InfluenzaPhase 2NCT05030324
A Study to Evaluate the Safety, Tolerability and Efficacy of XC221 in Patients With Uncomplicated Influenza or Other Acute Viral Upper Respiratory Infections
A Phase 2 study testing XC221 100 mg and XC221 200 mg in people with Influenza and Viral Respiratory Infection, run by Valenta Pharm JSC at 9 sites in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Influenza, Viral Respiratory Infection, Acute Viral Upper Respiratory Infections
- What is being tested?
- XC221 100 mg and XC221 200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 255 participants
- Where
- 9 sitesRussia
- Study dates
- 1 Oct 2021to 4 May 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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;
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- 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;
- Diabetes mellitus, grade 2-3 obesity;
- Patients who underwent surgery within 30 days prior to the screening and patients who are scheduled to undergo surgery during the study period, including diagnostic procedures or hospital stay;
- Patients with oncological diseases, HIV infection, or tuberculosis, including a medical history;
- Meningeal syndrome;
- Disorders of consciousness (in the form of stupor, sopor, delusion, delirium, etc.);
- Symptoms of pneumonia and possible acute respiratory distress syndrome (ARDS): cough with bloody frothy sputum, shortening of pulmonary sound with percussion, a large number of different-sized wet wheezing and profuse crepitus on auscultation, a sharp decrease in blood pressure (BP), deafness of heart sounds and arrhythmia;
- Positive rapid test result for SARS-CoV-2;
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
- Other reasons which would prevent the patient from participating in the study and make an unreasonable risk (in the investigator's opinion).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Russia9 sites
State autonomous health care institution "Engels City Clinical Hospital No. 1"
Engel's, 413116
Limited Liability Company "Health Energy"
Saint Petersburg, 194156
Limited Liability Company "MEDICAL CLINIC"
Saint Petersburg, 194356
St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"
Saint Petersburg, 194358
Saint Petersburg State Budgetary Healthcare Institution "City polyclinic No. 112"
Saint Petersburg, 195427
Limited Liability Company "Research Center Eco-Security"
Saint Petersburg, 196143
St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 4"
Saint Petersburg, 199178
Limited Liability Company "Meili"
Saint Petersburg, 199406
State budgetary institution of health care of the Yaroslavl region "Clinical Hospital No. 2"
Yaroslavl, 150030
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-сontrolled 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
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.
Read the detailed 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.
- Being tested
- XC221 100 mg, XC221 200 mg, Placebo
- Keywords
- Influenza, Viral Respiratory Infection, Viral Upper Respiratory Infections, Acute Viral Upper Respiratory Infections, Uncomplicated Influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XC221 100 mgDrug
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 mgDrug
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).
PlaceboDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Patients will assess and record body temperature 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.
Measured: 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)
Patients will assess and record the severity of symptom 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
Measured: 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).
Patients will assess and record the severity of symptom 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.
Measured: 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).
Patients will assess and record the severity of symptom 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.
Measured: 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).
Patients will assess and record the severity of symptom 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.
Measured: Day 1 - Day 6
Time to cough resolution (number of hours from the first dose of the drug to cough resolution, i.e. the time when the subject rates the 24-hour severity of this symptom at 0-1 point.
Patients will assess and record the severity of symptom 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.
Measured: Day 1 - Day 10
Patient rate with reported cough 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).
Patients will assess and record the severity of symptom 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.
Measured: Day 1 - Day 6
Time to muscle ache resolution (number of hours from the first dose of the drug to the resolution of muscle aches, i.e. the time when the subject rates the 24-hour severity of this symptom at 0-1 point
Patients will assess and record the severity of symptom 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.
Measured: Day 1 - Day 10
Patient rate with reported muscle ache 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).
Patients will assess and record the severity of symptom 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.
Measured: Day 1 - Day 6
Time to headache resolution (number of hours from the first dose of the drug to headache resolution, i.e. the time when the subject rates the 24-hour severity of this symptom at 0-1 point).
Patients will assess and record the severity of symptom 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.
Measured: Day 1 - Day 10
Patient rate with reported headache 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).
Patients will assess and record the severity of symptom 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.
Measured: Day 1 - Day 6
Time to fatigue resolution (number of hours from the first dose of the drug to fatigue resolution, i.e. the time when the subject rates the 24-hour severity of this symptom at 0-1 point).
Patients will assess and record the severity of symptom 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.
Measured: Day 1 - Day 10
Patient rate with reported fatigue 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).
Patients will assess and record the severity of symptom 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.
Measured: Day 1 - Day 6
Time to chills/sweats resolution (number of hours from the first dose of the drug to the resolution of chills/sweats, i.e. the time when the subject rates the 24-hour severity of this symptom at 0-1 point).
Patients will assess and record the severity of symptom 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.
Measured: Day 1 - Day 10
Patient rate with reported chills/sweats 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).
Patients will assess and record the severity of symptom 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.
Measured: Day 1 - Day 6
Frequency complications of influenza or other viral URIs (sinusitis, otitis, bronchitis, pneumonia).
Measured: Day 1 - Day 10
Time till elimination viruses based on qualitative PCR test (i.e. time to the first negative PCR test).
Measured: Day 1 - Day 10
The need for paracetamol or ibuprofen: daily dose on days 1-10.
Measured: Day 1 - Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start1 Oct 2021
- Primary completion4 May 2022
- Study completion4 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valenta Pharm JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030324
- Sponsor's protocol ID
- ХС221-02-01-2020
- Status last verified
- Jul 2023
- First submitted
- 26 Aug 2021
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-сontrolled 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
- ClinicalTrials.gov ID
- NCT05030324
- Acronym / sponsor ID
- ХС221-02-01-2020
- Keywords
- Influenza, Viral Respiratory Infection, Viral Upper Respiratory Infections, Acute Viral Upper Respiratory Infections, Uncomplicated Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Valenta Pharm JSCIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| XC221 100 mg | Experimental | Drug: XC221 100 mgSubjects 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 |
| XC221 200 mg | Experimental | Drug: XC221 200 mgSubjects 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 |
| Placebo | Placebo comparator | Drug: PlaceboSubjects 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men and women aged 18 to 65 years (inclusive);
- Signed Informed Consent Form;
- Clinical symptoms of mild to moderate influenza and other viral URIs:
- 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;
Key exclusion criteria (24 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XC221 100 mgRegardless 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). | Drug | XC221 100 mg |
| XC221 200 mgRegardless 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). | Drug | XC221 200 mg |
| PlaceboRegardless 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). | Drug | Placebo |
Primary outcome
Time (in hours) from the first dose of the drug to the resolution of all of the following symptoms/events.
Time frame: Day 1 - Day 10
• 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.
18 secondary outcomes
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).
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Day 1 - Day 6
Time to cough resolution (number of hours from the first dose of the drug to cough resolution, i.e. the time when the subject rates the 24-hour severity of this symptom at 0-1 point.
Time frame: Day 1 - Day 10
Patient rate with reported cough 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).
Time frame: Day 1 - Day 6
Time to muscle ache resolution (number of hours from the first dose of the drug to the resolution of muscle aches, i.e. the time when the subject rates the 24-hour severity of this symptom at 0-1 point
Time frame: Day 1 - Day 10
Patient rate with reported muscle ache 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).
Time frame: Day 1 - Day 6
Time to headache resolution (number of hours from the first dose of the drug to headache resolution, i.e. the time when the subject rates the 24-hour severity of this symptom at 0-1 point).
Time frame: Day 1 - Day 10
Patient rate with reported headache 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).
Time frame: Day 1 - Day 6
Time to fatigue resolution (number of hours from the first dose of the drug to fatigue resolution, i.e. the time when the subject rates the 24-hour severity of this symptom at 0-1 point).
Time frame: Day 1 - Day 10
Patient rate with reported fatigue 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).
Time frame: Day 1 - Day 6
Time to chills/sweats resolution (number of hours from the first dose of the drug to the resolution of chills/sweats, i.e. the time when the subject rates the 24-hour severity of this symptom at 0-1 point).
Time frame: Day 1 - Day 10
Patient rate with reported chills/sweats 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).
Time frame: Day 1 - Day 6
Frequency complications of influenza or other viral URIs (sinusitis, otitis, bronchitis, pneumonia).
Time frame: Day 1 - Day 10
Time till elimination viruses based on qualitative PCR test (i.e. time to the first negative PCR test).
Time frame: Day 1 - Day 10
The need for paracetamol or ibuprofen: daily dose on days 1-10.
Time frame: Day 1 - Day 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XC221 100 mg and XC221 200 mg in people with Influenza and Viral Respiratory Infection, run by Valenta Pharm JSC at 9 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time (in hours) from the first dose of the drug to the resolution of all of the following symptoms/events. (time frame: Day 1 - Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.