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Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise (BR)

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: NCT04992247
Recruitment Status : Not yet recruiting
First Posted : August 5, 2021
Last Update Posted : August 8, 2022
Sponsor:
Information provided by (Responsible Party):
Sorrento Therapeutics, Inc.

Brief Summary:
This is a Phase 2a randomized, placebo-controlled study designed to investigate the efficacy, safety and tolerability of COVI-MSC in treating post COVID-19 "long haul" pulmonary compromise.

Condition or disease Intervention/treatment Phase
Covid19 Biological: COVI-MSC Biological: Placebo Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2A Randomized, Placebo-Controlled Study of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise
Estimated Study Start Date : November 2022
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : September 2023


Arm Intervention/treatment
Experimental: COVI-MSC
Allogeneic culture-expanded adipose-derived mesenchymal stem cells (MSCs)
Biological: COVI-MSC

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


Placebo Comparator: Placebo
Excipient
Biological: Placebo
6 vials of placebo will be intravenously infused on Day 0, Day 2, or Day 4.




Primary Outcome Measures :
  1. Change in 6-Minute Walk Distance (6MWD) at Day 60 [ Time Frame: Baseline to Day 60 ]
    Change in 6MWD at Day 60


Secondary Outcome Measures :
  1. Change in 6MWD at Day 30 [ Time Frame: Baseline to Day 30 ]
    Change in 6MWD at Day 30

  2. Relief of symptoms on Day 30 and Day 60 [ Time Frame: Baseline to Day 30 and Day 60 ]
    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

  3. Change in Pulmonary Function [ Time Frame: Baseline to Day 30 and Day 60 ]
    Change in pulmonary function at Days 30 and 60, as measured by the single-breath test

  4. Change in oxygenation [ Time Frame: Baseline to Day 30 and Day 60 ]
    Change in oxygenation at Days 30 and 60, as measured by the SpO2/FiO2 ratio

  5. Change in biomarker levels [ Time Frame: Baseline to Day 60 ]
    Change in biomarker levels: plasma lipocalcin-2, matrix metalloproteinase-7, hepatocyte growth factor



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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)

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): NCT04992247


Contacts
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Contact: Mike Royal, MD (858)203-4100 ext 4146 mroyal@sorrentotherapeutics.com

Sponsors and Collaborators
Sorrento Therapeutics, Inc.
Investigators
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Study Director: Mike Royal, MD Sorrento Therapeutics, Inc.
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Responsible Party: Sorrento Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04992247    
Other Study ID Numbers: MSC-PLH-201BR
First Posted: August 5, 2021    Key Record Dates
Last Update Posted: August 8, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sorrento Therapeutics, Inc.:
covid19
long haul
post-acute covid
Additional relevant MeSH terms:
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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