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Trial - NCT04903327


Column Value
Trial registration number NCT04903327
Full text link
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04903327

First author
Last imported at : Jan. 11, 2023, 8 a.m.
Source : ClinicalTrials.gov

Not reported

Contact
Last imported at : Jan. 11, 2023, 8 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

2021-05-26

Recruitment status
Last imported at : Jan. 11, 2023, 8 a.m.
Source : ClinicalTrials.gov

Terminated

Study design
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : May 28, 2021, 12:32 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 - hospitalized with covid-19-induced ard or ards (any severity) with a pao2/fio2 (pf ratio) ≤ 300 - requires oxygen supplementation at screening - willing to follow contraception guidelines

Exclusion criteria
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

- current standard of care treatments for covid-19 appear to be working and the subject is clinically improving - a previous stem cell infusion unrelated to this trial - certain medical conditions that pose a safety risk to the subject - pregnant or breast feeding or planning to during the study - suspected uncontrolled active bacterial, fungal, viral, or other infection - history of splenectomy, lung transplant, or lung lobectomy - concurrent participation in another clinical trial involving therapeutic interventions - 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) expect for continuous positive airway pressure or bi-level positive airway pressure (cpap/bipap) used solely for sleep-disordered breathing

Number of arms
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Sorrento Therapeutics, Inc.

Inclusion age min
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Nov. 29, 2021, 10:30 p.m.
Source : ClinicalTrials.gov

Brazil

Type of patients
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Severe/critical disease at enrollment

Severity scale
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

7: Severe/critical disease at enrollment

Total sample size
Last imported at : Jan. 11, 2023, 8 a.m.
Source : ClinicalTrials.gov

43

primary outcome
Last imported at : May 31, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

All-cause mortality rate at Day 28

Notes
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : May 28, 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"}]