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

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ClinicalTrials.gov Identifier: NCT04606498
Recruitment Status : Recruiting
First Posted : October 28, 2020
Last Update Posted : September 8, 2021
Sponsor:
Collaborator:
Uniformed Services University of the Health Sciences
Information provided by (Responsible Party):
Henry M. Jackson Foundation for the Advancement of Military Medicine

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

Condition or disease Intervention/treatment
Covid19 Other: Observational

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Blood Purification With Seraph® 100 Microbind® Affinity Blood Filter for the Treatment of Severe COVID-19: An Observational Study (PURIFY-OBS-1)
Actual Study Start Date : December 18, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : February 1, 2022

Group/Cohort Intervention/treatment
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
Other: 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.
Other: 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
Other: Observational
Observational study only - no intervention




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


Biospecimen Retention:   Samples Without DNA
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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04606498


Contacts
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Contact: Marianne Spevak, BSHS 240-694-2067 mspevak@hjf.org
Contact: Catherine Grill, RN, BSN 919-452-0288 cgrill@traumainsight.com

Locations
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United States, California
VA Greater Los Angeles Healthcare System Recruiting
Los Angeles, California, United States, 90073
Contact: Michael Lewis, MD    213-220-5481    michael.lewis8@va.gov   
Contact: Nancy Mohler    310-869-8899    nancy.mohler@va.gov   
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Breandan Sullivan, MD    720-848-3321    breandan.sullivan@cuanshutz.edu   
United States, Florida
Advent Health Recruiting
Orlando, Florida, United States, 32803
Contact: Amay Parikh, MD    407-303-7556    amay.parikh.md@adventhealth.com   
Contact: Sara Guyler       sara.guyler@adventhealth.com   
United States, Georgia
Southeast Georgia Health System - Brunswick Campus Recruiting
Brunswick, Georgia, United States, 31520
Contact: Stephen Chitty, MD    912-466-7000    kimandstephen@comcast.net   
Contact: Sarah Mobbs, NP    912-466-5504    smobbs@sghs.org   
Eisenhower Army Medical Center (EAMC) Recruiting
Fort Gordon, Georgia, United States, 30905
Contact: LTC Ian Rivera, MD    706-787-8668    ian.m.rivera2.mil@mail.mil   
Contact: Susan Rogers    706-833-1558    susan.d.rogers.civ@mail.mil   
United States, Maryland
Uniformed Services University Not yet recruiting
Bethesda, Maryland, United States, 20814
Contact: Kevin Chung, MD    301-400-2605    Kevin.Chung@usuhs.edu   
Contact: Marianne Spevak, BSHS    240-694-2067    mspevak@hjf.org   
Sub-Investigator: Ian Stewart, MD         
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20814
Contact: Ian Stewart, MD    301-295-3943    ian.stewart@usuhs.edu   
Contact: Dutchabong Shaw, RN    301-295-0002    dutchabong.shaw.ctr@usuhs.edu   
United States, Mississippi
Forrest General Hospital Recruiting
Hattiesburg, Mississippi, United States, 39401
Contact: Brian Rifkin, MD    601-268-5700    brian.rifkin@hattiesburgclinic.com   
Contact: Karen Brooks, RN    601-288-4384    karen.brooks@hattiesburgclinic.com   
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Andrew Wilhelm, MD    604-984-5650    awilhelm@umc.edu   
Contact: Delia Owens    601-815-9231    dyowens@umc.edu   
United States, Texas
Baylor Scott & White Recruiting
Dallas, Texas, United States, 75246
Contact: Harold Szerlip, MD    214-820-2350    harold.szerlip@bswhealth.org   
Contact: Tan Coleman    214-818-2525    tanqunisha.coleman@bswhealth.org   
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Benjamin Levi, MD    214-648-7230    benjamin.levi@utsouthwestern.edu   
Contact: Emily Carlson    214-648-6743    emily.carlson@utsouthwestern.edu   
Methodist Hospital Completed
San Antonio, Texas, United States, 78229
University Of Texas Health San Antonio (UTHSA)- University Health Recruiting
San Antonio, Texas, United States, 78229
Contact: Kumar Sharma, MD    210-567-4700    sharmak3@uthscsa.edu   
Contact: Subrata Debnath, PhD    210-508-2889    nath@uthscsa.edu   
Brooke Army Medical Center Not yet recruiting
San Antonio, Texas, United States, 78234
Contact: Robert Walter, MD       robert.j.walter26.mil@mail.mil   
Contact: Mai Nguyen, MD       mai.t.nguyen36.civ@mail.mil   
Sponsors and Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
Uniformed Services University of the Health Sciences
Investigators
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Principal Investigator: Kevin Chung, MD Uniformed Services University of the Health Sciences
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Responsible Party: Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier: NCT04606498    
Other Study ID Numbers: PURIFY-OBS-1
First Posted: October 28, 2020    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:
Covid19
ICU
Seraph®-100 Microbind® Affinity Blood Filter
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases