Study to Assess Efficacy and Safety of XC221 200 mg in the Treatment of Influenza or Other ARVI

NCT03830905 | Completed Phase 2

• 1 other identifier: ARI-XC221-03
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 16

Brief Summary

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.

Conditions

Influenza; Acute Respiratory Viral Infections

Outcome Measures

Primary Outcomes (1)

• 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.

  From the moment of the first dose up to Day 14

Secondary Outcomes (11)

• The time before the onset of persistent improvement in clinical symptoms according to the Modified Jackson Scale for measuring respiratory symptoms (0 points).

  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.

  From the moment of the first dose up to Day 14

• Time to normalization of body temperature.

  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.

  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

  From the moment of the first dose up to Day 14

Other Outcomes (9)

• The average concentration of MxA protein in the blood at Visit 1, Visit 4 and at Visit 6.

  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.

  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.

  From Day 1 up to Day 6

Study Arms (2)

XC221

EXPERIMENTAL

XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period

Drug: XC221

Placebo

PLACEBO COMPARATOR

Placebo orally. 2 tablets of Placebo once daily during 3 days of treatment period

Drug: Placebo

Interventions

XC221 DRUG

Participants will receive 200 mg XC221 once a day during 3 days

XC221

Placebo DRUG

Participants will receive Placebo once a day during 3 days

Placebo

Eligibility Criteria

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

You may qualify if:

• Both sexes aged 18 years and older.
• Clinically diagnosed influenza or ARVI mild or moderate severity.
• Patient's body temperature ≥37.5ºС and at least 1 symptom from Modified Jackson Scale estimated more than 2 points.
• Uncomplicated course of influenza or ARVI based on clinical estimations.
• The first 36 hours from the beginning of symptoms of influenza or ARVI.
• Women of reproductive age (who are not in menopause and who have not undergone surgical sterilization) and men who have sexual activity should use a reliable method of contraception (acceptable methods of contraception in this study are: intrauterine devices, oral contraceptives, contraceptive patch, long-acting injectable contraceptives, a double barrier method (condom and diaphragm with spermicide) throughout the study period.
• Compliance with the treatment regimen, visits and laboratory examinations provided by the protocol.
• Signed Informed Consent Form.

You may not qualify if:

• Complications of influenza or ARVI (including the presence / development of bacterial infection).
• The need for inpatient treatment of influenza and ARVI.
• Hypersensitivity to excipients of the drug XC221 or placebo.
• Antiviral medications 7 days prior to screening (antiviral agents, interferons and interferon inducers, drugs that have immunomodulating action) or anti-infective agents of systemic or local action.
• Severe infection with signs of cardiovascular insufficiency development and other manifestations of infectious-toxic shock, as well as with the presence of neuroinfection syndrome (encephalic and meningoencephalic reactions, polyradiculoneuritis, neuritis).
• Signs of of viral pneumonia symptoms (the presence of two or more of the following symptoms): dyspnea, chest pain when coughing, systemic cyanosis, dullness of percussion sound with a symmetrical evaluation of the upper and lower sections of the lungs).
• Infectious diseases during the last week before including into the study.
• Bronchial asthma, COPD, pulmonary emphysema in history.
• History of increased convulsive activity.
• Severe, decompensated or unstable somatic diseases (any diseases or conditions that are life-threatening or may worsen the patient's prognosis, and make him/her ineligible for the clinical study).
• History of oncological diseases, HIV, tuberculosis.
• Drug or alcohol abuse.
• Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
• Participation in any other clinical trial in the last 90 days.
• Pregnancy or lactation.

Sponsors & Collaborators

• PHARMENTERPRISES LLC: lead
• RSV Therapeutics LLC: collaborator

Study Sites (16)

Federal State Budgetary Institution of Health "Northern Medical Clinical Center named after NA Semashko of the Federal Medical and Biological Agency"

Arkhangelsk, 163000, Russia

Location

Regional State Budgetary Institution of Health "Belgorod Regional Clinical Hospital of St. Joasaph"

Belgorod, 308007, Russia

Location

City Clinical Hospital №9

Izhevsk, 426063, Russia

Location

Kuban State Medical University

Krasnodar, 350063, Russia

Location

State budget institution of health care of the Moscow region "Krasnogorsk city hospital number 1"

Krasnogorsk, 143408, Russia

Location

Non-governmental Healthcare Institution "N.A.Semashko Road Clinical Hospital at the Lyublino station of the open joint-stock company "Russian Railways"

Moscow, 109386, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Ryazan State Medical University named after Academician I.P. Pavlova" of the Ministry of Health of the Russian Federation

Ryazan, 390026, Russia

Location

Ryazan State Medical University n.a. Pavlov

Ryazan, 390026, Russia

Location

The Center for Prevention and Fight about AIDS and Infectious Diseases

Saint Petersburg, 190103, Russia

Location

LLC "Aurora Medi"

Saint Petersburg, 193232, Russia

Location

The Consulting and Diagnostic Center with out-patient help of the Administration of the President of the Russian Federation

Saint Petersburg, 197110, Russia

Location

Research Institute of Influenza

Saint Petersburg, 197376, Russia

Location

City Clinical Hospital №40 of Kurortny District

Saint Petersburg, 197706, Russia

Location

LLC "Astarta"

Saint Petersburg, 199226, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Yaroslavl State Medical University" of the Ministry of Health of the Russian Federation

Yaroslavl, 150000, Russia

Location

State Budgetary Healthcare Institution (SBHI) of Yaroslavl region

Yaroslavl, 150007, 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 5, 2019
• Study Start: January 31, 2019
• Primary Completion: July 3, 2019
• Study Completion: July 3, 2019
• Last Updated: November 16, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (16)