Using convalescent plasma to treat COVID-19 patients
Infusion of Convalescent Plasma for the Treatment of Patients Infected With Severe Acute Respiratory Syndrome-Coronavirus-2 (COVID-19): A Double-blinded, Placebo-controlled, Proof-of-concept Study
This study is testing if giving convalescent plasma from recovered COVID-19 patients can help people over 40 who are hospitalized with the virus feel better compared to those receiving standard care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University of Illinois at Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT04442191 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of convalescent plasma, which contains antibodies from recovered COVID-19 patients, as a treatment for individuals currently hospitalized with the virus. Participants over 40 years old who test positive for SARS-CoV-2 will be randomly assigned to receive either convalescent plasma or fresh frozen plasma in a blinded manner. The study aims to assess both the clinical benefits and safety of this treatment approach, while also comparing outcomes with a control group receiving only supportive care.
Who should consider this trial
Good fit: Ideal candidates are hospitalized patients aged 40 and older with symptomatic COVID-19 requiring supplemental oxygen.
Not a fit: Patients who are on a ventilator or have a history of severe transfusion reactions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve recovery rates and reduce the severity of COVID-19 in hospitalized patients.
How similar studies have performed: Other studies have shown promise in using convalescent plasma for COVID-19 treatment, suggesting potential efficacy.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- University of Illinois at Chicago — Chicago, Illinois, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.