Efficacy and Safety Study of Ingavirin® 90 mg Once Daily to Treat Influenza and Other Acute Viral Infections in Adults

Influenza, Human Clinical Trial

Official title:

Randomised Double Blind Placebo Controlled Multicenter Study for Evaluation of Clinical Efficacy and Safety of Ingavirin 90 mg Once Daily to Treat Influenza and Other Acute Viral Infections in Adults.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03154515
• Other study ID #: 5P/08
• Status: Completed
• Phase: Phase 4
• First received: April 26, 2017
• Last updated: May 12, 2017
• Start date: January 2010
• Est. completion date: October 2014

Study information

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

Clinical Trial Summary

The purpose of this study is to determine whether Ingavirin® 90 mg once daily is effective and safe for the treatment of influenza and other laboratory confirmed acute respiratory viral infections in the course of standard therapy in patients 18-60 years old.

Description:

Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Trial of the Efficacy and Safety of Ingavirin in the Treatment of Influenza and Other Acute Viral Respiratory Infection. Study treatment was 5 days followed by 2 ± 1 days of follow up period. Thus, study participation was 7 ± 1 days (8 days max).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 445
• Est. completion date: October 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients with clinically diagnosed influenza, body temperature = 38 º? or other acute respiratory viral infection, body temperature = 37 º?, with no less than 2 symptoms of catarrhal and intoxication each:

• Intoxication symptoms: Dizziness, headache, chills, fever, sweating, fatigue, myalgia, pain while moving eyes, flushing, pale skin, sleep disturbances, decreased appetite, nausea, vomiting, epistaxis, cyanosis, meningeal signs.

• Catarrhal symptoms: Sore throat, rhinorrhea and nasal congestion, difficulty swallowing, hoarseness, stridor, wheezing, rattling dry and wet cough, expectoration.

• Laboratory confirmation of viral origin of the disease

• Uncomplicated influenza and other acute respiratory viral infections

• Interval between onset of symptoms and enrollment to the study not more than 48 hours

• Have read, understood and signed an informed consent form

Exclusion Criteria:

• Complicated course of influenza and other acute respiratory viral infections (secondary bacterial infection)

• Pregnancy and Breastfeeding

• Severe decompensated or unstable medical or psychiatric conditions (any diseases or conditions that threaten the life of the patient or worsen the patient's prognosis)

• Cancer, HIV infection, tuberculosis, including those in history

• History of alcohol and drug abuse

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ingavirin

• Placebo

Locations

Country	Name	City	State
Russian Federation	State educational institution of higher professional education "Chelyabinsk State Medical Academy of Federal Agency of Health Care and Social Development"	Chelyabinsk
Russian Federation	N.F. Gamaleya Scientific Research Institute of Epidemiology and Microbiology	Moscow
Russian Federation	State budgetary health care institution novosibirsk region "city clinical infectious diseases hospital no. 1"	Novosibirsk
Russian Federation	North-western State Medical University named after I.I.Mechnikov	Saint Petersburg
Russian Federation	Saratov State Medical University named after V. I. Razumovsky	Saratov
Russian Federation	Federal State Budgetary Educational Institution of Higher Education "Pacific State Medical University" of the Ministry of Healthcare of the Russian Federation	Vladivostok
Russian Federation	Volgograd State Medical University	Volgograd
Russian Federation	Yaroslavl State Medical University	Yaroslavl
Russian Federation	Federal State Budgetary Institution of Higher Professional Education "Urals State Medical University" of the Ministry of Healthcare of the Russian Federation	Yekaterinburg

Sponsors (1)

Lead Sponsor	Collaborator
Valenta Pharm JSC

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Treatment-Emergent Adverse Events	All adverse events recorded and analysed, to compare incidence rate with one of placebo.; Complete blood count test performed at the beginning and at the end of the study.; Vital signs taken and recorded at each visit throughout the study, usually every day for 7 ± 1 days.	Through study completion, an average of 8 days
Primary	Time to resolution of fever	Time from the start of study treatment to resolution of fever ( t = 36,9 º?, till the end of the follow up).	7 ± 1 days
Secondary	Time to resolution / alleviation of intoxication symptoms	Following symptoms were recorded and rated each visit, to evaluate symptoms progress: Dizziness, headache, chills, fever, sweating, fatigue, myalgia, pain while moving eyes, flushing, pale skin, sleep disturbances, decreased appetite, nausea, vomiting, epistaxis, cyanosis, meningeal signs.	7 ± 1 days
Secondary	Time to resolution / alleviation of catarrhal symptoms	Following symptoms were recorded and rated each visit, to evaluate symptoms progress: Sore throat, rhinorrhea and nasal congestion, difficulty swallowing, hoarseness, stridor, wheezing, rattling dry and wet cough, expectoration.	7 ± 1 days