer from major organ dysfunction; 4. suffer from significantly abnormal liver function: The ALT/AST level exceeds the normal upper limit by 5 times; the T- Bil level exceeds the normal upper limit by 2 times; 5. suffer from obstructive pneumonia caused by lung tumors, severe pulmonary interstitial fibrosis, pulmonary alveolar proteinosis, allergic alveolitis. 6. are pregnant: A positive result is obtained from the pregnancy test in women of childbearing age. 7. may be referred to a non-participating hospital within 72 hours; 8. have been using immunosuppressive agents or received organ transplants within the recent6 months. 9. are receiving extracorporeal life support (ECMO, ECCO2R, RRT); or 10. are expected to die within 48 hours. |
Interventions | |
Treatment 1 Novaferon+LPV/r (20mcg/400mg/100mg) Co-Intervention: Standard care Duration : 7-10 days | |
Control Lopinavir-Ritonavir (400mg/100mg) Co-Intervention: Standard care Duration : 7-10 days | |
Control Novaferon (20mcg) Co-Intervention: Standard care Duration : 7-10 days | |
Participants | |
Randomized 89 participants n1=30/ n2=29/ n3=30 | |
Characteristics of participants N=89 Mean age : 46.7 42 males Severity : Mild: n=0 / Moderate: n=84/ Severe: n=5 Critical: n=0 | |
Primary outcome | |
In the register Novel coronavirus nucleic acid clearance rate on day 6 after treatment (PT-PCR). | |
In the report The SARS-CoV-2 clearance rates in COVID-19 patients assessed on day 6 of antiviral treatment. | |
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/pre-print article, the study registry, protocol and SAP were used in data extraction and risk of bias assessment. 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. Mean values are reported for viral negative conversion outcomes, but SD is unreported. On July 15th 2020, we received additional information from authors on this study. Another update was made on August 10th, 2020 with data from the published report in the International Journal of Infectious Disease. |