Covid-19 Living Data

Trial *
Publication Mordyk A, Infektsionnye Bolezni (2021) (published paper)

Funding: No specific funding
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / Russia Follow-up duration (days): 22
Inclusion criteria	Presence of a clinically and laboratory confirmed diagnosis of "coronavirus infection COVID-19" (molecular genetic method - PCR and / or enzyme immunoassay (ELISA) mild, moderate forms of the disease treatment to the doctor no later than 48 hours from the moment of illness lack of therapy with drugs of the cytokine group and their inducers or other immunomodulatory drugs during the last two weeks before research the presence of a signed informed consent of the patient to participate in the study age from 18 to 65 years.
Exclusion criteria	Presence of hypersensitivity reactions a history of allergic reactions to interferon α-2b or its components, or an established allergic reaction at the time of first administration of study drug suspicion of the initial manifestations of a disease similar to COVID-19 symptoms (other infectious diseases, influenza-like syndrome at the onset of systemic diseases of the connective tissue, oncological, hematological and other pathologies) presence of concomitant disease the need for treatment which may affect the evaluation of the results of the study (atopic moderate to severe dermatitis, chronic diseases of the liver and kidneys, pronounced dysfunction of the thyroid gland and other diseases of the endocrine system (decompensated diabetes mellitus) severe diseases of the system hematopoiesis, epilepsy and other diseases of the central nervous system) other diseases which will not allow the patient to participate in research age under 18 and over 65 years old severe form of the disease the patient's unwillingness to strictly follow the doctor's prescription the use of group drugs cytokines and their inducers or other immunomodulatory drugs during the last two weeks before the start of the study and the need for their use during the study period taking other medications drugs that, according to investigator, may affect the course and the results of the clinical trial the presence of HIV infection, syphilis, hepatitis B, C with severe clinical and laboratory activity participation in another clinical study simultaneously or three months before the start of this one other heavy decompensated or unstable somatic diseases that threaten the patient's life or worsen the patient's prognosis, and also make it impossible to participation in a clinical trial pregnancy or breastfeeding period other conditions which, in the opinion researcher prevent the patient from being included in the study.
Interventions
	Treatment Interferon alpha-2b 3,000,000 IU rectally 3 times a day for 14 days; 4000 IU topically (nasal mucosa and palatine tonsils) 5 times a day for 14 days
	Control Standard care
Participants
	Randomized participants : Interferon alpha-2b=70 Standard care=70
	Characteristics of participants N= 140 Mean age : NR 70 males Severity : Mild: n=* / Moderate: n=* / Severe: n=0 Critical: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register NR
	In the report NR
Documents available	Protocol NR Statistical plan NR Data-sharing willing stated in the publication: Not reported
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	Only the published article was used in data extraction and risk of bias assessment. The abstract was available in English while the full paper was translated from Russian using Google translate. Neither the protocol, statistical analysis plan or registry were available and therefore we cannot determine if the intervention and outcomes were determined a priori.