Results of two post-registration clinical trials of the antiviral drug Kagocel effectiveness were published in the international database of clinical trials ClinicalTrials.gov.
The study Clinical and epidemiological effectiveness of the late interferon inducer in the prevention of ARVI and influenza during the pre-epidemic period of 2017-2018 (Kagocel for the Prevention of ARVI and Influenza in Adults Health Care Workers) conducted during the epidemiological season of the year 2017 showed that those medical workers who had direct contact with influenza and ARVI infected patients, and were subjected to prevention with Kagocel, demonstrated significant reduction in bacterial complications requiring prescription of antibacterial drugs. It was reliably established that, during the observation period, some of the control group subjects who did not take Kagocel had a repeated, two-time incidence of respiratory viral infections. There were no such patients in the main group taking Kagocel. The drug therapy was well tolerated.
The study Evaluation of the preventive effect of the late interferon inducer in relation to acute respiratory viral infections in young people (Kagocel for the Prevention of ARVI and Influenza in Young People) was observational, non-interventional and focused on the use of the drug Kagocel for the prevention of ARVI and influenza during the 2018 epidemic rise in the incidence in people aged 20-26 years. It showed that patients who had not received any medications to prevent ARVI and flu had a high, some 40%, incidence of ARVI or flu. Following a 28 day preventive course with the drug, the incidence of ARVI or flu was as low as 16 %. Moreover, against the background of prevention with Kagocel, the duration of ARVI or flu in patients was significantly shorter than that without prevention with any drugs. Clinical symptoms of ARVI in patients who were taking Kagocel were significantly less frequent than in the comparison group, were less pronounced, and corresponded to a mild degree of the disease.
In both cases, additional data was obtained on the safety of the antiviral drug Kagocel. Now, the complete data of the research is available not only to the Russian professional community, but also to the international general public, which complies with the best practices of the pharmaceutical industry.
It is worth reminding that the ClinicalTrials.gov website was established in the year 2000 by the US National Institutes of Health (NIH) in collaboration with the US Food and Drug Administration (US FDA), and is a recognized international source of information on the development and research of the effectiveness and safety of medicines and medical products. The ClinicalTrials.gov contains data of almost 358,000 studies conducted in 218 countries.
Publication of Research Protocol descriptions in an international database makes this information publicly available to medical and pharmaceutical professionals, regulatory institutions, as well as to patients and their families. The data is open to any interested person.
In 2016, an international post-registration study on the drug Kagocel, Treatment of ARVI and influenza in routine clinical practice (FLU-EE), was already published at ClinicalTrials.gov. Now it is supplemented by the results of two more trials.