Intermediate IND Severe Illness COVID-19 CP

Henry Ford Health

Status and phase: Withdrawn; Phase 1

Conditions: COVID; Severe Acute Respiratory Syndrome

Treatments: Drug: SARS-CoV-2 plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04411602

1589349

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Treatment with Convalescent Plasma

Experimental group

Description:

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.

Treatment:

Drug: SARS-CoV-2 plasma