Status:
UNKNOWN
ACT-20 in Patients With Severe COVID-19 Pneumonia
Lead Sponsor:
Aspire Health Science
Conditions:
COVID-19 Pneumonia
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
PHASE2
Brief Summary
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 mesen...
Detailed Description
This study will assess the safety and efficacy of ACT-20-MSC and ACT-20-CM administered intravenously to subjects with moderate to severe COVID-19 related pneumonia in two parts. Part 1 is an open-la...
Eligibility Criteria
Inclusion
- Male or female patients age 18 to 85, inclusive
- Confirmed positive test for COVID-19 by standard reverse transcriptase polymerase chain reaction (RT-PCR) assay or equivalent
- On mechanical ventilation (n=35), or high-flow O2 support (n=35) and:
- 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).
- Positive end-expiratory airway pressure (PEEP) ≥ 5 cmH2O
- Oxygen saturation ≤ 93%
- Non-cardiogenic bilateral pulmonary edema on frontal chest radiograph that cannot be explained by effusion, collapsed lung or lung nodule
- Able to understand and provide voluntary informed consent
Exclusion
- Unable to understand and provide voluntary informed consent
- Current infection with HIV-1, HIV-2, Hepatitis B, Hepatitis C or HTLV
- History of malignancy, other than non-melanoma skin cancer or non-metastatic prostate cancer
- Currently receiving extracorporeal life support or high-frequency oscillatory ventilation
- Weight \> 150 kg
- Current severe chronic respiratory disease, as demonstrated by:
- PaCO2 \> 50 mm Hg, or
- history of use of home oxygen
- Major trauma within the past 7 days
- Lung transplant recipient
- WHO Class III or IV pulmonary hypertension
- Documented deep vein thrombosis or pulmonary embolism within the past 3 months
- Currently pregnant or lactating
- Currently participating in another clinical trial, or participation in another clinical trial within 30 days of enrollment
- Hypersensitivity to Dextran-40 or Dimethyl Sulfoxide (DMSO)
- Current pharmacotherapy using hydroxychloroquine or Interleukin-6 inhibitors
- History of CVA or MI within 180 days of study enrollment
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2020
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04398303
Start Date
May 1 2020
End Date
October 1 2020
Last Update
May 21 2020
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