Clinical Trials Logo

Clinical Trial Summary

A multicenter, randomized, double-blind, placebo controlled comparative study to evaluate the safety, tolerability and efficacy of XC221 used at 100 mg daily and at 200 mg daily in patients with uncomplicated influenza or other acute viral upper respiratory infections (URIs) for 5 days of treatment. The primary objective of the study is to evaluate the efficacy of ХС221 at 100 mg and at 200 mg in comparison with placebo regarding its effect on the severity and duration of influenza symptoms and symptoms of other viral URIs (fever and other major signs and symptoms). The secondary objective of the study is to evaluate the safety of ХС221 at 100 mg and at 200 mg in comparison with placebo in the treatment of influenza ad other viral URIs.


Clinical Trial Description

Russian centers will participate in this study. This is a double-blind, placebo-control study, and therefore, in order to maintain the study design, subjects will be administered with placebo or the study drug depending on the treatment group they have been randomized into. The screening visit and all other visits of the study will be on an outpatient basis (including home visits). The study will consist of three periods: screening, randomization and initiation of treatment ( Day 1); treatment period (Day 1-5) and follow-up period (Day 6-20± 1 after completion of treatment with XC221 / Placebo). The duration of participation in the study for each patient will be no more than 21 days. 255 eligible patients will be randomized into three treatment groups (in a 1:1:1 ratio) and receive: study drug (ХС221) at 100 mg daily or at 200 mg daily, or placebo. Regardless other group, all study subjects should receive the standard symptomatic therapy for influenza and other viral URIs, taking into account the latest clinical guidelines (the necessity of symptomatic therapy will be decided by the Investigator). Group 1: subjects will receive 1 tablet of XC221, 100 mg tablets orally in the morning (between 7:00 and 11:00) and 1 tablet of placebo in the evening (between 19:00 and 23:00) regardless of food intake for 5 days. Group 2: subjects will receive 1 tablet of XC221, 100 mg tablets orally twice daily in the morning (between 7:00 and 11:00) and in the evening (between 19:00 and 23:00) regardless of food intake for 5 days. Group 3: subjects will receive 1 tablet of placebo orally twice daily, in the morning (between 7:00 and 11:00) and in the evening (between 19:00 and 23:00) regardless of food intake for 5 days. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05030324
Study type Interventional
Source Valenta Pharm JSC
Contact
Status Not yet recruiting
Phase Phase 2
Start date September 2021
Completion date December 2021

See also
  Status Clinical Trial Phase
Completed NCT03282240 - Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US Phase 3
Completed NCT00968539 - Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults Phase 3
Completed NCT00968526 - Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults Phase 3
Completed NCT00971425 - Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1) Phase 3
Completed NCT04074928 - Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects Phase 3
Active, not recruiting NCT04695717 - This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam Phase 3
Recruiting NCT03888989 - Response to Influenza Vaccine During Pregnancy Phase 4
Completed NCT04109222 - Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively Phase 4
Completed NCT02587221 - Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age Phase 3
Completed NCT03453801 - The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection Phase 1
Completed NCT01440387 - A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older Phase 3
Terminated NCT01195779 - Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children Phase 2
Completed NCT00972517 - Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children Phase 3
Recruiting NCT04570904 - Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
Recruiting NCT03331991 - Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel N/A
Completed NCT03673345 - Development of Childhood Anti-Influenza Immunity Phase 4
Completed NCT01949090 - Immunogenicity and Safety Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals H7N1 Influenza Vaccine Administered to Adults 65 Years of Age and Older Phase 2
Completed NCT03330899 - Safety and Immunogencity of H7N9 Influenza Antigen With 2 Adjuvant Formulations in Healthy Adults in Brazil Phase 1
Completed NCT04579614 - Performance Feedback in Health Care N/A
Completed NCT02915302 - Safety and Immunogenicity of Fluzone® Quadrivalent Vaccine Administered to Healthy Children Phase 4