Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration (REALIST) (COVID-19) (REALIST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03042143|
Recruitment Status : Active, not recruiting
First Posted : February 3, 2017
Last Update Posted : August 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Distress Syndrome||Biological: Human umbilical cord derived CD362 enriched MSCs Biological: Placebo (Plasma-Lyte 148)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
The phase 1 trial is an open label dose escalation pilot study in which cohorts of subjects with moderate to severe ARDS will receive increasing doses of a single infusion of Realist Orbcel-C in a 3+3 design. Initially 3 cohorts with 3 subjects/cohort.
In the completed Phase 1 REALIST trial, infusion of 400 million cells was achieved without any dose limiting toxicity at day 7 and has been approved by the DMEC as the intervention dose for this study.
The phase 2 trial is a randomised, double-blind, allocation concealed placebo-controlled study using the maximal tolerable dose as determined by the DMEC in patients with moderate to severe ARDS due to COVID-19 or other causes of ARDS.
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
The cell therapy facility and clinical trials pharmacist will be unblinded. The unblinded individuals will keep the treatment information confidential and will not discuss or release information on treatment allocation to the patient, the investigator, or other unauthorised personnel.
As in prior studies of MSCs, the infusion bag containing either the cell product or placebo will be masked at the time of preparation in the clinical site's cell therapy facility so that the contents of the infusion bag are not visible to the investigators or to the clinicians who are administering the study drug. The contents of the infusion bag will be administered through a masked infusion set.
|Official Title:||Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration (REALIST): An Open Label Dose Escalation Phase 1 Trial Followed by a Randomized, Double-blind, Placebo-controlled Phase 2 Trial (COVID-19)|
|Actual Study Start Date :||January 7, 2019|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||March 2024|
Experimental: Human umbilical cord derived CD362 enriched MSCs
Maximum tolerated dose from the phase 1 trial will be infused over 30 to 90 mins
Biological: Human umbilical cord derived CD362 enriched MSCs
Infusion of Human umbilical cord derived CD362 enriched MSCs
Placebo Comparator: Placebo (Plasma-Lyte 148) infusion
Plasma-Lyte 148 infused over 30 to 90 mins
Biological: Placebo (Plasma-Lyte 148)
Infusion of placebo
- Oxygenation index (OI) [ Time Frame: Day 7 ]OI is a physiological index of the severity of ARDS and measures both impaired oxygenation and the amount of mechanical ventilation delivered
- Incidence of Serious Adverse Events (SAEs) [ Time Frame: 90 days ]Incidence of SAEs
- Oxygenation index [ Time Frame: Days 4 and 14 ]
- Sequential Organ Failure Assessment (SOFA) score [ Time Frame: Days 4, 7 and 14 ]SOFA score is a measure of organ failure
- Respiratory compliance (Crs) [ Time Frame: Days 4, 7 and 14 ]Crs is a physiological measure of pulmonary function in ARDS
- Partial pressure of arterial oxygen to the fraction of inspired oxygen ratio (P/F ratio) [ Time Frame: Days 4, 7 and 14 ]P/F ratio is a physiological measure of pulmonary function in ARDS
- Driving Pressure [ Time Frame: Days 4, 7 and 14 ]
- Extubation and reintubation [ Time Frame: Up to day 14 or until the patient is discharged from ICU or the patient dies ]
- Ventilation free days at day 28 [ Time Frame: Day 28 ]
- Length of ICU and hospital stay [ Time Frame: Until the patient is discharged or the patient dies ]
- 28-day and 90-day mortality [ Time Frame: Up to 28 and 90 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03042143
|Belfast Health and Social Care Trust, Royal Hospitals|
|Belfast, Northern Ireland, United Kingdom, BT12 6BA|
|Principal Investigator:||Danny F McAuley, Professor||Belfast Health and Social Care Trust|