Clinical Trial: Safety and Efficacy of Investigational Anti-Influenza Immune Plasma in Treating Influenza

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Open-Label, Phase 2, Multicenter Safety and Exploratory Efficacy Study of Investigational Anti-Influenza Immune Plasma for the Treatment of Influenza (IRC002)

Brief Summary: This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza A or B. Hospitalized subjects with influenza A or B that have either a low oxygen level or a high respiratory rate will be eligible for study participation. This study will enroll adults, children and pregnant women.

Detailed Summary:

Morbidity and mortality occur despite treatment with current antivirals. Circulating influenza H1N1 and H3N2 isolates are highly resistant to amantadine and rimantadine, whereas previous seasonal H1N1 isolates were highly resistant to oseltamivir. So there is concern that circulating influenza A/H1N1 2009 virus may also acquire oseltamivir resistance.

This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza. Hospitalized subjects with influenza at risk for severe disease (as defined in the inclusion criteria) will be eligible for study participation. This study will enroll adults, children and pregnant women.

Up to 40 sites in the United States will participate in this protocol. One hundred eligible subjects will be randomized in a 1:1 ratio to receive either 2 units (or pediatric equivalent) of anti-influenza immune plasma on Study Day 0 in addition to standard care or standard care alone (50 subjects receiving standard care alone; 50 subjects receiving anti-influenza immune plasma and standard care).

Subjects will be assessed on Study Day 0 (pre-dose), 30 minutes post-dose (plasma arm only), and on Study Days 1, 2, 4, 7, 14, and 28. All subjects will undergo a series of efficacy, safety, and PK (HAI) assessments during the study. Blood samples will be collected at each time point (except Day 1). Nasal and oropharyngeal swabs for influenza PCR will be obtained on Days 0,1,2,4 and 7.


Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Current Primary Outcome: Time to normalization of respiratory status (defined as room air saturation of oxygen [SaO2] greater than or equal to 93% AND respiratory rate within normal ranges) [ Time Frame: Measured at Day 28 ]

Original Primary Outcome: Safety and Efficacy: The time to a 20% improvement in the OD score for age greater than or equal to 18 years, and PLOD score for age less than 18 years from Day 0 score in subjects treated with H1N1 plasma as compared to plasma.

Current Secondary Outcome:

  • Duration of clinical symptoms, fever, intensive care unit (ICU) stay, and hospitalization [ Time Frame: Measured at Day 28 ]
  • Time to resolution of symptoms and fever [ Time Frame: Measured at Day 28 ]
  • Mortality [ Time Frame: Measured at Day 28 ]
  • Acute lung injury [ Time Frame: Measured at Day 28 ]
  • Acute respiratory distress syndrome (ARDS) [ Time Frame: Measured at Day 28 ]
  • Time to 20% improvement in sequential organ failure assessment (SOFA) score for participants at least 18 years old and pediatric logistic organ dysfunction (PELOD) score for those younger than 18 years old [ Time Frame: Measured at study completion ]
  • Time to 50 millimeters of mercury (mm/Hg) improvement in partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) ratio [ Time Frame: Measured at study completion ]
  • Incidence and duration of both supplemental oxygen use and mechanical ventilation use [ Time Frame: Measured at Day 28 ]
  • Disposition following initial hospitalization [ Time Frame: Measured at Day 28 ]
  • Birth complications for pregnant women [ Time Frame: Measured at Day 28 ]
  • Adverse events and laboratory abnormalities [ Time Frame: Measured at Day 28 ]
  • Relationship between hemagglutination inhibition assay (HAI) and measures of viral clearance [ Time Frame: Measured at Day 28 ]


Original Secondary Outcome: Duration of clinical symptoms, fever, ICU stay and hospitalization. Time to resolution of symptoms and fever. Mortality.

Information By: National Institute of Allergy and Infectious Diseases (NIAID)

Dates:
Date Received: January 16, 2010
Date Started: December 2010
Date Completion:
Last Updated: August 12, 2016
Last Verified: August 2016