Protocol summary
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Study aim
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The main objective is to investigate the safety and efficacy of Exosomes therapy in patients with ARDS caused by Coronavirus pneumonia as an open-labeled randomized clinical trial.
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Design
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Controlled randomized clinical trial phase 1-2
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Settings and conduct
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The study will be conducted at Nikan Hospital , Shariati Hospital, Esfahan Shahid Sadoughi Hospital, Yazd Shahid Sadoughi Hospital. Participants, outcome assessors, and analyzers are unaware of the allocation of study groups.
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Participants/Inclusion and exclusion criteria
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Patients aged 18 to 65 years are included in the study with a definitive diagnosis of COVID-19, which subsequently develops acute respiratory distress syndrome (mild or moderate). COVID-19 patients with severe underlying disease or allergies to the ٍExosomes or its associated compounds are not included in the study.
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Intervention groups
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Patients allocated randomly to two groups: 1) Intervention 1, Patients will receive Six doses of Exosomes. 2) Control, Patients will receive conventional therapy.
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Main outcome variables
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Safety; Blood oxygen saturation; Decreased severity of pneumonia; Improvement of the acute respiratory syndrome
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200413047063N2
Registration date:
2021-04-14, 1400/01/25
Registration timing:
registered_while_recruiting
Last update:
2021-07-08, 1400/04/17
Update count:
1
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Registration date
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2021-04-14, 1400/01/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-03-21, 1400/01/01
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Expected recruitment end date
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2021-05-20, 1400/02/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Exosomes Derived from placental Mesenchymal Stem Cells as Treatment for Severe COVID-19: Phase 1 & 2 Clinical Trials
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Public title
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Exosomes Derived from placental Mesenchymal Stem Cells as Treatment for Severe COVID-19: Phase 1 & 2 Clinical Trials
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Confirmation of 2019-nCoV infection by RT-PCR Diagnosis of ARDS according to the Berlin definition of ARDS Requiring supplemental oxygen, PaO2/oxygen absorption concentration (FiO2) ≤ 300MMHG Pulmonary imaging shows that the focused progress > 50% in 24-48 hours Mild to Moderate 2019-nCoV pneumonia/ stay in the ICU <48 hours SOFA score between 2-3 point Pneumonia that is judged by chest radiograph or CT
Exclusion criteria:
Severe allergies or allergies after 1st injection to stem cell preparations and their components Patients with a malignant tumor, other serious systemic diseases, and psychosis Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection virus Patients with previous history of pulmonary embolism Liver or kidney SOFA score of more than 3 points; combined with other organ failure (need organ support), Stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated glomerular filtration rate (eGFR) < 30) Pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia Continuous use of immunosuppressive agents or organ transplants in the past 6 months In vitro life support (ECMO, ECCO2R, RRT) Pregnant or lactating women Uncontrolled underlying disease Be thought by researchers to be inappropriate to participate in this clinical study (Expected deaths within 48 hours, uncontrolled infections)
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Age
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From 18 years old to 70 years old
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Gender
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Both
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Phase
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1-2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants were randomly divided into two equal groups using a randomized double AB blocking method based on a random number table.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-09-19, 1399/06/29
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1399.454
Health conditions studied
1
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Description of health condition studied
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Acute Respiratory Distress Syndrome of COVID-19
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19
Primary outcomes
1
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Description
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Adverse events assesment
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Timepoint
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At the same time of each intervention, 12 hours after each intervention, on days 6, 7, 14 and 28 after the first intervention
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Method of measurement
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Secondary outcomes
1
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Description
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Biomarkers concentrations in plasma
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Timepoint
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At baseline, 7, 14, 28 days after the first intervention
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Method of measurement
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Biochemical examination
2
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Description
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Respiratory efficacy
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Timepoint
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From baseline to day 7
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Method of measurement
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Evaluated by the increase in PaO2/FiO2 ratio
3
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Description
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Intensive care unit-free days
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Timepoint
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Up to day 8
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Method of measurement
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Number of day
4
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Description
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Change in clinical symptoms
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Timepoint
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At Baseline, simultaneously with each intervention and on days 5, 6, 7, 14 after the first intervention
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Method of measurement
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Evaluation of Pneumonia Improvement
Intervention groups
1
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Description
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Intervention group:Intervention group: The intervention group 1, Patients will receive Six doses of Exosomes. One doses of 10×10e10 (±10%) Exosomes will intravenously infuse as a normally dropped single dose over 10-12 minutes at the infusion speed of 4-5 mL/minute in day 0 and day 1 and day 2. group:
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Category
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Treatment - Other
2
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Description
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Control group: Patients will receive conventional therapy
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Omid Cell and Tissue center
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Proportion provided by this source
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90
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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All collected deidentified IPD can be shared
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When the data will become available and for how long
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6 months after publication
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To whom data/document is available
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Researchers and clinicians
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Under which criteria data/document could be used
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Planning of similar studies in other academic centers
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From where data/document is obtainable
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e-Mail
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What processes are involved for a request to access data/document
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1-2 months after request
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Comments
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