Trial record 1 of 1 for:
NCT04367077
MultiStem Administration for COVID-19 Induced ARDS (MACoVIA) (MACoVIA)
|
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04367077 |
|
Recruitment Status :
Recruiting
First Posted : April 29, 2020
Last Update Posted : September 9, 2021
|
Sponsor:
Athersys, Inc
Information provided by (Responsible Party):
Athersys, Inc
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| ARDS | Biological: MultiStem Biological: Placebo | Phase 2 Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 400 participants |
| Allocation: | Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2/3 Study to Assess the Safety and Efficacy of MultiStem® Therapy in Subjects With Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease (COVID-19) |
| Actual Study Start Date : | April 28, 2020 |
| Estimated Primary Completion Date : | January 2023 |
| Estimated Study Completion Date : | December 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
COVID-19 (Coronavirus Disease 2019)
| Arm | Intervention/treatment |
|---|---|
| Experimental: MultiStem |
Biological: MultiStem
intravenous infusion |
| Placebo Comparator: Placebo |
Biological: Placebo
intravenous infusion |
Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
- 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 ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 89 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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
Information from the National Library of Medicine
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): NCT04367077
Contacts
| Contact: Athersys Clinical Trials Group | 2164263597 | macovia@athersys.com |
Locations
| United States, Illinois | |
| Athersys Investigational Site 107 | Recruiting |
| Chicago, Illinois, United States, 60601 | |
| Contact: Athersys Clinical Trials Group 216-426-3597 macovia@athersys.com | |
| United States, Ohio | |
| Athersys Investigational Site 103 | Recruiting |
| Akron, Ohio, United States, 44304 | |
| Contact: Athersys Clinical Trials Group 216-426-3597 macovia@athersys.com | |
| Athersys Investigational Site 101 | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Athersys Clinical Trials Group 216-426-3597 macovia@athersys.com | |
| Athersys Investigational Site 102 | Recruiting |
| Cleveland, Ohio, United States, 44109 | |
| Contact: Athersys Clinical Trials Group 216-426-3597 macovia@athersys.com | |
Sponsors and Collaborators
Athersys, Inc
Investigators
| Study Director: | Eric Jenkins, MD | Athersys, Inc |
| Responsible Party: | Athersys, Inc |
| ClinicalTrials.gov Identifier: | NCT04367077 |
| Other Study ID Numbers: |
B04-03 |
| First Posted: | April 29, 2020 Key Record Dates |
| Last Update Posted: | September 9, 2021 |
| Last Verified: | September 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Athersys, Inc:
|
COVID19 respiratory distress adult stem cells |
Additional relevant MeSH terms:
|
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |