Efficacy and Safety of Ergoferon in Children from 6 Months to 6 Years Old with Acute Respiratory Viral Infections in Contemporary Outpatient Practice: A Multicenter, Double-Blind, Placebo-Controlled Randomized Trial.

"Conflicts of Interest Geppe N.A., Blokhin B.M., Shamsheva O.V., Abdrakhmanova S.T., Alikhanova K.A., and Myrzabekova G.T. received a research grant for this RCT from OOO “NPF “MATERIA MEDICA HOLDING.” Geppe N.A. received the grant from OOO “NPF “MATERIA MEDICA HOLDING” to coach investigators for this RCT."

"This study was funded by a grant from OOO “NPF “MATERIA MEDICA HOLDING” (9, 3rd Samotyochny per., 127473, Moscow, Russia). Statistical analysis was provided by OOO “NPF “MATERIA MEDICA HOLDING.” Ergoferon is a drug manufactured by OOO “NPF “MATERIA MEDICA HOLDING.” The authors thank the research staff at the participating sites. The investigators involved were Olga Zhiglinskaya (St. Petersburg State Budgetary Healthcare Institution “City Polyclinic No. 44” on the basis of the Children's Polyclinic Department No. 41, Saint Petersburg), Natalia Chornaya (Federal State Budgetary Educational Institution of Higher Education “Yaroslavl State Medical University” of the Ministry of Health of the Russian Federation on the basis of the State Healthcare Institution of the Yaroslavl Region “Children's Polyclinic No. 5,” Yaroslavl), Irina Melnikova (Yaroslavl State Medical University of the Ministry of Health of the Russian Federation on the basis of the Children's Polyclinic No. 1 of the State Healthcare Institution of the Yaroslavl Region “Clinical Hospital No. 8”, Yaroslavl), Ildar Nurmeev (Federal State Budgetary Educational Institution of Higher Education “Kazan State Medical University” of the Ministry of Health of the Russian Federation on the basis of the State Autonomous Healthcare Institution “Children's Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan,” Kazan), Olga Perminova (State budgetary institution of health care of the Perm Territory “City Children's Clinical Polyclinic No. 5,” Perm), Alexander Korolev (Federal State Budgetary Educational Institution of Higher Education “Russian National Research Medical University named after N.I. Pirogov “Ministry of Health of the Russian Federation on the basis of the State Budgetary Institution of Health of the city of Moscow” Children's City Polyclinic No. 42, Moscow), Tatiana Romanova (State Budgetary Institution of Health of the Samara Region “Samara City Children's Clinical Hospital named after N.N. Ivanova,” Samara), Sofia Tsarkova (Municipal autonomous institution “Children's City Clinical Hospital No. 11” on the basis of Polyclinic No. 1, Yekaterinburg), and Ivan Shishimorov (Federal State Budgetary Educational Institution of Higher Education “Volgograd State Medical University” of the Ministry of Health of the Russian Federation on the basis of the Non-State Healthcare Institution “Departmental Clinical Hospital at st. Volgograd-1 JSC “Russian Railways,” Volgograd)."

"This international, multicenter, double-blind, placebo-controlled, randomized, parallel-group clinical trial was carried out between October 7, 2016, and January 9, 2019, in 10 medical institutions in the Russian Federation and in 3 institutions in the Republic of Kazakhstan (see Supplementary Materials (), Study overview). The study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice and was approved by the institutional review boards and the National Council for ethics. The protocol of the study and the study results are recorded in the international database ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03039621). Signed informed consent was obtained from all participants' parents/adopters prior to enrolment."