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Airvo, Standard of Care

Phase 2

Autologous Stem Cell Transplant | Unknown | Other |Avalon GloboCare Corp.|Last Updated: Jan 30, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Clinical trial landscape

Airvo, Standard of Care · 1 trial · 1 indication

Phase 2 1
NCT05358262High Heated Humidity in Stem Cell TransplantAutologous Stem Cell Transplant
RECRUITING90 Analytics
PHASE2RECRUITING
High Heated Humidity in Stem Cell Transplant
Autologous Stem Cell TransplantUnlock trial analytics

Study Endpoints

Primary Endpoints

Mucositis severity symptoms
During treatment (up to 30 days)

Mucositis is defined as inflammation of the oral and aerodigestive tract mucosa. Patient subjective measure, such as patient reported discomfort or sensation of inability to clear secretion will be observed using the Oral Mucositis Quality of Life Questionnaire.

Mucositis severity assessment
During treatment (up to 30 days)

Mucositis is defined as inflammation of the oral and aerodigestive tract mucosa. Patient objective measures, such as increased reddening of the mucosa to ulcerations will be observed using the Oral Assessment Guide.

Secondary Endpoints

Febrile Neutropenia
During treatment (up to 30 days)
Nosocomial infections
During treatment (up to 30 days)
Length of stay to be changed in hospital
During treatment (up to 30 days)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Intervention using the Airvo deviceEXPERIMENTALPatients randomized to this group will receive the standard of care as well as wear the Airvo (equipment to provide high heated humidity) starting on Day 0 of their transplant for a minimum of 4 hours a day (to be worn in one continuous block of time). The humidity is delivered by nasal cannula that goes into your nose, similar to wearing oxygen. The equipment stands on a pole and plugs into a power outlet. Patients may take off the equipment for short periods of time. Eg to go to the bathroom.
Standard of CareACTIVE_COMPARATORPatients randomized into this group will receive the usual standard of care for mucositis. The standard of care for mucositis at the Cross Cancer institute involves supportive therapies including oral hydration (water or wet sponges) or medicated mouthwashes.

Interventions

NameTypeDescription
AirvoDEVICEFisher \& Paykel's AIRVO 2 is a humidifier with integrated flow generator that delivers high flow warmed and humidified respiratory gases to spontaneously breathing patients through a variety of interfaces including nasal cannula. Flow can be delivered from 2 to 60 LPM
Standard of CareOTHERThe standard of care for mucositis at the Cross Cancer institute involves supportive therapies including oral hydration (water or wet sponges) or medicated mouthwashes.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Minimum 18 years of age 2. Have given written consent prior to any study-specific procedures or have had an acceptable individual capable of giving consent on the patient's behalf. 3. Have one of non-Hodgkin lymphoma, Hodgkin lymphoma, or multiple myeloma and found to require...

Countries:Canada
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Frequently asked questions about Airvo, Standard of Care

What is Airvo, Standard of Care used for?

Airvo, Standard of Care is used for patients undergoing autologous stem cell transplant. It is being studied as a treatment to support these patients, with the goal of improving outcomes related to the transplant procedure.

Who makes Airvo, Standard of Care?

Airvo, Standard of Care is being developed by Avalon GloboCare Corp., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol ALBT.

What phase is Airvo, Standard of Care in?

Airvo, Standard of Care is currently in Phase 2 clinical development. It is an investigational therapy, meaning it has not yet been approved by regulatory authorities and is still being evaluated in clinical trials for safety and efficacy.

What clinical trials is Airvo, Standard of Care in?

Airvo, Standard of Care is being studied in a Phase 2 clinical trial with the identifier NCT05358262, titled 'High Heated Humidity in Stem Cell Transplant'. This trial is currently recruiting participants and aims to enroll 90 patients undergoing autologous stem cell transplant.

Is Airvo, Standard of Care the same as Airvo?

Airvo, Standard of Care is a specific formulation or regimen of Airvo being evaluated in clinical trials. It is being tested as the standard of care comparator in a study for autologous stem cell transplant patients, meaning it represents the current standard treatment approach.