Recruiting

Phase 2

Convalescent PlasmaConvalescent Plasma as a Possible Treatment for COVID-19

Sponsor:

University of Illinois at Chicago

Code:

NCT04442191

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Convalescent plasma

Placebo

Study Details

Brief summary:

Patients who are ill with COVID-19 may benefit from receiving convalescent plasma infusions containing antibodies from donors who have recovered from the disease and are proven to no longer be infected. Given the current public health emergency due to COVID-19, the FDA has recently fast-tracked the use of convalescent plasma. The purpose for this study is to assess if convalescent plasma collected from donors previously infected with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, can provide clinical benefit to those acutely ill with the virus and to evaluate if such treatment is safe.

There will be two arms in the interventional study, where subjects will either be treated with convalescent plasma or fresh frozen plasma in a randomized and blinded manner. As an additional comparison, the clinical course of subjects enrolled during the period of the study who do not receive an alternative treatment for COVID-19 will be assessed.

Conditions

COVID-19

Study ID

NCT04442191

Start date

May 5, 2020

Status verified date

Jun, 2020

Completion date

May 5, 2021

Anticipated

Primary completion date

May 5, 2021

Anticipated

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Convalescent plasma

This study will utilize convalescent plasma from donors recovered from infection with SARS-CoV-2 (which causes COVID-19) with neutralizing antibody titers >1:64.

placebo comparator: Placebo

Placebo utilized in this study will include Fresh Frozen Plasma collected before the COVID-19 pandemic began. As an extra control, some of this plasma will be saved and tested for COVID-19 antibodies to ensure they are not present.

Interventions

Convalescent plasma

This study will use convalescent plasma collected from those who have previously had COVID-19 and have been shown to have cleared the infection and made antibodies against the virus.

Placebo

The placebo arm of this study will use fresh frozen plasma that presumably does not contain antibodies against COVID-19.

Primary outcome measure

Oxygen supplementation [ Time Frame: 8 days ]

Central Contacts and Locations

Locations

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Jesica A Herrick, MD, MS

312-996-1834 Christe5@uic.edu

Principal Investigator:

Jesica A Herrick, MD

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Jun 22, 2020

Last verified

Jun, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2020-06-22.