Convalescent Plasma to Limit Coronavirus Associated Complications

Mayo Clinic

Status and phase: Withdrawn; Phase 2

Conditions: Coronavirus

Treatments: Biological: Convalescent Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04325672

20-002864

Details and patient eligibility

About

Researchers are trying to assess the treatment potential and safety of anti-SARS-CoV-2 convalescent plasma in patients with acute respiratory symptoms with confirmed COVID-19.

Full description

High titer human convalescent plasma will be extracted from apheresis donations from twenty recently-sick and currently-recovered COVID-19 patients. An open-label, phase 2A clinical trial will then be conducted to administer convalescent plasma to twenty individuals with confirmed cases of COVID-19 to investigate the novel application of convalescent plasma in the treatment strategy of SARS-CoV-2.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must be 18 years of age or older
• Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. Patient is willing and able to provide written informed consent and comply with all protocol requirements.
• Patient agrees to storage of specimens for future testing.

Exclusion criteria

• Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period
• Receipt of pooled immunoglobulin in past 30 days
• Contraindication to transfusion or history of prior reactions to transfusion blood products

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Convalescent Plasma Group

Experimental group

Description:

Subjects will receive 1-2 units (300-600 mL) of plasma with an anti-SARS-CoV-2 titer of \>1:64.

Treatment:

Biological: Convalescent Plasma