Intermediate IND Severe Illness COVID-19 CP

• Status: Withdrawn
• Trial end date: 2021-04-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ascension South East Michigan

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.