A Phase 2 interventional study of XC221 and Placebo in Influenza and Acute Respiratory Viral Infections, sponsored by PHARMENTERPRISES LLC. Completed at 16 sites in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-16.
Sponsored by PHARMENTERPRISES LLC · Phase 2, Interventional, and Treatment
The innovative drug XC221 is planned for use in treatment of acute respiratory viral infections in a double-blind, randomized, placebo-controlled, comparative multicenter study assessing the safety, tolerability and efficacy of XC221 at a dose of 200 mg per day in patients with uncomplicated influenza or other acute respiratory viral infections during the 3-days treatment.
A double-blind, randomized, placebo-controlled, comparative multicenter study in two groups. A total of 120 patients with uncomplicated influenza or other acute respiratory viral infections are planned to be randomized. Patients will be randomized into 2 groups: 60 patients in the treatment group 200 mg XC221 and 60 patients in the placebo group. The purpose of the clinical trial is to assess the safety, tolerability and efficacy of the drug XC21 in treatment of influenza or other acute respiratory viral infections. The primary objective is to demonstrate the difference between the groups in the time of the onset of sustained improvement in clinical symptoms according to the Modified Jackson Scale. The study will consist of the following periods: screening (duration not more than 36 hours from the moment of the first symptoms of the disease), treatment period (3 days), follow-up period (11 ± 1 days after completion of treatment with the study drug/placebo). The duration of participation in the study for each patient is no more than 16 days and 12 hours.
2,356 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.
This study's enrollment of 120 is below the median of 227 across 1,957 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →PHARMENTERPRISES LLC is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period
Drug: XC221
Placebo orally. 2 tablets of Placebo once daily during 3 days of treatment period
Drug: Placebo
Participants will receive 200 mg XC221 once a day during 3 days
Participants will receive Placebo once a day during 3 days
Time to sustained improvement in clinical symptoms according to the Modified Jackson Scale for measuring respiratory symptoms.
The time before the onset of sustained improvement in clinical symptoms according to the Modified Jackson Scale (no more than 1 point for each symptom), measured in hours from the moment of the first dose of the drug. Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 32 points) is a sum of the point for each symptom.
Time frame: From the moment of the first dose up to Day 14
The time before the onset of persistent improvement in clinical symptoms according to the Modified Jackson Scale for measuring respiratory symptoms (0 points).
The time of the first assessment of 3 consecutive ratings on the Modified Jackson Scale, in which all the clinical symptoms were 0 points. Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 32 points) is a sum of the point for each symptom.
Time frame: From the moment of the first dose up to Day 14
The time before the onset of persistent improvement in clinical symptoms according to the Modified Jackson Scale for measuring respiratory symptoms.
Total score of no more than 3 points, when there is no more than 1 point for each symptom, measured in hours from the moment of taking the first dose of the drug. Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 32 points) is a sum of the point for each symptom.
Time frame: From the moment of the first dose up to Day 14
Time to normalization of body temperature.
Measured in hours. Normalization means the establishment of body temperature below 37° C without a rise above these values in the subsequent observation period.
Time frame: From the moment of the first dose up to Day 14
The average score according to the Modified Jackson Scale for measuring respiratory symptoms at the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 8th days.
The average score according to the Modified Jackson Scale on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 8th days. Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 32 points) is a sum of the point for each symptom.
Time frame: From the moment of the first dose up to Day 14
The proportion of patients with a sum of not more than 3 points according to the Modified Jackson Scale for measuring respiratory symptoms at the 1st, 2nd, 3rd, 4th, 5th, 6th , The 7th, 8th days
Score for each symptom should be no higher than 1 point at the 1st, 2nd, 3rd, 4th, 5th, 6th , The 7th, 8th days from the moment of the start of treatment. Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 32 points) is a sum of the point for each symptom.
Time frame: From the moment of the first dose up to Day 14
The proportion of patients with the normalization of body temperature on the first - the 14th days from the start of treatment;
Time frame: From the moment of the first dose up to Day 14
Time to disappearance (0 points) of each of the symptoms according to the Modified Jackson Scale for measuring respiratory symptoms.
Symptom (sneezing, rhinorrhea, nasal congestion, cough, fever, malaise, chills, headache, myalgia, sore throat, tickling, hoarseness) manifested at the level of 2 or 3 points at the first assessment at Visit 0 (Day 0). Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 32 points) is a sum of the point for each symptom.
Time frame: From the moment of the first dose up to Day 14
The proportion of patients with 0 points score for each of the symptoms according to the Modified Jackson Scale for measuring respiratory symptoms.
Modified Jackson Scale (sneezing, rhinorrhea, nasal congestion, cough, fever, malaise, chills, headache, myalgia, sore throat, tickling, hoarseness) at the 2nd, 3rd 2nd, 4th, 5th, 6th, 7th and 8th days from the moment of the start of treatment in a population of patients with the corresponding symptom shown at the level of 2 or 3 points at Visit 0 (Day 0). Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 32 points) is a sum of the point for each symptom.
Time frame: From the moment of the first dose up to Day 14
The proportion of patients with a detected viral pathogen
The proportion of patients with a detected viral pathogen at Visit 0, Visit 4 and Visit 6.
Time frame: From the moment of the first dose up to Day 14
The proportion of patients with a detected viral pathogen at Visit 4 and Visit 6 compared with the initial proportion of such patients in the XC221.
Time frame: From the moment of the first dose up to Day 14
The frequency of adverse events (AEs) and serious adverse events (SAEs) in the XC221 treatment group and in the placebo group.
Time frame: From the moment of the first dose up to Day 14
The average concentration of MxA protein in the blood at Visit 1, Visit 4 and at Visit 6.
Time frame: From Day 1 up to Day 6
Changes in the concentration of MxA protein in the blood at Visit 4 and at Visit 6 compared to Visit 1.
Time frame: From Day 1 up to Day 6
The average concentration of C-reactive protein in the blood at Visit 1, Visit 4 and Visit 6.
Time frame: From Day 1 up to Day 6
Changes in the concentration of C-reactive protein in the blood at Visit 4 and Visit 6 compared to Visit 1.
Time frame: From Day 1 up to Day 6
The average concentration of cytokines at Visit 1, Visit 4 and at Visit 6.
The average concentration of 6Ckine, BCA-1, CTACK, ENA-78, Eotaxin, Eotaxin-2, Eotaxin-3, Fractalkine, GCP-2, GM-CSF, Gro-α, Gro-β, I-309, IFN- γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-16, IP-10, I-TAC, MCP-1, MCP-2, MCP-3, MCP-4, MDC, MIF, MIG, MIP-1α, MIP-1δ, MIP-3α, MIP-3β, MPIF-1, SCYB16, SDF-1α + β, TARC, TECK, TNF-α in blood at Visit 1, Visit 4 and at Visit 6.
Time frame: From Day 1 up to Day 6
The percentage change in the concentration of cytokines at Visit 4 and at Visit 6 compared with Visit 1.
The percentage change in the concentration of 6Ckine, BCA-1, CTACK, ENA-78, Eotaxin, Eotaxin-2, Eotaxin-3, Fractalkine, GCP-2, GM-CSF, Gro-α, Gro-β, I-309, IFN -γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-16, IP-10, I-TAC, MCP-1, MCP-2, MCP-3 , MCP-4, MDC, MIF, MIG, MIP-1α, MIP-1δ, MIP-3α, MIP-3β, MPIF-1, SCYB16, SDF-1α + β, TARC, TECK, TNF-α in blood at Visit 4 and Visit 6 compared with Visit 1.
Time frame: From Day 1 up to Day 6
Correlation between the concentration of cytokines/chemokines and the assessment of the Modified Jackson scale for measuring respiratory symptoms (in dynamics).
Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 32 points) is a sum of the point for each symptom.
Time frame: From the moment of the first dose up to Day 14
The average concentration of cytokines in a smear from the mucosa of the nasopharynx and oropharyngeal at Visit 1, Visit 4 and Visit 6
The average concentration of 6Ckine, BCA-1, CTACK, ENA-78, Eotaxin, Eotaxin-2, Eotaxin-3, Fractalkine, GCP-2, GM-CSF, Gro-α, Gro-β, I-309, IFN- γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-16, IP-10, I-TAC, MCP-1, MCP-2, MCP-3, MCP-4, MDC, MIF, MIG, MIP-1α, MIP-1δ, MIP-3α, MIP-3β, MPIF-1, SCYB16, SDF-1α + β, TARC, TECK, TNF-α in a smear from the mucosa of the nasopharynx and oropharyngeal at Visit 1, Visit 4 and Visit 6.
Time frame: From Day 1 up to Day 6
The percentage change in the concentration of cytokines in a smear from the mucous membrane of the nasopharynx and oropharynx of patients on Visit 4 and on Visit 6 compared to Visit 1.
The percentage change in the concentration of 6Ckine, BCA-1, CTACK, ENA-78, Eotaxin, Eotaxin-2, Eotaxin-3, Fractalkine, GCP-2, GM-CSF, Gro-α, Gro-β, I-309, IFN- γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-16, IP-10, I-TAC, MCP-1, MCP-2, MCP-3, MCP-4, MDC, MIF, MIG, MIP-1α, MIP-1δ, MIP-3α, MIP-3β, MPIF-1, SCYB16, SDF-1α + β, TARC, TECK, TNF-α in a smear from the mucous membrane of the nasopharynx and oropharynx of patients on Visit 4 and on Visit 6 compared to Visit 1.
Time frame: From Day 1 up to Day 6
Plan to share: No
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Ran from Jan 2019 to primary completion in Jul 2019, 5 months.
Of 86 industry-sponsored phase 2 interventional studies under Influenza, Human, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's 5 months is below that.
Counting every sponsor, half of 122 studies reached it within 10 months; a quarter within 5 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: XC221
PHARMENTERPRISES LLC