COVIDPhase 2NCT04614025
Open-label Multicenter Study to Evaluate the Efficacy of PLX-PAD for the Treatment of COVID-19
A Phase 2 study testing PLX-PAD in people with COVID and ARDS, run by Pluristem Ltd. at 9 sites in 2 countries.
Trial summary
This clinical trial will examine if a new treatment of Mesenchymal-like Adherent stromal Cells (called PLX-PAD) can help patients intubated and mechanically ventilated due to COVID-19 to recover more quickly with less complications. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- PLX-PAD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 19 Oct 2020to 7 Feb 2023
- Phase
- Phase 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
- Willing and able to provide written informed consent, or with a legal representative who can provide informed consent.
- Male or non-pregnant female adult 18-85 years of age at time of enrollment.
- Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in any specimen up to 21 days prior to randomization.
- Meets definition of ARDS according to Berlin criteria.
Who cannot join
- Body weight under 55 kg (121 lbs)
- Serum creatinine level of over 1.5 mg/dL at time of randomization.
- Total Bilirubin ≥2 mg/dL at time of randomization.
- Known allergy to any of the following: dimethyl sulfoxide (DMSO), human serum albumin, bovine serum albumin.
- Stroke or acute myocardial infarction/unstable angina within 3 months prior to randomization.
- Chronic Obstructive Pulmonary disease GOLD stage above II.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Israel5 sites
Emek Medical Center
Afula, 1834111
Bnai Zion Medical Center
Haifa, 31048
Rambam Health Care Campus
Haifa, 3109601
Galilee Medical Center
Nahariya, 22100
Baruch Padeh Medical Center, Poriya
Tiberias, 15208
Germany4 sites
Charite Campus Virchow
Berlin, 10117
Campus Benjamin Franklin - CBF Charité - Universitätsmedizin
Berlin, 12203
University of hospital Bonn
Bonn, 53127
Hospital Cologne-Merheim
Cologne, 51109
About this study
Official title: A Randomized, Controlled, Multicenter, Parallel-Group Phase IIa Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX-PAD for the Treatment of Severe COVID-19
This clinical trial will examine if a new treatment of Mesenchymal-like Adherent stromal Cells (called PLX-PAD) can help patients intubated and mechanically ventilated due to COVID-19 to recover more quickly with less complications.
- Being tested
- PLX-PAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLX-PADBiological
PLX-PAD - allogeneic ex-vivo expanded placental mesenchymal-like adherent stromal cells
| Study group | Role | What they receive |
|---|---|---|
| PLX-PAD Treatment | Experimental | PLX-PAD 300 million cells (20 million/mL) administered via 15 IM injections (1 mL each).
Single administration in addition to best standard medical care. Receives: Biological: PLX-PAD |
| Control Group | No intervention | Best standard medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ventilator-free days
Measured: 28 days
Secondary outcomes (2)
All-cause mortality
Measured: 28 and 60 days
Duration of mechanical ventilation
Measured: 28 and 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start19 Oct 2020
- Primary completion4 Aug 2021
- Study completion7 Feb 2023
Why it stopped: The decision to bring the Study to early clinical readout came in response to COVID-19's evolution as a disease, and the significant changes in the standard of care, leading to an increase in the severity of conditions of the intubated patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pluristem Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614025
- Sponsor's protocol ID
- PLX-COV-03
- Status last verified
- Aug 2024
- First submitted
- 2 Nov 2020
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multicenter, Parallel-Group Phase IIa Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX-PAD for the Treatment of Severe COVID-19
- ClinicalTrials.gov ID
- NCT04614025
- Acronym / sponsor ID
- PLX-COV-03
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The decision to bring the Study to early clinical readout came in response to COVID-19's evolution as a disease, and the significant changes in the standard of care, leading to an increase in the severity of conditions of the intubated patients.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Pluristem Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 4 Aug 2021 (actual)
- Study completion
- 7 Feb 2023 (actual)
- First posted
- 3 Nov 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.
This clinical trial will examine if a new treatment of Mesenchymal-like Adherent stromal Cells (called PLX-PAD) can help patients intubated and mechanically ventilated due to COVID-19 to recover more quickly with less complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLX-PAD Treatment | Experimental | Biological: PLX-PADPLX-PAD 300 million cells (20 million/mL) administered via 15 IM injections (1 mL each). Single administration in addition to best standard medical care. |
| Control Group | No intervention | –Best standard medical care |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willing and able to provide written informed consent, or with a legal representative who can provide informed consent.
- Male or non-pregnant female adult 18-85 years of age at time of enrollment.
- Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in any specimen up to 21 days prior to randomization.
- Meets definition of ARDS according to Berlin criteria.
Key exclusion criteria (6 listed)
- Body weight under 55 kg (121 lbs)
- Serum creatinine level of over 1.5 mg/dL at time of randomization.
- Total Bilirubin ≥2 mg/dL at time of randomization.
- Known allergy to any of the following: dimethyl sulfoxide (DMSO), human serum albumin, bovine serum albumin.
- Stroke or acute myocardial infarction/unstable angina within 3 months prior to randomization.
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 |
|---|---|---|
| PLX-PADPLX-PAD - allogeneic ex-vivo expanded placental mesenchymal-like adherent stromal cells | Biological | PLX-PAD Treatment |
Primary outcome
Number of ventilator-free days
Time frame: 28 days
2 secondary outcomes
All-cause mortality
Time frame: 28 and 60 days
Duration of mechanical ventilation
Time frame: 28 and 60 days
Results and safety
The study was stopped early (reason given: The decision to bring the Study to early clinical readout came in response to COVID-19's evolution as a disease, and the significant changes in the standard of care, leading to an increase in the severity of conditions of the intubated patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PLX-PAD in people with COVID and ARDS, run by Pluristem Ltd. at 9 sites in 2 countries.
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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Israel, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
The study was stopped early (reason given: The decision to bring the Study to early clinical readout came in response to COVID-19's evolution as a disease, and the significant changes in the standard of care, leading to an increase in the severity of conditions of the intubated patients.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of ventilator-free days (time frame: 28 days). 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 29 Aug 2024.