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Safety and Efficacy of Investigational Anti-Influenza Immune Plasma in Treating Influenza (IRC002)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01052480
First received: January 16, 2010
Last updated: April 19, 2017
Last verified: April 2017
Results First Received: April 19, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Influenza A
Influenza B
Interventions: Biological: Anti-Influenza Immune Plasma
Drug: Standard Care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Plasma and Standard Care

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Standard Care

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza


Participant Flow:   Overall Study
    Plasma and Standard Care   Standard Care
STARTED   49   49 
COMPLETED   41   32 
NOT COMPLETED   8   17 
Lost to Follow-up                3                3 
Protocol Violation                1                0 
Withdrawal by Subject                3                7 
Physician Decision                0                2 
Death                1                5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Plasma and Standard Care

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.

Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Standard Care: Standard care for hospitalized people with influenza

Standard Care

Participants will receive standard care.

Standard Care: Standard care for hospitalized people with influenza

Total Total of all reporting groups

Baseline Measures
   Plasma and Standard Care   Standard Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 49   49   98 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 50 
 (38 to 66) 
 57 
 (39 to 71) 
 53 
 (38 to 69) 
Age, Customized 
[Units: Participants]
Count of Participants
     
<18   4   7   11 
>=18   45   42   87 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      24  49.0%      27  55.1%      51  52.0% 
Male      25  51.0%      22  44.9%      47  48.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      4   8.2%      6  12.2%      10  10.2% 
Not Hispanic or Latino      43  87.8%      39  79.6%      82  83.7% 
Unknown or Not Reported      2   4.1%      4   8.2%      6   6.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      1   2.0%      1   1.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      16  32.7%      9  18.4%      25  25.5% 
White      29  59.2%      32  65.3%      61  62.2% 
More than one race      1   2.0%      2   4.1%      3   3.1% 
Unknown or Not Reported      3   6.1%      5  10.2%      8   8.2% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Normalization of Respiratory Status (Primary Efficacy Population)   [ Time Frame: Measured from Day 0 through Day 28 ]

2.  Secondary:   Time to Normalization of Respiratory Status (All Randomized Participants)   [ Time Frame: Measured from Day 0 through Day 28 ]

3.  Secondary:   Duration of Time to Resolution of Clinical Symptoms   [ Time Frame: Measured from Day 0 through Day 28 ]

4.  Secondary:   Duration of Time to Resolution of Fever   [ Time Frame: Measured from Day 0 through Day 28 ]

5.  Secondary:   Duration of Time to Resolution of All Symptoms and Fever   [ Time Frame: Measured from Day 0 through Day 28 ]

6.  Secondary:   Time to 20% Improvement in Sequential Organ Failure Assessment (SOFA) Score for Participants >= 18 Years Old and Pediatric Logistic Organ Dysfunction (PELOD) Score for Participants < 18 Years Old   [ Time Frame: Measured from Day 0 through Day 28 ]

7.  Secondary:   50 Millimeters of Mercury (mm/Hg) Improvement in PaO2/FiO2 Ratio Over Time   [ Time Frame: Measured at Days 1, 2, 4, 7, 14, 28 ]

8.  Secondary:   In-hospital Mortality   [ Time Frame: Measured from Day 0 through Day 28 ]

9.  Secondary:   28-day Mortality   [ Time Frame: Measured from Day 0 through Day 28 ]

10.  Secondary:   Duration of Hospitalization   [ Time Frame: Measured from Day 0 through Day 28 ]

11.  Secondary:   Number of ICU Admissions   [ Time Frame: Measured from Day 0 through Day 28 ]

12.  Secondary:   Duration of Stay in ICU   [ Time Frame: Measured from Day 0 through Day 28 ]

13.  Secondary:   Days on Supplemental Oxygen   [ Time Frame: Measured from Day 0 through Day 28 ]

14.  Secondary:   Duration of Supplemental Oxygen   [ Time Frame: Measured from Day 0 through Day 28 ]

15.  Secondary:   Incidence of Acute Respiratory Distress Syndrome (ARDS) Present   [ Time Frame: Measured at Days 0, 1, 2, 4, 7, 14, 28 ]

16.  Secondary:   Days on Mechanical Ventilation   [ Time Frame: Measured from Day 0 through Day 28 ]

17.  Secondary:   Duration of Mechanical Ventilation   [ Time Frame: Measured from Day 0 through Day 28 ]

18.  Secondary:   Disposition Following Initial Hospitalization   [ Time Frame: Measured from Day 0 through Day 28 ]

19.  Secondary:   Duration of Viral Shedding < Lower Limit of Quantification (LLOQ) in Nasal Swabs   [ Time Frame: Measured from Day 0 through Day 28 ]

20.  Secondary:   Incidence and Week of Gestation of Delivery of a Live Pre-term Infant for Pregnant Women   [ Time Frame: Measured through to Day 28 ]

21.  Secondary:   Incidence and Duration of Pre-term Labor (Defined as Labor Occurring < 36 Weeks) for Pregnant Women   [ Time Frame: Measured through Day 28 ]

22.  Secondary:   Incidence of Spontaneous Abortion or Stillborn Fetus for Pregnant Women   [ Time Frame: Measured from Day 0 through Day 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: John Beigel, M.D.
Organization: Leidos Biomedical Research, Inc. is support to the National Institute of Allergy and Infectious Diseases (NIAID)
phone: 301-451-9881
e-mail: jbeigel@niaid.nih.gov


Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01052480     History of Changes
Other Study ID Numbers: 10-I-0043
IRC002 ( Other Identifier: NIAID Influenza Research Collaboration )
Study First Received: January 16, 2010
Results First Received: April 19, 2017
Last Updated: April 19, 2017