Studies
| Study First Submitted Date | 2021-07-28 |
| Study First Posted Date | 2021-08-05 |
| Last Update Posted Date | 2023-04-12 |
| Start Month Year | February 2024 |
| Primary Completion Month Year | July 2024 |
| Verification Month Year | April 2023 |
| Verification Date | 2023-04-30 |
| Last Update Posted Date | 2023-04-12 |
Detailed Descriptions
| Sequence: | 20688482 |
| Description | This is a Phase 2a randomized, placebo-controlled multicenter study designed to investigate the efficacy, safety and tolerability of COVI-MSC in treating post COVID-19 "long haul" pulmonary compromise. COVI-MSC will be administered intravenously on Day 0, Day 2, and Day 4. |
Conditions
| Sequence: | 52082700 |
| Name | Covid19 |
| Downcase Name | covid19 |
Id Information
| Sequence: | 40088142 |
| Id Source | org_study_id |
| Id Value | MSC-PLH-201BR |
Design Groups
| Sequence: | 55496619 | Sequence: | 55496620 |
| Group Type | Experimental | Group Type | Placebo Comparator |
| Title | COVI-MSC | Title | Placebo |
| Description | Allogeneic culture-expanded adipose-derived mesenchymal stem cells (MSCs) | Description | Excipient |
Interventions
| Sequence: | 52395851 | Sequence: | 52395852 |
| Intervention Type | Biological | Intervention Type | Biological |
| Name | COVI-MSC | Name | Placebo |
| Description | 2, 4 or 6 MSC vials (approximately 15 million cells/vial) will be intravenously infused on Day 0, Day 2, or Day 4 depending on assignment to treatment group. Group A: 2 MSC vials infused on D0 and 2 vials of placebo on D2 and D4 Group B: 2 MSC vials infused on D0 and D2 and 2 vials of placebo on D4 Group C: 2 MSC vials infused on D0 and D4 and 2 vials of placebo on D2 Group D: 2 MSC vials infused on D0, D2 and D4 | Description | 6 vials of placebo will be intravenously infused on Day 0, Day 2, or Day 4. |
Keywords
| Sequence: | 79722677 | Sequence: | 79722678 | Sequence: | 79722679 |
| Name | covid19 | Name | long haul | Name | post-acute covid |
| Downcase Name | covid19 | Downcase Name | long haul | Downcase Name | post-acute covid |
Design Outcomes
| Sequence: | 177077791 | Sequence: | 177077792 | Sequence: | 177077793 | Sequence: | 177077794 | Sequence: | 177077795 | Sequence: | 177077796 |
| Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Change in 6-Minute Walk Distance (6MWD) at Day 60 | Measure | Change in 6MWD at Day 30 | Measure | Relief of symptoms on Day 30 and Day 60 | Measure | Change in Pulmonary Function | Measure | Change in oxygenation | Measure | Change in biomarker levels |
| Time Frame | Baseline to Day 60 | Time Frame | Baseline to Day 30 | Time Frame | Baseline to Day 30 and Day 60 | Time Frame | Baseline to Day 30 and Day 60 | Time Frame | Baseline to Day 30 and Day 60 | Time Frame | Baseline to Day 60 |
| Description | Change in 6MWD at Day 60 | Description | Change in 6MWD at Day 30 | Description | Relief of symptoms on Day 30 and Day 60 based on a categorical Symptom Relief Scale, where 0 = no benefit and 4 = nearly complete benefit | Description | Change in pulmonary function at Days 30 and 60, as measured by the single-breath test | Description | Change in oxygenation at Days 30 and 60, as measured by the SpO2/FiO2 ratio | Description | Change in biomarker levels: plasma lipocalcin-2, matrix metalloproteinase-7, hepatocyte growth factor |
Browse Conditions
| Sequence: | 193135006 | Sequence: | 193135007 | Sequence: | 193135008 | Sequence: | 193135009 | Sequence: | 193135010 | Sequence: | 193135011 | Sequence: | 193135012 | Sequence: | 193135013 | Sequence: | 193135014 | Sequence: | 193135015 | Sequence: | 193135016 | Sequence: | 193135017 |
| Mesh Term | COVID-19 | Mesh Term | Pneumonia, Viral | Mesh Term | Pneumonia | Mesh Term | Respiratory Tract Infections | Mesh Term | Infections | Mesh Term | Virus Diseases | Mesh Term | Coronavirus Infections | Mesh Term | Coronaviridae Infections | Mesh Term | Nidovirales Infections | Mesh Term | RNA Virus Infections | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases |
| Downcase Mesh Term | covid-19 | Downcase Mesh Term | pneumonia, viral | Downcase Mesh Term | pneumonia | Downcase Mesh Term | respiratory tract infections | Downcase Mesh Term | infections | Downcase Mesh Term | virus diseases | Downcase Mesh Term | coronavirus infections | Downcase Mesh Term | coronaviridae infections | Downcase Mesh Term | nidovirales infections | Downcase Mesh Term | rna virus infections | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48237361 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | Sorrento Therapeutics, Inc. |
Overall Officials
| Sequence: | 29233688 |
| Role | Study Director |
| Name | Mike Royal, MD |
| Affiliation | Sorrento Therapeutics, Inc. |
Central Contacts
| Sequence: | 11990391 |
| Contact Type | primary |
| Name | Mike Royal, MD |
| Phone | (858)203-4100 |
| mroyal@sorrentotherapeutics.com | |
| Phone Extension | 4146 |
| Role | Contact |
Design Group Interventions
| Sequence: | 68031718 | Sequence: | 68031719 |
| Design Group Id | 55496619 | Design Group Id | 55496620 |
| Intervention Id | 52395851 | Intervention Id | 52395852 |
Eligibilities
| Sequence: | 30714028 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| Criteria | Inclusion Criteria: Has had prior laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen Has had a recent (within a week) negative SARS-CoV-2 test (an approved PCR or antigen test) Has had at least moderate or severe post-COVID-19 pulmonary symptoms for at least 3 months which have resulted in reduced physical functioning compared to pre-COVID-19 status Willing to follow contraception guidelines Exclusion Criteria: Clinically improving pulmonary status over the month prior to screening Undergone a previous stem cell infusion unrelated to this trial Pregnant or breast feeding or planning for either during the study Suspected uncontrolled active bacterial, fungal, viral, or other infection Any significant medical condition, laboratory value or other illness that in the investigator's opinion would interfere or prevent safe participation in the study History of a splenectomy, lung transplant or lung lobectomy Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable) |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 253945680 |
| Registered In Calendar Year | 2021 |
| Were Results Reported | False |
| Has Single Facility | False |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 1 |
| Number Of Secondary Outcomes To Measure | 5 |
Designs
| Sequence: | 30460597 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Treatment |
| Time Perspective | |
| Masking | Quadruple |
| Subject Masked | True |
| Caregiver Masked | True |
| Investigator Masked | True |
| Outcomes Assessor Masked | True |
Responsible Parties
| Sequence: | 28827056 |
| Responsible Party Type | Sponsor |