Study to Assess Efficacy and Safety of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections

Multicenter Double-blinded Placebo-Controlled Parallel-Group Randomized Clinical Trial of Efficacy, Safety and Choice of an Optimum Dose of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections in Adults

A multicenter double-blinded, randomized, placebo-controlled, parallel-group comparative Phase II clinical study to assess safety, tolerability, efficacy and optimal dose of XC221 vs. placebo in patients with uncomplicated influenza or other ARVI during a 3-day treatment.

The primary objective of the study is to demonstrate the difference in time before the onset of a sustained improvement in clinical symptoms according to the Modified Jackson Scale for ARVI and to determine the optimal dose of XC221 in the treatment of influenza and other ARVI.

Study Overview

• Status: Completed
• Conditions: Influenza; Acute Respiratory Viral Infections
• Intervention / Treatment: Drug: XC221 100 mg; Drug: XC221 200 mg; Drug: Placebo

Detailed Description

11 Russian centers were planned for participation in this study. The study consists of three periods: screening, treatment and follow-up.

All eligible patients will be randomized into 3 groups (groups A, B and C) in a 1:1:1 ratio:

Group A - XC221 100 mg daily (40 patients); Group B - XC221 200 mg daily (40 patients); Group C - Placebo (40 patients).

During the treatment period (3 days), patients will receive XC221 / placebo daily on a background of standard symptomatic therapy. The follow-up period lasts for 11 days.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• Russian Federation
  • Izhevsk, Russian Federation, 426063
    • City Clinical Hospital №9
  • Krasnodar, Russian Federation, 350063
    • Kuban State Medical University
  • Rostov-on-Don, Russian Federation, 344000
    • City Clinical Hospital №1 n.a. Semashko
  • Ryazan', Russian Federation, 390026
    • Ryazan State Medical University n.a. Pavlov
  • Saint Petersburg, Russian Federation, 190103
    • The Center for Prevention and Fight about AIDS and Infectious Diseases
  • Saint Petersburg, Russian Federation, 197110
    • The Consulting and Diagnostic Center with out-patient help of the Administration of the President of the Russian Federation
  • Saint Petersburg, Russian Federation, 197376
    • Research Institute of Influenza
  • Saint Petersburg, Russian Federation, 197706
    • City Clinical Hospital №40 of Kurortny District
  • Saransk, Russian Federation, 430024
    • Mordovia State Medical University n.a. N.P.Ogarev, Clinical site - Republic Infectious Clinical Hospital
  • Volgograd, Russian Federation, 400131
    • Volgograd State Medical University, Clinical site - Infectious Regional Clinical Hospital № 1
  • Yaroslavl, Russian Federation, 150007
    • Сlinical Hospital №3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Men and women aged 18 to 45 years (inclusively).
2. Clinically diagnosed influenza or ARVI.
3. Patient's body temperature ≥37.5ºС and at least 1 symptom from Modified Jackson Scale estimated more than 2 points.
4. Uncomplicated course of influenza or ARVI based on clinical estimations.
5. The first 36 hours from the beginning of symptoms of influenza or ARVI.
6. 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.
7. Compliance with the treatment regimen, visits and laboratory examinations provided by the protocol.
8. Signed Informed Consent Form.

Exclusion Criteria:

1. Existence of complications of influenza or ARVI (including the presence / development of bacterial infection).
2. Hypersensitivity to excipients of the drug XC221 or placebo.
3. Antiviral medications in 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.
4. 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).
5. Signs of the development of viral pneumonia (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).
6. Infectious diseases during the last week before including into the study.
7. History of bronchial asthma.
8. History of increased convulsive activity.
9. 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).
10. History of oncological diseases, HIV, tuberculosis.
11. Diabetes mellitus.
12. Drug or alcohol abuse.
13. Participation in any other clinical trial in the last 90 days.
14. Pregnancy or lactation.
15. Military or prison populations.
16. Impossibility or inability to comply with the study procedures.
17. A member of the investigator's family or other person interested in the results of the study.
18. Abnormal laboratory results, which, according to the study doctor, interfere with the patient's inclusion in the study.
19. History of renal insufficiency.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XC221 100 mg; XC221 100 mg orally. 1 tablet of XC221 100 mg +1 tablet of Placebo 100 mg (in total 2 tablets) once daily during 3 days of treatment period	Drug: XC221 100 mg; once daily during 3 days.
Experimental: XC221 200 mg; XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period	Drug: XC221 200 mg; once daily during 3 days.
Placebo Comparator: Placebo; Placebo orally. 2 tablets of Placebo 100 mg once daily during 3 days of treatment period	Drug: Placebo; once daily during 3 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Sustained Improvement in Clinical Symptoms Based on Modified Jackson Scale for ARVI	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 time of randomization up to Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Body Temperature Normalization	Time to body temperature normalization since treatment initiation, measured in hours (normalization is regarded as setting of body temperature below 37°C without elevation above these values)	From the time of randomization assessed up to Day 14
Percentage of Patients With Complications	The percentage of patients with complications of influenza/acute viral URI	From the time of randomization up to Day 14
The Area Under the Curve "Modified Jackson Scale Score" During 3-day Therapy	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 randomization up to 3 days of treatment

Collaborators and Investigators

• Sponsor: PHARMENTERPRISES LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2018
• Primary Completion (Actual): June 28, 2018
• Study Completion (Actual): June 28, 2018

Study Registration Dates

• First Submitted: February 28, 2018
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (Actual): March 6, 2018

Study Record Updates

• Last Update Posted (Actual): November 4, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Orthomyxoviridae Infections; Infections; Communicable Diseases; Virus Diseases; Influenza, Human
• Other Study ID Numbers: ARI-XC221-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No