Efficacy and safety of Ergoferon versus oseltamivir in adult outpatients with seasonal influenza virus infection: a multicenter, open-label, randomized trial.
OBJECTIVE
Ergoferon is an antiviral complex drug containing released-active forms of antibodies to interferon gamma, CD4, and histamine. Its efficacy and safety in the treatment of acute respiratory viral infections has been reported previously. The aim of this study was to compare Ergoferon with oseltamivir.


METHODS
A multicenter, open-label, randomized controlled trial of patients aged 18 to 65 years, who had tested positive for influenza A or B antigens, was performed. A total of 156 patients were enrolled as the intention-to-treat population; these patients were assigned randomly to receive either Ergoferon or oseltamivir (n=78 in each group).


RESULTS
The percentage of patients achieving a normal body temperature (≤37.0°С) following 5 days of treatment did not differ significantly between the groups. The mean duration of fever in the Ergoferon and oseltamivir groups was 2.1±1.5 days and 2.3±1.6 days, respectively (p=0.01). The average time to the resolution of influenza symptoms was approximately 3 days, with no significant between-group difference. Total quality of life scores were similar in the two groups following 5 days of drug administration. The incidence of adverse events did not differ significantly between the groups, nor were there any serious adverse events.


CONCLUSIONS
Ergoferon and oseltamivir were equally effective and safe in adult outpatients with seasonal influenza A or B virus infection.


BACKGROUND
ClinicalTrials.gov identifierNCT01804946.
Smolensk State Medical University, Smolensk, Russian Federation.
Vladimir
V
Rafalsky
Federal Research Clinical Center under Federal Medical and Biological Agency of Russia, Moscow, Russian Federation.
Alexander
A
Averyanov
Pirogov Russian National Research Medical University, Moscow, Russian Federation.
Boris
B
Bart
Polyclinic No. 3, Moscow, Russian Federation.
Elena
E
Minina
OOO NPF 'Materia Medica Holding', 3rd Samotyochny per., 9, 127473, Moscow, Russian Federation.
Mikhail
M
Putilovskiy
OOO NPF 'Materia Medica Holding', 3rd Samotyochny per., 9, 127473, Moscow, Russian Federation. Electronic address: AndrianovaEN@materiamedica.ru.
Elena
E
Andrianova
The Institute of General Pathology and Pathophysiology, Moscow, Russian Federation.
Oleg
O
Epstein
D000293:Adolescent; D000328:Adult; D000368:Aged; D000906:Antibodies / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000627:therapeutic use*; D015704:CD4 Antigens / Q000276:immunology; D005260:Female; D005334:Fever / Q000188:drug therapy; D006632:Histamine / Q000276:immunology; D006801:Humans; D007251:Influenza, Human / Q000188:drug therapy* / Q000821:virology*; D007371:Interferon-gamma / Q000276:immunology; D008297:Male; D008875:Middle Aged; D053139:Oseltamivir / Q000627:therapeutic use*; D010045:Outpatients; D011788:Quality of Life; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D000906:Antibodies; D000998:Antiviral Agents; D015704:CD4 Antigens; C000621422:ergoferon; D053139:Oseltamivir; D006632:Histamine; D007371:Interferon-gamma
Ergoferon; Influenza; Oseltamivir; Released-activity