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Blood Purification With Seraph 100 Microbind Affinity Blood Filter for Treatment of Severe COVID19 Observational Study (PURIFY-OBS-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04606498
Recruitment Status : Active, not recruiting
First Posted : October 28, 2020
Last Update Posted : April 4, 2022
Sponsor:
Collaborator:
Uniformed Services University of the Health Sciences
Information provided by (Responsible Party):
Henry M. Jackson Foundation for the Advancement of Military Medicine

Tracking Information
First Submitted Date October 26, 2020
First Posted Date October 28, 2020
Last Update Posted Date April 4, 2022
Actual Study Start Date December 18, 2020
Estimated Primary Completion Date May 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 27, 2020)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 27, 2020)
  • Time spent on mechanical ventilation [ Time Frame: From intubation date through extubation or day 28 of study ]
    Length of time on ventilator
  • 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
  • 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
  • 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
  • Mortality [ Time Frame: From diagnosis of Covid (day 0) to date of death up to day 28 ]
    survival
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Blood Purification With Seraph 100 Microbind Affinity Blood Filter for Treatment of Severe COVID19 Observational Study
Official Title Blood Purification With Seraph® 100 Microbind® Affinity Blood Filter for the Treatment of Severe COVID-19: An Observational Study (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 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

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
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.
Sampling Method Probability Sample
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.
Condition Covid19
Intervention Other: Observational
Observational study only - no intervention
Study Groups/Cohorts
  • 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
    Intervention: Other: Observational
  • 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.
    Intervention: Other: Observational
  • 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
    Intervention: Other: Observational
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: October 27, 2020)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 1, 2022
Estimated Primary Completion Date May 1, 2022   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04606498
Other Study ID Numbers PURIFY-OBS-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Henry M. Jackson Foundation for the Advancement of Military Medicine
Original Responsible Party Same as current
Current Study Sponsor Henry M. Jackson Foundation for the Advancement of Military Medicine
Original Study Sponsor Same as current
Collaborators Uniformed Services University of the Health Sciences
Investigators
Principal Investigator: Kevin Chung, MD Uniformed Services University of the Health Sciences
PRS Account Henry M. Jackson Foundation for the Advancement of Military Medicine
Verification Date April 2022