Effects of COVID-19 Convalescent Plasma (CCP) on Coronavirus-associated Complications in Hospitalized Patients

STATUS

Recruiting
participants needed

30
sponsor

Priscilla Hsue, MD

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Updated on 19 February 2024

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covid-19

SARS

chest imaging

respiratory symptom

coronavirus infection

acute respiratory syndrome (sars)

Summary

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The purpose of this study assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms up to 14 days after the onset of initial symptoms.

Description

A total of 30 eligible subjects will be randomized in a 1:1 ratio to receive either convalescent fresh frozen plasma (frozen within 8 hours of collection) of PF24 (frozen within 24 hours) from blood donors who have recovered from COVID-19 containing antibodies to SARS-CoV-2 or control (standard fresh frozen plasma collected prior to 12/1/2019 or with documented negative SARS-CoV-2 antibody). Should additional anti-COVID agents (anti-viral and/or anti-inflammatory) become available for use as standard of care during implementation, the sample size will be recalculated and increased to account for the estimated impact that these agents may have on the reducing the progression to the primary endpoint of severe hypoxemia.

Details

Condition	Covid 19, Sars-CoV2
Age	18years - 100years
Treatment	Placebo, COVID-19 Convalescent Plasma (CCP)
Clinical Study Identifier	NCT04421404
Sponsor	Priscilla Hsue, MD
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Patients 18 years of age
	Hospitalized with COVID-19
	Enrolled within 72 hours of hospitalization OR within day 14 from first signs of illness
	Pulmonary infiltrates on chest imaging
	Oxygenation of <95% on room air
	Laboratory confirmed COVID-19
Exclusion Criteria
	Contraindication to transfusion due to inability to tolerate additional fluid, such as due to decompensated congestive heart failure
	Baseline requirement for oxygen supplementation prior to COVID-19 infection or use of positive pressure therapy for sleep disordered breathing
	Currently experiencing severe hypoxemic failure, as defined in study endpoints
	Prior receipt of plasma products, IVIG, or hyperimmune globulin within past 3 months
	Not currently enrolled another interventional clinical trial of COVID-19 treatment
	Note: If taking medications with potential anti-COVID activity that do not yet
	have data to support efficacy, such as hydroxychloroquine, these medications
	must be stopped prior to enrollment. Receipt of current standard of care
	COVID-19 treatment, including remdesivir is permitted and should be recorded
	as a concomitant medication
	Note: Pregnancy is not exclusionary but will merit additional discussion of
	risks & benefits in the context of ongoing pregnancy

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Effects of COVID-19 Convalescent Plasma (CCP) on Coronavirus-associated Complications in Hospitalized Patients