Intermediate IND Severe Illness COVID-19 CP

December 15, 2025 updated by: Henry Ford Health System
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Novi, Michigan, United States, 48374
        • Ascension Providence Hospital, Novi Campus
      • Southfield, Michigan, United States, 48075
        • Ascension Providence Hospital, Southfield Campus
      • Warren, Michigan, United States, 48093
        • Ascension Macomb-Oakland Hospital, Warren Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Track patient progress for 28 days post initial convalescent dose.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Track patient progress for 28 days post initial convalescent dose.
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.
Track patient progress for 28 days post initial convalescent dose.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2020

Primary Completion (Actual)

April 7, 2021

Study Completion (Actual)

April 7, 2021

Study Registration Dates

First Submitted

May 22, 2020

First Submitted That Met QC Criteria

May 29, 2020

First Posted (Actual)

June 2, 2020

Study Record Updates

Last Update Posted (Estimated)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1589349

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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