COVID-19 Pneumonia Clinical Trial
— SAMPSON-1Official title:
Safety and Tolerability of Allogeneic Umbilical Cord Derived Mesenchymal Stromal Cells (UC-MSCs) to Limit COVID Associated ComplicatioNs: An Open Label, Phase 1 Study in Hospitalized Patients (SAMPSON-1)
This is an open-label phase 1 clinical trial of allogeneic umbilical cord derived mesenchymal stromal cells (MSCs) for hospitalized individuals with COVID-19 or other viral pneumonias. Hospitalized individuals who are within 7 days of the onset of a viral pneumonia will be given 2 doses of MSCs at days 1 and 3 after consent. The safety of intravenous infusion will be tested and course of the oxygen response to treatment over 90 days will be evaluated.
Status | Not yet recruiting |
Enrollment | 10 |
Est. completion date | May 2027 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. 2. Patient or their surrogate is willing and able to provide written informed consent and comply with all protocol requirements. 3. Diagnosis with Mild or Moderate Pneumonia not requiring mechanical ventilation: Patient must have at least one of the following features: i. Bilateral pneumonia present on chest radiograph or computed tomography ii. Partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) on arterial blood gas showing: >100mmHg and = 300mmHg regardless of oxygen dose at time of testing. iii. Pulse oxygen saturation (SpO2) at rest = 93% or any degree of hypoxia requiring supplemental oxygen 4. Patient agrees to storage of specimens for future testing. 5. Willingness to undergo mechanical ventilation for worsening Exclusion Criteria: 1. Intubation with mechanical ventilation prior to study enrolment. High flow nasal cannula and non-invasive mechanical ventilation is allowed. 2. Pneumonia caused by bacteria, mycoplasma, chlamydia, legionella, fungi or other viruses 3. Obstructive pneumonia induced by lung cancer or other known causes 4. Significant comorbid illness likely to impact the outcome of COVID-19 including but not limited to active malignancy other than skin cancer. 5. Patients who are participating in other therapeutic clinical trials within 30 days of consent. 6. History of long-term use of immunosuppressive agents including prednisone dose >5mg daily over the 30 days prior to enrollment. 7. History of severe chronic respiratory disease and requirement for long-term oxygen therapy 8. Undergoing hemodialysis or peritoneal dialysis 9. Estimated or actual rate of creatinine clearance < 15 ml/min 10. History of moderate and severe liver disease (Child-Pugh score >12) 11. Substance abuse sufficient that the patient is unlikely to comply with testing requirements. 12. History of deep venous thrombosis, pulmonary embolism, cerebral vascular disease within the last 3 years 13. Known HIV, hepatitis virus, or syphilis infection 14. Co-Infection of tuberculosis, influenza virus, adenovirus and other respiratory infection virus 15. Moribund patient not expected to survive > 24hours 16. Allergy to diphenhydramine, or hydrocortisone 17. Any condition unsuitable for the study as determined by the investigators 18. Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period. 19. Receipt of experimental therapy for COVID-19 with the exception of convalescent plasma, dexamethasone or another corticosteroid, or remdesivir in an open label study. |
Country | Name | City | State |
---|---|---|---|
United States | Medical University of South Carolina | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina | Pandorum International, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change is PaO2/FiO2 ratio from baseline to day 5 | Change in oxygenation | 5 days | |
Other | Anti-SARS-CoV-2 titers | Antibody titers to the SARS-CoV-2 virus | 14, 21 and 28 days | |
Other | Nasopharyngeal swab SARS-CoV-2 RT-PCR | Rates, levels and duration of SARS-CoV-2 RNA in nasopharyngeal swabs using RT-PCR | Day 5 | |
Primary | Clinical deterioration | Change in oxygen saturation or clinical symptoms | 6 hours | |
Secondary | Serious Adverse Events | Cumulative incidence of all serious adverse events | 90 days | |
Secondary | ICU transfer | Need for transfer to an intensive care unit | 90 days | |
Secondary | Respiratory support | Type and duration of respiratory support | 90 days | |
Secondary | Hospital mortality and length of stay | Hospital mortality and length of stay | 90 days | |
Secondary | Ventilator free days | Days off of mechanical ventilation | 90 Days | |
Secondary | 28 day mortality | 28 day mortality | 28 days |
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