A Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Interferon Alfa-n3 Therapy in Addition to Standard of Care in Adults Hospitalized Due to Acute Severe Influenza
- Conditions
- Health Condition 1: null- Adult patients hospitalized due to acute severe influenza
- Registration Number
- CTRI/2010/091/001115
- Lead Sponsor
- Hemispherx Biopharma Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Applicable
- Sex
- Not specified
- Target Recruitment
- 60
1. Age greater than equal to 18 to less than 60 years of age, male or female.
2. Able to provide informed consent, or for whom consent may be provided by Legally Acceptable Representative or guardian.
3. Subject must have at least two of the following five clinical presentations:
a. Oral temperature greater than 38.0 degree Celsius (greater than 100.4 degree fahrenneit )
b. Oxygen saturation less than 92 percent without supplemental oxygen
c.Respiration rate less than 24 per minute
d. Heart rate greater than 100 per minute
e. Systolic Blood pressure less than 100 mm Hg
4. Presence of at least one respiratory symptom (cough, sore throat, or nasal congestion) of any severity (mild, moderate, or severe).
5. Presence of at least one constitutional symptom (headache, myalgia, feverishness (a feeling that you have a fever), or fatigue) of any severity (mild, moderate, or severe).
6. Onset of illness no more than 72 hours before hospital admission. Note-Time of onset of illness is defined as either (1) the time when the temperature was first measured as elevated (greater than 38.0 degree Celsius (greater than 100.4 degree fehrenite), OR (2) the time when the subject experienced the presence of at least one respiratory symptom AND the presence of at least one constitutional symptom.
7. Hospitalization criteria- Either severity of illness that, in the Investigators judgment, justifies hospitalization of the subject for supportive care, OR presence of one or more of the following factors-
a.Presence of chronic obstructive pulmonary disease (COPD) or other chronic lung disease requiring daily pharmacotherapy.
b.Current history of congestive heart failure or angina.
c.Presence of diabetes mellitus, clinically stable or unstable.
d. Transcutaneous oxygen saturation less than 94 percent without supplemental oxygen for at least 5 minutes, or a medically significant decrease in oxygen saturation from an established baseline value (an investigative site at altitude greater than 2000 ft above sea level will utilize different criteria for oxygen saturation).
e.History of chronic renal impairment not requiring dialysis.
f.Serum creatinine greater than 2.0 mg per dL.
8. Diagnosis of clinical influenza with a positive Rapid Antigen Test (RAT) for influenza A and/or influenza B (using a Sponsor-approved test kit, or kits). If available at a site, a sponsor approved ELISA assay for influenza virus may be utilized.
9. Females must be using an effective contraception method or other form of birth control prior to and during the study and use will continue through 4 weeks after completion of study drug administration.
10. Males will ensure that their female partners of childbearing potential will utilize an effective contraceptive method or other form of birth control to avoid pregnancy.
1. Subjects who have developed clinical manifestations of influenza after having been hospitalized for a condition other than confirmed or suspected influenza.
2. Blood platelet count of less than 100 x 109/L.
3. Serum bilirubin greater than 3 mg/dL at time of screening evaluation.
4. Serum ALT or AST greater than 3 times the upper limit of normal at time of screening evaluation.
5. Congestive heart failure of NYHA Class III or Class IV functional status (see Appendix 18.0).
6. Requirement for vasopressor support to maintain satisfactory hemodynamic status at time of screening evaluation.
7. Serum creatinine greater than 3.0 mg/dL at time of screening evaluation.
8. Subjects who require peritoneal dialysis or hemofiltration.
9. Altered neurologic status as defined by a Glasgow Coma Score of less than or equal to 11, unless medically induced (see Appendix 19.0).
10. Females who are pregnant (positive urine or serum pregnancy test at screening evaluation) or lactating.
11. Actively undergoing systemic chemotherapy or radiotherapy treatment for a malignancy.
12. A history of allergy to eggs or mice.
13. An initial peripheral absolute neutrophil count below 1500/mm3
14. Prior hematopoietic stem cell transplantation or solid organ transplant during the previous 4 months.
15. Presence of a pre-existing chronic infection that is undergoing or requiring medical therapy (i.e., tuberculosis).
16. Presence of any pre-existing illness that, in the opinion of the investigator, would place the subject at an unreasonably increased risk through participation in this study.
17. Previous treatment with Interferons (alpha, beta or gamma) of any origin (recombinant or human leukocyte-derived).
18. Participation as a subject in any study of an experimental treatment for any condition within the 30 days prior to the time of the screening evaluation.
19. Subjects who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.
20. Subjects who can not receive subcutaneous injections.
21. Subjects with a history of HIV disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine if Alferon N Injection® treatment reduces the Time to Clinical Stability (days) defined as the normalization of the following five vital signs: temperature 38°C oral; oxygen saturation 92%; respiratory rate 24/minutes; heart rate 100/minute; and systolic BP 100 mmHgTimepoint: 10 hours (+ 2 hours) after the last dose of interferon prior to hospital discharge and at the follow up visit on day 30+3
- Secondary Outcome Measures
Name Time Method 1. Safety of Alferon N Injection® at the dosage used in this study. 2. Time to hospital discharge ability (days) defined as the duration of time from admission to the hospital to when the attending physician declares that subject is ready to be discharged as a result of improvement or resolution of the 5 elements that clinical stability. <br/ ><br>3. Time to hospital discharge (days) <br/ ><br>Timepoint: 10 hours(+ 2 hors after the last dose of interferon prior to hospital discharge and at the follow up visit on day 30+3