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Intermediate IND Severe Illness COVID-19 CP

Sponsor
Ascension South East Michigan (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04411602
Collaborator
(none)
0
Enrollment
3
Locations
1
Arm
12
Actual Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Severely ill patients with COVID-19 severe respiratory distressSeverely 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 :
Apr 7, 2020
Actual Primary Completion Date :
Apr 7, 2021
Actual Study Completion Date :
Apr 7, 2021

Arms and Interventions

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 Names:
  • Convalescent plasma

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Transfusion of patients in the ICU with convalescent plasma for COVID-19-induced respiratory failure. [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 [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) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ascension Providence Hospital, Novi Campus Novi Michigan United States 48374
    2 Ascension Providence Hospital, Southfield Campus Southfield Michigan United States 48075
    3 Ascension Macomb-Oakland Hospital, Warren Campus Warren Michigan United States 48093

    Sponsors and Collaborators

    • Ascension South East Michigan

    Investigators

    • Principal Investigator: Shukri David, MD, Ascension Providence Hospital, Southfield Campus
    • Principal Investigator: Debra J Levan, DO, Ascension Macomb-Oakland Hospital, Warren Campus

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ascension South East Michigan
    ClinicalTrials.gov Identifier:
    NCT04411602
    Other Study ID Numbers:
    • 1589349
    First Posted:
    Jun 2, 2020
    Last Update Posted:
    Jul 9, 2021
    Last Verified:
    Jul 1, 2021
    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:
    Severe Acute Respiratory Syndrome

    Study Results

    No Results Posted as of Jul 9, 2021