Status:
WITHDRAWN
Intermediate IND Severe Illness COVID-19 CP
Lead Sponsor:
Henry Ford Health System
Conditions:
Severe Acute Respiratory Syndrome
COVID
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 (...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04411602
Start Date
April 7 2020
End Date
April 7 2021
Last Update
December 19 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
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