Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000478910
Ethics application status
Approved
Date submitted
12/04/2020
Date registered
16/04/2020
Date last updated
15/08/2022
Date data sharing statement initially provided
16/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Cord Blood Therapy to prevent progression of COVID-19 related pneumonia
Scientific title
Cord Blood Therapy to prevent progression of COVID-19 related pneumonia
Secondary ID [1] 300991 0
None
Universal Trial Number (UTN)
Trial acronym
CBC-19 study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 317032 0
Pneumonia 317033 0
Condition category
Condition code
Infection 315196 315196 0 0
Studies of infection and infectious agents
Respiratory 315215 315215 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
5 million/ kg expanded umbilical cord blood cells (max -500 million cells) given intravenously over an hour by hospital staff under observation by research team. Single administration sourced from off the shelf UCB units. This is in addition to standard supportive management as per hospital protocol.
Intervention code [1] 317316 0
Treatment: Other
Comparator / control treatment
Standard supportive management. as per hospital protocol
This will include oxygen therapy, non-invasive or invasive ventilator support as needed, intravous therapy, antivirals or antibiotics, blood products, montoring, etc as per clinical team management.
Control group
Active

Outcomes
Primary outcome [1] 323452 0
Safety and tolerability of UCB cell administration (absence of immediate and short-term side effects, including allergic reactions, line related effects, infection)
This will be assessed based on partipant rports, and hospital charts and monitoring
Timepoint [1] 323452 0
24 hrs (collection of hourly vital monitoring data, examination at 24 hrs)
Primary outcome [2] 323453 0
Clinical improvement, as documented by change of patient status on a seven-category ordinal scale (to be completed by hospital staff or researcher)
Seven-category ordinal scale:
1, not hospitalised with resumption of normal activities; 2, not hospitalised, but unable to resume normal activities; 3, hospitalised, not requiring supplemental oxygen; 4, hospitalised, requiring supplemental oxygen; 5, hospitalised, requiring humidified nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both; 6,hospitalised, requiring ECMO, invasive mechanical ventilation, ECMO or both; and 7, death.
Timepoint [2] 323453 0
Assessed every day until resolution of symptoms or death
Secondary outcome [1] 381996 0
Time to clinical stability (need for hospitalisation as assesed by hospital staff)
Timepoint [1] 381996 0
Assessed daily until resolution of symptoms requiring hospitalisation
Secondary outcome [2] 381997 0
Individual symptom resolution (as assessed by staff in hospital/ or by patient at home)
Timepoint [2] 381997 0
Assessed daily until resolution of individual symptom
Secondary outcome [3] 381998 0
Need and duration of mechanical ventilation (as assessed by hospital staff)
Timepoint [3] 381998 0
Assessed daily until time to cessation of ventilation
Secondary outcome [4] 381999 0
Secondary bacterial infection (as assessed by any cultures taken)
Timepoint [4] 381999 0
Assesed daily until hospital discharge
Secondary outcome [5] 382000 0
All cause mortality
Timepoint [5] 382000 0
30- day and 90-day
Secondary outcome [6] 382001 0
Immune response (as assessed by blood samples taken)
Timepoint [6] 382001 0
1 week after UCB infusion/ control enrolment

Eligibility
Key inclusion criteria
Hospitalised patients with confirmed SARS-CoV2 infection (based on appropriate nucleic acid or other testing), and
1) Expected to remain an in-patient for at least 48 hours with
2) Features consistent with viral pneumonia on Chest CT or X-Ray (in the opinion of the investigator) and
3) Are unable to maintain a peripheral oxygen saturation of 95% or greater in room air
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Patients with known allergies to stem cell preparations
2) Patients with known significant lung disease before COVID-19 presentation
3) Receiving invasive/ mechanical ventilatory support
4) Patients with underlying disease, comorbidities or clinical status that in the opinion of the investigator suggests death is imminent and/or likely to occur the next 48 hours
5) Currently on other investigational stem cell therapies
6) Known pregnancy
7) Patient unable to provide consent
8) The treating team deems that enrolment in the study is not in the best interests of the patient.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes. Allocation concealment will happen via sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2023
Actual
Date of last participant enrolment
Anticipated
31/08/2023
Actual
Date of last data collection
Anticipated
30/11/2023
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 305437 0
Self funded/Unfunded
Name [1] 305437 0
Dr Atul Malhotra
Country [1] 305437 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Rd
Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 305835 0
None
Name [1] 305835 0
Address [1] 305835 0
Country [1] 305835 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305756 0
Monash Health HREC
Ethics committee address [1] 305756 0
246 Clayton Road
Clayton VIC 3168
Ethics committee country [1] 305756 0
Australia
Date submitted for ethics approval [1] 305756 0
08/04/2020
Approval date [1] 305756 0
01/05/2020
Ethics approval number [1] 305756 0

Summary
Brief summary
Umbilical Cord Blood derived cells have the potential for use in the treatment of acute COVID-19 associated pneumonia which can lead to Acute Respiratory Distress Syndrome (ARDS). The capacity to obtain expanded, off the shelf, cord blood units, containing highly potent anti-inflammatory and immune-modulatory cells, will provide a therapeutic option for patients displaying a compromised respiratory system following COVID-19 infection, before the disease progresses to ARDS and death.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101486 0
Dr Atul Malhotra
Address 101486 0
Monash Health
246 Clayton Road
Clayton
VIC 3168
Country 101486 0
Australia
Phone 101486 0
+61 3 8572 3650
Fax 101486 0
Email 101486 0
[email protected]
Contact person for public queries
Name 101487 0
Dr Atul Malhotra
Address 101487 0
Monash Health
246 Clayton Road
Clayton
VIC 3168
Country 101487 0
Australia
Phone 101487 0
+61 3 8572 3650
Fax 101487 0
Email 101487 0
[email protected]
Contact person for scientific queries
Name 101488 0
Dr Atul Malhotra
Address 101488 0
Monash Health
246 Clayton Road
Clayton
VIC 3168
Country 101488 0
Australia
Phone 101488 0
+61 3 8572 3650
Fax 101488 0
Email 101488 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseUmbilical cord blood therapy to prevent progression of COVID-19 related pneumonia: A structured summary of a study protocol for a pilot randomised controlled trial.2020https://dx.doi.org/10.1186/s13063-020-04387-y
EmbaseMesenchymal stromal cells for acute respiratory distress syndrome (ARDS), sepsis, and COVID-19 infection: optimizing the therapeutic potential.2021https://dx.doi.org/10.1080/17476348.2021.1848555
N.B. These documents automatically identified may not have been verified by the study sponsor.