Clinical trial to compare the benefit and safety of a single infusion of VIS410, the study medicine added to standard Tamiflu® treatment to that of treatment with Tamiflu® alone in hospitalized adults with flu infection requiring oxygen support
- Conditions
- Influenza A infection in hospitalized patients who need supplemental oxygenMedDRA version: 20.0Level: LLTClassification code 10022002Term: Influenza A virus infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2016-004009-15-ES
- Lead Sponsor
- Visterra, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 390
Subjects meeting all of the following criteria are eligible to participate in this study:
1. Male and female subjects aged = 18 years. For a country where the legal age of consent is >18 years old, the country requirements should be followed.
2. 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
3. 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.
4. Need for supplemental oxygen of at least 40% (4 L/min) and/or hypoxemia defined as SpO2 of less than 90%
5. Women of childbearing potential must have a negative pregnancy test within 2 days prior to VIS410/placebo infusion.
6. Women should fulfill one of the following criteria:
a. Post-menopausal; either amenorrhea = 12 months or follicle stimulating hormone > 40 mIU/mL as documented in their medical history
b. Surgically sterile; hysterectomy, bilateral oophorectomy, or tubal ligation
c. Women of childbearing potential participating in heterosexual relations must be willing to use adequate contraception from screening until 60 days post VIS410/placebo infusion (see Section 6.2).
7. 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 (see Section 6.2) when having heterosexual intercourse, from screening until 60 days post VIS410/placebo infusion.
8. Subject is able and willing to comply with study procedures, as per protocol.
9. Subject, or a legally authorized representative (LAR), is able to understand the purpose and risks of the study and willing to give voluntary written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 190
Subjects meeting any of the following criteria are excluded from participation in this study:
1. 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)
2. History of receiving monoclonal antibody products (including VIS410) within 3 months prior to VIS410/placebo dosing or planned administration during the study period
3. 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
4. Subjects with influenza B infection
5. Subjects with lung transplant or history of severe chronic lung disease or any condition requiring > 2 L/minute of home oxygen therapy (ie, severe chronic obstructive pulmonary disease [COPD], pulmonary fibrosis)
6. Subjects on extracorporeal membrane oxygenation (ECMO) at time of randomization
7. 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
8. Hospitalization for > 48 hours prior to randomization
9. High probability of mortality within 48 hours of randomization as determined by the Investigator
10. Women who are pregnant, breast-feeding, or considering to become pregnant
11. Subjects in whom nasopharyngeal swabbing is not possible
12. Subjects weighing less than 45 kg
13. 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
14. Presence of any preexisting illness that, in the opinion of the Investigator, would place the subject at an unreasonably increased risk through participation in this study
15. Subjects unable to comply with study protocol procedures and study visit schedules for whatever reason
16. 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method