Covid-19 Living Data

Trial NCT04527575
Publication Ryzhikov AB, Infektsiia Immun, 2021

Funding: Public/non profit (Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing (Rospotrebnadzor))
Conflict of interest: Yes

Methods
	RCT
	Location : Single center / Russia Follow-up duration (months): 9
	EpiVacCorona (n=43) Placebo (n=43)
Inclusion criteria	Signed and dated informed consent Verified diagnosis is "healthy" according to the data of the standard clinical, laboratory and instrumental examination methods Age from 18 to 60 years old inclusive Body mass index from 18.5 to 30 kg / m3 Ability to attend all scheduled visits and all planned procedures and examinations Consent of volunteers to use effective contraceptive methods throughout the study, including the observation period for possible post-vaccination reactions
Exclusion criteria	contacts with COVID-19 patients for 14 days prior to the start of the clinical trial hypersensitivity to any component of the vaccine and the history of allergic reactions to any vaccination in the past the history of serious post-vaccination reactions/complications pregnancy and breastfeeding military personnel on conscription symptoms of any disease at the time of inclusion in the study or if it has passed less than 4 weeks since recovery the history of any acute respiratory disease within less than 3 months prior to inclusion in the study the history of tuberculosis, cancer, autoimmune diseases, skin diseases (pemphigus, psoriasis, eczema, atopic dermatitis) long-term use (more than 14 days) of immunosuppressive drugs, systemic glucocorticosteroids or immunomodulatory drugs within 6 months prior to the study vaccination with any vaccine within one month prior to inclusion taking immunoglobulin drugs or blood products within last 3 months prior to the study donation of 450 ml or more of blood or plasma within less than 2 months prior to the study participation in other clinical trials within less than 3 months prior to the study alcohol or drug addiction taking more than 10 units of alcohol per week positive test for HIV, viral hepatitis B and C, lues venerea false inclusion (violation of inclusion and non-inclusion criteria) or the appearance of non-inclusion criteria during the study exclusion due to a clinically significant deviation from the protocol/violation of the protocol and/or refusal of a volunteer to continue
Interventions
	Intervention 2 IM doses of 225 (±45) mcg, 21 days apart
	Control 2 IM doses of placebo, 21 days apart
Participants
	Randomized 86 participants
	Characteristics of participants Type of participants: Healthy adult volunteers N=86 47 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: NR Age range: 18-57
	Description of participants Healthy adult SARS-CoV-2 infection-free volunteers in a single center in Russia.
Primary outcome
	In the register The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2 within 9 months post vaccination [ Time Frame: throughout the study, an average of 270 days ]
	In the report the proportions of vaccinated volunteers who do not have any laboratory-confirmed symptoms of SARS-CoV-2 in combination with one or more of the following symptoms: fever or chills; cough; shortness of breath or labored breathing; fatigue; muscle pain; headache; loss of taste or smell; sore throat; nasal congestion or runny nose; nausea or vomiting; and diarrhea within 9 months of vaccination versus a placebo
Documents available	Protocol NR Statistical plan * Data-sharing stated: NR Data accessibility: corresponding author: Aleksandr B. Ryzhikov, E-mail: ryzhik@vector.nsc.ru
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 was used in data extraction and risk of bias assessment. Protocol, statistical analysis plan, or supplementary appendix (mentioned in the report) were not available at the time of data extraction. The published article reports on interim analyses of a phase 1 (single arm, not extracted) and phase 2 (RCT, extracted) study. The target sample size specified in the registry was achieved. The primary outcome in the report reflects the one in the registry. An overall adverse event outcome in the registry not clearly reported. Some biochemical and hematological outcomes are reported that were not in the registry. There is no change from the trial registration in the population, intervention, or control.