Study to Evaluate the Efficacy, Safety, and Tolerability of the Ingavirin Forte Capsules (Valenta Pharm JSC) at Different Doses in Subjects With Influenza and Other Acute Respiratory Viral Infections.

Sponsor
Valenta Pharm JSC
Study ID
NCT07420985
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute Respiratory Viral Infection
  • Influenza

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Ingavirin Forte, 90 mg + 5 mg, Capsules — DRUG
    90 mg + 5 mg, 1 capsule twice a day, for 5 days
  • Ingavirin Forte, 90 mg + 10 mg, Capsules — DRUG
    90 mg + 10 mg, 1 capsule twice a day, for 5 days
  • Ingavirin Forte, 90 mg + 20 mg, Capsules — DRUG
    90 mg + 20 mg,1 capsule twice a day, for 5 days
  • Ingavirin, 90 mg, Capsules — DRUG
    90 mg, 1 capsule twice a day, for 5 days
  • Placebo — DRUG
    1 capsule twice a day, for 5 days

Study Details

The objective of this study is to investigate the efficacy, safety, and tolerability of investigational product Ingavirin forte capsules (Valenta Pharm JSC) administered at different doses compared with medicinal product Ingavirin, 90 mg, capsules (Valenta Pharm JSC) in subjects with influenza or other acute respiratory viral infections (ARVIs).

Key Dates

First listed
Feb 19, 2026
Start date
Oct 24, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ingavirin Forte, 90 mg + 5 mg, Capsules
    Subjects will receive Ingavirin Forte, 90 mg + 5 mg, 1 capsule twice daily (morning and evening), for 5 consecutive days.
  • Experimental: Ingavirin Forte, 90 mg + 10 mg, Capsules
    Subjects will receive Ingavirin Forte, 90 mg + 10 mg, 1 capsule twice daily (morning and evening), for 5 consecutive days.
  • Experimental: Ingavirin Forte, 90 mg + 20 mg, Capsules
    Subjects will receive Ingavirin Forte, 90 mg + 20 mg, 1 capsule twice daily (morning and evening), for 5 consecutive days.
  • Active Comparator: Ingavirin Forte, 90 mg , Capsules
    Subjects will receive Ingavirin, 90 mg, 1 capsule twice daily (morning and evening), for 5 consecutive days.
  • Placebo Comparator: Placebo, Capsules
    Subjects will receive Placebo, 1 capsule twice daily (morning and evening), for 5 consecutive days.

Primary Outcome Measure

Time (in hours) from the first dose of the study drug to the sustained resolution of all the following symptoms/events (with each resolved symptom/event persisting for at least 24 hours without the use of NSAIDs and/or decongestants): [ Time Frame: Day 1 - Day 10 of the study. ]

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