Phase 2
N=98
Safety and Efficacy of Investigational Anti-Influenza Immune Plasma in Treating Influenza
Influenza A · Influenza B
Bottom Line
View on ClinicalTrials.gov: NCT01052480 ↗Enrolled (actual)
98
Serious AEs
29.6%
Results posted
May 2017
Primary outcome: Primary: Time to Normalization of Respiratory Status (Primary Efficacy Population) — 7; 28 days — p=0.069
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Anti-Influenza Immune Plasma (Biological); Standard Care (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Normalization of Respiratory Status (Primary Efficacy Population) |
7; 28 | 0.069 |
| SECONDARY Time to Normalization of Respiratory Status (All Randomized Participants) |
14; NA | — |
| SECONDARY Duration of Time to Resolution of Clinical Symptoms |
NA; NA | — |
| SECONDARY Duration of Time to Resolution of Fever |
NA; NA | — |
| SECONDARY Duration of Time to Resolution of All Symptoms and Fever |
NA; NA | — |
| 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 |
4; 28 | — |
| SECONDARY 50 Millimeters of Mercury (mm/Hg) Improvement in PaO2/FiO2 Ratio Over Time |
11; 14; 12; 12; 7; 11 | — |
| SECONDARY In-hospital Mortality |
1; 5 | — |
| SECONDARY 28-day Mortality |
1; 5 | — |
| SECONDARY Duration of Hospitalization |
6; 11 | — |
| SECONDARY Number of ICU Admissions |
40; 38; 2; 5; 0; 2 | — |
| SECONDARY Duration of Stay in ICU |
2.5; 3 | — |
| SECONDARY Days on Supplemental Oxygen |
7; 8 | — |
| SECONDARY Duration of Supplemental Oxygen |
7; 8 | — |
| SECONDARY Incidence of Acute Respiratory Distress Syndrome (ARDS) Present |
0; 3 | — |
| SECONDARY Days on Mechanical Ventilation |
0; 3 | — |
| SECONDARY Duration of Mechanical Ventilation |
0; 3 | — |
| SECONDARY Disposition Following Initial Hospitalization |
21; 17; 9; 6; 4; 6 | — |
| SECONDARY Duration of Viral Shedding < Lower Limit of Quantification (LLOQ) in Nasal Swabs |
1; 1 | — |
| SECONDARY Incidence and Week of Gestation of Delivery of a Live Pre-term Infant for Pregnant Women |
— | — |
| SECONDARY Incidence and Duration of Pre-term Labor (Defined as Labor Occurring < 36 Weeks) for Pregnant Women |
— | — |
| SECONDARY Incidence of Spontaneous Abortion or Stillborn Fetus for Pregnant Women |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of influenza A or B within 72 hours prior to enrollment (by local assay including rapid antigen, direct fluorescent antibody (DFA), polymerase chain reaction (PCR), or culture, and must be able to detect and distinguish influenza A from influenza B)
- Hospitalization for signs and symptoms of influenza (decision for hospitalization will be up to the individual treating clinician).
- Abnormal respiratory status, defined as room air saturation of oxygen (SaO2) less than 93% or tachypnea (respiratory rate above an age adjusted normal range)
- Agree to the storage of specimens and data
- ABO compatible plasma available on site or available within 24 hours after randomization with activity against locally circulating strains of influenza
Exclusion Criteria
- Receipt of non-licensed treatment for influenza within the last 2 weeks (or plans to receive any time during the study). This does not include licensed drugs at non approved doses, off-label indications, or drugs available under an Emergency Use Authorization (EUA).
- History of severe allergic reaction to blood products (as judged by the investigator).
- Medical conditions for which receipt of 500 mL volume (or 8 mL/kg for pediatric patients) may be dangerous to the subject (e.g. decompensated congestive heart failure [CHF], etc.)
- Clinical suspicion that etiology of acute illness is primarily due to a condition other than active influenza virus replication (e.g., a bacterial or fungal infection)
Data sourced from ClinicalTrials.gov (NCT01052480). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.