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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 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

120

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 45 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Legemiddel: XC221 100 mg
once daily during 3 days.
Eksperimentell: XC221 200 mg
XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period
Legemiddel: XC221 200 mg
once daily during 3 days.
Placebo komparator: Placebo
Placebo orally. 2 tablets of Placebo 100 mg once daily during 3 days of treatment period
Legemiddel: Placebo
once daily during 3 days.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to Sustained Improvement in Clinical Symptoms Based on Modified Jackson Scale for ARVI
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to Body Temperature Normalization
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

PHARMENTERPRISES LLC

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

12. februar 2018

Primær fullføring (Faktiske)

28. juni 2018

Studiet fullført (Faktiske)

28. juni 2018

Datoer for studieregistrering

Først innsendt

28. februar 2018

Først innsendt som oppfylte QC-kriteriene

28. februar 2018

Først lagt ut (Faktiske)

6. mars 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. november 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. oktober 2019

Sist bekreftet

1. oktober 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ARI-XC221-02

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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