Covid-19 Living Data

Trial NCT04385095 ; EudraCT 2020-001023-14
Publication Monk PD, Lancet Respir Med, 2020 (published paper)
Dates: 2020-03-30 to 2020-05-30
Funding: Private (Synairgen Research, UK)
Conflict of interest: Yes

Methods
	RCT Blinding:
	Location : Multicenter / UK Follow-up duration (days): 28
Inclusion criteria	1) Positive virus test for SARS-CoV-2 using RT-PCR, or positive point-of-care viral infection test in the presence of strong clinical suspicion of SARS-CoV-2 infection; 2) Male or female, ≥18 years of age at the time of consent; 3) Admitted to hospital due to the severity of their COVID-19 disease who presented with clinical symptoms consistent with COVID-19: High temperature and/or New continuous cough, Loss or change to sense of smell and/or taste; 4) Provided informed consent; 5) Hospitalised female patients had to be ≥1 year postmenopausal, surgically sterile, or using an acceptable method of contraception
Exclusion criteria	1) Any condition, including findings in the patients’ medical history or in the pre-randomisation study assessments that in the opinion of the Investigator, constituted a risk or a contraindication for the participation of the patient into the study or that could have interfered with the study objectives, conduct or evaluation; 2) Current or previous participation in another clinical trial where the patient had received a dose of an Investigational Medicinal Product (IMP) containing small molecules within 30 days or 5 half-lives (whichever was longer) prior to entry into this study or containing biologicals within 3 months prior to entry into this study; 3) Ventilated or in intensive care; 4) Inability to use a nebuliser with a mouthpiece; 5) History of hypersensitivity to natural or recombinant IFN-β or to any of the excipients in the drug preparation; 6) Females who were breast-feeding, lactating, pregnant or intending to become pregnant
Interventions
	Treatment Placebo *
	Control Nebulised interferon beta-1a (6 MIU in 0.65 mL of solution) Duration : 14 days
Participants
	Randomized 101 participants (n₁=51 / n₂= 50)
	Characteristics of participants N=101 Mean age : 57.1 58 males Severity : Mild: n=30 / Moderate: n=64/ Severe: n=2 Critical: n=0
Primary outcome
	In the register Change in condition measured using the Ordinal Scale for Clinical Improvement during the dosing period [ Time Frame: Day 1 to Days 15 and 28 ]
	In the report change in clinical condition on the WHO Ordinal Scale for Clinical Improvement (OSCI) during the dosing period
Documents available	Protocol Yes. In English Statistical plan NR 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 article, the study registry and protocol were used in data extraction and risk of bias assessment. The study reached planned sample size and reports on the hospital setting part of the pilot phase. The home based setting part of the pilot phase had not been reported at the time of assessing this study. A pivotal phase was also planned. Several outcomes specified in the trial registry and protocol were not reported in the published article, including progression and evolution of pneumonia, National Early Warning Score 2 (NEWS2) assessment of acute-illness severity, concomitant medications, and virus clearance. There is no change from the trial registration in the intervention and control treatments.