RecruitingPhase 3NCT04376034

Convalescent Plasma Collection and Treatment in Pediatrics and Adults

Convalescent Plasma Collection From Individuals That Recovered From COVID19 and Treatment of Critically Ill Individuals With Donor Convalescent Plasma

Sponsor

West Virginia University

Enrollment

240 participants

Start Date

Apr 16, 2020

Study Type

INTERVENTIONAL

Conditions

COVID19 Coronavirus Coronavirus Infection Virus Diseases RNA Virus Infections

Summary

This is a prospective study, involving contacting potential plasma donors and the use of their plasma to help fight off infections of those suffering from COVID19 in accordance to collection guidelines for plasma and FDA IND requirement. This study will include up to 240 participants potentially receiving convalescent plasma and up to 1000 potential donors. There are 3 basic arms to the study: mild, moderate and severe/critical severity. All 3 severity groups are eligible for enrollment, but mild severity will not be given plasma unless there is progression. Moderate severity will given up to 1 unit of plasma and severe/critical severity up to 2 units. There is no placebo group, however given the excepted issues of shortages of plasma, intention to treat will be used for analysis.

Eligibility

Min Age: 31 Days

Plain Language Summary

Simplified for easier understanding

This study has two components: collecting convalescent plasma from people who have recovered from COVID-19, and transfusing that plasma to severely ill COVID-19 patients who may benefit from the antibodies it contains. Convalescent plasma is blood plasma from recovered patients that contains antibodies against the virus. The idea is that these antibodies can help seriously ill patients fight the infection when their own immune response is insufficient. Donors must have fully recovered from COVID-19 and have confirmed high levels of neutralising antibodies. Recipients must have severe or life-threatening COVID-19 and confirmed infection. Both adult and paediatric patients can receive convalescent plasma through this study. You may be eligible to donate if: - You had a confirmed COVID-19 diagnosis and fully recovered - All symptoms resolved at least 28 days ago (or 14 days ago with a negative test) - You are 18 or older (female donors must never have been pregnant or have negative HLA antibodies) - You weigh at least 50 kg - You have adequate neutralising antibody levels You may be eligible to receive plasma if: - You are over 30 days old with confirmed severe or life-threatening COVID-19 You may NOT be eligible if: - You are a donor who does not meet Red Cross donation criteria - You are a recipient who is not critically ill or not confirmed COVID-19 positive - You are a recipient with known Selective IgA Deficiency without confirmed absence of anti-IgA antibodies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALConvalescent Plasma 1 Unit

Each adult recipient will receive 1 units of plasma, each unit will consist of about 200 to 250 mL. Each pediatric recipient will receive 10mL/kg up to 1 unit of plasma.

BIOLOGICALConvalescent Plasma 2 Units

Those that meet severe or critical criteria will be given 2 units if available or 1 unit if 2 units are not available. Those that are given 1 unit may receive the second unit (or the remainder of the maximum pediatric weight calculated amount of plasma up to 1 additional unit) if they progress to severe or critical condition or if already in severe or critical condition but only received 1 unit secondary to shortages. Each pediatric recipient will receive 10mL/kg up to 2 units of plasma.

OTHERStandard of Care

Those that meet mild severity will be allowed to enroll in the study, but will not receive plasma unless there is progression of illness into the moderate/rapid progression or greater category.