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Trial - NCT04654481


Column Value
Trial registration number NCT04654481
Full text link
Last imported at : Dec. 7, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

First author
Last imported at : May 7, 2022, 5 a.m.
Source : ClinicalTrials.gov

Patricia Walker

Contact
Last imported at : May 7, 2022, 5 a.m.
Source : ClinicalTrials.gov

not reported

Registration date
Last imported at : Dec. 7, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2020-12-04

Recruitment status
Last imported at : May 7, 2022, 5 a.m.
Source : ClinicalTrials.gov

Terminated

Study design
Last imported at : Dec. 7, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Dec. 7, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Dec. 7, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Dec. 7, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Blind label

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

single-center

Study aim
Last imported at : Dec. 7, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Long covid

Inclusion criteria
Last imported at : Dec. 7, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - adult males and females ≥18 years - existing diagnosis of copd for >6 months - chronic productive cough - radiographic evidence of flattening of the diaphragm - prior covid-19 diagnosis - clinically followed by mount sinai covid-19 post recovery and respiratory institute. - ability to provide informed consent - ability to read and fill out survey questionnaires via redcap (surveys will be available in english and spanish) - access to a home computer, tablet, or smartphone

Exclusion criteria
Last imported at : Dec. 7, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

- presenting with hypoxia (02 sat <90%) - acute covid-19 infection - home oxygen dependent - established diagnosis of cystic fibrosis - history of osteoporosis or rib fracture - active hemoptysis - pneumothorax

Number of arms
Last imported at : Dec. 7, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Dec. 7, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Icahn School of Medicine at Mount Sinai

Inclusion age min
Last imported at : Dec. 7, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Dec. 7, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Dec. 7, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Dec. 7, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Patients recovered from covid

Severity scale
Last imported at : Dec. 7, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : May 7, 2022, 5 a.m.
Source : ClinicalTrials.gov

1

primary outcome
Last imported at : Dec. 7, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Change in Presence of Fever;Change in Oxygen Saturation level;Change in forced expiratory volume in one second (FEV1)

Notes
Last imported at : Dec. 7, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Dec. 7, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 578, "treatment_name": "High frequency chest wall oscillation (hfcwo)", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]