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Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19

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ClinicalTrials.gov Identifier: NCT04434131
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Michelle Harkins, University of New Mexico

Study Description
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Brief Summary:
This is an open label pilot study designed to provide access to treatment with investigational convalescent plasma and assess the relationship between NAb titers in the investigational convalescent plasma compared to changes in NAb levels in the recipient in hospitalized patients with COVID-19.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Convalescent Plasma Phase 2

Detailed Description:

Primary objectives are as follows:

  1. To provide access to treatment with investigational convalescent plasma to inpatients with documented COIVD-19 infection
  2. To measure NAb titers in an aliquot of the CP administered, to measure the volume of CP administered, and determine whether there is a correlation between the NAb dose (in NAb units/kg body weight, where a unit is the reciprocal of the endpoint NAb titer in the CP multiplied by the volume in ml) and change or lack of change when comparing pre-treatment and day one NAb titers.

Secondary, exploratory objectives are as follows:

  1. To evaluate the safety of convalescent plasma (CP) administration in hospitalized COVID-19 patients
  2. To evaluate viral shedding of SARSCoV-2 in nasopharyngeal or nasal samples before and on days 3, 7, and 14 after CP transfusion
  3. To perform genomic analysis of the SARS-CoV-2 from patients before and after treatment with CP transfusion
  4. Determine cumulative incidence of disease severity (transfer to ICU, type of respiratory support, LOS, and mortality)
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Open, Non-comparative Pilot Study to Provide Access to Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19
Actual Study Start Date : April 28, 2020
Estimated Primary Completion Date : April 28, 2021
Estimated Study Completion Date : April 28, 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Arm
The investigational product is anti-SARS-CoV-2 convalescent plasma obtained from former patients identified as having recovered from COVID-19 and obtained by Vitalant from local and national donors following national blood donation guidelines. All subjects receive the convalescent plasma.
 Drug: Convalescent Plasma
Study subjects will receive 1 unit (200mL) of SARS-CoV-2 convalescent plasma collected from a single donor who recovered from COVID-19.


Outcome Measures
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Primary Outcome Measures :
  1. Correlation between the NAb dose titer in the convalescent plasma and change or lack of change when comparing pre-treatment and day one NAb titers to inpatients with documented COIVD-19 infection [ Time Frame: 14 days ]
    To provide access to treatment with investigational convalescent plasma and measure NAb titers in an aliquot of the CP administered, to measure the volume of CP administered, and determine whether there is a correlation between the NAb dose titer in the CP and change or lack of change when comparing pre-treatment and day one NAb titers to inpatients with documented COIVD-19 infection


Secondary Outcome Measures :
  1. Rapid deterioration as evidenced by increase in ordinal or news score within 4 hours of transfusion [ Time Frame: 14 days ]
    To evaluate the safety of convalescent plasma (CP) administration as determined by rapid deterioration of respiratory or clinical status on transfusion of SARS-CoV-2 convalescent plasma

  2. Number of participants with clearance of viral shedding of SARSCoV-2 in nasopharyngeal or nasal samples [ Time Frame: 14 days ]
    To evaluate number of participants with clearance of viral shedding of SARSCoV-2 in nasopharyngeal or nasal samples on days 3, 7, and 14 after CP transfusion.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must be 18 years of age or older.
  2. Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. If COVID-19 test results are pending or done at enrolment, test results must be positive prior to administration of convalescent plasma.
  3. Patient (or legally authorized representative, LAR) is willing and able to provide written informed consent and comply with all protocol requirements.
  4. For patients unable to consent, consent by the legally authorized representative (LAR) may be obtained by phone.

Exclusion Criteria:

  1. Female subjects with positive pregnancy test or breastfeeding.
  2. Receipt of pooled immunoglobulin in past 30 days.
  3. Contraindication to transfusion or history of prior severe allergic reactions to transfused blood products.
  4. On ECMO or in refractory shock at entry
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04434131


Locations
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United States, New Mexico
University of New Mexico Health Sciences Center Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Michelle Harkins, MD    505-272-4751    MHarkins@salud.unm.edu   
Contact: Greg Mertz, MD       GMertz@salud.unm.edu   
Sponsors and Collaborators
University of New Mexico
  Study Documents (Full-Text)

Documents provided by Michelle Harkins, University of New Mexico:
Informed Consent Form  [PDF] April 29, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Michelle Harkins, Division Chief of Pulmonary/ Critical Care/Sleep Medicine, University of New Mexico
ClinicalTrials.gov Identifier: NCT04434131    
Other Study ID Numbers: 20-227
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No