Pulmonary FibrosisPhase 2NCT05387239
Safety and Effectiveness of VL-PX10 + VL-P22 Treatment on Pulmonary Fibrosis Secondary to Covid-19
A Phase 2 study of Pulmonary Fibrosis and COVID-19 Respiratory Infection, run by Vitti Labs, LLC at 1 site in United States.
Trial summary
The COVID-induced fibrotic lung damage continues long after viral infection has subsided and is exhibited by severe respiratory pathology and concomitant symptoms. The long-lasting sequelae in patients who have recovered from severe COVID indicate that there is a 30% chance of developing a persistent respiratory… Read more about this study
- Who is it for?
- Ages 25 to 90 years
- Conditions the study is for
- Pulmonary Fibrosis, COVID-19 Respiratory Infection
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2022to Dec 2024
- 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 25 to 90 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 between 25 years (including) to 90 years old
- Confirmed and documented COVID-19 infection history with confirmed diagnosis of Pulmonary Fibrosis
- Negative to current Covid-19 infection as tested by RT-PCR/rapid antigen tests
- Able to perform a 6-minute walk test
- Blood routine, liver and kidney functions test values are within controllable range
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- Adequate hepatic function as evidenced by ALT and AST < 2X ULN and bilirubin < 1.5X ULN for the reference lab
- Adequate renal function as evidenced by a serum creatinine ≤ 1.5 X ULN for the reference laboratory OR a calculated creatinine clearance of ≥ 60 mL/min by the Cockcroft-Gault Equation
- Adequate hematopoietic function as evidenced by white blood cells ≥ 3x109 / L and platelets ≥ 100x109 / L
- 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:
- Clinically relevant heart condition such as, but not limited to, uncontrolled heart failure, severe pulmonary hypertension, atrial fibrillation or significant congenital heart disease
- Severe asthma on chronic therapy with biologics or steroids
- Active smokers as defined as individuals who currently smokes at least one cigarette or equivalent product a day. (Ex-smokers who had regularly smoked but who had not smoked the previous month are eligible)
- Evidence of active malignancy, or prior history of active malignancy not in remission.
- Life expectancy of < 6 months
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- Patient included in another ongoing interventional therapeutic trial.
- Pregnant or Lactating.
- Serious or life-threatening co-morbidities, that in the opinion of the investigators, may compromise the safety or compliance with the study guidelines and tracking.
Trial locations and contacts
1 site in 1 country.
About this study
The COVID-induced fibrotic lung damage continues long after viral infection has subsided and is exhibited by severe respiratory pathology and concomitant symptoms. The long-lasting sequelae in patients who have recovered from severe COVID indicate that there is a 30% chance of developing a persistent respiratory system pathology and a 10% chance of developing a severe pathology. The symptoms of lung fibrosis include a severe disruption of respiration, reduction of exercise tolerance, and concomitant development of persistent fibrotic lung damage. This study intends to evaluate benefits of a combination of VL-P22 and VL-PX10 in Covid-19 patients exhibiting pulmonary fibrosis.
Read the detailed description
Multiple clinical trials are underway to explore options for treatment of pulmonary fibrosis in patients with history of COVID. Mesenchymal stem cell (MSC)-based therapies have been used worldwide for various pulmonary diseases. A recent review of over 110 reports of clinical trials worldwide with MSC-based therapies in pulmonary diseases found that these therapies have been reported to be safe and effective in the treatment of acute/viral pulmonary disease, community-acquired pneumonia (CAP), chronic obstructive pulmonary disease (COPD), bronchopulmonary dysplasia (BPD), interstitial lung diseases (ILD), chronic pulmonary fibrosis, bronchiolitis obliterans syndrome (BOS) and lung cancer. A phase 2 clinical trial in 101 severe Covid-19 patients with lung damage using human umbilical cord derived MSCs found that the treatment exerted numerical improvement in whole lung lesion volume and the 6-minute walk test from baseline to day 28 compared with the placebo.
This proof of concept, double-blind, placebo-controlled trial will evaluate the safety and efficacy of intravenous infusion of VL-PX10 and VL-P22, versus placebo, for use in the treatment of Covid induced Pulmonary Fibrosis. 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: VL-PX10 and VL-P22 plus standard care
- Placebo: Saline plus standard care
The study duration would be 5 days of treatment plus 12 weeks follow up.
- Conditions
- Pulmonary Fibrosis, COVID-19 Respiratory Infection
- Being tested
- VL-PX10 and VL-P22 plus standard care, Placebo
- Medical subject headings
- Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VL-PX10 and VL-P22 plus standard careDrug
The treatment consists of administration of VL-P22 and VL-PX10 plus standard care
PlaceboDrug
Saline plus standard care
| Study group | Role | What they receive |
|---|---|---|
| Experimental/treatment arm | Experimental | Not described Receives: Drug: VL-PX10 and VL-P22 plus standard care |
| 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.
Evaluate incidences of Treatment-Emergent Adverse Events following following VL-PX10 and VL-P22 administration to patients exhibiting Covid induced Pulmonary Fibrosis.
Presence of adverse events in less than 10% of the study population, as a measure of safety
Measured: 3 months
To evaluate the efficacy of VL-PX10 and VL-P22 administration in alleviating long term symptoms of Covid induced Pulmonary Fibrosis, compared to placebo.
Change in distance walked on the six-minute walk test (6MWT). The 6MWT is a validated endpoint commonly used in clinical trial research.
Measured: 3 months
Secondary outcomes (3)
Change in Pulse Oximetry During the 6MWT
Oxygen saturation (pulse oximetry) during the 6-minute walk test (6MWT)
Measured: 3 months
Incidence of Re-Hospitalization
Incidence of hospitalization after initial discharge and initiating treatment
Measured: 3 months
Quality of Life assessment as collected using the SF-36
The SF-36 (v2) is a self-administered questionnaire containing 36 items that measures functional status, well-being, and overall evaluation of health in 8 domains.
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 start30 Nov 2022
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (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 Pulmonary FibrosisStudies 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
- 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
- NCT05387239
- Sponsor's protocol ID
- EW-02
- 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 VL-PX10 + VL-P22 Treatment on Pulmonary Fibrosis Secondary to Covid-19
- ClinicalTrials.gov ID
- NCT05387239
- Acronym / sponsor ID
- EW-02
- Conditions
- Pulmonary Fibrosis, COVID-19 Respiratory Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Sponsor request
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Vitti Labs, LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (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.
The COVID-induced fibrotic lung damage continues long after viral infection has subsided and is exhibited by severe respiratory pathology and concomitant symptoms. The long-lasting sequelae in patients who have recovered from severe COVID indicate that there is a 30% chance of developing a persistent respiratory system pathology and a 10% chance of developing a severe pathology. The symptoms of lung fibrosis include a severe disruption of respiration, reduction of exercise tolerance, and concomitant development of persistent fibrotic lung damage. This study intends to evaluate benefits of a combination of VL-P22 and VL-PX10 in Covid-19 patients exhibiting pulmonary fibrosis.
Detailed description
Multiple clinical trials are underway to explore options for treatment of pulmonary fibrosis in patients with history of COVID. Mesenchymal stem cell (MSC)-based therapies have been used worldwide for various pulmonary diseases. A recent review of over 110 reports of clinical trials worldwide with MSC-based therapies in pulmonary diseases found that these therapies have been reported to be safe and effective in the treatment of acute/viral pulmonary disease, community-acquired pneumonia (CAP), chronic obstructive pulmonary disease (COPD), bronchopulmonary dysplasia (BPD), interstitial lung diseases (ILD), chronic pulmonary fibrosis, bronchiolitis obliterans syndrome (BOS) and lung cancer. A phase 2 clinical trial in 101 severe Covid-19 patients with lung damage using human umbilical cord derived MSCs found that the treatment exerted numerical improvement in whole lung lesion volume and the 6-minute walk test from baseline to day 28 compared with the placebo.
This proof of concept, double-blind, placebo-controlled trial will evaluate the safety and efficacy of intravenous infusion of VL-PX10 and VL-P22, versus placebo, for use in the treatment of Covid induced Pulmonary Fibrosis. 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: VL-PX10 and VL-P22 plus standard care
- Placebo: Saline 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: VL-PX10 and VL-P22 plus standard care |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 25 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects will be eligible for enrollment in the study only if they meet the following criteria:
Key exclusion criteria (9 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 |
|---|---|---|
| VL-PX10 and VL-P22 plus standard careThe treatment consists of administration of VL-P22 and VL-PX10 plus standard care | Drug | Experimental/treatment arm |
| PlaceboSaline plus standard care | Drug | Placebo |
Primary outcome
Evaluate incidences of Treatment-Emergent Adverse Events following following VL-PX10 and VL-P22 administration to patients exhibiting Covid induced Pulmonary Fibrosis.
Time frame: 3 months
Presence of adverse events in less than 10% of the study population, as a measure of safety
To evaluate the efficacy of VL-PX10 and VL-P22 administration in alleviating long term symptoms of Covid induced Pulmonary Fibrosis, compared to placebo.
Time frame: 3 months
Change in distance walked on the six-minute walk test (6MWT). The 6MWT is a validated endpoint commonly used in clinical trial research.
3 secondary outcomes
Change in Pulse Oximetry During the 6MWT
Time frame: 3 months
Incidence of Re-Hospitalization
Time frame: 3 months
Quality of Life assessment as collected using the SF-36
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 2 study of Pulmonary Fibrosis and COVID-19 Respiratory Infection, 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 10 inclusion and 9 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 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?
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?
Evaluate incidences of Treatment-Emergent Adverse Events following following VL-PX10 and VL-P22 administration to patients exhibiting Covid induced Pulmonary Fibrosis. (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.