Severe Acute Respiratory Syndrome (SARS)Phase 1/2NCT06002841
Extracellular Vesicles From Mesenchymal Cells in the Treatment of Acute Respiratory Failure
A Phase 1/2 study testing intravenous treatment with EVs in people with Severe Acute Respiratory Syndrome (SARS) and Acute Respiratory Distress Syndrome (ARDS), run by D'Or Institute for Research and Education at 1 site in Brazil.
Trial summary
This is a phase I/II, randomized, double-blind, placebo-controlled clinical trial that will evaluate the safety and potential efficacy of therapy with extracellular vesicles (EVs) obtained from mesenchymal stromal cells (MSCs), patients with moderate to severe acute respiratory distress syndrome due to COVID-19 or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Acute Respiratory Syndrome (SARS), Acute Respiratory Distress Syndrome (ARDS), Pneumonia
- What is being tested?
- intravenous treatment with EVs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2024to 1 Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years old;
- Chest CT radiological image with ground-glass opacities or chest X-ray with - bilateral infiltrates characteristic of pulmonary edema;
- In invasive mechanical ventilation with PEEP 5 cm H2O and PaO2/FiO2<250mmHg;
- Respiratory failure not explained by cardiac causes or fluid overload.
Who cannot join
- Unable to provide informed consent;
- Pregnancy or breastfeeding;
- Patients with active malignancy who have received chemotherapy in the last 2 years;
- Life expectancy of less than 6 months or in exclusive palliative care;
- Severe liver failure, with a Child-Pugh score > 12;
- Previous renal failure: patients already undergoing dialysis or patients with GFR < 30ml/min/1.73 m2
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- Clinical or radiological suspicion of tuberculosis;
- Chronic respiratory failure;
- Use of ECMO;
- Moribund (high probability of death within the next 48 hours).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital São Rafael
Salvador, Estado de Bahia, 41253-190
Carolina Nonaka, phD, +55 (71) 3281-6970, carolina.nonaka@hsr.com.br
Tânia Aravena, B.Sc, +55 (71) 98748-6532, tania.mariela@hsr.com.br
About this study
Official title: Extracellular Vesicles From Mesenchymal Cells in the Treatment of Acute Respiratory Failure Associated With SARS-CoV-2 and Other Etiologies: a Clinical Trial, Randomized, Double-blind.
This is a phase I/II, randomized, double-blind, placebo-controlled clinical trial that will evaluate the safety and potential efficacy of therapy with extracellular vesicles (EVs) obtained from mesenchymal stromal cells (MSCs), patients with moderate to severe acute respiratory distress syndrome due to COVID-19 or other etiology. Participants will be allocated to receive EVs obtained from MSCs or placebo (equal volume of Plasma-Lyte A). Blinding will cover the participants, the multidisciplinary intensive care team and the investigators.
Read the detailed description
The studied population will consist of 15 patients diagnosed with acute respiratory failure syndrome admitted to the intensive care unit of Hospital São Rafael. This research aims to assess the safety and potential effectiveness of intravenous therapy using extracellular vesicles derived from mesenchymal cells in patients with moderate to severe acute respiratory distress syndrome. The treatment group will receive intravenous administration of extracellular vesicles obtained from mesenchymal cells, while the control group will receive a placebo.
EV group: will consist of 10 participants who will receive two infusions of 25 mL of the investigational product (Plasma-Lyte A solution containing EVs obtained from MSCs), intravenously, at intervals of 48 h.
Placebo group: will consist of 5 participants who will receive an equal volume of Plasma-Lyte A, intravenously, following the same schedule as the IV group: two infusions with an interval of 48 hours.
- Conditions
- Severe Acute Respiratory Syndrome (SARS), Acute Respiratory Distress Syndrome (ARDS), Pneumonia
- Being tested
- intravenous treatment with EVs, intravenous treatment with placebo solution
- Keywords
- SARS-CoV-2, intravenous therapy, extracellular vesicles, ARDS, mesenchymal cells
- Medical subject headings
- Severe Acute Respiratory Syndrome, Respiratory Distress Syndrome, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous treatment with EVsBiological
intravenous treatment with extracellular vesicles
intravenous treatment with placebo solutionBiological
intravenous treatment with placebo solution (without extracellular vesicles)
| Study group | Role | What they receive |
|---|---|---|
| EV group | Experimental | will consist of 10 participants who will receive two infusions of 25 mL of the investigational product (Plasma-Lyte A solution containing EVs obtained from MSCs), intravenously, at intervals of 48 h. Receives: Biological: intravenous treatment with EVs |
| Placebo group | Placebo comparator | will consist of 5 participants who will receive an equal volume of Plasma-Lyte A, intravenously, following the same schedule as the IV group: two infusions with an interval of 48 hours. Receives: Biological: intravenous treatment with placebo solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure administration of extracellular vesicles (EVs) up to 28 days
Measure as reported adverse events up to 28 days after treatment or placebo administration to evaluate safety of treatment
Measured: 28 days
Secondary outcomes (6)
All-cause mortality
at days 14 and 28 after randomization;
Measured: Day 14 and day 28
Variation in the Ratio PaO2/FiO2
PaO2 (arterial partial pressure of oxygen)/FiO2 (fraction of inspired oxygen) on the day of randomization and at 24 hours, 48 hours and 7 days after the first infusion;
Measured: Baseline, day 01, day 02 and day 07
Variation in the SOFA index
Variation in the SOFA index (Assessment of Sequential Organ Failure) at the time of randomization and during follow-up until discharge from the intensive care unit;
Measured: day 01, day 02, day 07, day 09, day 14 and day 29
Exploratory laboratory analysis
variation in total and differential laboratory analysis.
Measured: 30 days
Duration of the period of hospitalization
from hospital time in the intensive care unit (ICU)
Measured: 30 days
Duration of the period of ICU ventilation
If applicable,will be measured the time of mechanical ventilation.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Feb 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Severe Acute Respiratory Syndrome (SARS)Studies 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
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D'Or Institute for Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Sao Rafael, Rio de Janeiro State Research Supporting Foundation (FAPERJ), Oswaldo Cruz Foundation
- Responsible party
- Sponsor
- Investigators
- Bruno Souza, M.D, Principal investigator, Instituto D'Or de Pesquisa e Ensino (IDOR), Salvador, BrazilPatrícia Rocco, M.D, Principal investigator, Universidade Federal do Rio de Janeiro (UFRJ)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002841
- Sponsor's protocol ID
- EVs_2023
- Status last verified
- Aug 2023
- First submitted
- 27 Jul 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abels ER, Breakefield XO. Introduction to Extracellular Vesicles: Biogenesis, RNA Cargo Selection, Content, Release, and Uptake. Cell Mol Neurobiol. 2016 Apr;36(3):301-12. doi: 10.1007/s10571-016-0366-z. Epub 2016 Apr 6.
PubMed 27053351Alipoor SD, Mortaz E, Garssen J, Movassaghi M, Mirsaeidi M, Adcock IM. Exosomes and Exosomal miRNA in Respiratory Diseases. Mediators Inflamm. 2016;2016:5628404. doi: 10.1155/2016/5628404. Epub 2016 Sep 25.
PubMed 27738390Antunes MA, Braga CL, Oliveira TB, Kitoko JZ, Castro LL, Xisto DG, Coelho MS, Rocha N, Silva-Aguiar RP, Caruso-Neves C, Martins EG, Carvalho CF, Galina A, Weiss DJ, Lapa E Silva JR, Lopes-Pacheco M, Cruz FF, Rocco PRM. Mesenchymal Stromal Cells From Emphysematous Donors and Their Extracellular Vesicles Are Unable to Reverse Cardiorespiratory Dysfunction in Experimental Severe Emphysema. Front Cell Dev Biol. 2021 May 31;9:661385. doi: 10.3389/fcell.2021.661385. eCollection 2021.
PubMed 34136481de Castro LL, Xisto DG, Kitoko JZ, Cruz FF, Olsen PC, Redondo PAG, Ferreira TPT, Weiss DJ, Martins MA, Morales MM, Rocco PRM. Human adipose tissue mesenchymal stromal cells and their extracellular vesicles act differentially on lung mechanics and inflammation in experimental allergic asthma. Stem Cell Res Ther. 2017 Jun 24;8(1):151. doi: 10.1186/s13287-017-0600-8.
PubMed 28646903Cruz FF, Borg ZD, Goodwin M, Sokocevic D, Wagner DE, Coffey A, Antunes M, Robinson KL, Mitsialis SA, Kourembanas S, Thane K, Hoffman AM, McKenna DH, Rocco PR, Weiss DJ. Systemic Administration of Human Bone Marrow-Derived Mesenchymal Stromal Cell Extracellular Vesicles Ameliorates Aspergillus Hyphal Extract-Induced Allergic Airway Inflammation in Immunocompetent Mice. Stem Cells Transl Med. 2015 Nov;4(11):1302-16. doi: 10.5966/sctm.2014-0280. Epub 2015 Sep 16.
PubMed 26378259De Jong OG, Van Balkom BW, Schiffelers RM, Bouten CV, Verhaar MC. Extracellular vesicles: potential roles in regenerative medicine. Front Immunol. 2014 Dec 3;5:608. doi: 10.3389/fimmu.2014.00608. eCollection 2014.
PubMed 25520717Kordelas L, Rebmann V, Ludwig AK, Radtke S, Ruesing J, Doeppner TR, Epple M, Horn PA, Beelen DW, Giebel B. MSC-derived exosomes: a novel tool to treat therapy-refractory graft-versus-host disease. Leukemia. 2014 Apr;28(4):970-3. doi: 10.1038/leu.2014.41. No abstract available.
PubMed 24445866Lanyu Z, Feilong H. Emerging role of extracellular vesicles in lung injury and inflammation. Biomed Pharmacother. 2019 May;113:108748. doi: 10.1016/j.biopha.2019.108748. Epub 2019 Mar 14.
PubMed 30877881Lasser C, Jang SC, Lotvall J. Subpopulations of extracellular vesicles and their therapeutic potential. Mol Aspects Med. 2018 Apr;60:1-14. doi: 10.1016/j.mam.2018.02.002. Epub 2018 Feb 16.
PubMed 29432782Naji A, Eitoku M, Favier B, Deschaseaux F, Rouas-Freiss N, Suganuma N. Biological functions of mesenchymal stem cells and clinical implications. Cell Mol Life Sci. 2019 Sep;76(17):3323-3348. doi: 10.1007/s00018-019-03125-1. Epub 2019 May 4.
PubMed 31055643Raposo G, Stoorvogel W. Extracellular vesicles: exosomes, microvesicles, and friends. J Cell Biol. 2013 Feb 18;200(4):373-83. doi: 10.1083/jcb.201211138.
PubMed 23420871Sengupta V, Sengupta S, Lazo A, Woods P, Nolan A, Bremer N. Exosomes Derived from Bone Marrow Mesenchymal Stem Cells as Treatment for Severe COVID-19. Stem Cells Dev. 2020 Jun 15;29(12):747-754. doi: 10.1089/scd.2020.0080. Epub 2020 May 12.
PubMed 32380908Silva JD, de Castro LL, Braga CL, Oliveira GP, Trivelin SA, Barbosa-Junior CM, Morales MM, Dos Santos CC, Weiss DJ, Lopes-Pacheco M, Cruz FF, Rocco PRM. Mesenchymal Stromal Cells Are More Effective Than Their Extracellular Vesicles at Reducing Lung Injury Regardless of Acute Respiratory Distress Syndrome Etiology. Stem Cells Int. 2019 Aug 21;2019:8262849. doi: 10.1155/2019/8262849. eCollection 2019.
PubMed 31531026Shi MM, Yang QY, Monsel A, Yan JY, Dai CX, Zhao JY, Shi GC, Zhou M, Zhu XM, Li SK, Li P, Wang J, Li M, Lei JG, Xu D, Zhu YG, Qu JM. Preclinical efficacy and clinical safety of clinical-grade nebulized allogenic adipose mesenchymal stromal cells-derived extracellular vesicles. J Extracell Vesicles. 2021 Aug;10(10):e12134. doi: 10.1002/jev2.12134. Epub 2021 Aug 14.
PubMed 34429860D'Souza-Schorey C, Schorey JS. Regulation and mechanisms of extracellular vesicle biogenesis and secretion. Essays Biochem. 2018 May 15;62(2):125-133. doi: 10.1042/EBC20170078. Print 2018 May 15.
PubMed 29666210
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracellular Vesicles From Mesenchymal Cells in the Treatment of Acute Respiratory Failure Associated With SARS-CoV-2 and Other Etiologies: a Clinical Trial, Randomized, Double-blind.
- ClinicalTrials.gov ID
- NCT06002841
- Acronym / sponsor ID
- EVs_2023
- Conditions
- Severe Acute Respiratory Syndrome (SARS), Acute Respiratory Distress Syndrome (ARDS), Pneumonia
- Keywords
- SARS-CoV-2, intravenous therapy, extracellular vesicles, ARDS, mesenchymal cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- D'Or Institute for Research and EducationUniversity, hospital or other
- Collaborators
- Hospital Sao Rafael, Rio de Janeiro State Research Supporting Foundation (FAPERJ), Oswaldo Cruz Foundation
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 21 Aug 2023 (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 is a phase I/II, randomized, double-blind, placebo-controlled clinical trial that will evaluate the safety and potential efficacy of therapy with extracellular vesicles (EVs) obtained from mesenchymal stromal cells (MSCs), patients with moderate to severe acute respiratory distress syndrome due to COVID-19 or other etiology. Participants will be allocated to receive EVs obtained from MSCs or placebo (equal volume of Plasma-Lyte A). Blinding will cover the participants, the multidisciplinary intensive care team and the investigators.
Detailed description
The studied population will consist of 15 patients diagnosed with acute respiratory failure syndrome admitted to the intensive care unit of Hospital São Rafael. This research aims to assess the safety and potential effectiveness of intravenous therapy using extracellular vesicles derived from mesenchymal cells in patients with moderate to severe acute respiratory distress syndrome. The treatment group will receive intravenous administration of extracellular vesicles obtained from mesenchymal cells, while the control group will receive a placebo.
EV group: will consist of 10 participants who will receive two infusions of 25 mL of the investigational product (Plasma-Lyte A solution containing EVs obtained from MSCs), intravenously, at intervals of 48 h.
Placebo group: will consist of 5 participants who will receive an equal volume of Plasma-Lyte A, intravenously, following the same schedule as the IV group: two infusions with an interval of 48 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| EV group | Experimental | Biological: intravenous treatment with EVswill consist of 10 participants who will receive two infusions of 25 mL of the investigational product (Plasma-Lyte A solution containing EVs obtained from MSCs), intravenously, at intervals of 48 h. |
| Placebo group | Placebo comparator | Biological: intravenous treatment with placebo solutionwill consist of 5 participants who will receive an equal volume of Plasma-Lyte A, intravenously, following the same schedule as the IV group: two infusions with an interval of 48 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >= 18 years old;
- Chest CT radiological image with ground-glass opacities or chest X-ray with - bilateral infiltrates characteristic of pulmonary edema;
- In invasive mechanical ventilation with PEEP 5 cm H2O and PaO2/FiO2<250mmHg;
- Respiratory failure not explained by cardiac causes or fluid overload.
Key exclusion criteria (10 listed)
- Unable to provide informed consent;
- Pregnancy or breastfeeding;
- Patients with active malignancy who have received chemotherapy in the last 2 years;
- Life expectancy of less than 6 months or in exclusive palliative care;
- Severe liver failure, with a Child-Pugh score > 12;
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 |
|---|---|---|
| intravenous treatment with EVsintravenous treatment with extracellular vesicles | Biological | EV group |
| intravenous treatment with placebo solutionintravenous treatment with placebo solution (without extracellular vesicles) | Biological | Placebo group |
Primary outcome
Measure administration of extracellular vesicles (EVs) up to 28 days
Time frame: 28 days
Measure as reported adverse events up to 28 days after treatment or placebo administration to evaluate safety of treatment
6 secondary outcomes
All-cause mortality
Time frame: Day 14 and day 28
Variation in the Ratio PaO2/FiO2
Time frame: Baseline, day 01, day 02 and day 07
Variation in the SOFA index
Time frame: day 01, day 02, day 07, day 09, day 14 and day 29
Exploratory laboratory analysis
Time frame: 30 days
Duration of the period of hospitalization
Time frame: 30 days
Duration of the period of ICU ventilation
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Background: PubMed 27053351Abels ER, Breakefield XO. Introduction to Extracellular Vesicles: Biogenesis, RNA Cargo Selection, Content, Release, and Uptake. Cell Mol Neurobiol. 2016 Apr;36(3):301-12. doi: 10.1007/s10571-016-0366-z. Epub 2016 Apr 6.
- Background: PubMed 27738390Alipoor SD, Mortaz E, Garssen J, Movassaghi M, Mirsaeidi M, Adcock IM. Exosomes and Exosomal miRNA in Respiratory Diseases. Mediators Inflamm. 2016;2016:5628404. doi: 10.1155/2016/5628404. Epub 2016 Sep 25.
- Background: PubMed 34136481Antunes MA, Braga CL, Oliveira TB, Kitoko JZ, Castro LL, Xisto DG, Coelho MS, Rocha N, Silva-Aguiar RP, Caruso-Neves C, Martins EG, Carvalho CF, Galina A, Weiss DJ, Lapa E Silva JR, Lopes-Pacheco M, Cruz FF, Rocco PRM. Mesenchymal Stromal Cells From Emphysematous Donors and Their Extracellular Vesicles Are Unable to Reverse Cardiorespiratory Dysfunction in Experimental Severe Emphysema. Front Cell Dev Biol. 2021 May 31;9:661385. doi: 10.3389/fcell.2021.661385. eCollection 2021.
- Background: PubMed 28646903de Castro LL, Xisto DG, Kitoko JZ, Cruz FF, Olsen PC, Redondo PAG, Ferreira TPT, Weiss DJ, Martins MA, Morales MM, Rocco PRM. Human adipose tissue mesenchymal stromal cells and their extracellular vesicles act differentially on lung mechanics and inflammation in experimental allergic asthma. Stem Cell Res Ther. 2017 Jun 24;8(1):151. doi: 10.1186/s13287-017-0600-8.
- Background: PubMed 26378259Cruz FF, Borg ZD, Goodwin M, Sokocevic D, Wagner DE, Coffey A, Antunes M, Robinson KL, Mitsialis SA, Kourembanas S, Thane K, Hoffman AM, McKenna DH, Rocco PR, Weiss DJ. Systemic Administration of Human Bone Marrow-Derived Mesenchymal Stromal Cell Extracellular Vesicles Ameliorates Aspergillus Hyphal Extract-Induced Allergic Airway Inflammation in Immunocompetent Mice. Stem Cells Transl Med. 2015 Nov;4(11):1302-16. doi: 10.5966/sctm.2014-0280. Epub 2015 Sep 16.
- Background: PubMed 25520717De Jong OG, Van Balkom BW, Schiffelers RM, Bouten CV, Verhaar MC. Extracellular vesicles: potential roles in regenerative medicine. Front Immunol. 2014 Dec 3;5:608. doi: 10.3389/fimmu.2014.00608. eCollection 2014.
- Background: PubMed 24445866Kordelas L, Rebmann V, Ludwig AK, Radtke S, Ruesing J, Doeppner TR, Epple M, Horn PA, Beelen DW, Giebel B. MSC-derived exosomes: a novel tool to treat therapy-refractory graft-versus-host disease. Leukemia. 2014 Apr;28(4):970-3. doi: 10.1038/leu.2014.41. No abstract available.
- Background: PubMed 30877881Lanyu Z, Feilong H. Emerging role of extracellular vesicles in lung injury and inflammation. Biomed Pharmacother. 2019 May;113:108748. doi: 10.1016/j.biopha.2019.108748. Epub 2019 Mar 14.
- Background: PubMed 29432782Lasser C, Jang SC, Lotvall J. Subpopulations of extracellular vesicles and their therapeutic potential. Mol Aspects Med. 2018 Apr;60:1-14. doi: 10.1016/j.mam.2018.02.002. Epub 2018 Feb 16.
- Background: PubMed 31055643Naji A, Eitoku M, Favier B, Deschaseaux F, Rouas-Freiss N, Suganuma N. Biological functions of mesenchymal stem cells and clinical implications. Cell Mol Life Sci. 2019 Sep;76(17):3323-3348. doi: 10.1007/s00018-019-03125-1. Epub 2019 May 4.
- Background: PubMed 23420871Raposo G, Stoorvogel W. Extracellular vesicles: exosomes, microvesicles, and friends. J Cell Biol. 2013 Feb 18;200(4):373-83. doi: 10.1083/jcb.201211138.
- Background: PubMed 32380908Sengupta V, Sengupta S, Lazo A, Woods P, Nolan A, Bremer N. Exosomes Derived from Bone Marrow Mesenchymal Stem Cells as Treatment for Severe COVID-19. Stem Cells Dev. 2020 Jun 15;29(12):747-754. doi: 10.1089/scd.2020.0080. Epub 2020 May 12.
- 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.
Bruno Souza, M.D principal investigator
Instituto D'Or de Pesquisa e Ensino (IDOR), Salvador, Brazil
Patrícia Rocco, M.D principal investigator
Universidade Federal do Rio de Janeiro (UFRJ)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing intravenous treatment with EVs in people with Severe Acute Respiratory Syndrome (SARS) and Acute Respiratory Distress Syndrome (ARDS), run by D'Or Institute for Research and Education at 1 site in Brazil.
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 10 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 Aug 2023. 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 Brazil. 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 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 Carolina Nonaka, phD (+55 (71) 3281-6970, carolina.nonaka@hsr.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure administration of extracellular vesicles (EVs) up to 28 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?
On the ClinicalTrials.gov record for NCT06002841, which also lists 20 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 21 Aug 2023.