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

NCT05544916 | Completed Phase 3

• 1 other identifier: XC221-03-04-2022
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 13

Brief Summary

The main purpose of the study was to evaluate the effectiveness of XC221, tablets, at a dose of 200 mg/day compared to placebo in patients with uncomplicated influenza or other acute respiratory viral infections (ARIs). An additional purpose of the study was to evaluate the safety of XC221, tablets, at a dose of 200 mg/day compared to placebo in patients with uncomplicated influenza or other ARIs.

Conditions

Influenza; Respiratory Viral Infection

Outcome Measures

Primary Outcomes (1)

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

  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 (66)

• 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 10

• 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 (2)

XC221

EXPERIMENTAL

Patients will take 1 tablet of XC221, tablets, 100 mg twice daily, in the morning (between 7:00 and 11:00 a.m.) and in the evening (between 7:00 and 11:00 p.m.), for 5 days.

Drug: XC221

Placebo

PLACEBO COMPARATOR

Patients will take 1 placebo pill orally twice a day, in the morning (between 7:00 and 11:00 a.m.) and in the evening (between 7:00 and 11:00 p.m.), for 5 days.

Drug: Placebo

Interventions

XC221 DRUG

200 mg/day, for 5 days

XC221

Placebo DRUG

2 tablets/day, for 5 days

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 between the ages of 18 and 65 years inclusive;
• Presence of written consent to participate in the study in accordance with applicable law;
• Clinical signs of mild to moderate influenza or other acute respiratory infections (ARIs): an increase in body temperature, measured at the axilla, with a value between 38.0 °C and 39.5 °C, inclusive, during the current illness and without taking antipyretics within the last 8 h at the time of screening; at least one respiratory manifestation of influenza or other ARI (cough, runny nose/ stuffy nose, sore throat) of at least 2 points on a 4-point scale; at least one systemic manifestation of influenza or other ARI (headache, muscle pain, chills/sweating, fatigue) of at least 2 points on a 4-point scale.
• No indication for hospitalization at the time of enrollment in the study;
• Duration of illness from manifestation of symptoms to the first dose of study drug/placebo not more than 48 hours;
• Negative pregnancy test for women of preserved reproductive potential;
• Consent to use adequate contraceptive methods throughout the study and for 30 days after study completion;
• Ability to understand the requirements for study participants, to give written consent to participate in the study (including the use and communication of patient health information relevant to the study) and to comply with the procedures of the study protocol.

You may not qualify if:

• Pregnant and breastfeeding women;
• Known hypersensitivity to the study drug, including the active and/or excipients.
• Lactase deficiency, lactose intolerance, glucose-galactose malabsorption, galactose intolerance;
• Diagnosis of COVID-19 established or probable at present (based on examination and analysis of epidemiological history);
• Positive result of rapid test for SARS-CoV-2;
• Blood oxygen saturation (SpO2) ≤ 95%, respiratory rate ≥ 22/min.
• Complicated course of influenza or other acute respiratory infections;
• Participation in any other clinical trial within 90 days prior to the screening period;
• Known (based on medical history) or suspected alcohol abuse, psychotropic drugs, drug dependence, drug addiction;
• Presence of mental illness, including a history of mental illness;
• Clinical suspicion of pneumonia or other bacterial infections (including sinusitis, otitis media, urinary tract infection, meningitis, sepsis, etc.) requiring prescription of antibacterial drugs;
• Taking antibiotics, antivirals, or immunomodulatory drugs for \< 48 h before the study and/or plans to use these groups of drugs (other than the study drug) during the study;
• Use of systemic, inhaled, or nasal glucocorticosteroids within 30 days prior to the study and/or plans to use glucocorticosteroids (except topical cutaneous agents) during the study;
• Failure to withdraw for the duration of the study other medications that may affect the outcome of this study, such as antiviral medications, or medications that are incompatible with the study therapy;
• Any cardiovascular, renal, hepatic, gastrointestinal, endocrine or nervous system diseases, severe decompensated chronic (including chronic kidney disease and chronic liver disease) or acute diseases or any other condition/disease that, in the opinion of the investigator, would make it unsafe for the patient to participate in the study;

Sponsors & Collaborators

• Valenta Pharm JSC: lead

Study Sites (13)

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

Engel's, 413116, Russia

Location

Medical Diagnostic Center "Medexpert", LLC

Engel's, Russia

Location

Unimed-C Jsc

Moscow, 119571, Russia

Location

Professors' Clinic LLC.

Perm, 614070, Russia

Location

Limited Liability Company "Health Energy"

Saint Petersburg, 194156, 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

Saint Petersburg State Budgetary Institution of Healthcare "City Pokrovskaya Hospital"

Saint Petersburg, 199106, 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

"Medical Clinic" Ltd.

Saint Petersburg, 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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 19, 2022
• Study Start: August 5, 2022
• Primary Completion: February 1, 2023
• Study Completion: May 4, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

RU (13)