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Trial - NCT04909892


Column Value
Trial registration number NCT04909892
Full text link
Last imported at : June 4, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04909892

First author
Last imported at : Sept. 18, 2021, 5 a.m.
Source : ClinicalTrials.gov

Mike Royal, MD

Contact
Last imported at : Sept. 18, 2021, 5 a.m.
Source : ClinicalTrials.gov

mroyal@sorrentotherapeutics.com

Registration date
Last imported at : June 4, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

2021-06-02

Recruitment status
Last imported at : Sept. 18, 2021, 5 a.m.
Source : ClinicalTrials.gov

Withdrawn

Study design
Last imported at : June 4, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : June 4, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : June 4, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : June 4, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : June 4, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : June 4, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Long covid

Inclusion criteria
Last imported at : June 4, 2021, 12:32 a.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 : June 4, 2021, 12:32 a.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 - 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 : June 4, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : June 4, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Sorrento Therapeutics, Inc.

Inclusion age min
Last imported at : June 4, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : June 4, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : June 4, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

None

Type of patients
Last imported at : June 4, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Patients recovered from covid

Severity scale
Last imported at : June 4, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Sept. 18, 2021, 5 a.m.
Source : ClinicalTrials.gov

0

primary outcome
Last imported at : June 4, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

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

Notes
Last imported at : June 4, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : June 4, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : June 4, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "1 vial", "treatment_id": 787, "treatment_name": "Mesenchymal stem cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "2 vial", "treatment_id": 787, "treatment_name": "Mesenchymal stem cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}]