Study to Evaluate the Efficacy and Safety of IV VIS410 Plus Oseltamivir Versus Oseltamivir Alone in Hospitalized Adults With Influenza A Infection Requiring Oxygen Support

• Status: Completed
• Trial end date: 2018-11-22
• Target enrollment: 0
• Participant gender: All

Summary

This study is to compare the efficacy and safety of VIS410 in combination with oseltamivir vs oseltamivir alone in severely ill subjects with influenza A infection requiring oxygen support.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Visterra, Inc.
• Treatments: Oseltamivir

Criteria

Inclusion Criteria:

• Male and female subjects aged ≥ 18 years.

• Test positive for influenza A by rapid antigen test or with another commercially available test on an adequate nasopharyngeal specimen in accordance with the manufacturer's instructions, or an acceptable local test, including PCR, FIA, or ELISA

• Onset of influenza symptoms no more than 5 days before VIS410/placebo infusion; symptoms may include cough, dyspnea, sore throat, fever, myalgias, headache, nasal symptoms (rhinorrhea, congestion), fatigue, diarrhea, anorexia, nausea, and vomiting.

• Requirement for oxygen support including any positive pressure ventilation

• Women of childbearing potential must have a negative pregnancy test within 2 days prior to VIS410/placebo infusion.

• Women should fulfill one of the following criteria:

• Post-menopausal; either amenorrhea ≥ 12 months or follicle stimulating hormone > 40 mIU/mL as documented in their medical history

• Surgically sterile; hysterectomy, bilateral oophorectomy, or tubal ligation

• Women of childbearing potential participating in heterosexual sexual relations must be willing to use adequate contraception from screening until 60 days post VIS410/placebo infusion.

• Non-vasectomized (or vasectomized less than 6 months prior to dosing) male subjects who have a female partner of childbearing potential must use an effective birth control method from screening until 60 days post VIS410/placebo infusion.

• Subject, or a legally acceptable representative (LAR), is able to understand the purpose and risks of the study and willing to give voluntary written informed consent.

Exclusion Criteria:

• Known or suspected intolerance or hypersensitivity to VIS410, oseltamivir, pretreatment medications (diphenhydramine, or to both ibuprofen and acetylsalicylic acid [ASA]), or closely related compounds (eg, other monoclonal antibodies)

• Subjects who have received VIS410 in the past

• History of receiving monoclonal antibody products (including VIS410) within 3 months prior to VIS410/placebo dosing or planned administration during the study period

• Subjects who have taken more than 6 doses of an approved antiviral therapy for influenza within the prior 96 hours (eg, oral oseltamivir, inhaled zanamivir, IV peramivir, or oral ribavirin) between onset of symptoms and VIS410/placebo dosing

• Subjects with known co-infection with influenza B or other viral respiratory infections (e.g., respiratory syncytial virus, parainfluenza viruses, respiratory adenoviruses)

• Subjects with lung transplant or history of severe chronic lung disease, including cystic fibrosis or any condition requiring home oxygen therapy

• Subjects on extracorporeal membrane oxygenation (ECMO) at time of randomization

• Subjects with end stage renal disease who are not undergoing hemodialysis

• Subjects with active graft-vs-host disease, hematopoietic stem cell transplant within the previous 90 days, or human immunodeficiency virus infection with a CD4 cell count of less than 200 per cubic millimeter

• Hospitalization for > 48 hours prior to randomization

• High probability of mortality within 48 hours of randomization as determined by the Investigator

• Subjects weighing less than 45 kg

• Enrollment in any other investigational drug or device study, any disease or vaccine study within 30 days prior to Day 1 or within 5 half-lives of the investigational compound, whichever is longer

• Known or suspected alcohol or drug abuse, that is, abuse of a level that would compromise the safety or cooperation of the subject in the opinion of the Investigator