Convalescent Plasma as a Possible Treatment for COVID-19

Launched by UNIVERSITY OF ILLINOIS AT CHICAGO · Jun 19, 2020

Keywords

ClinConnect Summary

This clinical trial is studying whether convalescent plasma, which is a treatment made from the blood of people who have recovered from COVID-19, can help patients who are currently ill with the virus. The trial is specifically looking at patients aged 40 and older who are hospitalized due to COVID-19 and have tested positive for the virus. To be eligible, these patients should be experiencing symptoms like fever or cough and may need extra oxygen to breathe comfortably.

Participants in the trial will be randomly assigned to receive either convalescent plasma or a different type of plasma that does not contain antibodies, and they will be monitored for safety and effectiveness. It's important for participants to agree not to take any other experimental COVID-19 treatments during the study period. This trial is currently recruiting participants, and those who join can help researchers understand if convalescent plasma is a helpful treatment for COVID-19.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients 40 years-old and over who are admitted to the University of Illinois Hospital (UIC) due to COVID-19
• • Positive oropharyngeal and/or nasopharyngeal swab test for SARS-CoV-2 by RT-PCR within the preceding 72 hours (performed by University of Illinois Hospital Laboratories or, if performed elsewhere, documented in the patient's UIC medical record)
• • Symptomatic infection with any of the following: fever, cough, dyspnea, or tachypnea \> 22 breaths/min
• • Need for supplemental oxygen, between 1-5 liters/minute by nasal canula, to maintain O2 saturations \>92%
• • Consents to comply with all protocol requirements
• • Agrees to storage of specimens for future testing
• Exclusion Criteria:
• • Patients with known Immunoglobulin A deficiency (high risk of severe or fatal anaphylactic reactions)
• • Patients who are on a ventilator
• • Patients with past history of severe transfusion reaction including transfusion-related acute lung injury (TRALI) or anaphylaxis
• • Patients with a baseline requirement for supplemental oxygen due to chronic lung disease or with known history of either moderate-to-severe asthma or emphysema.
• • Female subjects who report that they are pregnant or breastfeeding
• • Receipt of pooled immunoglobulin in the past 30 days
• • Patients must be willing to not take any another alternative experimental treatment for COVID-19 from the time they undergo enrollment until the 28-day follow-up phone call
• • •. Participants who are being treated with Remdesivir and have had their first dose of Remdesivir greater than 24 hours prior to the time they will receive their first dose of convalescent plasma
• • Patients with severe disease due to COVID-19, as manifested by a need for vasopressors, and/or diagnosis of Acute Respiratory Distress Syndrome