Study of Post-Exposure Ingavirin® Prophylaxis of Influenza and Acute Respiratory Viral Infections

Influenza, Human Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03189537
• Other study ID #: 2P/09
• Status: Completed
• Phase: Phase 3
• First received: June 8, 2017
• Last updated: June 15, 2017
• Start date: October 3, 2010
• Est. completion date: October 10, 2011

Study information

• Verified date: June 2017
• Source: Valenta Pharm JSC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 10, 2011
• Est. primary completion date: April 19, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Common Cold
• Communicable Diseases
• Flu
• Infection
• Influenza, Human
• Respiratory Tract Infections
• Viral Infection
• Virus Diseases

Intervention

Drug:
• Ingavirin (Imidazolyl Ethanamide Pentandioic Acid)
Broad-spectrum antiviral agent
• Placebo oral capsule
Placebo capsule to match Ingavirin capsule

Locations

Country	Name	City	State
Russian Federation	Research Institute of Influenza	Saint Petersburg
Russian Federation	Saratov State Medical University named after V. I. Razumovsky	Saratov

Sponsors (1)

Lead Sponsor	Collaborator
Valenta Pharm JSC

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in incidence of flu / other acute respiratory viral infections between Ingavirin and placebo groups	To evaluate incidence difference between Ingavirin and placebo groups. Incidence defined as ratio between number of people got sick in the group to all people in the group. 1) Efficiency Index (EI) was defined as incidence of flu in placebo group to incidence of flu in Ingavirin group. 2) Efficacy Ratio (ER) defined by formula: ER=(incidence in placebo group - incidence Ingavirin group)*100% then divided by incidence in placebo group.	Through study completion, an average of 37 days
Secondary	Comparative evaluation of prevalence and duration of flu and acute viral respiratory infection at participants who developed flu / avri		Through study completion, an average of 37 days