Covid-19 Living Data

Trial ChiCTR2000029638
Publication Li C, Ann Med (2021) (published paper)
Dates: 2020-02-10 to 2020-04-05
Funding: Mixed (New Coronavirus (2019-nCoV) Emergency Project of Sichuan University and the Novel Coronavirus Pneumonia Epidemic Research Project in West China Hospital, Sichuan University. Sichuan Huiyang Life Science & Technology Corp)
Conflict of interest: No

Methods
	RCT Blinding: single blinding
	Location : Multicenter / China Follow-up duration (days): 28
Inclusion criteria	Males and non-pregnant females aged 18 years or older, diagnosed with moderate-to-severe COVID-19 pneumonia according to the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia released by the National Health Commission of China. Moderate COVID-19 patients were featured by fever, respiratory symptoms, and radiographic pneumonia, while severe COVID-19 patients featured by any of the following signs: dyspnea, respiratory frequency ≥30/minute, oxygen saturation ≤94%, and PaO2/FiO2 ratio <300mmHg.
Exclusion criteria	Patients with any condition that would not allow the protocol to be followed safely history of allergy or hypersensitivity to interferons or any of the ingredients used in this trial history of myocardial infarction and other serious cardiovascular diseases unable to receive nebulized compound and/or voluntarily requested to withdraw from the trial.
Interventions
	Treatment rSIFN-co 12 million IU nebulized twice a day for maximum 28 days
	Control Interferon alpha 5 million IU nebulized twice a day for maximum 28 days
Participants
	Randomized participants : Interferon alpha=48 rSIFN-co=48
	Characteristics of participants N= 96 Mean age : NR 44 males Severity : Mild: n=0 / Moderate: n=83 / Severe: n=12 Critical: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register disease remission, time to clinical improvement,overall rates of clinical improvement assessed at days 7, 14, and 28,time to chest CT improvement, time to virus nucleic acid negative-conversion, overall rates of radiological improvement on days 7, 14
	In the report Time to clinical improvement, defined as the time from enrollment to an improvement of two points on a seven-category ordinal scale or live discharge from the hospital, whichever came first.
Documents available	Protocol NR Statistical plan NR Data-sharing willing stated in the publication:
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 and protocol were used in data extraction and risk of bias assessment. There is no change from the trial registration in the intervention and control treatments or in outcomes. It is unclear why one death in the Recombinant Super-Compound Interferon (rSIFN-co) arm after randomization but before receipt of study drug was excluded from all analyses, while one patient in the interferon-alpha arm who experienced acute exacerbation of the disease and administration of invasive ventilation after randomization but before receipt of study drug was retained in analyses of clinical outcomes. The study was updated on March 23rd, with data from Annals of Medicine, without substantial changes.