Study to Evaluate the Safety, Pharmacokinetics and Clinical Benefit of FLU-IGIV in Hospitalized Patients with Serious Influenza A Infection

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 18-007333
    NCT ID: NCT03315104
    Sponsor Protocol Number: IA-001

About this study

The purpose of this study is to determine the optimal dose of FLU-IGIV based upon evaluation of safety and pharmacokinetics in hospitalized patients with serious illness caused by laboratory-confirmed influenza A infection.
 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Provision of voluntary informed consent in writing by patient, or legally authorized representative.
  • Age ≥ 18 years old.
  • Locally determined positive influenza A infection (Rapid Antigen (Ag) Test or PCR) from a specimen obtained within 2 days prior to randomization.
  • Onset of symptoms ≤ 6 days before randomization, defined as when the patient first experienced at least one respiratory symptom or fever.
  • Hospitalized (or in observation unit) with influenza, with anticipated hospitalization for more than 24 hours and will be/already are receiving CDC recommended antiviral SOC (oseltamivir 75 mg/twice a day x 5 days; Section 4.1.1).
  • Experiencing ≥ 1 respiratory symptom (ex. cough, sore throat, nasal congestion) and ≥ 1 constitutional symptom (ex. headache, myalgia, feverishness or fatigue).
  • For women of child-bearing potential: willingness to abstain from sexual intercourse or use at least 1 form of hormonal or barrier contraception through Day 60 of the study.
  • Willingness to have blood and respiratory samples obtained and stored.
  • National Early Warning Score (NEW score) ≥ 3 at
  • screening.

Exclusion Criteria

  • Use of any investigational product within the past 30 days prior to screening.
  • History of hypersensitivity to blood or plasma products (as judged by the site investigator).
  • History of allergy to latex or rubber.
  • Known medical history of IgA deficiency.
  • Pregnancy or lactation.
  • Medical conditions for which receipt of a 500 mL volume of intravenous fluid may be dangerous to the patient (e.g., decompensated congestive heart failure), based on investigator’s medical opinion with careful consideration of
  • lab results.
  • Liver function LFT > 2.5 times ULN.
  • Renal Function GFR < 60 mL/min/1.73 m2 (age and sex  adjusted).
  • A pre-existing condition or use of a medication that, in the opinion of the site investigator, may place the individual at a substantially increased risk of thrombosis (e.g., cryoglobulinemia, severe refractory hypertriglyceridemia, or clinically significant monoclonal gammopathy).
  • An opinion of the investigator that it would be unwise to allow participation of the patient in the study (the reason for exclusion of the patient must be documented).
  • Receiving extracorporeal membrane oxygenation (ECMO). 
  • Anticipated life expectancy of < 90 days.
  • Confirmed bacterial pneumonia or any concurrent respiratory viral infection that is not influenza A (e.g., respiratory syncytial virus (RSV) infection).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Zelalem Temesgen, M.D.

Contact us for the latest status

Contact information:

Mary Johnson CCRP

(507)538-6511

Johnson.Mary15@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available