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.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Valenta Pharm JSC
- Enrollment
- 445
- Locations
- 9
- Primary Endpoint
- Time to resolution of fever
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double Blind
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Ingavirin
Imidazolyl ethanamide pentandioic acid 90 mg once daily for 5 days
Intervention: Ingavirin (Drug)
Placebo
Placebo capsule identical in appearance to Ingavirin capsule
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Time to resolution of fever
Time Frame: 7 ± 1 days
Time from the start of study treatment to resolution of fever ( t ≤ 36,9 ºС, till the end of the follow up).
Secondary Outcomes
- Time to resolution / alleviation of intoxication symptoms(7 ± 1 days)
- Time to resolution / alleviation of catarrhal symptoms(7 ± 1 days)