Clinical trial NCT03154515: Efficacy and Safety Study of Ingavirin® 90 mg Once Daily to Treat Influenza and Other Acute Viral Infections in Adults
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Common Cold
Influenza, Human
Acute Respiratory Infection
Keywords: Respiratory Tract Infections
Acute Respiratory Viral Infection
Lead sponsor: Valenta Pharm JSC
Sponsor class: INDUSTRY
First posted: 2017-05-16
Enrollment: 445
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

* Patients with clinically diagnosed influenza, body temperature ≥ 38 ºС or other acute respiratory viral infection, body temperature ≥ 37 ºС, 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

Primary outcomes:
measure: Time to resolution of fever
timeFrame: 7 ± 1 days
Secondary outcomes:
measure: Time to resolution / alleviation of intoxication symptoms
timeFrame: 7 ± 1 days
measure: Time to resolution / alleviation of catarrhal symptoms
timeFrame: 7 ± 1 days
Other outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Through study completion, an average of 8 days
Locations:
city: Chelyabinsk
country: Russian Federation
facility: State educational institution of higher professional education "Chelyabinsk State Medical Academy of Federal Agency of Health Care and Social Development"
city: Moscow
country: Russian Federation
facility: N.F. Gamaleya Scientific Research Institute of Epidemiology and Microbiology
city: Novosibirsk
country: Russian Federation
facility: State budgetary health care institution novosibirsk region "city clinical infectious diseases hospital no. 1"
city: Saint Petersburg
country: Russian Federation
facility: North-western State Medical University named after I.I.Mechnikov
city: Saratov
country: Russian Federation
facility: Saratov State Medical University named after V. I. Razumovsky
city: Vladivostok
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education "Pacific State Medical University" of the Ministry of Healthcare of the Russian Federation
city: Volgograd
country: Russian Federation
facility: Volgograd State Medical University
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl State Medical University
city: Yekaterinburg
country: Russian Federation
facility: Federal State Budgetary Institution of Higher Professional Education "Urals State Medical University" of the Ministry of Healthcare of the Russian Federation
Study officials:
affiliation: Valenta Pharm JSC
name: Ekaterina Zakharova, MD, PhD
role: STUDY_DIRECTOR
References: