Agree @Opfan17 very comprehensive study. 90 days is the greatest time length for a secondary endpoint. Does this mean we will be waiting till September??? clarification appreciated.Primary Outcome Measures :
- Number of all-cause mortality [ Time Frame: 30 days ]
Number of all-cause mortality within 30 days of randomization.
Secondary Outcome Measures :
- Number of days alive off mechanical ventilatory support [ Time Frame: 60 days ]
Number of days alive off mechanical ventilatory support calculated as the number of days, within the 60 days window, that patients were alive and free of mechanical ventilatory support.- Number of adverse events [ Time Frame: 30 days ]
Safety analyses will be assessed by adverse event rates calculated as the ratio of the total number of events over 30 days divided by total patient-time at risk for the specific event from randomization.- Number of participants alive at day 7 [ Time Frame: 7 days ]
- Number of participants alive at day 14 [ Time Frame: 14 days ]
- Number of participants alive at day 60 [ Time Frame: 60 days ]
- Number of participants alive at day 90[ Time Frame: 90 days ]
- Number of participants with resolution and/or improvement of ARDS [ Time Frame: 7 days ]
The number and percent of patients with resolution and/or improvement of ARDS at day 7- Number of participants with resolution and/or improvement of ARDS [ Time Frame: 14 days ]
The number and percent of patients with resolution and/or improvement of ARDS at day 14- Number of participants with resolution and/or improvement of ARDS [ Time Frame: 21 days ]
The number and percent of patients with resolution and/or improvement of ARDS at day 21- Number of participants with resolution and/or improvement of ARDS [ Time Frame: 30 days ]
The number and percent of patients with resolution and/or improvement of ARDS at day 30- Change from baseline of the severity of ARDS [ Time Frame: baseline and 7 days ]
Change from baseline of the severity of ARDS according to Berlin Criteria at days 7 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.- Change from baseline of the severity of ARDS [ Time Frame: baseline and 14 days ]
Change from baseline of the severity of ARDS according to Berlin Criteria at days 14 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.- Change from baseline of the severity of ARDS [ Time Frame: baseline and 21 days ]
Change from baseline of the severity of ARDS according to Berlin Criteria at days 21 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.- Change from baseline of the severity of ARDS [ Time Frame: baseline and 30 days ]
Change from baseline of the severity of ARDS according to Berlin Criteria at days 30 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.- Length of stay [ Time Frame: 12 months ]
Hospital length of stay- Clinical Improvement Scale [ Time Frame: 7 days ]
Change from baseline in Clinical Improvement Scale at day 7. Clinical Improvement Scale full scale from 1 to 7, with higher score indicating more clinical improvement.- Clinical Improvement Scale [ Time Frame: 14 days ]
Change from baseline in Clinical Improvement Scale at day 14. Full scale from 1 to 7, with higher score indicating more clinical improvement.- Clinical Improvement Scale [ Time Frame: 21 days ]
Change from baseline in Clinical Improvement Scale at day 21. Clinical Improvement Scale full scale from 1 to 7, with higher score indicating more clinical improvement.- Clinical Improvement Scale [ Time Frame: 30 days ]
Change from baseline in Clinical Improvement Scale at day 30. Clinical Improvement Scale full scale from 1 to 7, with higher score indicating more clinical improvement.- Change in serum hs-CRP concentration [ Time Frame: baseline and 7 days ]
Changes from baseline in serum hs-CRP concentration at days 7- Change in serum hs-CRP concentration [ Time Frame: baseline and 14 days ]
Changes from baseline in serum hs-CRP concentration at days 14- Change in serum hs-CRP concentration [ Time Frame: baseline and 21 days ]
Changes from baseline in serum hs-CRP concentration at days 21- Change in serum hs-CRP concentration [ Time Frame: baseline and 30 days ]
Changes from baseline in serum hs-CRP concentration at days 30- Change in IL-6 inflammatory marker level [ Time Frame: baseline and 7 days ]
Changes from baseline in IL-6 inflammatory marker level at 7 days- Change in IL-6 inflammatory marker level [ Time Frame: baseline and 14 days ]
Changes from baseline in IL-6 inflammatory marker level at 14 days- Change in IL-6 inflammatory marker level [ Time Frame: baseline and 21 days ]
Changes from baseline in IL-6 inflammatory marker level at 21 days- Change in IL-6 inflammatory marker level [ Time Frame: baseline and 30 days ]
Changes from baseline in IL-6 inflammatory marker level at 30 days- Change in IL-8 inflammatory marker level [ Time Frame: baseline and 7 days ]
Changes from baseline in IL-6 inflammatory marker level at 7 days- Change in IL-8 inflammatory marker level [ Time Frame: baseline and 14 days ]
Changes from baseline in IL-6 inflammatory marker level at 14 days- Change in IL-8 inflammatory marker level [ Time Frame: baseline and 21 days ]
Changes from baseline in IL-6 inflammatory marker level at 21 days- Change in IL-8 inflammatory marker level [ Time Frame: baseline and 30 days ]
Changes from baseline in IL-6 inflammatory marker level at 30 days- Change in TNF-alpha inflammatory marker level [ Time Frame: baseline and 7 days ]
Changes from baseline in TNF-alpha inflammatory marker level at 7 days- Change in TNF-alpha inflammatory marker level [ Time Frame: baseline and 14 days ]
Changes from baseline in TNF-alpha inflammatory marker level at 14 days- Change in TNF-alpha inflammatory marker level [ Time Frame: baseline and 21 days ]
Changes from baseline in TNF-alpha inflammatory marker level at 21 days- Change in TNF-alpha inflammatory marker level [ Time Frame: baseline and 30 days ]
Changes from baseline in TNF-alpha inflammatory marker level at 30 days
while Im pasting walls of text, here are the inclusion criteria for revision:CriteriaInclusion Criteria
- 18 years or older
- Patient has coronavirus disease COVID-19 confirmed by real-time reverse transcription polymerase chain reaction (RT-PCR) assay or other diagnostic test
Patient requiring mechanical ventilatory support with moderate to severe ARDS as determined by the following criteria (adapted from the Berlin criteria)
- Bilateral opacities must be present on a chest radiograph or computed tomographic (CT) scan. These opacities are not fully explained by pleural effusions, lobar collapse, lung collapse, or pulmonary nodules.
- Respiratory failure not fully explained by cardiac failure or fluid overload.
- Moderate to severe impairment of oxygenation must be present, as defined by the ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2). The severity of the hypoxemia defines the severity of the ARDS:
- Moderate ARDS: PaO2/FiO2 >100 mmHg and ≤200 mmHg, on ventilator settings that include PEEP ≥5 cm H2O OR
- Severe ARDS: PaO2/FiO2 ≤100 mmHg on ventilator settings that include PEEP ≥5 cm H2O
- High sensitivity C-Reactive Protein (hs-CRP) serum level >4.0 mg/dL
- Acute Physiologic and Chronic Health Evaluation (APACHE IV) score >5
- The patient or his/her legally authorized representative (LAR) is able to provide informed consent
Exclusion Criteria
- Currently receiving extracorporeal membrane oxygenation (ECMO) or high frequency oscillatory ventilation (HFOV)
- Females who are pregnant or lactating
- Patients with established positive bacterial blood cultures prior to enrollment or suspicion of superimposed bacterial pneumonia
- Patients with untreated HIV infection
- Patients who have been intubated for more than 72 hours
- Creatinine clearance less than 30 mL/minute
- LFTs (ALT or AST) > 5x normal
- Known hypersensitivity to DMSO or to porcine or bovine proteins
- History of prior respiratory disease with requirement for supplemental oxygen
- Any end-stage organ disease which in the opinion of the investigator may possibly affect the safety of remestemcel-L treatment
- Receiving an investigational cellular therapy agent
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Agree @Opfan17 very comprehensive study. 90 days is the greatest...
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