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History of Changes for Study: NCT04606498
Observing ICU Patients on Seraph® 100 Filter for COVID-19 Patients (PURIFY-OBS-1)
Latest version (submitted September 2, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 27, 2020 None (earliest Version on record)
2 October 29, 2020 Study Identification and Study Status
3 October 30, 2020 Study Status and Study Identification
4 November 2, 2020 Study Status and Study Identification
5 November 17, 2020 Contacts/Locations and Study Status
6 January 10, 2021 Recruitment Status, Study Status, Contacts/Locations and Oversight
7 February 1, 2021 Study Status and Contacts/Locations
8 February 22, 2021 Contacts/Locations and Study Status
9 April 5, 2021 Contacts/Locations and Study Status
10 April 8, 2021 Contacts/Locations and Study Status
11 July 22, 2021 Contacts/Locations and Study Status
12 September 7, 2021 Contacts/Locations and Study Status
13 December 16, 2021 Recruitment Status, Study Status and Contacts/Locations
14 April 1, 2022 Study Status
15 September 2, 2022 Study Status and Contacts/Locations
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Study NCT04606498
Submitted Date:  October 27, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: PURIFY-OBS-1
Brief Title: Observing ICU Patients on Seraph® 100 Filter for COVID-19 Patients (PURIFY-OBS-1)
Official Title: Blood Purification With Seraph® 100 Microbind® Affinity Blood Filter for the Treatment of Severe COVID-19: An Observational Study (PURIFY-OBS-1)
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2020
Overall Status: Not yet recruiting
Study Start: November 20, 2020
Primary Completion: December 31, 2021 [Anticipated]
Study Completion: February 1, 2022 [Anticipated]
First Submitted: October 26, 2020
First Submitted that
Met QC Criteria:
October 27, 2020
First Posted: October 28, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
October 27, 2020
Last Update Posted: October 28, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Responsible Party: Sponsor
Collaborators: Uniformed Services University of the Health Sciences
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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 inclusion/exclusion 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) institution's 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 inclusion/exclusion 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 institution's 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 inclusion/exclusion 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 subject's 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

Open or close this module Conditions
Conditions: Covid19
Keywords: Covid19
ICU
Seraph®-100 Microbind® Affinity Blood Filter
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Other
Biospecimen Retention: Samples Without DNA
Biospecimen Description: Biospecimen (blood, urine, sputum, swabs) will be collected at D0, before initiation of extracorporeal treatment, and on study days 1, 2, 3, 4, 7, 28, and 90-180. Since a goal of this study is to recruit as many subjects as possible (predominantly for safety purposes), if a patient is started on Seraph® 100 prior to being recruited for the study, lab collection will begin at the next time point. For example, if a patient is started on Seraph® 100 on a Sunday and the patient is not enrolled until Monday, study day 0 labs will be marked as missing and lab collection will begin on study day 1.
Enrollment: 200 [Anticipated]
Number of Groups/Cohorts 3
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
1- Retrospective
Retrospective Seraph® 100 - 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. A waiver of informed consent will be requested from the Institutional Review Board (IRB) to allow the collection of these retrospective data
Observational
Observational study only - no intervention
2 - Prospective
Prospective Seraph® 100 - To identify prospective Seraph® 100 patients, the individual site investigators will review currently admitted ICU patients for inclusion criteria and exclusion criteria. 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 eligibility will be offered the opportunity to consent and participate in the study. Note that patients that were started on Seraph® 100 before the date of approval but are still admitted, will not be eligible to give biospecimens.
Observational
Observational study only - no intervention
3 - Historical Control
The 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. A waiver of informed consent will be requested from the IRB to allow the collection of these retrospective data
Observational
Observational study only - no intervention
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Time spent on medications used to increase blood pressure
[ Time Frame: Measure from start of medication (day 0) to day 28 of study ]

list type of medication and length of medication for Blood pressure
Secondary Outcome Measures:
1. Time spent on mechanical ventilation
[ Time Frame: From intubation date through extubation or day 28 of study ]

Length of time on ventilator
2. Time spent in the intensive care unit (ICU)
[ Time Frame: admission to ICU (day 0) through ICU discharge or up to day 28 of study ]

Length of time patient in the ICU
3. Time spent in the hospital
[ Time Frame: from hospital admission (day 0) to discharge or up to day 28 ]

Length of time patient was hospitalized
4. Time spent on dialysis
[ Time Frame: Start of dialysis treatment (day 0) to end of dialysis or up to day 28 ]

length of time patient required dialysis
5. Mortality
[ Time Frame: From diagnosis of Covid (day 0) to date of death up to day 28 ]

survival
Open or close this module Eligibility
Study Population: This multi-center, observational study will attempt to recruit all patients treated with the Seraph® 100 under EUA #200165 in the United States at both civilian and military hospitals.
Sampling Method: Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

Prospective Seraph® 100

  1. Subject must be 18 years of age
  2. Per the FDA Approve EUA:

Subject must have confirmed COVID-19 infection and be admitted to the ICU with confirmed or imminent respiratory failure and any one of the following conditions:

  1. Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS); or
  2. Severe disease, defined as:
    1. Dyspnea,
    2. Respiratory frequency ≥ 30/min,
    3. Blood oxygen saturation ≤ 93%,
    4. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300, and/or
    5. Lung infiltrates > 50% within 24 to 48 hours; or
  3. Life-threatening disease, defined as:
    1. Respiratory failure,
    2. Septic shock, and/or
    3. Multiple organ dysfunction or failure. 2. Prospective study patients (or their Legally Authorized Representative (LAR)) provides informed consent. Patients or their legally authorized representative will be consented in their main language if they are not fluent in English.

    3. Prospective study patient is willing to complete all study visits as required by the protocol 4. For Military Treatment Facility (MTF) enrollment only - must be DEERS eligible for care at the MTF

Retrospective Seraph® 100

  1. Subject must be 18 years of age
  2. Per the FDA Approve EUA:

    Subject must have confirmed COVID-19 infection and be admitted to the ICU with confirmed or imminent respiratory failure and any one of the following conditions:

    1. Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS); or
    2. Severe disease, defined as:
      1. Dyspnea,
      2. Respiratory frequency ≥ 30/min,
      3. Blood oxygen saturation ≤ 93%,
      4. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300, and/or
      5. Lung infiltrates > 50% within 24 to 48 hours; or
    3. Life-threatening disease, defined as:
      1. Respiratory failure,
      2. Septic shock, and/or
      3. Multiple organ dysfunction or failure.
  3. Treated with Seraph® 100 from 17 April 2020 (date of EUA approval) to the date of study approval at the study site.

Historical Control

  1. Subject must be 18 years of age
  2. Per the FDA Approve EUA:

    Subject must have confirmed COVID-19 infection and be admitted to the ICU with confirmed or imminent respiratory failure and any one of the following conditions:

    1. Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS); or
    2. Severe disease, defined as:
      1. Dyspnea
      2. Respiratory frequency ≥ 30/min,
      3. Blood oxygen saturation ≤ 93%,
      4. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300, and/or
      5. Lung infiltrates > 50% within 24 to 48 hours; or
    3. Life-threatening disease, defined as:
    1. Respiratory failure,
    2. Septic shock, and/or
    3. Multiple organ dysfunction or failure.
  3. Hospitalized from 20 January 2020 to the date of study approval at the study site.

Exclusion Criteria:

Prospective

  1. Unwilling to provide informed consent
  2. Unable to provide informed consent and no LAR available to provide permission

Retrospective No specific exclusion criteria. However, patients treated with Seraph® 100 prior to approval of the study at a site and who remains admitted to the hospital at the time the study is approved, will be given the opportunity to participate in the study by signing consent for their health data to be collected (and not biospecimens).

Historical Controls:

Patients who remain admitted to the hospital at the time that the study is approved at the study site will be excluded.

Open or close this module Contacts/Locations
Central Contact Person: Marianne Spevak, BSHS
Telephone: 240-694-2067
Email: mspeavk@hjf.org
Central Contact Backup: Sophie Haralson
Telephone: 301-273-4740
Email: Sophie.Haralson.ctr@usuhs.edu
Study Officials: Kevin Chung, MD
Principal Investigator
Uniformed Services University of the Health Sciences
Locations: United States, Maryland
Uniformed Services University
Bethesda, Maryland, United States, 20814
Contact:Contact: Kevin Chung, MD 301-400-2605 Kevin.Chung@usuhs.edu
Contact:Contact: Marianne Spevak, BSHS 240-694-2067 mspevak@hjf.org
Contact:Sub-Investigator: Ian Stewart, MD
Contact:Sub-Investigator: Stephen Olsen, MD
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:

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