Clinical trial NCT03189537: Study of Post-Exposure Ingavirin® Prophylaxis of Influenza and Acute Respiratory Viral Infections
Official title: Double Blind Randomised Placebo Controlled Trial for Evaluation of Efficacy and Safety of Ingavirin® for Post-exposure Profilaxis During Rise in the Incidence of Influenza and Other Acute Respiratory Viral Infections in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza, Human
Acute Respiratory Infection
Common Cold
Flu
Viral Infection
Keywords: Profilaxis
Ingavirin
Lead sponsor: Valenta Pharm JSC
Sponsor class: INDUSTRY
First posted: 2017-06-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study was to evaluate efficacy of prophylactic Ingavirin intake by people having contact with sick people infected with influenza and other acute respiratory viral infections

Detailed description: The study includes 7 days of treatment period and 30 days of follow-up, 37 days total.

The participant was receiving Ingavirin or placebo for 7 days. Then during 30 days the participant was under supervision.

Visits were performed at days 2-7 (every day) since inclusion and then every 5 days during follow-up period.

Wherever during the study the participant developed symptoms of flu or other acute respiratory viral infection, the participant was taken for medical care to observe his condition, symptoms dynamics, lab tests, including laboratory verification of viral origin of the disease. Medical care was established for 10±2 days since symptoms. Everyday for 3 days and additional visits for 5±1 and 10±2 days of the disease.

The patient had the required symptomatic treatment, additionally the patient could be institutionalised if necessary.

Wherever the participant developed symptoms during treatment period, the patient was taken investigational drug on schedule.

Eligibility criteria: Inclusion Criteria:

* Participants who do have continuous contact with ill person (staff members, dormitory, family members), laboratory confirmed viral origin, during influenza/other acute viral respiratory disease season
* First exposure with the ill person who is present with symptoms of flu or acute respiratory viral infection (fever, intoxication, catarrhal symptoms) ≤ 48 hours
* Signed Informed Contest to participate in the study
* Contraception throughout the study

Exclusion Criteria:

* Interferone or interferone inducers intake, or substances with action on immune system intake less then 3 months before inclusion
* Anti-virals intake, other then investigational drug, throughout the study
* Vaccination for Influenza less than 1 year before inclusion
* Pregnant or lactating

Primary outcomes:
measure: Difference in incidence of flu / other acute respiratory viral infections between Ingavirin and placebo groups
timeFrame: Through study completion, an average of 37 days
Secondary outcomes:
measure: Comparative evaluation of prevalence and duration of flu and acute viral respiratory infection at participants who developed flu / avri
timeFrame: Through study completion, an average of 37 days
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Research Institute of Influenza
city: Saratov
country: Russian Federation
facility: Saratov State Medical University named after V. I. Razumovsky
Study officials:
affiliation: Valenta Pharm JSC
name: Ekaterina Zakharova, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Shul'diakov AA, Liapina EP, Kuznetsov VI. [Current principles in the chemoprophylaxis of acute respiratory viral infections]. Ter Arkh. 2013;85(11):27-33. Russian.