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Trial - NCT04992247


Column Value
Trial registration number NCT04992247
Full text link
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04992247

First author
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

Mike Royal, MD

Contact
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

mroyal@sorrentotherapeutics.com

Registration date
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

2021-08-05

Recruitment status
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

Long covid

Inclusion criteria
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - has had prior laboratory-confirmed sars-cov-2 infection as determined by an approved polymerase chain reaction (pcr) or an approved antigen test of any specimen - has had a recent (within a week) negative sars-cov-2 test (an approved pcr or antigen test) - has had at least moderate or severe post-covid-19 pulmonary symptoms for at least 3 months which have resulted in reduced physical functioning compared to pre-covid-19 status - willing to follow contraception guidelines

Exclusion criteria
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

- clinically improving pulmonary status over the month prior to screening - undergone 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 - any significant medical condition, laboratory value or other illness that in the investigator's opinion would interfere or prevent safe participation in the study - history of a splenectomy, lung transplant or lung lobectomy - concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)

Number of arms
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

Sorrento Therapeutics, Inc.

Inclusion age min
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

None

Type of patients
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

Patients recovered from covid

Severity scale
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

60

primary outcome
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

Change in 6-Minute Walk Distance (6MWD) at Day 60

Notes
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 63, "treatment_name": "Allogeneic culture-expanded adipose-derived mesenchymal stem cells (mscs)", "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"}]