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.

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorValenta Pharm JSC

About this trial

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).

Eligibility criteria

Qualifiers

Voluntarily and personally signed Informed Consent Form (ICF) by a participant obtained prior to the conduct of any study-related procedure;

Males and females aged 18 to 65 years (inclusive) at the time of signing the ICF;

Subjects with influenza or other acute respiratory viral infections confirmed by polymerase chain reaction (PCR);

Body temperature >38,0 °С at randomization, with no intake NSAID within 12 hours before randomization;

Disqualifiers

Clinically significant allergic history;

Hypersensitivity to active substances of medical produtcs Ingavirin and Ingavirin forte, and/or to any excipient contaned in the investigational medicinal product or comparator;

Intolerance to active substances of medical produtcs Ingavirin and Ingavirin forte, and/or to any excipient contaned in the investigational medicinal product or comparator;

Known galactose intolerance, lactase deficiency, or glucose-galactose malabsorption;

Trial design

Treatments tested in this trial

  • Ingavirin Forte, 90 mg + 5 mg, Capsules
  • Ingavirin Forte, 90 mg + 10 mg, Capsules
  • Ingavirin Forte, 90 mg + 20 mg, Capsules
  • Ingavirin, 90 mg, Capsules
  • Placebo

Treatment groups

300 Participants
are divided into 5 treatment groups

Sponsors and collaborators