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Convalescent Plasma Collection and Treatment in Pediatrics and Adults

Primary Purpose

COVID19, Coronavirus Infection, Coronavirus

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Convalescent Plasma 1 Unit
Convalescent Plasma 2 Units
Standard of Care
Sponsored by
West Virginia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID19 focused on measuring Covid19, Covid 19, Convalescent Plasma, SARS-CoV-2, Pediatric, Pediatrics

Eligibility Criteria

31 Days - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Plasma donation:

    1. Prior diagnosis of COVID-19 documented by a laboratory test

      1. Abbott RealTime SARS-CoV-2 real-time reverse transcription polymerase chain reaction (rRT-PCR) test on the Abbott m2000 System (Inpatient WVU testing)
      2. Other testing methods and vendors using FDA approved detection methods of SARS-CoV-2 under the Emergency Use Authorization (EUA)
    2. Complete resolution of symptoms at least 28 days prior to donation
    3. Complete resolution of symptoms for at least 14 days with negative repeat COVID-19 testing approved by the FDA EUA
    4. Female donors age 18+ that have never been pregnant or negative for HLA antibodies
    5. Male donors age 18+
    6. Negative results for COVID-19 either from one or more nasopharyngeal swab specimens or by a molecular diagnostic test from blood. A partial list of available tests can be accessed at https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations.
    7. Defined SARS-CoV-2 neutralizing antibody titers, if testing can be conducted (e.g., of at least 1:1602, 1:360 up to 1:640 is preferred. In shortage case 1:80 is acceptable)
    8. At least or greater than 50kg of weight
  • Plasma Recipients:

    1. Individuals of any age above 30 days of life, sex, or pregnancy status suffering from confirmed COVID19 and in rapid progression, severe or critical condition meeting the FDA IND guidelines.
    2. Must have laboratory confirmed COVID19
    3. Must have severe or immediately life-threatening COVID19
    4. Must provide informed consent/assent

Exclusion Criteria:

  • Plasma donation:

    1. Individuals that do not meet the requirement from the American Red Cross for plasma donation or equivalent
    2. Individuals plasma that has not passed safety screening after procurement by the American Red Cross for plasma donation or equivalent
  • Plasma Recipients

    1. Individuals with COVID19 who are not in clinical concern for rapid progression, severe or critical condition
    2. Individuals who are in critical condition that are not confirmed to have COVID19
    3. Individuals with known Selective IgA Deficiency, that has not been found to be absent of anti-IgA antibodies

Sites / Locations

  • WVU MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Active Comparator

Arm Label

Mild Severity

Moderate Severity

Severe or Critical Severity

Arm Description

Eligible to enroll in study and will be monitored for progression. Will not initially receive plasma.

Adult patients will be treated with 1 unit (200mL) of convalescent plasma Pediatric patients will be treated with 10mg/kg up to 1 unit of convalescent plasma.

Adult patients will be treated with up to 2 units of convalescent plasma Pediatric patients will be treated with 10mg/kg up to 2 units of convalescent plasma.

Outcomes

Primary Outcome Measures

Plasma Donor
Time it takes to identify eligible donors whom are willing to donate
Plasma Donor
Time it takes the plasma collection center to contact willing donors whom are allowed to donate plasma
Plasma Recipient
Time from consent to infusion
Plasma Recipient
Survival

Secondary Outcome Measures

Plasma Donor
Time until plasma is donated
Plasma Recipient
Incident of treatment-Emergent Adverse Events [Safety and Tolerability]
Plasma Recipient
Morbidity reduction
Plasma Recipient
Reduced Length of Stay in hospital
Plasma Recipient
Reduced Length of Stay on Advance Respiratory Support

Full Information

First Posted
April 19, 2020
Last Updated
May 1, 2020
Sponsor
West Virginia University
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1. Study Identification

Unique Protocol Identification Number
NCT04376034
Brief Title
Convalescent Plasma Collection and Treatment in Pediatrics and Adults
Official Title
Convalescent Plasma Collection From Individuals That Recovered From COVID19 and Treatment of Critically Ill Individuals With Donor Convalescent Plasma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Recruiting
Study Start Date
April 16, 2020 (Actual)
Primary Completion Date
March 30, 2021 (Anticipated)
Study Completion Date
March 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
West Virginia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
Convalescent plasma (here on referred to as plasma) has been used in emergency life-threatening situations to treat infections for over 100 years. The plasma is donated by an individual that has recovered from the very same infection that another person is infected with. This plasma is enriched in the antibodies that recognize and helped the body's immune system fight off the infection. When transfused from donor to recipient those antibodies will aid the recipient in fighting off the infection. In recent history this has been used to fight Ebola. Recently, the Federal Food and Drug Agency (FDA) made possible expedited Investigational New Drug (IND) process for plasma use in the fight against COVID19 for emergency and lifesaving uses. There are several other investigational drugs for treatment of COVID19 such as: Remdesivir, an antiviral. The off-label use of hydroxychloroquine, Lopinavir/ritonavir, or Tocilizumab have been authorized. Convalescent plasma mechanism of action helps to promote health by working with one's own immune system and will not interfere with the other proposed medications. It also will not weaken the immune system as the investigational and off label medications have the potential to do. Convalescent plasma is time honored and although investigational for each use against novel or rare infections, it is the basis for IgG infusions in the immunodeficient populations. Currently the use of IgG infusions such as Intravenous IgG (IVIG) is assumed to not have the right antibodies from donors in the general public. This is secondary to the novel nature of the COVID19 and the fact that the IVIG available today was collected 6 to 12 months ago from plasma donors; prior to the COVID19's outbreak discovery in China. It is for that reason that IVIG is not recommended at this time and the FDA has made special fast-tracking announcements for plasma use for COVID19. Currently, plasma is the only treatment that has a previous history of success in these novel or rare viral outbreak situations. It has already been reported to have been associated with survival of 5 out of 5 participants in a pilot study in China For the purpose of this study advanced respiratory support will include any measure of respiratory support above low flow nasal cannula oxygen (2 Liters/minute flow rate). For the purpose of this study dyspnea will be defined as any shortness of breath that is not completely relieved with the use of low flow nasal canula oxygen set to 2 Liters/minute flow rate and/or requiring breathing treatments such as but not limited to: bronchodilators more than every 4 hours to relieve symptoms. In the event that more than one recipient is identified and plasma is available in less than the total number of approved recipients, priority will be given to those approved by the FDA for the IND use of plasma for severe or critical condition. If there still exists a deficit of plasma, the priority will be given to those on advanced respiratory support with the most critical settings (if unclear then will be considered a tie); active pressor treatments; age <1 years of age with days of life, age adjusted for prematurity as a tie breaker; age >60 with years as a tie breaker; and lastly lottery pull with potential remaining recipients as the final tie breaker.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID19, Coronavirus Infection, Coronavirus, Virus Diseases, RNA Virus Infections
Keywords
Covid19, Covid 19, Convalescent Plasma, SARS-CoV-2, Pediatric, Pediatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Model Description
Prospective intervention
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mild Severity
Arm Type
Other
Arm Description
Eligible to enroll in study and will be monitored for progression. Will not initially receive plasma.
Arm Title
Moderate Severity
Arm Type
Active Comparator
Arm Description
Adult patients will be treated with 1 unit (200mL) of convalescent plasma Pediatric patients will be treated with 10mg/kg up to 1 unit of convalescent plasma.
Arm Title
Severe or Critical Severity
Arm Type
Active Comparator
Arm Description
Adult patients will be treated with up to 2 units of convalescent plasma Pediatric patients will be treated with 10mg/kg up to 2 units of convalescent plasma.
Intervention Type
Biological
Intervention Name(s)
Convalescent Plasma 1 Unit
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Convalescent Plasma 2 Units
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Plasma Donor
Description
Time it takes to identify eligible donors whom are willing to donate
Time Frame
Measured in days for 365 days
Title
Plasma Donor
Description
Time it takes the plasma collection center to contact willing donors whom are allowed to donate plasma
Time Frame
Measured in days for 365 days
Title
Plasma Recipient
Description
Time from consent to infusion
Time Frame
Measured evey 24 hours up to 30 days
Title
Plasma Recipient
Description
Survival
Time Frame
Measured in days with 30 day from discharge follow-up
Secondary Outcome Measure Information:
Title
Plasma Donor
Description
Time until plasma is donated
Time Frame
Measured every 24 hours up to 1 year
Title
Plasma Recipient
Description
Incident of treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame
Day 1, 2, 3, 4, 7, and 30 day
Title
Plasma Recipient
Description
Morbidity reduction
Time Frame
Day 1, 2, 3, 4, 7, and 30 day
Title
Plasma Recipient
Description
Reduced Length of Stay in hospital
Time Frame
Measured every 24 hours until patient discharged from hospital up to 1 year
Title
Plasma Recipient
Description
Reduced Length of Stay on Advance Respiratory Support
Time Frame
Measured every 24 hours until Off Advanced Respiratory Support up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
31 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Plasma donation: Prior diagnosis of COVID-19 documented by a laboratory test Abbott RealTime SARS-CoV-2 real-time reverse transcription polymerase chain reaction (rRT-PCR) test on the Abbott m2000 System (Inpatient WVU testing) Other testing methods and vendors using FDA approved detection methods of SARS-CoV-2 under the Emergency Use Authorization (EUA) Complete resolution of symptoms at least 28 days prior to donation Complete resolution of symptoms for at least 14 days with negative repeat COVID-19 testing approved by the FDA EUA Female donors age 18+ that have never been pregnant or negative for HLA antibodies Male donors age 18+ Negative results for COVID-19 either from one or more nasopharyngeal swab specimens or by a molecular diagnostic test from blood. A partial list of available tests can be accessed at https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations. Defined SARS-CoV-2 neutralizing antibody titers, if testing can be conducted (e.g., of at least 1:1602, 1:360 up to 1:640 is preferred. In shortage case 1:80 is acceptable) At least or greater than 50kg of weight Plasma Recipients: Individuals of any age above 30 days of life, sex, or pregnancy status suffering from confirmed COVID19 and in rapid progression, severe or critical condition meeting the FDA IND guidelines. Must have laboratory confirmed COVID19 Must have severe or immediately life-threatening COVID19 Must provide informed consent/assent Exclusion Criteria: Plasma donation: Individuals that do not meet the requirement from the American Red Cross for plasma donation or equivalent Individuals plasma that has not passed safety screening after procurement by the American Red Cross for plasma donation or equivalent Plasma Recipients Individuals with COVID19 who are not in clinical concern for rapid progression, severe or critical condition Individuals who are in critical condition that are not confirmed to have COVID19 Individuals with known Selective IgA Deficiency, that has not been found to be absent of anti-IgA antibodies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Peppers, DO, PhD
Phone
304-594-2483
Email
brian.peppers@hsc.wvu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Giblin Sutton, PharmD
Phone
304-293-0928
Email
giblinl@wvumedicine.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Peppers, DO, PhD
Organizational Affiliation
WVU Medicine Children's
Official's Role
Principal Investigator
Facility Information:
Facility Name
WVU Medicine
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Convalescent Plasma Collection and Treatment in Pediatrics and Adults

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