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

Valenta Pharm

Status and phase: Completed; Phase 4

Conditions: Acute Respiratory Infection; Influenza, Human; Common Cold

Treatments: Drug: Placebo; Drug: Ingavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03154515

5P/08

Details and patient eligibility

About

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.

Full 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).

Enrollment: 445 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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445 participants in 2 patient groups, including a placebo group

Ingavirin

Experimental group

Description:

Imidazolyl ethanamide pentandioic acid 90 mg once daily for 5 days

Treatment:

Drug: Ingavirin

Placebo

Placebo Comparator group

Description:

Placebo capsule identical in appearance to Ingavirin capsule

Treatment:

Drug: Placebo