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Intermediate IND Severe Illness COVID-19 CP

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ClinicalTrials.gov Identifier: NCT04411602
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
Ascension South East Michigan

Brief Summary:
Beyond supportive care, there are currently no proven therapeutic options for pneumonia due to coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19 and will be available when sufficient numbers of people have recovered. Such persons should have high titer neutralizing immunoglobulin-containing plasma.

Condition or disease Intervention/treatment Phase
Severe Acute Respiratory Syndrome COVID Drug: SARS-CoV-2 plasma Phase 1

Detailed Description:

Subjects will receive open-label screened plasma from COVID-19+ clinically resolved individuals (≥14 days post-resolution). Dosing of single or double plasma units (weight based < and > 90Kg) will be administered on days 0, 2, 4, 6, and 8 (based on plasma availability), or until futility (if either occurs before day 8) is determined by the ICU. Doses can be omitted at the discretion of the treating clinician (e.g., TRALI events are 100% donor-dependent and do not prohibit future transfusions).

The study drug is the investigational product, anti-SARS-CoV-2 convalescent plasma obtained from the American Red Cross or local plasma supply (medicDal center or city/region-wide shared blood bank) from patients identified as having recovered from COVID-19. Donors and samples will be screened for infections transmitted via transfusion (e.g. HIV, HBV, HCV, WNV, HTLV-I/II, T.cruzi, ZIKV) both through the use of the uniform donor questionnaire and FDA mandated blood donor screening tests. Plasma will be collected using apheresis technology or whole blood collection in accordance with standard FDA and blood bank protocols.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Severely ill patients with COVID-19 severe respiratory distress
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intermediate IND Severe Illness COVID-19 CP
Actual Study Start Date : April 7, 2020
Estimated Primary Completion Date : May 3, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment with Convalescent Plasma
SARS-CoV-2 convalescent plasma from approved donors will be transfused into severely ill patients with confirmed COVID-19 severe respiratory distress. Plasma will be administered on days 0, 2,4, 6 and 8.
Drug: SARS-CoV-2 plasma
To determine feasibility of convalescent plasma for treating patients in the ICU with COVID-19.
Other Name: Convalescent plasma




Primary Outcome Measures :
  1. Transfusion of patients in the ICU with convalescent plasma for COVID-19-induced respiratory failure. [ Time Frame: Track patient progress for 28 days post initial convalescent dose. ]
    Identification of patient population in ICU that are in acute respiratory failure due to COVID-19 and transfuse with convalescent plasma


Secondary Outcome Measures :
  1. Ventilatory free days [ Time Frame: Track patient progress for 28 days post initial convalescent dose. ]
    Measure reduction in ventilator use and/or changes in mechanical ventilator parameters

  2. Patient mortality (including death from any cause) [ Time Frame: Track patient progress for 28 days post initial convalescent dose. ]
    Measure length of stay from the time of admission to the hospital and subsequent admission to the ICU. Document resolution of COVID-19 infection or alternatively patient death.



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

Inclusion Criteria:

  • Laboratory confirmed COVID-19
  • Severe or Immediately life threatening COVID-19
  • Dyspnea
  • Respiratory frequency > 30/minute
  • Blood oxygen saturation <93%
  • Life-threatening disease is defined as the following
  • Respiratory Failure.
  • Septic shock, and/or,
  • Multiple organ dysfunction or failure.

Exclusion Criteria:

  • Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
  • Other documented uncontrolled infection.
  • Severe DIC needing factor replacement, FFP, cryoprecipitate.
  • On dialysis.
  • Active intracranial bleeding.
  • Clinically significant myocardial ischemia.

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): NCT04411602


Contacts
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Contact: Yulia Abidov, RN 248-849-5328 yulia.abidov@ascension.org
Contact: Shukri David, MD (248) 552-9858 shukri.david@ascension.org

Locations
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United States, Michigan
Ascension Providence Hospital, Novi Campus Recruiting
Novi, Michigan, United States, 48374
Contact: Yulia Abidov, RN    248-849-5328    yulia.abidov@ascension.org   
Principal Investigator: Shukri David, MD         
Ascension Providence Hospital, Southfield Campus Recruiting
Southfield, Michigan, United States, 48075
Contact: Yulia Abidov, RN    248-849-5328    yulia.abidov@ascension.org   
Ascension Macomb-Oakland Hospital, Warren Campus Recruiting
Warren, Michigan, United States, 48093
Contact: Teresa Jacobson, BS    586-576-4087    teresa.jacobson@ascension.org   
Sponsors and Collaborators
Ascension South East Michigan
Investigators
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Principal Investigator: Shukri David, MD Ascension Providence Hospital, Southfield Campus
Principal Investigator: Debra J Levan, DO Ascension Macomb-Oakland Hospital, Warren Campus
Publications:

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Responsible Party: Ascension South East Michigan
ClinicalTrials.gov Identifier: NCT04411602    
Other Study ID Numbers: 1589349
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ascension South East Michigan:
Corona Virus
Convalescent plasma
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases