Role of telemedicine centre Moscow city health department in randomized double-blind placebo-controlled multi-centre clinical trial in parallel assignment of efficacy, safety and immunogenicity of combined vector vaccine GAM-COVID-VAC in SARS-COV-2 infection prophylactic treatment

Introduction (relevance). The increase in COVID-19 cases worldwide, since the end of January 2020, has required the development, as soon as possible, of a safe and effective vaccine against a new SARS-CoV-2 infection. Scientists of the «N.F. Gamalei Institute» have created and registered the world's first vaccine aimed at preventing the development of COVID-19 - Gam-COVID-Vac. The study was carried out as part of the project of the Department of Health of the city of Moscow "Scientific laboratory" Moscow polyclinic "". Purpose: assess the necessity and effectiveness of the telemedicine consultation system within the framework of the conducted clinical trial of the Gam-Covid-Vac vaccine Materials and methods. In order to estimate the effectiveness, safety and immunogenicity of the Gam-Covid-Vac vaccine, in September 2020 the Moscow City Health Department established Research Centers on the basis of 20 polyclinics. The main tasks of the research centers were the selection of healthy volunteers, in the number of 40,000 people, and screening, randomization and prospective observation of them. The duration of participation in the study of one subject was 180 + 14 days. To assess the health status of volunteers, 5 scheduled visits to a research doctor were conducted. The subjects of the study could also talk with a doctor distantly, assist of telemedicine consultations. For this purpose, a Telemedicine Center was created under the management of the Department of Health of the city of Moscow. Special algorithms have been developed for doctors conducting telemedicine consultations with clear and understandable mechanisms of interaction with the patient. The information received from the subject was filled in the electronic diary of the volunteer by the doctor, and also treatment tactics were determined. Results. During the study with the assistance of telemedicine technologies, more than 425,000 distance consultations were carried out. Distant consultations showed high productivity and significantly affected the reliability of the information obtained on the health status of subjects. Conclusions. It is difficult to overestimate the participation of the Telemedicine Center of the Moscow City Health Department in the framework of the conducted clinical study. Telemedicine consultations have significantly facilitated the work of doctors of Research Centers. They made it possible to real time present, an objective health situation of the clinical trial volunteer.