Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04606498
Status:
UNKNOWN
Last Update Posted:
2022-11-01
First Post:
2020-10-26
Brief Title:
Blood Purification With Seraph 100 Microbind Affinity Blood Filter for Treatment of Severe COVID19 Observational Study
Sponsor:
Henry M Jackson Foundation for the Advancement of Military Medicine
Organization:
Henry M Jackson Foundation for the Advancement of Military Medicine
Study Overview
Official Title:
Blood Purification With Seraph 100 Microbind Affinity Blood Filter for the Treatment of Severe COVID-19 An Observational Study PURIFY-OBS-1
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PURIFY-OBS-1
Brief Summary:
This is a multi-center observational study that will enroll 1 patients with severe COVID-19 who have agreed to undergo therapy with Seraph 100 under the existing EUA 2 patients medical record data that have been previously treated with the Seraph 100 after the date of the EUA approval 17 April 2020 but before the date that the study is approved at the study site and 3 a convenience sample of patients medical record data in a historical control group who were admitted to the ICU at participating sites with severe COVID-19 infection meeting the EUA treatment criteria but not treated with Seraph 100 up to the time the PURIFY-OBS protocol is approved at the site
Detailed Description:
This is a multi-center observational study that will enroll 1 patients with severe COVID-19 who have agreed to undergo therapy with Seraph 100 under the existing EUA 2 patients medical record data that have been previously treated with the Seraph 100 after the date of the EUA approval 17 April 2020 but before the date that the study is approved at the study site and 3 a convenience sample of patients medical record data in a historical control group who were admitted to the ICU at participating sites with severe COVID-19 infection meeting the EUA treatment criteria but not treated with Seraph 100 up to the time the PURIFY-OBS protocol is approved at the site
At the time of protocol approval data from all patients who have been treated up until that date will be collected retrospectively Patients who meet the treatment criteria and are identified as candidates for Seraph 100 with plans for treatment initiation will be enrolled prospectively after informed consent has been obtained Biospecimen collection blood urine sputum swabs will be planned for prospectively enrolled patients at various time-points However if subjects do not want to contribute samples they will be given the option of contributing only their clinical data for analysis Specific Seraph 100 treatment procedures will be determined by each individual site Recommendations for treatment related procedures are provided by the company Additionally among sites participating in PURIFY-OBS all patients who met EUA treatment criteria but were NOT initiated on therapy will be enrolled retrospectively into a historical control group Procedures for identifying study subjects will be as follows
Retrospective Seraph 100 As noted in the inclusionexclusion criteria this group will be composed of subjects that were treated with Seraph 100 after the date of the EUA approval 17 April 2020 but before the date that the study is approved at the study site To identify patients the site investigator will query 1 institutions electronic medical record for critical ill patients treated with Seraph 100 and 2 attending intensive care physicians and nephrologists who have provided care to critically ill patients with COVID-19 A waiver of informed consent will be requested from the Institutional Review Board IRB to allow the collection of these retrospective data
Prospective Seraph 100 To identify prospective Seraph 100 patients the individual site investigators will review currently admitted ICU patients for inclusion criteria 1and 2 see above The study team will then ask the physician caring for the patient to contact the study team should the patient require therapy with Seraph 100 Additionally the study team will review the medical records of admitted patients to see if they have recently been started on Seraph Patients found to meet inclusionexclusion criteria or their LARs will be offered the opportunity to sign an informed consent and participate in the study Note that patients that were started on Seraph 100 before the date of approval for a study site but are still admitted will not be eligible to give biospecimens However they will be given the option of signing an informed consent so that their data can be used in the study
Historical Control Our historical control group will be a sample of convenience composed of patients admitted to the ICU at participating sites with severe COVID-19 infection meeting the EUA treatment criteria but not treated with Seraph 100 up to the time the PURIFY-OBS protocol is approved at the site The individual site investigators will be responsible for querying their institutions electronic medical records to identify critically ill patients with COVID-19 admitted from the date of EUA approval 17 April 2020 until the date the protocol was approved at their study site These records will then be further examined by the local study team to ensure that the patients meet the inclusionexclusion criteria detailed above Note that patients will be excluded if they are still admitted to the hospital on or after the date that the protocol was approved at that study site A waiver of informed consent will be requested from the Institutional Review Board IRB to allow the collection of these retrospective data
Study Timeline Each included subjects medical record will be reviewed from the time of hospital admission through hospital discharge Enrollment will be conducted over a 2-year period up to 200 patients total including both retrospective and prospective patients For prospective patients who consent biospecimen blood urine sputum will be collected before initiation of extracorporeal treatment 1 hour following treatment as well as days 1 2 3 4 7 28 and 90-180
At the time of protocol approval data from all patients who have been treated up until that date will be collected retrospectively Patients who meet the treatment criteria and are identified as candidates for Seraph 100 with plans for treatment initiation will be enrolled prospectively after informed consent has been obtained Biospecimen collection blood urine sputum swabs will be planned for prospectively enrolled patients at various time-points However if subjects do not want to contribute samples they will be given the option of contributing only their clinical data for analysis Specific Seraph 100 treatment procedures will be determined by each individual site Recommendations for treatment related procedures are provided by the company Additionally among sites participating in PURIFY-OBS all patients who met EUA treatment criteria but were NOT initiated on therapy will be enrolled retrospectively into a historical control group Procedures for identifying study subjects will be as follows
Retrospective Seraph 100 As noted in the inclusionexclusion criteria this group will be composed of subjects that were treated with Seraph 100 after the date of the EUA approval 17 April 2020 but before the date that the study is approved at the study site To identify patients the site investigator will query 1 institutions electronic medical record for critical ill patients treated with Seraph 100 and 2 attending intensive care physicians and nephrologists who have provided care to critically ill patients with COVID-19 A waiver of informed consent will be requested from the Institutional Review Board IRB to allow the collection of these retrospective data
Prospective Seraph 100 To identify prospective Seraph 100 patients the individual site investigators will review currently admitted ICU patients for inclusion criteria 1and 2 see above The study team will then ask the physician caring for the patient to contact the study team should the patient require therapy with Seraph 100 Additionally the study team will review the medical records of admitted patients to see if they have recently been started on Seraph Patients found to meet inclusionexclusion criteria or their LARs will be offered the opportunity to sign an informed consent and participate in the study Note that patients that were started on Seraph 100 before the date of approval for a study site but are still admitted will not be eligible to give biospecimens However they will be given the option of signing an informed consent so that their data can be used in the study
Historical Control Our historical control group will be a sample of convenience composed of patients admitted to the ICU at participating sites with severe COVID-19 infection meeting the EUA treatment criteria but not treated with Seraph 100 up to the time the PURIFY-OBS protocol is approved at the site The individual site investigators will be responsible for querying their institutions electronic medical records to identify critically ill patients with COVID-19 admitted from the date of EUA approval 17 April 2020 until the date the protocol was approved at their study site These records will then be further examined by the local study team to ensure that the patients meet the inclusionexclusion criteria detailed above Note that patients will be excluded if they are still admitted to the hospital on or after the date that the protocol was approved at that study site A waiver of informed consent will be requested from the Institutional Review Board IRB to allow the collection of these retrospective data
Study Timeline Each included subjects medical record will be reviewed from the time of hospital admission through hospital discharge Enrollment will be conducted over a 2-year period up to 200 patients total including both retrospective and prospective patients For prospective patients who consent biospecimen blood urine sputum will be collected before initiation of extracorporeal treatment 1 hour following treatment as well as days 1 2 3 4 7 28 and 90-180
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