Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04782700
Status:
WITHDRAWN
Last Update Posted:
2022-02-16
First Post:
2021-02-25
Brief Title:
P-Co-Li Pulmonary Covid-19 Study
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
P-CO-Li Pulmonary Covid-19 Longterm Intervention Study
Status:
WITHDRAWN
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to recruitment we decided to withdraw the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to determine whether the use of steroids versus watchful waiting improves pulmonary function tests in patients with history of COVID 19 infection who have residual hypoxemia and lung infiltrates This is a non-inferiority trial which tests whether the outcomes after watchful waiting are not worst than after the use of steroids with a margin of acceptable inferiority The study team will limit inclusion to patients who have PCR- confirmed COVID19 at least in 10-weeks prior to enrollment persistent opacities on chest imaging and hypoxemia either at rest or during ambulation
Detailed Description:
Rationale The long-term pulmonary effects of COVID-19 infection have not been characterized Many of the patients that have recovered from the initial infection still experience respiratory symptoms require oxygen supplementation andor have persistent opacities in chest imaging The implications of these findings are not well described at this time and it is unclear if these patients will eventually develop pulmonary fibrosis or fully recover No standard therapy has been studied for this specific population and the use of steroids have only been tested in the acute setting Outpatient providers are currently not sure whether to prescribe steroids or to carefully watch over time This is a real-world question about which option is better and whether the risks of steroids outweigh the potential benefit when compared to watchful waiting The investigator propose that watchful waiting is not inferior to the use of steroids in improving the pulmonary function tests of these patients at 12 weeks
Methodology The investigators will include patients with history of COVID-19 infection who have persistent opacities on chest imaging and who are hypoxemic - either at rest or with ambulation at least 10 weeks post-COVID19 PCR positivity The study team will randomize patients in a 11 fashion to receive either watchful waiting vs steroids The study team will follow the patients over time with sequential pulmonary function tests and clinic visits at baseline 12 weeks 6 months and 12 months 24 and 36 months The first 12 weeks will include weekly brief phone calls to check on the patients and to ask them to rate their dyspnea on the modified Borg Dyspnea Scale Thereafter phone follow up will occur monthly
Outcomes
Outcomes will be measured at baseline 12 weeks 6-months 12-months 24-months and 36-months For the first 12 weeks weekly mBorg Dyspnea Scale will also be obtained
The primary outcome will be worsening in pulmonary function tests baseline to over 12 weeks defined as absolute value of FVC worsened by 10 OR absolute value of DLCO worsened by 15 As a real-world study if patients are unable to receive PFTs before their physician decides to escalate therapy a 2-point worsening increase in mBorg will be considered as patient having achieved the primary outcome
The secondary outcomes will include collection of the following 1 Hypoxemia increased oxygen supplementation by 1Lmin or 3 decrease in pulse Ox at ambulation to HR number 2 6MWT where possible 3 SR-36 questionnaire 4 PROMIS short forms 5 mBorg Dyspnea Scale 6 CT scan findings where obtained as part of standard of care and 7 PFT changes over time All outcomes will be analyzed as binary variables 20 worsening YN or clinically meaningful worsening from baseline and as continuous variables to each time-point to follow-up
The tertiary outcomes will include changes in COVID19 bundle labs inflammatory markers D-dimer metabolic panel CBC COVID IgG radiographic improvement where obtained as part of standard of care by the treating provider HgA1c pro-calcitonin and documented infections These values will be obtained from the medical record if already ordered by other providers or will be ordered by the research team at the specified follow-up timepoints Of note radiology testing will not be ordered by the research team but will be at the discretion of the clinical providers who will be advised about clinic-set standards for frequency and timing of follow up
Weekly phone call check-in will be made for the first 12-weeks asking mBorg and monthly thereafter and check-in clinic appointments will occur at 12 weeks and as needed
Methodology The investigators will include patients with history of COVID-19 infection who have persistent opacities on chest imaging and who are hypoxemic - either at rest or with ambulation at least 10 weeks post-COVID19 PCR positivity The study team will randomize patients in a 11 fashion to receive either watchful waiting vs steroids The study team will follow the patients over time with sequential pulmonary function tests and clinic visits at baseline 12 weeks 6 months and 12 months 24 and 36 months The first 12 weeks will include weekly brief phone calls to check on the patients and to ask them to rate their dyspnea on the modified Borg Dyspnea Scale Thereafter phone follow up will occur monthly
Outcomes
Outcomes will be measured at baseline 12 weeks 6-months 12-months 24-months and 36-months For the first 12 weeks weekly mBorg Dyspnea Scale will also be obtained
The primary outcome will be worsening in pulmonary function tests baseline to over 12 weeks defined as absolute value of FVC worsened by 10 OR absolute value of DLCO worsened by 15 As a real-world study if patients are unable to receive PFTs before their physician decides to escalate therapy a 2-point worsening increase in mBorg will be considered as patient having achieved the primary outcome
The secondary outcomes will include collection of the following 1 Hypoxemia increased oxygen supplementation by 1Lmin or 3 decrease in pulse Ox at ambulation to HR number 2 6MWT where possible 3 SR-36 questionnaire 4 PROMIS short forms 5 mBorg Dyspnea Scale 6 CT scan findings where obtained as part of standard of care and 7 PFT changes over time All outcomes will be analyzed as binary variables 20 worsening YN or clinically meaningful worsening from baseline and as continuous variables to each time-point to follow-up
The tertiary outcomes will include changes in COVID19 bundle labs inflammatory markers D-dimer metabolic panel CBC COVID IgG radiographic improvement where obtained as part of standard of care by the treating provider HgA1c pro-calcitonin and documented infections These values will be obtained from the medical record if already ordered by other providers or will be ordered by the research team at the specified follow-up timepoints Of note radiology testing will not be ordered by the research team but will be at the discretion of the clinical providers who will be advised about clinic-set standards for frequency and timing of follow up
Weekly phone call check-in will be made for the first 12-weeks asking mBorg and monthly thereafter and check-in clinic appointments will occur at 12 weeks and as needed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None