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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Severely ill patients with COVID-19 severe respiratory distress
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT04411602
Status
Withdrawn
Sponsor
Ascension South East Michigan

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.