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Trial - NCT05346120


Column Value
Trial registration number NCT05346120
Full text link
Last imported at : April 28, 2022, 3:30 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05346120

First author
Last imported at : April 28, 2022, 3:30 a.m.
Source : ClinicalTrials.gov

Mariano Montemayor

Contact
Last imported at : April 28, 2022, 3:30 a.m.
Source : ClinicalTrials.gov

Mariano.r.Montemayor@uth.tmc.edu

Registration date
Last imported at : April 28, 2022, 3:30 a.m.
Source : ClinicalTrials.gov

2022-04-26

Recruitment status
Last imported at : April 28, 2022, 3:30 a.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : April 28, 2022, 3:30 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : April 28, 2022, 3:30 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : April 28, 2022, 3:30 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : April 28, 2022, 3:30 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : April 28, 2022, 3:30 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : April 28, 2022, 3:30 a.m.
Source : ClinicalTrials.gov

Long covid

Inclusion criteria
Last imported at : April 28, 2022, 3:30 a.m.
Source : ClinicalTrials.gov

inclusion criteria: 1. the subject, or legally authorized representative, must be able to understand and voluntarily sign an informed consent document 2. diagnosed with covid-19 within the last 90 days 3. age 18 to 80 years 4. qids-sr> 11

Exclusion criteria
Last imported at : April 28, 2022, 3:30 a.m.
Source : ClinicalTrials.gov

1. a pre-covid-19 history of cognitive dysfunction, or chronic fatigue 2. exclude recurrent episodes of depression (allowed: a prior episode but completed medication at least 3 months before enrollment) 3. any medical or psychiatric condition which could confound study assessments 4. stroke within the last 3 months 5. developmental delay 6. any other condition that the investigator feels would pose a significant hazard to the patient if enrolled 7. current participation in any interventional research study 8. unable to return for follow-up visits for clinical evaluation, laboratory studies, or imaging evaluation

Number of arms
Last imported at : April 28, 2022, 3:30 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : April 28, 2022, 3:30 a.m.
Source : ClinicalTrials.gov

Sean Savitz

Inclusion age min
Last imported at : April 28, 2022, 3:30 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : April 28, 2022, 3:30 a.m.
Source : ClinicalTrials.gov

80

Countries
Last imported at : April 28, 2022, 3:30 a.m.
Source : ClinicalTrials.gov

None

Type of patients
Last imported at : April 28, 2022, 3:30 a.m.
Source : ClinicalTrials.gov

Patients recovered from covid

Severity scale
Last imported at : April 28, 2022, 3:30 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : April 28, 2022, 3:30 a.m.
Source : ClinicalTrials.gov

32

primary outcome
Last imported at : April 28, 2022, 3:30 a.m.
Source : ClinicalTrials.gov

Quick Inventory of Depressive Symptomatology (QIDS-SR)

Notes
Last imported at : April 28, 2022, 3:30 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : April 28, 2022, 3:30 a.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : April 28, 2022, 3:30 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 2447, "treatment_name": "Allogeneic marrow stromal 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"}]