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Convalescent Plasma for the Treatment of COVID-19 (Coronavirus Disease 2019)

NCT ID: NCT04554992

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-20

Study Completion Date

2022-06-30

Brief Summary

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This pilot, prospective study will assess the safety and efficacy of COVID-19 convalescent plasma versus standard care as treatment for severe and/or critical COVID-19 (as defined in the inclusion criteria) in adults 18 years of age and older. A total of 350 eligible subjects will receive a transfusion of anti-SARS-CoV2 ( severe acute respiratory syndrome) convalescent plasma.

Detailed Description

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Patients meeting inclusion/exclusion criteria will be approached for study consent based on the time of hospital admission and the availability of an blood type compatible product. 300mL plasma units of COVID-19 convalescent patients will be utilized for transfusion. During a period of 14 days, the patient will be eligible to receive up to 10 units of plasma, to be completed with 4 hours as per institutional transfusion standard operating procedures. Transfusion by apheresis (plasma exchange) may be employed to reduce the risk of volume overload. The number of units to be used will be determined by the study team based on protocol inclusion and exclusion criteria, and clinical evaluation of the patient's severity and response.

Subjects will be followed for at least 60 days or up to 3 months following initial transfusion for adverse event monitoring and data collection.

Conditions

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Covid19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Given that this is a pilot study to evaluate the safety of treatment with convalescent COVID-19 plasma versus standard care in subjects with severe and/or critical COVID-19 between the cases and historical controls without predetermined data, a convenient sample size of 700 patients (350 per group) has been proposed.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

All subjects recruited will be transfused with COVID 19 convalescent plasma. A prospective comparison with matched historical controls receiving standard care will be employed.

Group Type EXPERIMENTAL

COVID 19 Convalescent Plasma

Intervention Type BIOLOGICAL

COVID 19 convalescent plasma is a blood product collected from donors who have recovered from a previous COVID 19 infection

Interventions

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COVID 19 Convalescent Plasma

COVID 19 convalescent plasma is a blood product collected from donors who have recovered from a previous COVID 19 infection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

Recipient must meet criteria outlined in the recent Investigational COVID-19 Convalescent Plasma - Emergency INDs (investigational new drug) guidance (https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds)

Exclusion Criteria

1. History of prior severe reactions to transfusion of blood products with imputability of probable or definite as defined by Center of Disease Control National Healthcare Safety Network Hemovigilance Module \[see https://www.cdc.gov/nhsn/PDFs/Biovigilance/BV-HV-protocol-current.pdf\].
2. Has underlying uncompensated and untreatable end stage disease.
3. Fluid overload or other condition that would contraindicate administration of plasma
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Methodist Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Eric Salazar

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Salazar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

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Houston Methodist Hopsital

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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00025121

Identifier Type: -

Identifier Source: org_study_id