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Acute Respiratory Distress SyndromePhase 1/2CIRCA-19NCT04400032

Cellular Immuno-Therapy for COVID-19 Acute Respiratory Distress Syndrome

A Phase 1/2 study testing Mesenchymal Stromal Cells in people with Acute Respiratory Distress Syndrome and Covid19, run by Ottawa Hospital Research Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The clinical picture of the novel corona virus 2 (SARS-CoV-2) disease (COVID-19) is rapidly evolving. Although infections may be mild, up to 25% of all patients admitted to hospital require admission to the intensive care unit, and as many as 40% will progress to develop severe problems breathing due to the acute… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Respiratory Distress Syndrome, Covid19
What is being tested?
Mesenchymal Stromal Cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteCanada
Study dates
15 May 2020to 22 Apr 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age of ≥18 years
  • Laboratory-confirmed SARS-CoV-2 infection during the current admission
  • On invasive, non-invasive mechanical ventilation (NIV) (PEEP≥5 cmH20) or high-flow nasal canula (HFNC) oxygen therapy (minimum total flow rate of 40 lpm)
  • ARDS (onset <96h) as per the international consensus definition (P/F) ratio < 300 on fraction of inspired oxygen (FiO2)≥0.5, with PEEP ≥5cm H2O or on HFNC), not due to cardiac causes.

Who cannot join

  • An individual who meets any of the following criteria will be excluded from participation in this trial:
  • No consent/inability to obtain consent
  • Moribund patient not expected to survive 24 hours
  • Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
  • Currently receiving extracorporeal life support
  • Pregnant or lactating
Show all 16Show fewer
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Moderate to severe chronic liver disease (Childs-Pugh Score > 12)
  • Severe chronic respiratory disease with a baseline PaCO2 > 50 mm Hg or the use of home oxygen
  • Lung transplant patient
  • Documented deep venous thrombosis or pulmonary embolism within the past 3 months
  • Inability/contra-indications to receiving local standard of care thromboprophylaxis
  • Chronic immunosuppression (any chronic immunotherapy including daily oral steroid use >6months)
  • Known HIV, Hep B/C positive, or active Tuberculosis
  • Multisystem shock (SOFA score of >2 in >2 systems)
  • Patient, surrogate, or physician not committed to full support including intubation (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

About this study

Official title: Cellular Immuno-Therapy for COVID-19 ARDS (CIRCA-19)

The clinical picture of the novel corona virus 2 (SARS-CoV-2) disease (COVID-19) is rapidly evolving. Although infections may be mild, up to 25% of all patients admitted to hospital require admission to the intensive care unit, and as many as 40% will progress to develop severe problems breathing due to the acute respiratory distress syndrome (ARDS). ARDS often requires mechanical ventilation, with a 50% risk of mortality. Researchers at the Ottawa Hospital Research Institute (OHRI) have been studying the potential therapeutic role of mesenchymal stromal/stem cells, or MSCs, for the treatment of ARDS for over a decade. This has led to the world's first clinical trial using MSC therapy for patients with severe infections (sepsis) which is often associated with ARDS (NCT02421484). This trial demonstrated tolerability, and potential signs of efficacy. In addition, the investigators have established expertise in producing clinical-grade MSCs and have received approval from Health Canada for the use of MSCs in three different clinical studies.

This protocol consists of 2 sequential trials using the same trial infrastructure, noted as the Phase 1 trial 'CIRCA-1901' and the Phase 2a trial 'CIRCA-1902'. CIRCA-1901 is an open-label, dose-escalating and safety trial using a 3+3+3 design to determine the safety, and maximum feasible tolerated dose of repeated delivery of Umbilical Cord Mesenchymal Stromal Cells (UC-MSC) intravenously. The investigators will enroll up to 9 patients; each receiving repeated unit doses of UC-MSCs delivered by IV infusion on each of 3 consecutive days (24±4 hours apart) according to the following dose-escalation schedule (3 patients per dose panel): (i) Panel 1: 25 million cells/unit dose (cumulative dose: 75 million MSCs), (ii) Panel 2: 50 million cells/unit dose (cumulative dose: 150 million MSCs), (iii) Panel 3: up to 90 million cells/unit dose (cumulative dose: up to 270 million MSCs). If no safety issues are identified, we will continue to the Phase 2a trial.

CIRCA-1902 is a single-arm, open-label extension of the CIRCA-1901 trial to assess early signs of efficacy (major morbidity and mortality). The Phase 2a trial (CIRCA-1902) will enroll 12 patients to assess early signals of benefit on mortality and major morbidity in a high risk, high mortality population.

Being tested
Mesenchymal Stromal Cells
Keywords
ARDS, COVID-19, Mesenchymal Stromal Cells
Medical subject headings
Respiratory Distress Syndrome, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mesenchymal Stromal CellsBiological

    The Mesenchymal Stromal Cells will be administered intravenously

Study groups in NCT04400032
Study groupRoleWhat they receive
Panel 1Experimental25 million cells/unit dose (cumulative dose: 75 million MSCs)
Receives: Biological: Mesenchymal Stromal Cells
Panel 2Experimental50 million cells/unit dose (cumulative dose: 150 million MSCs)
Receives: Biological: Mesenchymal Stromal Cells
Panel 3Experimentalup to 90 million cells/unit dose (cumulative dose: up to 270 million MSCs)
Receives: Biological: Mesenchymal Stromal Cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

    Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 to determine the maximum feasible tolerated dose (MFTD) of UC-MSCs given to patients with COVID-19

    Measured: At time of infusion until one year post-infusion

Secondary outcomes (2)

  1. Number of Participants alive by Day 28

    Number of Participants alive by Day 28

    Measured: Day 28

  2. Number of Participants with ventilator-free Days by Day 28

    Number of Participants with ventilator-free Days by Day 28

    Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2020
  2. Study start15 May 2020
  3. Primary completion22 Apr 2021
  4. Study completion22 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
CIRCA-1901 is is a dose-escalating and safety trial using a 3+3+3 design to determine the safety, and maximum feasible tolerated dose (MFTD) of intravenously (IV) delivered umbilical cord derived MSCs (UC-MSCs). If no safety issues are identified, we will continue to the Phase 2a trial. CIRCA-1902 is a single-arm, open-label extension of the CIRCA-1901 trial to assess early signs of efficacy (major morbidity and mortality). The Phase 2a trial (CIRCA-1902) will enroll 12 patients to assess early signals of benefit on mortality and major morbidity in a high risk, high mortality population.
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04400032
Sponsor's protocol ID
20200243-01H
Acronym
CIRCA-19
Status last verified
Apr 2021
First submitted
27 Apr 2020
Last updated
26 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Mesenchymal Stromal Cells in people with Acute Respiratory Distress Syndrome and Covid19, run by Ottawa Hospital Research Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 (time frame: At time of infusion until one year post-infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04400032.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.

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