A Phase 2/3 interventional study of MultiStem and Placebo in ARDS, sponsored by Healios K.K.. Terminated at 4 sites in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Healios K.K. · Phase 2/3, Interventional, and Treatment
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Among 1,859 studies in COVID-19 with a site in United States — 120 open to participants now, 210 under way, 16 of them phase 3. COVID-19 · United States.
Among the 1,859 studies in COVID-19 with a site in United States, this one is the 1,015th largest by enrollment of the 1,321 interventional ones that give a count, is one of 818 that started in 2020, is one of 70 in phase 2/3, and was the 242nd registered.
7,992 studies on the registry are indexed under COVID-19; 466 are open to participants now.
Browse COVID-19 studies →120 of the 1,859 studies in COVID-19 with a site in United States are open now. Recruiting first, the newest first:
ModernaTX, Inc. · Sites in United States
Ages 12+ · Healthy volunteers
National Institute on Deafness and Other Communication Disorders (NIDCD) · Sites in United States
Ages 18–99 · Healthy volunteers
Shionogi · Sites in United States, Bulgaria, Japan
Ages 12+
ModernaTX, Inc. · Sites in United States, Argentina, Dominican Republic and 3 more countries
Ages 6 mo–11 yrs · Healthy volunteers
BioNTech SE · Sites in United States
Ages 5+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 356 COVID-19 studies recruiting now, 206 (58%) set no upper age limit and 83 (23%) stop at 75 or younger; 91 take children under 18; 135 take healthy volunteers.
This study: 18 Years to 89 Years · all sexes · no healthy volunteers.
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1,859 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 240 · Phase 2 481 · Phase 3 244 · Phase 4 60
First in 2007; this study’s year is marked. 818 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 22 is below the median of 102 across 4,365 interventional studies indexed under COVID-19.
Median enrollment 91 across the 1,321 interventional studies, 300 across the 521 observational. Of the 1,414 that completed or were terminated, 719 (51%) have results posted.
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638 of 1,859 have an industry lead sponsor. The 10 most frequent:
Healios K.K. is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Healios K.K. has 1 study filed under COVID-19 — fewer than ten, so there is no comparison to draw.
85 of the studies in COVID-19 with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06928272Phase 3Douglas D. FraserLong Covid (LC)-REVITALIZE - A Long Covid Repurposed Drug Study | 2026-12 |
| NCT07798648Phase 3BioNTech SEA Study of COVID-19 Vaccine(s) in Children and Adults | 2027-04-21 |
| NCT07013474Phase 3PfizerA Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised | 2027-09-28 |
| NCT06679140Phase 3PfizerA Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease | 2027-10-01 |
| NCT05624450Phase 3AstraZenecaEfficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen | 2027-11-04 |
Add all 85 to your calendar (.ics) → With an account.
Among the 1,859 studies in COVID-19 with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Multicenter investigation featuring an open-label lead-in followed by a double blinded, randomized, placebo-controlled Phase 2/3 part to evaluate the safety and efficacy of MultiStem therapy in subjects with moderate to severe Acute Respiratory Distress Syndrome (ARDS) due to pathogens including COVID-19.
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Diagnosis of new acute-onset moderate to severe ARDS, as defined by the Berlin criteria, requiring an endotracheal or tracheal tube, Evidence of pneumonia or severe localized or systemic infection
Exclusion Criteria:
Moribund subject who, in the opinion of the Investigator, is not expected to survive at least 48 hours and End-stage severe chronic lung disease
Biological: MultiStem
Biological: Placebo
intravenous infusion
intravenous infusion
Ventilator-Free Days
Time frame: Day 0 through Day 28.
Safety and Tolerability as measured by the incidence of treatment-emergent adverse events as assessed by CTCAE v5.0.
Time frame: Day 28
All-cause mortality
Time frame: Day 60
Ranked hierarchical composite outcome of alive and ventilator-free
Time frame: Day 28
Ventilator-free days
Time frame: Day 0 through Day 60
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2020 to primary completion in Oct 2024, 53 months.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Invimestrocel
Healios K.K.