COVID-19 Pneumonia Clinical Trial
Official title:
A Phase 1/2 Randomized, Placebo-Controlled Trial of ACT-20 in Patients With Severe COVID-19 Pneumonia
The primary objective of this study is determine the safety and efficacy of ACT-20-MSC (allogenic human umbilical derived mesenchymal stem cells) and ACT-20-CM (allogenic human umbilical derived mesenchymal stem cells in conditioned media) in patients with moderate to severe COVID-19 pneumonia.
Status | Not yet recruiting |
Enrollment | 70 |
Est. completion date | October 2020 |
Est. primary completion date | October 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: 1. Male or female patients age 18 to 85, inclusive 2. Confirmed positive test for COVID-19 by standard reverse transcriptase polymerase chain reaction (RT-PCR) assay or equivalent 3. On mechanical ventilation (n=35), or high-flow O2 support (n=35) and: 1. Disease severity level of "moderate" (PaO2/FiO2 of 100-200) (n=35), or "severe" (PaO2/FiO2 < 100) (n=35) as established using the Berlin Criteria for ARDS (Barbas, Isola & Caser, 2014; Baron & Levy, 2016). 2. Positive end-expiratory airway pressure (PEEP) = 5 cmH2O 3. Oxygen saturation = 93% 4. Non-cardiogenic bilateral pulmonary edema on frontal chest radiograph that cannot be explained by effusion, collapsed lung or lung nodule 5. Able to understand and provide voluntary informed consent Exclusion Criteria: 1. Unable to understand and provide voluntary informed consent 2. Current infection with HIV-1, HIV-2, Hepatitis B, Hepatitis C or HTLV 3. History of malignancy, other than non-melanoma skin cancer or non-metastatic prostate cancer 4. Currently receiving extracorporeal life support or high-frequency oscillatory ventilation 5. Weight > 150 kg 6. Current severe chronic respiratory disease, as demonstrated by: 1. PaCO2 > 50 mm Hg, or 2. history of use of home oxygen 7. Major trauma within the past 7 days 8. Lung transplant recipient 9. WHO Class III or IV pulmonary hypertension 10. Documented deep vein thrombosis or pulmonary embolism within the past 3 months 11. Currently pregnant or lactating 12. Currently participating in another clinical trial, or participation in another clinical trial within 30 days of enrollment 13. Hypersensitivity to Dextran-40 or Dimethyl Sulfoxide (DMSO) 14. Current pharmacotherapy using hydroxychloroquine or Interleukin-6 inhibitors 15. History of CVA or MI within 180 days of study enrollment |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Aspire Health Science |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality at day 30 | 30 days post treatment | ||
Secondary | Ventilated Subjects - Ventilator Free Days | Number of ventilator-free days | 28 days post treatment | |
Secondary | Ventilated Subjects - Improvement in Ventilator Settings | Improvement in ventilator settings: Minute ventilation, PEEP, FiO2 | 28 days post treatment, or until off of ventilator | |
Secondary | High-Flow O2 Support Subjects - Step-Down O2 Therapy | Days of step-down O2 therapy as evidenced by: improvement in required volume, change to nasal cannula or face mask delivery or improvement in required concentration. | 30 days post treatment, or until off of high-flow O2 support | |
Secondary | High Flow O2 Support Subjects - Respiration Rate | Respiration Rate < 30 for > 24 hours. | 30 days post treatment, or until off of high-flow O2 support | |
Secondary | Both Ventilated and High-Flow O2 Support Subjects - ICU-Free Days | Number of ICU-free days | 30 days post treatment, or until off of ventilator or high-flow O2 support | |
Secondary | Both Ventilated and High-Flow O2 Support Subjects - Pulmonary Function Improvement | Improvement in pulmonary function as evidenced by A-A oxygen gradient, O2 saturation | 30 days post treatment, or until off of ventilator or high-flow O2 support | |
Secondary | Both Ventilated and High-Flow O2 Support Subjects - Increased Berlin Score | Increased Berlin Criteria score > 24 hours | 30 days post treatment, or until off of ventilator or high-flow O2 support |
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