Covid-19 Living Data

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	patients gave written consent for participation in the study. Male and nonpregnant female patients at 18 years of age or older were eligible after they were confirmed as SARS-CoV-2 positive by RT-PCR. In addition, patients were included if their peripheral capillary oxygen saturation (SpO2) was > 94% on room air at screening. Symptoms of infection include fever, cough, and myalgia, with diarrhea, with the subsequent development of dyspnea or of pneumonia on chest CT. Patients with moderate pneumonia were then included following Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 7) released by National Health Commission & State Administration of Traditional Chinese Medicine on March 3, 2020)
Exclusion criteria	physician's decision that involvement in the trial was not in the patient's best interest, presence of any condition that would not allow the protocol to be followed safely, known allergy or hypersensitivity to IFN-κ and TFF2, known severe liver disease (e.g., cirrhosis, with an alanine aminotransferase level >5 × the upper limit of the normal range (9–50 U/L) or an aspartate aminotransferase level >5 × the upper limit of the normal range (15–40 U/L)). Breastfeeding and pregnant patients were also excluded.
Interventions
	Treatment Interferon kappa+TFF2 TFF2: 5 mg Interferon kappa: 2 mg Aerosol inhalation once a day for 6 days
	Control Standard care Definition of Standard care: All enrolled patients started to receive standard care once they were admitted to the hospital. Standard care included symptomatic treatment with hydroxychloroquine, antibiotic agents, vasopressors, antifever medicine, vitamin C, immune enhancers, or traditional Chinese medicines.
Participants
	Randomized 80 participants (n₁=40 / n₂= 40)
	Characteristics of participants N=80 Mean age : 35.3 51 males Severity : Mild: n=0 / Moderate: n=80/ Severe: n=0 Critical: n=0
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 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 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.