Trial ChiCTR2000030262
Publication Fu W, EClinicalMedicine (2020) (published paper)
Dates: 2020-03-23 to 2020-05-23
Funding: Public/non profit (National Science Foundation of China, the National Major Project for Control and Prevention of Infectious Disease in China, the Second Batch of Emergency Science and Technology Projects of Shanghai Science and Technolog)
Conflict of interest: Yes
Methods | |
RCT Blinding: Unblinded | |
Location :
Single center / China Follow-up duration (days): 60 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
IFN-k+TFF2 TFF2: 5 mg Interferon kappa: 2 mg Aerosol inhalation once a day for 6 days |
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Control
Standard care | |
Participants | |
Randomized participants : IFN-k+TFF2=40 Standard care=40 | |
Characteristics of participants N= 80 Mean age : NR 51 males Severity : Mild: n=0 / Moderate: n=80 / Severe: n=0 Critical: n=0 Number of vaccinated participants: NR | |
Primary outcome | |
In the register Viral load, Clinical features, Inflammation, Pulmonary imaging, routine blood test, In-hospital days, routine urine test, blood biochemical | |
In the report Timing to achieve viral RNA negative conversion for SARS-CoV-2 in all three specimens, including nasopharyngeal swabs, throat swabs and stool swabs. | |
Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication:
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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 study report, the trial registry, study protocol and statistical analysis plan were used in data extraction and assessment of risk of bias. The published study, protocol and analysis differ from the trial registration in that while there are four study arms in the registry (one standard of care arm and three treatment arms with varying schedules of the study drug), there are two arms in the other documents (one standard of care arm and treatment arm with a single schedule of the study drug). In addition, there are differences between the various documents in randomization method and primary and secondary outcomes. |