RECRUITING

Convalescent Plasma as a Possible Treatment for COVID-19

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-05-05

Study Completion:2021-05-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04442191

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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 * Patients with severe disease due to COVID-19, as manifested by a need for vasopressors, and/or diagnosis of Acute Respiratory Distress Syndrome

Inclusion Criteria

Exclusion 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

* 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
* Patients with severe disease due to COVID-19, as manifested by a need for vasopressors, and/or diagnosis of Acute Respiratory Distress Syndrome

Contacts and Locations

Study Locations (Sites)

University of Illinois at Chicago

Chicago, Illinois, 60612

United States

Collaborators and Investigators

Sponsor: University of Illinois at Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-05-05

Study Completion Date2021-05-05

Study Record Updates

Study Start Date2020-05-05

Study Completion Date2021-05-05

Terms related to this study

Additional Relevant MeSH Terms

COVID-19