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| Column | Value |
|---|---|
| Trial registration number | NCT04905836 |
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Full text link
Last imported at : May 31, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : May 31, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : May 31, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
mroyal@sorrentotherapeutics.com |
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Registration date
Last imported at : May 31, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
2021-05-28 |
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Recruitment status
Last imported at : Dec. 1, 2021, 11 p.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : May 31, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : May 31, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : May 31, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : May 31, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : May 31, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Oct. 20, 2021, 9:03 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - laboratory-confirmed sars-cov-2 infection as determined by an approved polymerase chain reaction (pcr) or an approved antigen test of any specimen (can be documented from inpatient medical record) - hospitalized with at least "severe" covid-19-induced ard or ards as defined per fda guidance; covid-19: developing drugs and biological products for treatment or prevention - requires oxygen supplementation at screening - willing to follow contraception guidelines |
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Exclusion criteria
Last imported at : Oct. 20, 2021, 9:03 a.m. Source : ClinicalTrials.gov |
- current standard of care treatments for covid-19 appear to be working and the subject is clinically improving - has severe ards with a pao2/fio2 (pf ratio) ≤ 100 mmhg or spo2/fio2 ratio < 150 mmhg with peep ≥ 5cm h2o - a previous stem cell infusion unrelated to this trial - pregnant or breast feeding or planning for either during the study - suspected uncontrolled active bacterial, fungal, viral, or other infection (aside from infection with covid-19) - history of a splenectomy, lung transplant or lung lobectomy - concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable) - expected survival or time to withdrawal of life-sustaining treatments expected to be < 7 days - has an existing "do not intubate" order - has undergone home mechanical ventilation (noninvasive ventilation or via tracheotomy) except for continuous positive airway pressure or bi-level positive airway pressure (cpap/bipap) used solely for sleep-disordered breathing (eg, obstructive sleep apnea) - has any significant medical condition, laboratory abnormality or psychiatric illness that in the investigator's opinion would interfere or prevent the subject from safely participating in the study |
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Number of arms
Last imported at : May 31, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : May 31, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Sorrento Therapeutics, Inc. |
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Inclusion age min
Last imported at : May 31, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : May 31, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Dec. 1, 2021, 11 p.m. Source : ClinicalTrials.gov |
United States |
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Type of patients
Last imported at : May 31, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Severe/critical disease at enrollment |
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Severity scale
Last imported at : May 31, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
7: Severe/critical disease at enrollment |
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Total sample size
Last imported at : Aug. 12, 2021, 4 p.m. Source : ClinicalTrials.gov |
60 |
|
primary outcome
Last imported at : Oct. 20, 2021, 9:03 a.m. Source : ClinicalTrials.gov |
All-cause mortality rate at Day 28;Incidence of all adverse events (AEs) (safety);Incidence of infusion-related adverse events (safety);Incidence of severe adverse events (safety);Incidence of treatment-emergent adverse events (safety) |
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Notes
Last imported at : May 31, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : May 31, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Phase 2 |
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Arms
Last imported at : May 31, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 60, "treatment_name": "Allogeneic adipose-derived mesenchymal stem cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |