A Study to Evaluate the Safety, Tolerability and Efficacy of XC221 in Patients With Uncomplicated Influenza or Other Acute Viral Upper Respiratory Infections

NCT05030324 | Completed Phase 2

• 1 other identifier: ХС221-02-01-2020
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Influenza; Viral Respiratory Infection; Acute Viral Upper Respiratory Infections

Keywords

Influenza; Viral Respiratory Infection; Viral Upper Respiratory Infections; Acute Viral Upper Respiratory Infections; Uncomplicated Influenza

Outcome Measures

Primary Outcomes (1)

• Time (in hours) from the first dose of the drug to the resolution of all of the following symptoms/events.

  • fever (the day of fever resolution is the first day on which stable normal body temperature is achieved (\<37.0°C without the use of antipyretics)); All achieved symptoms/events scores maintained for at least 24 h at 0-1 point: * nasal congestion/runny nose; * sore throat; * cough; * muscle aches; * headaches; * fatigue; * chills/sweats. Patients will assess and record the severity of all symptoms on a 4-point scale in the Patient's Diary for 10 days 2 times a day with a 12 ± 2 h interval before the next use of symptomatic agents, where: 0 points - no symptom; 1 point - the minimum severity of the symptom; 2 points - moderate severity of the symptom; 3 points - the maximum severity of the symptom.

  Day 1 - Day 10

Secondary Outcomes (18)

• Time to decrease in 24-hour body temperature to ≤ 37.0°C without using antipyretics (number of hours from the first dose of the study treatment to a decrease in 24-hour body temperature to ≤ 37.0°C).

  Day 1 - Day 10

• Time to nasal congestion/runny nose resolution (number of hours from the first dose of the drug to runny nose/congestion resolution, i.e. the time when the subject rates the 24-hour severity of this symptom at 0-1 point)

  Day 1 - Day 10

• Patient rate with reported nasal congestion/runny nose resolution by day 4 and day 6 from treatment initiation (i.e. patient rate who assessed the 24-hour severity of this symptom at 0-1 point).

  Day 1 - Day 6

• Time to sore throat resolution (number of hours from the first dose of the drug to sore throat resolution, i.e. the time when the subject rates the 24-hour severity of this symptom at 0-1 point).

  Day 1 - Day 10

• Patient rate with reported sore throat resolution by day 4 and day 6 from treatment initiation (i.e. patient rate who assessed the 24-hour severity of this symptom at 0-1 point).

  Day 1 - Day 6

Study Arms (3)

XC221 100 mg

EXPERIMENTAL

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

Drug: XC221 100 mg

XC221 200 mg

EXPERIMENTAL

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

Drug: XC221 200 mg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

XC221 100 mg DRUG

Regardless of the group, all study subjects will 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).

XC221 100 mg

XC221 200 mg DRUG

Regardless of the group, all study subjects will 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).

XC221 200 mg

Placebo DRUG

Regardless of the group, all study subjects will 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).

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18 to 65 years (inclusive);
• Signed Informed Consent Form;
• Clinical symptoms of mild to moderate influenza and other viral URIs:
• an increased axillary temperature of ≥38.0°С ≤39.5°С during the current illness without the use of antipyretics in the last 8 hours at the time of screening;
• at least one of the respiratory signs and symptoms of influenza or other viral URIs (cough, runny nose/nasal congestion, sore throat) scored at least 2 points on a 4-point scale;
• at least one of the systemic signs and symptoms of influenza or other viral URIs (headaches, muscle aches, chills/sweats, fatigue) scored at least 2 points on a 4-point scale.
• Absence of indications for hospitalization at the time of enrollment;
• Duration of illness from symptom manifestation to the first drug dose/placebo no more than 48 h;
• Negative pregnancy test for women of childbearing potential;
• A consent to use adequate birth control methods throughout the treatment and for 30 days thereafter;
• Patients who are able to understand and comply with treatment and procedures during the study.

You may not qualify if:

• Pregnant and lactating women;
• Known or suspected hypersensitivity to the active substance or to excipients of the drug XC221 or placebo;
• An established or currently suspected diagnosis (based on the assessment of the patient's health and epidemiological medical history) of COVID-19;
• Oxygen saturation (SpO2) ≤ 95%, respiration rate (RR) ≥ 22/min.
• Complications of influenza or other viral URIs;
• Participation in another clinical trial within 90 days prior to screening;
• Known (based on the medical history) or suspected abuse of alcohol or psychotropic drugs;
• Patients with psychotic diseases, including in the medical history;
• Moderate viral URI (fever ≥ 38.5°С) accompanied by exacerbation of concomitant conditions;
• Clinically suspected pneumonia or other bacterial infections (including sinusitis, otitis media, urinary tract infection, meningitis, sepsis, etc.) requiring antibacterial therapy;
• Taking antibiotics, antivirals, or immunomodulatory drugs within \< 48 h prior to treatment initiation and/or planning to use these types of drugs (except for the investigational products) during the study;
• Use of systemic, inhaled or nasal corticosteroids within 30 days prior to treatment initiation and/or planning to use corticosteroids (except for topical dermatological agents) during the study;
• The inability to cancel during the study period other drugs that can affect the result of this study, for example, antiviral drugs, or drugs that are incompatible with the study's therapy;
• Any diseases of cardiac, renal, hepatic, gastrointestinal, endocrine and nervous system, severe decompensated chronic (including chronic renal and liver diseases) or acute diseases, or any other conditions/diseases which would make participation in the study unsafe (in the investigator's opinion);
• Patients receiving any vaccines within 90 days prior to enrollment;

Sponsors & Collaborators

• Valenta Pharm JSC: lead

Study Sites (9)

State autonomous health care institution "Engels City Clinical Hospital No. 1"

Engel's, 413116, Russia

Location

Limited Liability Company "Health Energy"

Saint Petersburg, 194156, Russia

Location

Limited Liability Company "MEDICAL CLINIC"

Saint Petersburg, 194356, Russia

Location

St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"

Saint Petersburg, 194358, Russia

Location

Saint Petersburg State Budgetary Healthcare Institution "City polyclinic No. 112"

Saint Petersburg, 195427, Russia

Location

Limited Liability Company "Research Center Eco-Security"

Saint Petersburg, 196143, Russia

Location

St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 4"

Saint Petersburg, 199178, Russia

Location

Limited Liability Company "Meili"

Saint Petersburg, 199406, Russia

Location

State budgetary institution of health care of the Yaroslavl region "Clinical Hospital No. 2"

Yaroslavl, 150030, Russia

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

XC221

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Tablets identical in terms of composition, appearance and labeling to XC221 tablets, but without active substance will be used as Placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be randomized into three treatment groups (in a 1:1:1 ratio) receiving: study drug (ХС221) at 100 mg daily or at 200 mg daily, or placebo

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 1, 2021
• Study Start: October 1, 2021
• Primary Completion: May 4, 2022
• Study Completion: May 4, 2022
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (9)