Back to resultsACT-20 in Patients With Severe COVID-19 Pneumonia
Primary Purpose
COVID-19 Pneumonia
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ACT-20-MSC
ACT-20-CM
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Pneumonia focused on measuring Stem cells, Pneumonia, COVID, COVID-19, Coronavirus, SARS-CoV-2
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
ACT-20-MSC in ACT-20-CM
ACT-20-CM
Placebo
Arm Description
Conventional treatment plus ACT-20-MSC in ACT-20-CM administered intravenously
Conventional treatment plus ACT-20-CM administered intravenously
Conventional treatment plus placebo (MEM-α) administered intravenously
Outcomes
Primary Outcome Measures
Mortality at day 30
Secondary Outcome Measures
Ventilated Subjects - Ventilator Free Days
Number of ventilator-free days
Ventilated Subjects - Improvement in Ventilator Settings
Improvement in ventilator settings: Minute ventilation, PEEP, FiO2
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.
High Flow O2 Support Subjects - Respiration Rate
Respiration Rate < 30 for > 24 hours.
Both Ventilated and High-Flow O2 Support Subjects - ICU-Free Days
Number of ICU-free days
Both Ventilated and High-Flow O2 Support Subjects - Pulmonary Function Improvement
Improvement in pulmonary function as evidenced by A-A oxygen gradient, O2 saturation
Both Ventilated and High-Flow O2 Support Subjects - Increased Berlin Score
Increased Berlin Criteria score > 24 hours
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04398303
Brief Title
ACT-20 in Patients With Severe COVID-19 Pneumonia
Official Title
A Phase 1/2 Randomized, Placebo-Controlled Trial of ACT-20 in Patients With Severe COVID-19 Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2020 (Anticipated)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aspire Health Science
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 mesenchymal stem cells in conditioned media) in patients with moderate to severe COVID-19 pneumonia.
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-label study of 10 subjects, 5 with moderate COVID-19 pneumonia and 5 with severe COVID-19 pneumonia. Of these 10 subjects, 5 will receive ACT-20-CM and 5 will receive ACT-20-MSC resuspended in ACT-20-CM.
Part 2 is a randomized, blinded, placebo-controlled study of 60 patients, 30 with moderate COVID-19 pneumonia and 30 with severe COVID-19 pneumonia. Randomization will be 1:1:1 ACT-20-MSC in ACT-20-CM, ACT-20-CM or placebo. The placebo is MEM-α, a widely used sterile culture media that contains non-essential amino acids, nucleosides, vitamins, glucose, sodium pyruvate and lipoic acid.
Subjects treated at each investigative site will provide written informed consent prior to the conduct of any study-related procedures. Thereafter, they will be screened and those meeting the inclusion/exclusion criteria will be enrolled into the trial and undergo all the study procedures including the intravenous administration of the investigational medical product (IMP = ACT-20-MSC in ACT-20-CM or ACT-20-CM) or placebo. The IMP will be administered in addition to any standard of care treatment the subject is receiving.
Subjects will be assessed daily while in hospital. Following discharge from hospital, subjects will be following for an additional three month period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia
Keywords
Stem cells, Pneumonia, COVID, COVID-19, Coronavirus, SARS-CoV-2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ACT-20-MSC in ACT-20-CM
Arm Type
Experimental
Arm Description
Conventional treatment plus ACT-20-MSC in ACT-20-CM administered intravenously
Arm Title
ACT-20-CM
Arm Type
Experimental
Arm Description
Conventional treatment plus ACT-20-CM administered intravenously
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Conventional treatment plus placebo (MEM-α) administered intravenously
Intervention Type
Biological
Intervention Name(s)
ACT-20-MSC
Intervention Description
1 million cells / kg body weight in 100 ml in conditioned media
Intervention Type
Biological
Intervention Name(s)
ACT-20-CM
Intervention Description
100 ml of conditioned media only
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
100 ml of MEM-α
Primary Outcome Measure Information:
Title
Mortality at day 30
Time Frame
30 days post treatment
Secondary Outcome Measure Information:
Title
Ventilated Subjects - Ventilator Free Days
Description
Number of ventilator-free days
Time Frame
28 days post treatment
Title
Ventilated Subjects - Improvement in Ventilator Settings
Description
Improvement in ventilator settings: Minute ventilation, PEEP, FiO2
Time Frame
28 days post treatment, or until off of ventilator
Title
High-Flow O2 Support Subjects - Step-Down O2 Therapy
Description
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.
Time Frame
30 days post treatment, or until off of high-flow O2 support
Title
High Flow O2 Support Subjects - Respiration Rate
Description
Respiration Rate < 30 for > 24 hours.
Time Frame
30 days post treatment, or until off of high-flow O2 support
Title
Both Ventilated and High-Flow O2 Support Subjects - ICU-Free Days
Description
Number of ICU-free days
Time Frame
30 days post treatment, or until off of ventilator or high-flow O2 support
Title
Both Ventilated and High-Flow O2 Support Subjects - Pulmonary Function Improvement
Description
Improvement in pulmonary function as evidenced by A-A oxygen gradient, O2 saturation
Time Frame
30 days post treatment, or until off of ventilator or high-flow O2 support
Title
Both Ventilated and High-Flow O2 Support Subjects - Increased Berlin Score
Description
Increased Berlin Criteria score > 24 hours
Time Frame
30 days post treatment, or until off of ventilator or high-flow O2 support
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Fairbairn
Phone
403-921-5854
Email
regulatory@aspire2cure.com
12. IPD Sharing Statement
Links:
URL
http://aspire2cure.com
Description
Related Info
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ACT-20 in Patients With Severe COVID-19 Pneumonia
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