COVID-19 Acute Respiratory Distress SyndromePhase 1NCT05387278
Safety and Effectiveness of Placental Derived Exosomes and Umbilical Cord Mesenchymal Stem Cells in Moderate to Severe Acute Respiratory Distress Syndrome (ARDS) Associated With the Novel Corona Virus Infection (COVID-19)
A Phase 1 study testing EV-Pure™ and WJ-Pure™ in people with COVID-19 Acute Respiratory Distress Syndrome and Respiratory Distress Syndrome, run by Vitti Labs, LLC at 1 site in United States.
Trial summary
Recent advances have been made in prevention of the viral infection via vaccines but there is still need for effective treatment options for patients. Novel therapies need to be developed to further improve clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome, Respiratory Distress Syndrome
- What is being tested?
- EV-Pure™ and WJ-Pure™
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2025to Dec 2025
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be eligible for enrollment in the study only if they meet the following criteria:
- Male or female, aged at 18 years (including) to 75 years old.
- Patient with a confirmed SARS-CoV-2 infection (by positive reverse-transcription polymerase chain reaction (RT-PCR) from nasopharyngeal sample or any other sample)
- Hospitalized with moderate to severe ARDS.
- Have ARDS or acute lung injury, comply with any of the following:
- Respiratory distress, Respiratory rate (RR) ≥ 30 times/min ii. Pulse oxygen saturation (SpO2) at rest ≤ 93% iii. Partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) ≤ 300mmHg
- If childbearing age: agree to practice effective birth control from screening until 12 weeks after the last study treatment.
Who cannot join
- Subjects will be ineligible for enrollment in the study if they meet any of the following criteria:
- Patient under invasive mechanical ventilation for more than 48 hours
- Allergic or hypersensitive to any of the ingredients.
- Pneumonia caused by bacteria, mycoplasma, chlamydia, legionella, fungi or other viruses.
- Obstructive HABP/VABP induced by lung cancer or other known causes.
- Carcinoid syndrome.
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- History of long-term use of immunosuppressive agents.
- History of Class III or IV pulmonary arterial hypertension.
- Patient with chronic respiratory disease under oxygen therapy.
- Undergoing hemodialysis or peritoneal dialysis.
- Estimated or actual rate of creatinine clearance < 15 mL/min.
- History of moderate and severe liver disease (Child-Pugh score >12).
- History of deep venous thrombosis or pulmonary embolism within the last 3 years.
- Undergoing extracorporeal membrane oxygenation (ECMO) or high-frequency oscillatory ventilation support.
- Patient included in another ongoing interventional therapeutic trial.
- Pregnant or Lactating.
- Any condition of unsuitable for the study determined by Principal Investigator (PI).
Trial locations and contacts
1 site in 1 country.
About this study
Recent advances have been made in prevention of the viral infection via vaccines but there is still need for effective treatment options for patients. Novel therapies need to be developed to further improve clinical outcomes. The biggest medical challenge in the response to COVID-19 is ARDS requiring hospitalization in an intensive care setting and ventilator dependence. Intravenously administered umbilical cord derived exosomes and stem cells have been reported in literature to alleviate pulmonary distress in such patients.
The purpose of this study is to explore the safety and benefits of intravenous administration of WJPure and EVPure in the treatment of COVID-19 patients with moderate to severe ARDS. .
Read the detailed description
One of the hallmark features of the progression of COVID-19 is lung injury from the viral infection leading to potentially acute respiratory distress syndrome (ARDS) and respiratory failure requiring ventilator support. In patients who survive ARDS, regardless of the pathology, there is evidence that their long-term quality of life is adversely affected.
The rationale for the dose and dosing regimen proposed in this study is based on the safe administration and benefits of this treatment regimen reported to us last year by physicians trying to treat moderate to severe COVID-19 patients. In those reports, the intravenous route of administration was used. It has been reported that dosing every 2 days amplified the benefit of the combination of exosomes and mesenchymal stem cells. It has been suggested based on clinical experience that the exosomes and MSCs are complementary to one another as well as enhancing the innate abilities of both.
During the early days of the pandemic, intravenous infusion of a mixture of EV-Pure™ and WJ-Pure™ was reported to benefit hospitalized patients with moderate to severe COVID-19 related ARDS. This study is designed to systematically explore the risk and benefits of intravenous infusion of EV-Pure™ and WJ-Pure™ in the treatment of hospitalized COVID-19 patients with moderate to severe ARDS.
This is a proof of concept, double-blind, placebo-controlled trial to evaluate the safety and efficacy of intravenous infusion of EV-Pure™ and WJ-Pure™, versus placebo, for use in the treatment of moderate to severe ARDS related to COVID-19. This is an add-on treatment study; subjects will be allowed to take standard of care treatments available.
The study will have two arms (n=10 each):
- Experimental/treatment arm: EV-Pure™ and WJ-Pure™ plus standard care
- Placebo: Cryopreservation media plus standard care
The study duration would be 5 days of treatment plus 12 weeks follow up.
- Being tested
- EV-Pure™ and WJ-Pure™, Placebo
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EV-Pure™ and WJ-Pure™Drug
The treatment consists of administration of WJ-Pure™ and EV-Pure™ plus standard care
PlaceboDrug
Cryopreservation media plus standard care
| Study group | Role | What they receive |
|---|---|---|
| Experimental/treatment arm | Experimental | Not described Receives: Drug: EV-Pure™ and WJ-Pure™ |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Assess the safety of EV-Pure™ and WJ-Pure™ administration in patients exhibiting moderate to severe ARDS associated with COVID-19, compared to placebo.
Evaluate incidences of Treatment-Emergent Adverse Events following EV-Pure™ and WJ-Pure™ administeration in patients exhibiting moderate to severe ARDS associated with COVID-19 compared to placebo. Presence of adverse events in less than 10% of the study population, as a measure of safety
Measured: 3 months
To assess the efficacy of EV-Pure™ and WJ-Pure™ compared to placebo, in patients with moderate to severe ARDS assoociated with COVID-19
Clinical data will be evaluated to determine if there were any significant changes in the COVID-19 symptoms in patients in the treated versus placebo groups. The following information will be collected to evaluate the effectiveness of the treatment at 4 weeks post- treatment:
- Discharged home on no supplemental oxygen
- Discharged home on supplemental oxygen
- Continued hospitalization on no oxygen
- Continued hospitalization on oxygen but not in ICU
- Continued hospitalization on oxygen in ICU (invasive and noninvasive ventilatory support)
- Death
Measured: 3 Months
Secondary outcomes (3)
Time to clinical improvement
The following information will be collected from the subjects during the follow-up visits or calls:
- Medical history review
- Physical exam and vital signs
- Assessment for delayed adverse reactions
Measured: 3 months
Overall Survival
Survival of the subjects in the 2 arms of the study
Measured: 3 months
COVID-19 polymerase chain reaction (PCR) test result as negative
COVID-19 polymerase chain reaction (PCR) test result as negative in the subjects in the 2 arms of the study
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start20 Mar 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Sponsor request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vitti Labs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387278
- Sponsor's protocol ID
- EW-01
- Status last verified
- Sep 2024
- First submitted
- 16 May 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Placental Derived Exosomes and Umbilical Cord Mesenchymal Stem Cells in Moderate to Severe Acute Respiratory Distress Syndrome (ARDS) Associated With the Novel Corona Virus Infection (COVID-19)
- ClinicalTrials.gov ID
- NCT05387278
- Acronym / sponsor ID
- EW-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Sponsor request
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Vitti Labs, LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 May 2022 (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.
Recent advances have been made in prevention of the viral infection via vaccines but there is still need for effective treatment options for patients. Novel therapies need to be developed to further improve clinical outcomes. The biggest medical challenge in the response to COVID-19 is ARDS requiring hospitalization in an intensive care setting and ventilator dependence. Intravenously administered umbilical cord derived exosomes and stem cells have been reported in literature to alleviate pulmonary distress in such patients.
The purpose of this study is to explore the safety and benefits of intravenous administration of WJPure and EVPure in the treatment of COVID-19 patients with moderate to severe ARDS. .
Detailed description
One of the hallmark features of the progression of COVID-19 is lung injury from the viral infection leading to potentially acute respiratory distress syndrome (ARDS) and respiratory failure requiring ventilator support. In patients who survive ARDS, regardless of the pathology, there is evidence that their long-term quality of life is adversely affected.
The rationale for the dose and dosing regimen proposed in this study is based on the safe administration and benefits of this treatment regimen reported to us last year by physicians trying to treat moderate to severe COVID-19 patients. In those reports, the intravenous route of administration was used. It has been reported that dosing every 2 days amplified the benefit of the combination of exosomes and mesenchymal stem cells. It has been suggested based on clinical experience that the exosomes and MSCs are complementary to one another as well as enhancing the innate abilities of both.
During the early days of the pandemic, intravenous infusion of a mixture of EV-Pure™ and WJ-Pure™ was reported to benefit hospitalized patients with moderate to severe COVID-19 related ARDS. This study is designed to systematically explore the risk and benefits of intravenous infusion of EV-Pure™ and WJ-Pure™ in the treatment of hospitalized COVID-19 patients with moderate to severe ARDS.
This is a proof of concept, double-blind, placebo-controlled trial to evaluate the safety and efficacy of intravenous infusion of EV-Pure™ and WJ-Pure™, versus placebo, for use in the treatment of moderate to severe ARDS related to COVID-19. This is an add-on treatment study; subjects will be allowed to take standard of care treatments available.
The study will have two arms (n=10 each):
- Experimental/treatment arm: EV-Pure™ and WJ-Pure™ plus standard care
- Placebo: Cryopreservation media plus standard care
The study duration would be 5 days of treatment plus 12 weeks follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental/treatment arm | Experimental | Drug: EV-Pure™ and WJ-Pure™ |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects will be eligible for enrollment in the study only if they meet the following criteria:
Key exclusion criteria (17 listed)
- Subjects will be ineligible for enrollment in the study if they meet any of the following criteria:
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 |
|---|---|---|
| EV-Pure™ and WJ-Pure™The treatment consists of administration of WJ-Pure™ and EV-Pure™ plus standard care | Drug | Experimental/treatment arm |
| PlaceboCryopreservation media plus standard care | Drug | Placebo |
Primary outcome
To Assess the safety of EV-Pure™ and WJ-Pure™ administration in patients exhibiting moderate to severe ARDS associated with COVID-19, compared to placebo.
Time frame: 3 months
Evaluate incidences of Treatment-Emergent Adverse Events following EV-Pure™ and WJ-Pure™ administeration in patients exhibiting moderate to severe ARDS associated with COVID-19 compared to placebo. Presence of adverse events in less than 10% of the study population, as a measure of safety
To assess the efficacy of EV-Pure™ and WJ-Pure™ compared to placebo, in patients with moderate to severe ARDS assoociated with COVID-19
Time frame: 3 Months
Clinical data will be evaluated to determine if there were any significant changes in the COVID-19 symptoms in patients in the treated versus placebo groups. The following information will be collected to evaluate the effectiveness of the treatment at 4 weeks post- treatment: 1. Discharged home on no supplemental oxygen 2. Discharged home on supplemental oxygen 3. Continued hospitalization on no oxygen 4. Continued hospitalization on oxygen but not in ICU 5. Continued hospitalization on oxygen in ICU (invasive and noninvasive ventilatory support) 6. Death
3 secondary outcomes
Time to clinical improvement
Time frame: 3 months
Overall Survival
Time frame: 3 months
COVID-19 polymerase chain reaction (PCR) test result as negative
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EV-Pure™ and WJ-Pure™ in people with COVID-19 Acute Respiratory Distress Syndrome and Respiratory Distress Syndrome, run by Vitti Labs, LLC at 1 site in United States.
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 7 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: paused, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 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.
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?
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?
To Assess the safety of EV-Pure™ and WJ-Pure™ administration in patients exhibiting moderate to severe ARDS associated with COVID-19, compared to placebo. (time frame: 3 months). The study lists 2 primary outcomes in all. 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 19 Sep 2024.