COVID-19 PneumoniaPhase 1/2NCT04398303
ACT-20 in Patients With Severe COVID-19 Pneumonia
A Phase 1/2 study testing ACT-20-MSC and ACT-20-CM in people with COVID-19 Pneumonia, run by Aspire Health Science.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- ACT-20-MSC and ACT-20-CM
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- May 2020to Oct 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- COVID-19 Pneumonia
- Being tested
- ACT-20-MSC, ACT-20-CM, Placebo
- Keywords
- Stem cells, Pneumonia, COVID, COVID-19, Coronavirus, SARS-CoV-2
- Medical subject headings
- Pneumonia, COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-20-MSCBiological
1 million cells / kg body weight in 100 ml in conditioned media
ACT-20-CMBiological
100 ml of conditioned media only
PlaceboBiological
100 ml of MEM-α
| Study group | Role | What they receive |
|---|---|---|
| ACT-20-MSC in ACT-20-CM | Experimental | Conventional treatment plus ACT-20-MSC in ACT-20-CM administered intravenously Receives: Biological: ACT-20-MSC |
| ACT-20-CM | Experimental | Conventional treatment plus ACT-20-CM administered intravenously Receives: Biological: ACT-20-CM |
| Placebo | Placebo comparator | Conventional treatment plus placebo (MEM-α) administered intravenously Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at day 30
Measured: 30 days post treatment
Secondary outcomes (7)
Ventilated Subjects - Ventilator Free Days
Number of ventilator-free days
Measured: 28 days post treatment
Ventilated Subjects - Improvement in Ventilator Settings
Improvement in ventilator settings: Minute ventilation, PEEP, FiO2
Measured: 28 days post treatment, or until off of ventilator
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.
Measured: 30 days post treatment, or until off of high-flow O2 support
High Flow O2 Support Subjects - Respiration Rate
Respiration Rate < 30 for > 24 hours.
Measured: 30 days post treatment, or until off of high-flow O2 support
Both Ventilated and High-Flow O2 Support Subjects - ICU-Free Days
Number of ICU-free days
Measured: 30 days post treatment, or until off of ventilator or high-flow O2 support
Both Ventilated and High-Flow O2 Support Subjects - Pulmonary Function Improvement
Improvement in pulmonary function as evidenced by A-A oxygen gradient, O2 saturation
Measured: 30 days post treatment, or until off of ventilator or high-flow O2 support
Both Ventilated and High-Flow O2 Support Subjects - Increased Berlin Score
Increased Berlin Criteria score > 24 hours
Measured: 30 days post treatment, or until off of ventilator or high-flow O2 support
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study startMay 2020 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aspire Health Science
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398303
- Sponsor's protocol ID
- AHS 20-03
- Status last verified
- May 2020
- First submitted
- 20 May 2020
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Randomized, Placebo-Controlled Trial of ACT-20 in Patients With Severe COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04398303
- Acronym / sponsor ID
- AHS 20-03
- Conditions
- COVID-19 Pneumonia
- Keywords
- Stem cells, Pneumonia, COVID, COVID-19, Coronavirus, SARS-CoV-2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Aspire Health ScienceUniversity, hospital or other
- Study start
- May 2020 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ACT-20-MSC in ACT-20-CM | Experimental | Biological: ACT-20-MSCConventional treatment plus ACT-20-MSC in ACT-20-CM administered intravenously |
| ACT-20-CM | Experimental | Biological: ACT-20-CMConventional treatment plus ACT-20-CM administered intravenously |
| Placebo | Placebo comparator | Biological: PlaceboConventional treatment plus placebo (MEM-α) administered intravenously |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT-20-MSC1 million cells / kg body weight in 100 ml in conditioned media | Biological | ACT-20-MSC in ACT-20-CM |
| ACT-20-CM100 ml of conditioned media only | Biological | ACT-20-CM |
| Placebo100 ml of MEM-α | Biological | Placebo |
Primary outcome
Mortality at day 30
Time frame: 30 days post treatment
7 secondary outcomes
Ventilated Subjects - Ventilator Free Days
Time frame: 28 days post treatment
Ventilated Subjects - Improvement in Ventilator Settings
Time frame: 28 days post treatment, or until off of ventilator
High-Flow O2 Support Subjects - Step-Down O2 Therapy
Time frame: 30 days post treatment, or until off of high-flow O2 support
High Flow O2 Support Subjects - Respiration Rate
Time frame: 30 days post treatment, or until off of high-flow O2 support
Both Ventilated and High-Flow O2 Support Subjects - ICU-Free Days
Time frame: 30 days post treatment, or until off of ventilator or high-flow O2 support
Both Ventilated and High-Flow O2 Support Subjects - Pulmonary Function Improvement
Time frame: 30 days post treatment, or until off of ventilator or high-flow O2 support
Both Ventilated and High-Flow O2 Support Subjects - Increased Berlin Score
Time frame: 30 days post treatment, or until off of ventilator or high-flow O2 support
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ACT-20-MSC and ACT-20-CM in people with COVID-19 Pneumonia, run by Aspire Health Science.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Fairbairn (403-921-5854, regulatory@aspire2cure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality at day 30 (time frame: 30 days post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.