Covid19PURIFY-OBS-1NCT04606498
Blood Purification With Seraph 100 Microbind Affinity Blood Filter for Treatment of Severe COVID19 Observational Study
An observational study of Covid19, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 14 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Observational
- How many people
- 200 participants
- Where
- 14 sitesUnited States
- Study dates
- 18 Dec 2020to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Prospective Seraph® 100
- Subject must be 18 years of age
- 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:
- Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS); or
- Severe disease, defined as:
Show all 49Show fewer
- Dyspnea,
- Respiratory frequency ≥ 30/min,
- Blood oxygen saturation ≤ 93%,
- Partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300, and/or
- Lung infiltrates > 50% within 24 to 48 hours; or
- Life-threatening disease, defined as:
- Respiratory failure,
- Septic shock, and/or
- 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
- Subject must be 18 years of age
- 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:
- Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS); or
- Severe disease, defined as:
- Dyspnea,
- Respiratory frequency ≥ 30/min,
- Blood oxygen saturation ≤ 93%,
- Partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300, and/or
- Lung infiltrates > 50% within 24 to 48 hours; or
- Life-threatening disease, defined as:
- Respiratory failure,
- Septic shock, and/or
- Multiple organ dysfunction or failure.
- Treated with Seraph® 100 from 17 April 2020 (date of EUA approval) to the date of study approval at the study site.
- Historical Control
- Subject must be 18 years of age
- 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:
- Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS); or
- Severe disease, defined as:
- Dyspnea
- Respiratory frequency ≥ 30/min,
- Blood oxygen saturation ≤ 93%,
- Partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300, and/or
- Lung infiltrates > 50% within 24 to 48 hours; or
- Life-threatening disease, defined as:
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- Respiratory failure,
- Septic shock, and/or
- Multiple organ dysfunction or failure.
- Hospitalized from 20 January 2020 to the date of study approval at the study site.
Who cannot join
- Prospective
- Unwilling to provide informed consent
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
University of Colorado Hospital
Aurora, Colorado, 80045
Ian Stewart
Bethesda, Maryland, 20814
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814
Southeast Georgia Health System - Brunswick Campus
Brunswick, Georgia, 31520
Baylor Scott & White
Dallas, Texas, 75246
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Eisenhower Army Medical Center (EAMC)
Fort Gordon, Georgia, 30905
Forrest General Hospital
Hattiesburg, Mississippi, 39401
University of Mississippi Medical Center
Jackson, Mississippi, 39216
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Advent Health
Orlando, Florida, 32803
Methodist Hospital
San Antonio, Texas, 78229
University Of Texas Health San Antonio (UTHSA)- University Health
San Antonio, Texas, 78229
Brooke Army Medical Center
San Antonio, Texas, 78234
About this 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)
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
Read the 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
- Conditions
- Covid19
- Being tested
- Observational
- Keywords
- Covid19, ICU, Seraph®-100 Microbind® Affinity Blood Filter
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational study only - no intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent on medications used to increase blood pressure
list type of medication and length of medication for Blood pressure
Measured: Measure from start of medication (day 0) to day 28 of study
Secondary outcomes (5)
Time spent on mechanical ventilation
Length of time on ventilator
Measured: From intubation date through extubation or day 28 of study
Time spent in the intensive care unit (ICU)
Length of time patient in the ICU
Measured: admission to ICU (day 0) through ICU discharge or up to day 28 of study
Time spent in the hospital
Length of time patient was hospitalized
Measured: from hospital admission (day 0) to discharge or up to day 28
Time spent on dialysis
length of time patient required dialysis
Measured: Start of dialysis treatment (day 0) to end of dialysis or up to day 28
Mortality
survival
Measured: From diagnosis of Covid (day 0) to date of death up to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start18 Dec 2020
- Primary completion31 Oct 2022
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Uniformed Services University of the Health Sciences
- Responsible party
- Sponsor
- Investigators
- Ian Stewart, MD, Principal investigator, USUHS/WRNMMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606498
- Sponsor's protocol ID
- PURIFY-OBS-1
- Acronym
- PURIFY-OBS-1
- Status last verified
- Oct 2022
- First submitted
- 26 Oct 2020
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Purification With Seraph® 100 Microbind® Affinity Blood Filter for the Treatment of Severe COVID-19: An Observational Study (PURIFY-OBS-1)
- ClinicalTrials.gov ID
- NCT04606498
- Acronym / sponsor ID
- PURIFY-OBS-1 / PURIFY-OBS-1
- Conditions
- Covid19
- Keywords
- Covid19, ICU, Seraph®-100 Microbind® Affinity Blood Filter
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- Uniformed Services University of the Health Sciences
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1- Retrospective | – | Other: ObservationalRetrospective 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 |
| 2 - Prospective | – | Other: ObservationalProspective 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. |
| 3 - Historical Control | – | Other: ObservationalThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (49 listed)
- Prospective Seraph® 100
- Subject must be 18 years of age
- 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:
- Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS); or
Key exclusion criteria (6 listed)
- Prospective
- Unwilling to provide informed consent
- 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).
- Patients who remain admitted to the hospital at the time that the study is approved at the study site will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalObservational study only - no intervention | Other | 1- Retrospective, 2 - Prospective, 3 - Historical Control |
Primary outcome
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
5 secondary outcomes
Time spent on mechanical ventilation
Time frame: From intubation date through extubation or day 28 of study
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
Time spent in the hospital
Time frame: from hospital admission (day 0) to discharge or up to day 28
Time spent on dialysis
Time frame: Start of dialysis treatment (day 0) to end of dialysis or up to day 28
Mortality
Time frame: From diagnosis of Covid (day 0) to date of death up to day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Stewart, MD principal investigator
USUHS/WRNMMC
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 49 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent on medications used to increase blood pressure (time frame: Measure from start of medication (day 0) to day 28 of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.