Plasma Adsorption in Patients With Confirmed COVID-19

Respiratory Failure Clinical Trial

Official title:

Plasma Adsorption in Patients With Confirmed COVID-19 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04358003
• Other study ID #: MH-007/B
• Status: Completed
• Phase: N/A
• Start date: May 20, 2020
• Est. completion date: April 1, 2022

Study information

• Verified date: April 2022
• Source: Marker Therapeutics AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To characterize the ability of the D2000 Cartridge in combination with the Optia SPD Protocol to reduce the morbidity and mortality associated with SARS-CoV-2 infection in patients admitted to the ICU.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: April 1, 2022
• Est. primary completion date: November 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years old
• Admitted to ICU
• Diagnosis of SARS-CoV-2 with 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.

• Patient fact sheet is provided to the subject.
• Subject or legal representative is able and willing to give informed consent. If authorized by the IRB, emergent plasma adsorption with the D2000 cartridge may be initiated prior to consent.

Exclusion Criteria:

• Treatment limitation or a do not attempt to resuscitate in place
• Pregnancy
• Significant or uncontrolled bleeding
• In the opinion of the investigator, any other condition that precludes plasma adsorption with the D2000

Related Conditions & MeSH terms

• ARDS
• COVID-19
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Marker Therapeutics D2000 Cartridge (D2000) for use with the Spectra Optia® Apheresis System (Optia SPD Protocol)
Subjects will receive one treatment per day with the D2000 Cartridge for up to 4 hours (treatment cycle) for up to seven (7) days. Treatment may extend beyond 7 days, up to 14 days total, if deemed necessary and useful by the principal investigator (PI). Additional cartridges may be used, if needed, to achieve the maximum daily treatment duration of 4 hours. Each day, before initiating the treatment cycle, pre-treatment chemistry and hematology, coagulation status, and disease severity scores (SOFA, APACHE II) will be collected. Then, immediately following the therapy on each treatment day, post-therapy measurements will also be collected. Study Exit. Subjects will be exited from the study after the Day 28 follow-up visit which will occur 28 days after Study Day 1. Subjects will be included in the study for a total of 28 days. Subjects may also choose to discontinue at any time or conclude participation at the discretion of the PI or the subject's treating physician.

Locations

Country	Name	City	State
United States	UNM Health Science Center	Albuquerque	New Mexico
United States	UT Southwestern/Clements Hospital	Dallas	Texas
United States	Inova Fairfax Medical Campus	Falls Church	Virginia
United States	UTMB	Galveston	Texas
United States	University of Arkansas for Medical Sciences (UAMS)	Little Rock	Arkansas
United States	Providence Portland Medical Center	Portland	Oregon
United States	Reading Hospital	West Reading	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Marker Therapeutics AG	Terumo BCT

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality		Day 28
Secondary	Change in Sequential Organ Failure Assessment [SOFA] scores	Scale of 0-24 with a higher number indicating a worse outcome	Day 28