Clinical Trials

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

Rochester, MN

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

Study type:
Interventional
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.
Study phase:
2
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.

About this study

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 13-007734
NCT ID:
NCT01052480
Sponsor Protocol Number:
IRC-002

A Study Evaluating the Safety and Effectiveness of Anti-Influenza Intravenous Hyperimmune Immunoglobulin (IVIG) for Adults Hospitalized with Influenza

Rochester, MN

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A Study Evaluating the Safety and Effectiveness of Anti-Influenza Intravenous Hyperimmune Immunoglobulin (IVIG) for Adults Hospitalized with Influenza

Study type:
Interventional
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.
Study phase:
3
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.

About this study

Influenza (the flu) is a common illness that usually occurs in autumn and winter. The flu is usually mild, but can cause serious illness or death. The purpose of this study is to test the safety and effectiveness of an antibody against the flu (called intravenous hyperimmune immunoglobulin or IVIG) in people who are hospitalized for severe flu.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 14-007168
NCT ID:
NCT02287467
Sponsor Protocol Number:
INSIGHT 006: FLU-IVIG

A Study to Evaluate Entolimod on Immune System Aging in Healthy Geriatric Subjects Receiving Influenza Vaccination

Rochester, MN

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A Study to Evaluate Entolimod on Immune System Aging in Healthy Geriatric Subjects Receiving Influenza Vaccination

Study type:
Interventional
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.
Study phase:
2
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.

About this study

The purpose of this study is to measure changes of the anti- A/H1N1, anti-A/H3N2, and anti-B influenza virus strains serum circulating antibodies (as assessed using hemagglutination inhibition (HAI) assay) levels in elderly patients.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 19-004847
NCT ID:
NCT04176133
Sponsor Protocol Number:
19-004847

Anti-Influenza Hyperimmune Intravenous Immunoglobulin Pilot Study (INSIGHT 005: Flu-IVIG Pilot)

Rochester, MN

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Anti-Influenza Hyperimmune Intravenous Immunoglobulin Pilot Study (INSIGHT 005: Flu-IVIG Pilot)

Study type:
Interventional
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.
Study phase:
1
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.

About this study

The purpose of this randomized, double-blind, placebo-controlled trial of intravenous hyperimmune immunoglobulin (Flu-IVIG) in individuals with influenza A or B is to determine the pharmacokinetic (PK) profile of Flu-IVIG and assess whether antibody levels observed following Flu-IVIG transfusion are similar to those predicted. This pilot study will inform a larger study that will be powered to compare Flu-IVIG with placebo for efficacy.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 13-007815
NCT ID:
NCT02008578
Sponsor Protocol Number:
14-I-0031

A Study Comparing the Effectiveness and Safety of High-Titer versus Low-Titer Anti-Influenza Immune Plasma for the Treatment of Severe Influenza A

Rochester, MN

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A Study Comparing the Effectiveness and Safety of High-Titer versus Low-Titer Anti-Influenza Immune Plasma for the Treatment of Severe Influenza A

Study type:
Interventional
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.
Study phase:
3
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.

About this study

The purpose of this study is to assess the effectiveness and safety of giving anti-influenza immune plasma, as an addition to standard of care antivirals, to patients hospitalized with severe influenza A infection.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 15-006843
NCT ID:
NCT02572817
Sponsor Protocol Number:
IRC-005

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

Rochester, MN

See Details

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

Study type:
Interventional
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.
Study phase:
2
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.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

Print study details

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

A Study to Better Understand the Immune Response to the Flu Vaccine (MF59) and the High Dose Flu Vaccine (HDFlu) in People 65 Years of Age and Older

Rochester, MN

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A Study to Better Understand the Immune Response to the Flu Vaccine (MF59) and the High Dose Flu Vaccine (HDFlu) in People 65 Years of Age and Older

Study type:
Interventional
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.

About this study

The purpose of this research study is to better understand the immune response to the Adjuvanted Subunit flu vaccine (MF59) and the High Dose flu vaccine (HDFlu) in people 65 years of age and older.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 17-010601
NCT ID:
NCT03603509
Sponsor Protocol Number:
17-010601

Bioinformatics Approach to Influenza A/H1N1 Vaccine Immune Profiling

Rochester, MN

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Bioinformatics Approach to Influenza A/H1N1 Vaccine Immune Profiling

Study type:
Interventional
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.

About this study

The purpose of this study is to provide novel information describing how immune responses to inactivated influenza A/H1N1 vaccine are generated.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 10-003310

A Study to Collect Blood Samples to Study Immune Response Genes that may be Associated with an Increased Risk of Severe Influenza

Rochester, MN

See Details

A Study to Collect Blood Samples to Study Immune Response Genes that may be Associated with an Increased Risk of Severe Influenza

Study type:
Observational
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.

About this study

The purpose of this study is to obtain a whole blood sample from which DNA will be extracted to study polymorphisms in immune response genes and other geneticvariants that may be associated with an increased risk of disease progression among individuals with infectious diseases of public health importance who are enrolled in qualifying INSIGHT studies.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 12-005439
Sponsor Protocol Number:
12-005439

A Study to Evaluate a Real-Time Diagnostic Platform for the Detection of Influenza Strains in Saliva

Rochester, MN

See Details

A Study to Evaluate a Real-Time Diagnostic Platform for the Detection of Influenza Strains in Saliva

Study type:
Observational
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.

About this study

The purpose of this study is to develop a colorimetric test for influenza virus detection in a chemically engineered cup/tube. When sample fluid (saliva) is in the tube, the fluid color turning blue indicates a positive result. We are in the process of developing this test, and will test on saliva samples from flu patients.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 19-002796
Sponsor Protocol Number:
19-002796

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Search Results 1-10 of 13 for

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

A Study Evaluating the Safety and Effectiveness of Anti-Influenza Intravenous Hyperimmune Immunoglobulin (IVIG) for Adults Hospitalized with Influenza

A Study to Evaluate Entolimod on Immune System Aging in Healthy Geriatric Subjects Receiving Influenza Vaccination

Anti-Influenza Hyperimmune Intravenous Immunoglobulin Pilot Study (INSIGHT 005: Flu-IVIG Pilot)

A Study Comparing the Effectiveness and Safety of High-Titer versus Low-Titer Anti-Influenza Immune Plasma for the Treatment of Severe Influenza A

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

A Study to Better Understand the Immune Response to the Flu Vaccine (MF59) and the High Dose Flu Vaccine (HDFlu) in People 65 Years of Age and Older

Bioinformatics Approach to Influenza A/H1N1 Vaccine Immune Profiling

A Study to Collect Blood Samples to Study Immune Response Genes that may be Associated with an Increased Risk of Severe Influenza

A Study to Evaluate a Real-Time Diagnostic Platform for the Detection of Influenza Strains in Saliva

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