Covid19NCT04487691
Nebulized PL for Post-COVID-19 Syndrome
A study testing Nebulized Platelet Lysate and Nebulized Sterile Saline in people with Covid19, run by Regenexx, LLC at 1 site in United States.
Trial summary
To evaluate and compare nebulized platelet lysate to placebo control of saline administered via handheld nebulizer 1x daily for eight weeks to determine effect on lung function in patients with post-COVID-19 ARDS syndrome. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Covid19
- What is being tested?
- Nebulized Platelet Lysate and Nebulized Sterile Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2020to 15 Jun 2021
- Phase
- Interventional
- 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
- Voluntary signature of the IRB approved Informed Consent
- At least 4-weeks post ventilator or oxygen dependent ARDS treated for at least 48 hours in the ICU
- Patient is stable enough to have been discharged home
- Male or female ages 18-85
- Two weeks to 1-year post hospital discharge
- Ongoing activity intolerance due to dyspnea related to ARDS
Show all 11Show fewer
- Is independent, ambulatory, and can comply with all post-operative evaluations and visits
- 6-minute walk test distance of < 450 M
- SF-36 physical component score < 60
- ARDS caused by viral pneumonia including COVID-19 confirmed through an RNA anti-body test
- Normal to mild post-ARDS reactive airway disease
Who cannot join
- Oxygen dependent on nasal canula greater than 2-L per minute
- Dependent on inhaled corticosteroid at the discretion of the physician
- Unable to complete any of the outcomes measured (Spirometry, 6MWD, SF-36, etc.)
- Active known secondary bacterial or viral infection
- Active moderate or severe post-ARDS reactive airway disease at the discretion of the physician
- Pre-morbid COPD
- Medication list will be reviewed on a case by case basis to allow for flexibility as post-COVID-19 patients' medication list may vary
- Other medical comorbidities/conditions that may preclude participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autologous Nebulized Platelet Lysate for Post COVID-19 Syndrome
To evaluate and compare nebulized platelet lysate to placebo control of saline administered via handheld nebulizer 1x daily for eight weeks to determine effect on lung function in patients with post-COVID-19 ARDS syndrome.
Read the detailed description
This is a double-blind, randomized, placebo controlled single-center study using nebulized platelet lysate compared to placebo control of saline administered via handheld nebulizer 1x daily for eight weeks to determine effect on lung function in patients with post-COVID-19 ARDS syndrome.
20 patients randomized to Treatment group: Inhaled nebulized platelet lysate (PL) 1x daily for eight weeks 20 patients randomized to Control group: Inhaled nebulized saline, 1x daily for eight weeks.
Outcomes will be measured at 4-weeks, 8-weeks, 3-months, 6- months
Goals for this study are as follows:
- Investigate and compare the efficacy of autologous PL inhaled via handheld ultrasonic nebulizer, 2-ml once per day for 4-weeks compared to saline control (Phase 1), early treatment timepoint.
- Investigate and compare the efficacy of autologous PL inhaled via handheld ultrasonic nebulizer, 2-ml once per day for 8-weeks compared to saline control (Phase 1), final treatment timepoint.
- Investigate, compare, and monitor long term function and quality of life through 6-months for treatment arm compared to control.
- Conditions
- Covid19
- Being tested
- Nebulized Platelet Lysate, Nebulized Sterile Saline
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized Platelet LysateBiological
Approximately 520 cc of autologous venous blood (within AABB guideline limits) will be drawn and platelet lysate (PL), maximizing the patients baseline platelet levels (~2-4x baseline) will be produced in a clean room setting using the Regenexx, LLC proprietary lab protocols (PL-M) utilizing a double lysis technique. From that sample, a high growth factor lysate will be created using a double lysis technique, and a sample will be retained to quantify the protein profile of the PL via ELISA quantitative analysis. The PL will be aliquoted into 56 (n=28x2) 2-ml ampules using sterile technique which will then be frozen at -20°C. The patient will unfreeze each ampule and place it into a handheld ultrasonic nebulizer and inhale the platelet lysate following the nebulizer manufacture's protocol until the treatment is completed. The treatment will be applied once a day for 8-weeks.
Nebulized Sterile SalineOther
Approximately 520 cc of autologous venous blood (within AABB guideline limits) will be drawn and donated for research purposes to keep patient blinded to group allocation. Sterile normal saline to mimic the appearance of the platelet lysate will be aliquoted into 56 (n=28x2) 2-ml ampules using sterile technique which will then be frozen at -20°C. The patient will unfreeze each ampule and place it into a handheld ultrasonic nebulizer and inhale the sterile saline following the nebulizer manufacture's protocol until the treatment is completed. The treatment will be applied once a day for 8-weeks.
| Study group | Role | What they receive |
|---|---|---|
| Platelet Lysate | Experimental | Inhaled nebulized platelet lysate (PL), 2-ml 1x per day for 8 weeks. Receives: Biological: Nebulized Platelet Lysate |
| Saline | Active comparator | Inhaled nebulized normal sterile saline, 2-ml 1x per day for 8-weeks. Receives: Other: Nebulized Sterile Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spirometry-FVC and FEV1/FVC tests
Changes in pre and post treatment spirometry measures
Measured: 4 weeks; 8 weeks
Secondary outcomes (9)
Spirometry-FVC and FEV1/FVC tests
Changes from pre and post treatment spirometry measures
Measured: 3 months, 6 months
6 Minute Walk Distance test (6MWD)
Changes in distance walked during 6MWD test from pre to post treatment
Measured: 4 weeks; 8 weeks; 3 months; 6 months
Distance-desaturation product from 6MWD
Changes in distance-desaturation product from 6MWD from pre to post treatment
Measured: 4 weeks; 8 weeks; 3 months; 6 months
San Diego Shortness of Breath Questionnaire (SOBQ)
Changes in San Diego Shortness of Breath Questionnaire (SOBQ) score from pre to post; treatment; scores range from 0-120 with higher scores equaling greater breathing impairment
Measured: 4 weeks; 8 weeks; 3 months; 6 months
Short Form-36 (SF-36)
Changes in SF-36 scores from pre to post treatment; 8 subscales 0-100 range where lower scores equal more disability
Measured: 4 weeks; 8 weeks; 3 months; 6 months
Modified Single Assessment Numeric Evaluation (SANE)
Average SANE score post treatment; scores range from 0-100 where 0=no improvement and 100=100% improvement in breathing condition
Measured: 4 weeks; 8 weeks; 3 months; 6 months
Medications
changes in medications from pre to post treatment
Measured: 4 weeks; 8 weeks; 3 months; 6 months
Incidence of adverse events
Incidence of adverse events after treatment
Measured: 4 weeks; 8 weeks; 3 months; 6 months
Incidence of surgical/other treatment interventions
Incidence of surgical/other treatment interventions after treatment
Measured: 4 weeks; 8 weeks; 3 months; 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start8 Dec 2020
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regenexx, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Centeno, MD, Principal investigator, Centeno-Schultz Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487691
- Sponsor's protocol ID
- RGX2020-RCT01
- Status last verified
- Jan 2022
- First submitted
- 23 Jul 2020
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prem K, Liu Y, Russell TW, Kucharski AJ, Eggo RM, Davies N; Centre for the Mathematical Modelling of Infectious Diseases COVID-19 Working Group; Jit M, Klepac P. The effect of control strategies to reduce social mixing on outcomes of the COVID-19 epidemic in Wuhan, China: a modelling study. Lancet Public Health. 2020 May;5(5):e261-e270. doi: 10.1016/S2468-2667(20)30073-6. Epub 2020 Mar 25.
PubMed 32220655Chan KS, Pfoh ER, Denehy L, Elliott D, Holland AE, Dinglas VD, Needham DM. Construct validity and minimal important difference of 6-minute walk distance in survivors of acute respiratory failure. Chest. 2015 May;147(5):1316-1326. doi: 10.1378/chest.14-1808.
PubMed 25742048Hopkins RO, Weaver LK, Collingridge D, Parkinson RB, Chan KJ, Orme JF Jr. Two-year cognitive, emotional, and quality-of-life outcomes in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2005 Feb 15;171(4):340-7. doi: 10.1164/rccm.200406-763OC. Epub 2004 Nov 12.
PubMed 15542793Salama SM, Kamel IH, Ghanim M, Elsherif A. (2019). The Efficacy of Autologous Nebulized Platelet Rich Plasma (PRP) As an Early Adjuvant Therapeutic and Prognostic Treatment Modality in the Management of Inhalation Lung Injury. Egypt, J Plast Reconstr Surg. 43: 203-208. 10.21608/ejprs.2019.65115
Geiger S, Hirsch D, Hermann FG. Cell therapy for lung disease. Eur Respir Rev. 2017 Jun 28;26(144):170044. doi: 10.1183/16000617.0044-2017. Print 2017 Jun 30.
PubMed 28659506Rubio MM. (2019). Beyond the Ordinary: The Effect of Cellular Therapy on Quality of Life in Chronic Lung Disease. J Clin Res Med. 2(4): 1-8. https://researchopenworld.com/beyond-the-ordinary-the-effect-of-cellular-therapy-on-quality-of-life-in-chronic-lung-disease/ Accessed 3/27/20.
Mammoto T, Chen Z, Jiang A, Jiang E, Ingber DE, Mammoto A. Acceleration of Lung Regeneration by Platelet-Rich Plasma Extract through the Low-Density Lipoprotein Receptor-Related Protein 5-Tie2 Pathway. Am J Respir Cell Mol Biol. 2016 Jan;54(1):103-13. doi: 10.1165/rcmb.2015-0045OC.
PubMed 26091161Centeno C, Markle J, Dodson E, Stemper I, Hyzy M, Williams C, Freeman M. The use of lumbar epidural injection of platelet lysate for treatment of radicular pain. J Exp Orthop. 2017 Nov 25;4(1):38. doi: 10.1186/s40634-017-0113-5.
PubMed 29177632Del Fante C, Perotti C, Bonferoni MC, Rossi S, Sandri G, Ferrari F, Scudeller L, Caramella CM. Platelet lysate mucohadesive formulation to treat oral mucositis in graft versus host disease patients: a new therapeutic approach. AAPS PharmSciTech. 2011 Sep;12(3):893-9. doi: 10.1208/s12249-011-9649-3. Epub 2011 Jul 6.
PubMed 21732159
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Nebulized Platelet Lysate for Post COVID-19 Syndrome
- ClinicalTrials.gov ID
- NCT04487691
- Acronym / sponsor ID
- RGX2020-RCT01
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Regenexx, LLCIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 27 Jul 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.
To evaluate and compare nebulized platelet lysate to placebo control of saline administered via handheld nebulizer 1x daily for eight weeks to determine effect on lung function in patients with post-COVID-19 ARDS syndrome.
Detailed description
This is a double-blind, randomized, placebo controlled single-center study using nebulized platelet lysate compared to placebo control of saline administered via handheld nebulizer 1x daily for eight weeks to determine effect on lung function in patients with post-COVID-19 ARDS syndrome.
20 patients randomized to Treatment group: Inhaled nebulized platelet lysate (PL) 1x daily for eight weeks 20 patients randomized to Control group: Inhaled nebulized saline, 1x daily for eight weeks.
Outcomes will be measured at 4-weeks, 8-weeks, 3-months, 6- months
Goals for this study are as follows:
- Investigate and compare the efficacy of autologous PL inhaled via handheld ultrasonic nebulizer, 2-ml once per day for 4-weeks compared to saline control (Phase 1), early treatment timepoint.
- Investigate and compare the efficacy of autologous PL inhaled via handheld ultrasonic nebulizer, 2-ml once per day for 8-weeks compared to saline control (Phase 1), final treatment timepoint.
- Investigate, compare, and monitor long term function and quality of life through 6-months for treatment arm compared to control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet Lysate | Experimental | Biological: Nebulized Platelet LysateInhaled nebulized platelet lysate (PL), 2-ml 1x per day for 8 weeks. |
| Saline | Active comparator | Other: Nebulized Sterile SalineInhaled nebulized normal sterile saline, 2-ml 1x per day for 8-weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Voluntary signature of the IRB approved Informed Consent
- At least 4-weeks post ventilator or oxygen dependent ARDS treated for at least 48 hours in the ICU
- Patient is stable enough to have been discharged home
- Male or female ages 18-85
- Two weeks to 1-year post hospital discharge
Key exclusion criteria (8 listed)
- Oxygen dependent on nasal canula greater than 2-L per minute
- Dependent on inhaled corticosteroid at the discretion of the physician
- Unable to complete any of the outcomes measured (Spirometry, 6MWD, SF-36, etc.)
- Active known secondary bacterial or viral infection
- Active moderate or severe post-ARDS reactive airway disease at the discretion of the physician
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 |
|---|---|---|
| Nebulized Platelet LysateApproximately 520 cc of autologous venous blood (within AABB guideline limits) will be drawn and platelet lysate (PL), maximizing the patients baseline platelet levels (~2-4x baseline) will be produced in a clean room setting using the Regenexx, LLC proprietary lab protocols (PL-M) utilizing a double lysis technique. From that sample, a high growth factor lysate will be created using a double lysis technique, and a sample will be retained to quantify the protein profile of the PL via ELISA quantitative analysis. The PL will be aliquoted into 56 (n=28x2) 2-ml ampules using sterile technique which will then be frozen at -20°C. The patient will unfreeze each ampule and place it into a handheld ultrasonic nebulizer and inhale the platelet lysate following the nebulizer manufacture's protocol until the treatment is completed. The treatment will be applied once a day for 8-weeks. | Biological | Platelet Lysate |
| Nebulized Sterile SalineApproximately 520 cc of autologous venous blood (within AABB guideline limits) will be drawn and donated for research purposes to keep patient blinded to group allocation. Sterile normal saline to mimic the appearance of the platelet lysate will be aliquoted into 56 (n=28x2) 2-ml ampules using sterile technique which will then be frozen at -20°C. The patient will unfreeze each ampule and place it into a handheld ultrasonic nebulizer and inhale the sterile saline following the nebulizer manufacture's protocol until the treatment is completed. The treatment will be applied once a day for 8-weeks. | Other | Saline |
Primary outcome
Spirometry-FVC and FEV1/FVC tests
Time frame: 4 weeks; 8 weeks
Changes in pre and post treatment spirometry measures
9 secondary outcomes
Spirometry-FVC and FEV1/FVC tests
Time frame: 3 months, 6 months
6 Minute Walk Distance test (6MWD)
Time frame: 4 weeks; 8 weeks; 3 months; 6 months
Distance-desaturation product from 6MWD
Time frame: 4 weeks; 8 weeks; 3 months; 6 months
San Diego Shortness of Breath Questionnaire (SOBQ)
Time frame: 4 weeks; 8 weeks; 3 months; 6 months
Short Form-36 (SF-36)
Time frame: 4 weeks; 8 weeks; 3 months; 6 months
Modified Single Assessment Numeric Evaluation (SANE)
Time frame: 4 weeks; 8 weeks; 3 months; 6 months
Medications
Time frame: 4 weeks; 8 weeks; 3 months; 6 months
Incidence of adverse events
Time frame: 4 weeks; 8 weeks; 3 months; 6 months
Incidence of surgical/other treatment interventions
Time frame: 4 weeks; 8 weeks; 3 months; 6 months
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Background: PubMed 32220655Prem K, Liu Y, Russell TW, Kucharski AJ, Eggo RM, Davies N; Centre for the Mathematical Modelling of Infectious Diseases COVID-19 Working Group; Jit M, Klepac P. The effect of control strategies to reduce social mixing on outcomes of the COVID-19 epidemic in Wuhan, China: a modelling study. Lancet Public Health. 2020 May;5(5):e261-e270. doi: 10.1016/S2468-2667(20)30073-6. Epub 2020 Mar 25.
- Background: PubMed 25742048Chan KS, Pfoh ER, Denehy L, Elliott D, Holland AE, Dinglas VD, Needham DM. Construct validity and minimal important difference of 6-minute walk distance in survivors of acute respiratory failure. Chest. 2015 May;147(5):1316-1326. doi: 10.1378/chest.14-1808.
- Background: PubMed 15542793Hopkins RO, Weaver LK, Collingridge D, Parkinson RB, Chan KJ, Orme JF Jr. Two-year cognitive, emotional, and quality-of-life outcomes in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2005 Feb 15;171(4):340-7. doi: 10.1164/rccm.200406-763OC. Epub 2004 Nov 12.
- BackgroundSalama SM, Kamel IH, Ghanim M, Elsherif A. (2019). The Efficacy of Autologous Nebulized Platelet Rich Plasma (PRP) As an Early Adjuvant Therapeutic and Prognostic Treatment Modality in the Management of Inhalation Lung Injury. Egypt, J Plast Reconstr Surg. 43: 203-208. 10.21608/ejprs.2019.65115
- Background: PubMed 28659506Geiger S, Hirsch D, Hermann FG. Cell therapy for lung disease. Eur Respir Rev. 2017 Jun 28;26(144):170044. doi: 10.1183/16000617.0044-2017. Print 2017 Jun 30.
- BackgroundRubio MM. (2019). Beyond the Ordinary: The Effect of Cellular Therapy on Quality of Life in Chronic Lung Disease. J Clin Res Med. 2(4): 1-8. https://researchopenworld.com/beyond-the-ordinary-the-effect-of-cellular-therapy-on-quality-of-life-in-chronic-lung-disease/ Accessed 3/27/20.
- Background: PubMed 26091161Mammoto T, Chen Z, Jiang A, Jiang E, Ingber DE, Mammoto A. Acceleration of Lung Regeneration by Platelet-Rich Plasma Extract through the Low-Density Lipoprotein Receptor-Related Protein 5-Tie2 Pathway. Am J Respir Cell Mol Biol. 2016 Jan;54(1):103-13. doi: 10.1165/rcmb.2015-0045OC.
- Background: PubMed 29177632Centeno C, Markle J, Dodson E, Stemper I, Hyzy M, Williams C, Freeman M. The use of lumbar epidural injection of platelet lysate for treatment of radicular pain. J Exp Orthop. 2017 Nov 25;4(1):38. doi: 10.1186/s40634-017-0113-5.
- Background: PubMed 21732159Del Fante C, Perotti C, Bonferoni MC, Rossi S, Sandri G, Ferrari F, Scudeller L, Caramella CM. Platelet lysate mucohadesive formulation to treat oral mucositis in graft versus host disease patients: a new therapeutic approach. AAPS PharmSciTech. 2011 Sep;12(3):893-9. doi: 10.1208/s12249-011-9649-3. Epub 2011 Jul 6.
- 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.
Christopher Centeno, MD principal investigator
Centeno-Schultz Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nebulized Platelet Lysate and Nebulized Sterile Saline in people with Covid19, run by Regenexx, 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 11 inclusion and 8 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 4 Feb 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low enrollment). 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?
Spirometry-FVC and FEV1/FVC tests (time frame: 4 weeks; 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04487691, which also lists 9 linked publications.
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 4 Feb 2022.