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

NCT03455491 | Completed Phase 2 Results

• 1 other identifier: ARI-XC221-02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Acute Respiratory Viral Infections; Influenza

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time to Body Temperature Normalization

  From the time of randomization assessed up to Day 14

• Percentage of Patients With Complications

  From the time of randomization up to Day 14

• The Area Under the Curve "Modified Jackson Scale Score" During 3-day Therapy

  From randomization up to 3 days of treatment

Study Arms (3)

XC221 100 mg

EXPERIMENTAL

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

XC221 200 mg

EXPERIMENTAL

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

Drug: XC221 200 mg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

XC221 100 mg DRUG

once daily during 3 days.

XC221 100 mg

XC221 200 mg DRUG

once daily during 3 days.

XC221 200 mg

Placebo DRUG

once daily during 3 days.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women aged 18 to 45 years (inclusively).
• Clinically diagnosed influenza or ARVI.
• 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:

• Existence of complications of influenza or ARVI (including the presence / development of bacterial infection).
• Hypersensitivity to excipients of the drug XC221 or placebo.
• 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.
• 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 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).
• Infectious diseases during the last week before including into the study.
• History of bronchial asthma.
• 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.
• Diabetes mellitus.
• Drug or alcohol abuse.
• Participation in any other clinical trial in the last 90 days.
• Pregnancy or lactation.
• Military or prison populations.

Sponsors & Collaborators

• PHARMENTERPRISES LLC: lead

Study Sites (11)

City Clinical Hospital №9

Izhevsk, 426063, Russia

Location

Kuban State Medical University

Krasnodar, 350063, Russia

Location

City Clinical Hospital №1 n.a. Semashko

Rostov-on-Don, 344000, 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

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

Mordovia State Medical University n.a. N.P.Ogarev, Clinical site - Republic Infectious Clinical Hospital

Saransk, 430024, Russia

Location

Volgograd State Medical University, Clinical site - Infectious Regional Clinical Hospital № 1

Volgograd, 400131, Russia

Location

Сlinical Hospital №3

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

Results Point of Contact

• Title: CEO Vladimir Nebolsin
• Organization: PHARMENTERPRISES LLC

ph@pharmenterprises.ru

+7 (985) 728-75-72

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Blinding will carried out by using Placebo equivalent to XC221 tablets without active substance and the corresponding labeling of the study drug.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 6, 2018
• Study Start: February 12, 2018
• Primary Completion: June 28, 2018
• Study Completion: June 28, 2018
• Last Updated: November 4, 2019
• Results First Posted: November 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (11)