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Completed

NCT Number: NCT04358003

Plasma Adsorption in Patients With Confirmed COVID-19

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.

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Key information

Conditions

Respiratory Failure ARDS COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences (UAMS), Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Marker Therapeutics D2000 Cartridge (D2000) for use with the Spectra Optia® Apheresis System (Optia SPD Protocol)

Device

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.

Primary outcomes

  1. All-cause mortality

    Time frame: Day 28

Secondary outcomes

  1. Change in Sequential Organ Failure Assessment [SOFA] scores

    Time frame: Day 28

    Scale of 0-24 with a higher number indicating a worse outcome

Sponsors and collaborators

Lead sponsor

Marker Therapeutics AG

Industry

Collaborators

  • Terumo BCT

Registry information

Official study title

Plasma Adsorption in Patients With Confirmed COVID-19 Infection

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 22, 2020
Registry last updated
Apr 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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