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

14 oktober 2019 uppdaterad av: PHARMENTERPRISES LLC

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

120

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 45 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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
Läkemedel: XC221 100 mg
once daily during 3 days.
Experimentell: XC221 200 mg
XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period
Läkemedel: XC221 200 mg
once daily during 3 days.
Placebo-jämförare: Placebo
Placebo orally. 2 tablets of Placebo 100 mg once daily during 3 days of treatment period
Läkemedel: Placebo
once daily during 3 days.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time to Sustained Improvement in Clinical Symptoms Based on Modified Jackson Scale for ARVI
Tidsram: From the time of randomization up to Day 14

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time to Body Temperature Normalization
Tidsram: From the time of randomization assessed up to Day 14
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
Tidsram: From the time of randomization up to Day 14
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
Tidsram: From randomization up to 3 days 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.
From randomization up to 3 days of treatment

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

PHARMENTERPRISES LLC

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

12 februari 2018

Primärt slutförande (Faktisk)

28 juni 2018

Avslutad studie (Faktisk)

28 juni 2018

Studieregistreringsdatum

Först inskickad

28 februari 2018

Först inskickad som uppfyllde QC-kriterierna

28 februari 2018

Första postat (Faktisk)

6 mars 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 november 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 oktober 2019

Senast verifierad

1 oktober 2019

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ARI-XC221-02

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Nej

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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