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Trial record 33 of 118 for:    oseltamivir

Comparative Clinical Trial of Efficacy and Safety of Ergoferon Versus Oseltamivir in Treatment of Influenza

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ClinicalTrials.gov Identifier: NCT01850446
Recruitment Status : Completed
First Posted : May 9, 2013
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Materia Medica Holding

Brief Summary:

The purpose of this study is:

  • to assess efficacy of Ergoferon for treatment of influenza;
  • to assess safety of Ergoferon for treatment of influenza;
  • to compare efficacy of Ergoferon and Oseltamivir for treatment of influenza.

Condition or disease Intervention/treatment Phase
Influenza Drug: Ergoferon Drug: Oseltamivir Phase 4

Detailed Description:
The overall duration of a patient participation in the trial is 6 days (screening/randomization/therapy onset - day 1; study therapy period - day 1-5; follow-up period - day 6).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Parallel-group Randomized Clinical Trial of Efficacy and Safety of Ergoferon Versus Oseltamivir in Treatment of Influenza
Actual Study Start Date : February 20, 2015
Actual Primary Completion Date : April 16, 2018
Actual Study Completion Date : April 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
Drug Information available for: Oseltamivir

Arm Intervention/treatment
Experimental: Ergoferon (1 tablet 3 times a day) Drug: Ergoferon
Safety and Efficacy

Active Comparator: Oseltamivir (Tamiflu) - 1 capsule (75mg) two times a day Drug: Oseltamivir
Safety and Efficacy
Other Name: Tamiflu




Primary Outcome Measures :
  1. Proportion of patient demonstrating recovery/ improvement in health [ Time Frame: On day 2, 3, 4 and 5 of the treatment ]

    Based on the results of objective examination conducted by a physician;

    Recovery criteria: body temperature ≤37.0° C + lack of symptoms; Improvement criteria: body temperature ≤37.2 ° C + total intensity of all symptoms (except for fever index) ≤2 scores.



Secondary Outcome Measures :
  1. Dynamics of fever [ Time Frame: On day 2, 3, 4 and 5 of the treatment ]
    Changes in body temperature on day 2, 3, 4 and 5 of the treatment in comparison with the baseline

  2. Average duration of fever [ Time Frame: 6 days ]
    Criteria of no fever - body temperature lower than 37.0° C for 24 hours

  3. Proportion of patients with normal body temperature (no more than 37.0ºС) [ Time Frame: On day 2, 3, 4, 5 of the treatment ]
  4. Severity of clinical manifestations of influenza (fever, general symptoms and nasal/ throat/ chest symptoms) in scores [ Time Frame: On day 1, 2, 3, 4 and 5 of the treatment ]
    Based on the result of objective examination conducted by a physician

  5. Duration of major clinical symptoms of influenza(fever, general symptoms and nasal/ throat/ chest symptoms) in days [ Time Frame: 6 days ]
    Based on the result of objective examination conducted by a physician

  6. The severity of influenza course [ Time Frame: On day 1, 2, 3, 4 and 5 of the treatment ]
    Based on the data on area under curve for total index of influenza severity; based on the results of objective examination conducted by a physician

  7. Quantity of antipyretics administration on day 1, 2, 3, 4 and 5 of the treatment [ Time Frame: Day 1, 2, 3, 4 and 5 of the treatment ]

    Antipyretics, which are allowed for use during clinical trial, are:

    1. Paracetamol;
    2. Metamizole sodium (if hyperthermia was not stopped by usage of paracetamol).

  8. Proportion of patients, who used antipyretics [ Time Frame: On day 1, 2, 3, 4 and 5 of the treatment ]
  9. Proportion of patients with the development of disease complications requiring antibiotics administration, and of patients with exacerbation of the disease course (the development of severe influenza) [ Time Frame: 6 days ]
  10. Proportion of patients with negative results of virology assay [ Time Frame: On day 3, 4, 5 and 6 of observation ]
    Based on the data on PCR of nasal sample

  11. Dynamics of parameters of immune status [ Time Frame: On day 1, 3 and 6 of observation ]
    • Parameters of phagocytosis of peripheral blood macrophages (on day 1, 3 and 6 of observation);
    • Concentration of regulators of T- cell immune response - IL2, IFN -γ, IL-18 (on day 1,3 and 6 of observation) and regulators of В-cellular antigen-specific immune response - IL-4, IL-16 (on day1, 3 and 6 of observation);
    • Level of leukocytes spontaneous and induced in vitro production of IFN-α and IFN-γ (on day 1, 3 and 6 of observation);
    • Absolute count of leukocytes, absolute and relative count of neutrophils, lymphocytes, monocyte, eosinophils, basophils on day 1, 3 and 6 of observation;
    • The peculiarities of leukocyte phenotype in the dinamyc of the disease course - absolute and relative count of CD3, CD4, CD8, CD4/CD8; leukocyte CD16, CD119 (on day 1, 3 and 6 of observation).



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged from 18 to 70 years inclusively.
  2. Patients, who were admitted to hospital within 48 hours from the onset of influenza signs.
  3. Patients with body temperature ≥37,8°C when visiting a doctor + intensity of influenza symptoms ≥4 score (presence of at least 1 general symptom ≥2 scores and 1 nasal/ throat/ chest symptom ≥ 2 scores or greater number of symptoms with the intensity ≥1 score).
  4. Diagnosed influenza confirmed by express diagnostics (OSOM Influenza A&B Test).
  5. The possibility to start therapy within 48 hours after the onset of the first symptoms of influenza.
  6. Usage of contraceptive methods by both gender patients of reproductive age during the trial and within 30 days after ending the participation in the trial.
  7. Availability of signed patient information sheet (Informed Consent form) for participation in the clinical trial.

Exclusion Criteria:

  1. Suspected pneumonia.
  2. Suspected initial manifestations of diseases that have symptoms similar to influenza symptoms (other acute respiratory and infectious diseases, influenza-like syndrome at the onset of systemic connective tissue disorders, oncohematology and other pathology).
  3. Patients requiring competitive antiviral drugs, which are prohibited during this trial.
  4. Medical history of primary and secondary immune deficiency: a) lymphoid system immunodeficiency (T-cell and/or B-cell immunity chain, immunodeficiency with predominant antibody deficiency); b) phagocyte deficiency; c) complement factors deficiency; d) combined immunodeficiency including AIDS induced by HIV infection; toxic, autoimmune, infectious, radial panleukopenia syndrome; general lymphocytopenia syndrome; syndrome of lymphocyte polyclonal activation; postsplenectomia syndrome; congenital asplenia; syndrome of immune complexes pathology associated with infectious, allergic and autoimmune diseases.
  5. Medical history of sarcoidosis.
  6. Oncological disease/suspected oncological disease.
  7. Exacerbation or decompensation of chronic diseases affecting the patient's ability to participate in the clinical trial.
  8. Medical history of polyvalent allergy.
  9. Allergy/ intolerance to any of the components of medications used in influenza treatment.
  10. Impaired glucose tolerance, type 1 and 2 diabetes mellitus.
  11. Malabsorption syndrome, including congenital or acquired lactose deficiency or any other disaccharide deficiency.
  12. Exacerbation or decompensation of chronic diseases affecting patient's ability to participate in the trial.
  13. Pregnancy and breast feeding.
  14. Drug addiction, alcohol usage in the amount exceeding 2 units of alcohol per day, mental disorders.
  15. Intake of medicines listed in the section "Prohibited concomitant treatment" for 1 month prior to the inclusion in the trial.
  16. Patients, who from the investigator's point of view, will fail to comply with the observation requirements of the trial or with the intake regimen of the investigated medicines.
  17. Participation in other clinical trials in the course of 1 month prior to the inclusion in the trial.
  18. Patient is related to the research personnel of the investigative site, who are directly involved in the trial or are the immediate family member of the researcher. The immediate family members includes husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted.
  19. Patient works for OOO "NPF "Materia Medica Holding" (i.e. is the company's employee, temporary contract worker or appointed official responsible for the carrying out the research) or the immediate relative.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850446


Locations
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Russian Federation
The Non-State Health Care Institution "Road Hospital of the Open Joint Stock Company" Russian Railways"
Chelyabinsk, Russian Federation, 454091
The State Budgetary Educational Institution of Higher Professional Education " Kazan State University of Medicine" Ministry of Health of the Russian Federation
Kazan, Russian Federation, 420012
Pirogov Russian National Research Medical University
Moscow, Russian Federation, 117997
Limited Liability Company "Scientific Research Centre Eco-safety"
Saint Petersburg, Russian Federation, 196143
St. Petersburg State Budgetary Healthcare Institution "City polyclinic №106"
Saint Petersburg, Russian Federation, 198328
Non-state health facility "Road Hospital Open Joint Stock Company" Russian Railways"
Sankt Petersburg, Russian Federation, 195271
Regional State Budgetary Healthcare Institution "Clinical Hospital №1"
Smolensk, Russian Federation, 214006
State Federal-Funded Educational Institution of Higher Training Smolensk State Medical University of the Ministry of Health of the Russian Federation
Smolensk, Russian Federation, 214019
Federal State Budgetary Military Educational Institution of Higher Professional Education "Military-Medicine Academy named after S. M. Kirov" of Ministry of Defence of Russian Federation
St. Petersburg, Russian Federation, 194044
St. Petersburg State Budgetary Health Care Institution " City policlinic No. 117"
St. Petersburg, Russian Federation, 194358
Sponsors and Collaborators
Materia Medica Holding

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Responsible Party: Materia Medica Holding
ClinicalTrials.gov Identifier: NCT01850446     History of Changes
Other Study ID Numbers: MMH-ER-003
First Posted: May 9, 2013    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Oseltamivir
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action