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

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ClinicalTrials.gov Identifier: NCT04421404
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : June 16, 2020
Sponsor:
Collaborators:
Blood Systems Research Institute
San Francisco General Hospital
Information provided by (Responsible Party):
Priscilla Hsue, MD, University of California, San Francisco

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
COVID-19 Sars-CoV2 Biological: COVID-19 Convalescent Plasma (CCP) Biological: Placebo Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects enrolled in the study will be randomized using a web based randomization procedure to receive convalescent plasma versus non-immune plasma at a 1:1 ratio.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Study investigators analyzing the data and participants will be blinded to the randomization. It may not be feasible to blind nursing staff to the treatment assignment to ensure proper ABO checking of the plasma unit at bedside per standard transfusion procedures, but every effort will be made to preserve blinding of the investigators, participant, and primary team providing care. An unblinded research assistant who is not involved in other aspects of the study will randomize the participant once enrolled. Randomization will be provided to an unblinded provider who is not part of the care team who will place the order for the plasma (CCP vs. control plasma) using a paper order that will not be part of the electronic medical record. The safety monitoring committee (SMC) will review study data, including unblinded data, to evaluate the safety, efficacy, study progress, and conduct of the study.
Primary Purpose: Treatment
Official Title: A Randomized Controlled Adaptive Study Comparing COVID-19 Convalescent Plasma (CCP) to Non-immune Plasma to Limit Coronavirus-associated Complications in Hospitalized Patients
Estimated Study Start Date : June 8, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: COVID-19 Convalescent Plasma
Subjects in the COVID-19 convalescent plasma group will receive a single infusion of 250 ml anti-SARS-CoV-2 convalescent fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.
Biological: COVID-19 Convalescent Plasma (CCP)
COVID-19 Convalescent Plasma (CCP) is a form of passive antibody therapy that involves the administration of anti-SARS-CoV-2 antibodies to a susceptible individual for the purpose of preventing or treating the infectious disease it causes. Convalescent plasma for this trial will be obtained from Vitalant (or American Red Cross if necessary). Patients identified as having recovered from COVID-19 will serve as potential donors. Potential donors will be screened using an anti-SARS-CoV-2 serologic assay and antibody levels will be determined.

Placebo Comparator: Placebo
Subjects in the placebo group will receive a single infusion of 250 ml of standard fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.
Biological: Placebo
Standard plasma will be obtained from Vitalant (or American Red Cross if necessary) and will be either collected prior to 12/1/2019 or tested and confirmed to be negative for anti-SARS-CoV-2.




Primary Outcome Measures :
  1. Severe Hypoxemic Respiratory Failure Endpoint [ Time Frame: Day 15 ]

    Progression to severe hypoxemic respiratory failure requiring sustained high levels of supplement oxygen as defined by protocol or death. The primary endpoint will be evaluated at day 15.

    Severe hypoxemic failure defined as more than 12 hours of:

    • > 6 L per minute oxygen delivery by face mask or non-rebreather
    • Non-invasive positive pressure ventilation
    • Any high flow nasal device OR
    • Endotracheal intubation for hypercarbia/hypoxia of any duration (excluding for procedures or depressed level of consciousness)
    • Death due to any cause


Secondary Outcome Measures :
  1. Severe Hypoxemic Respiratory Failure Endpoint [ Time Frame: Day 29 ]

    Progression to severe hypoxemic respiratory failure requiring sustained high levels of supplement oxygen as defined by protocol or death. The secondary endpoint will be evaluated at day 29.

    Severe hypoxemic failure defined as more than 12 hours of:

    • > 6 L per minute oxygen delivery by face mask or non-rebreather
    • Non-invasive positive pressure ventilation
    • Any high flow nasal device OR
    • Endotracheal intubation for hypercarbia/hypoxia of any duration (excluding for procedures or depressed level of consciousness)
    • Death due to any cause

  2. 8-Point Ordinal Scale Endpoint [ Time Frame: Day 29 ]

    Clinical efficacy of CCP relative to the control arm in adults hospitalized with COVID-19 according to clinical status as assessed by 8-point ordinal scale.

    • Death;
    • Hospitalized, on invasive mechanical ventilation or ECMO;
    • Hospitalized, on non-invasive ventilation or high flow oxygen devices;
    • Hospitalized, requiring supplemental oxygen;
    • Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise);
    • Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care;
    • Not hospitalized, limitation on activities and/or requiring home oxygen;
    • Not hospitalized, no limitations on activities.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 for Enrollment:

  1. Patients ≥18 years of age
  2. Hospitalized with COVID-19
  3. Enrolled within 72 hours of hospitalization OR within day 14 from first signs of illness
  4. Pulmonary infiltrates on chest imaging
  5. Oxygenation of <95% on room air
  6. Laboratory confirmed COVID-19

Exclusion Criteria

  1. Contraindication to transfusion due to inability to tolerate additional fluid, such as due to decompensated congestive heart failure
  2. Baseline requirement for oxygen supplementation prior to COVID-19 infection or use of positive pressure therapy for sleep disordered breathing
  3. Currently experiencing severe hypoxemic failure, as defined in study endpoints
  4. Prior receipt of plasma products, IVIG, or hyperimmune globulin within past 3 months
  5. 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


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): NCT04421404


Contacts
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Contact: Kelvin Moore, BA 628-206-5145 kelvin.moore@ucsf.edu
Contact: Rebecca Park, MS 628-206-5801 rebecca.park@ucsf.edu

Locations
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United States, California
San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Contact: Kelvin Moore, BA    628-206-5145    kelvin.moorejr@ucsf.edu   
Contact: Rebecca Park, MS    628-206-5801    rebecca.park2@ucsf.edu   
Principal Investigator: Priscilla Hsue, MD         
Principal Investigator: Annie Leutkemeyer, MD         
Sub-Investigator: Rachel Bystritsky, MD         
Sub-Investigator: Lisa Winston, MD         
UCSF Medical Center at Mount Zion Recruiting
San Francisco, California, United States, 94115
Contact: Kelvin Moore, BS    628-206-5145    kelvin.moorejr@ucsf.edu   
Contact: Rebecca Park, MA    628-206-5801    rebecca.park2@ucsf.edu   
Principal Investigator: Annie Leutkemeyer, MD         
Principal Investigator: Priscilla Hsue, MD         
University of California, San Francisco Medical Center (Parnassus Campus) Recruiting
San Francisco, California, United States, 94143
Contact: Kelvin Moore, BS    628-206-5145    kelvin.moorejr@ucsf.edu   
Contact: Rebecca Park, MA    628-206-5801    rebecca.park2@ucsf.edu   
Sub-Investigator: Carolyn Hendrickson, MD         
Sub-Investigator: Brian Graham, MD         
Sub-Investigator: Vivek Jain, MD         
Sub-Investigator: Rachel Bystritsky, MD         
Sub-Investigator: Jonathan Esensten, MD         
Sponsors and Collaborators
Priscilla Hsue, MD
Blood Systems Research Institute
San Francisco General Hospital
Investigators
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Principal Investigator: Priscilla Hsue, MD University of California, San Francisco
Principal Investigator: Annie Leutkemeyer, MD University of California, San Francisco
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Responsible Party: Priscilla Hsue, MD, Professor of Medicine, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04421404    
Other Study ID Numbers: 20-30794
First Posted: June 9, 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
Keywords provided by Priscilla Hsue, MD, University of California, San Francisco:
COVID-19
Sars-CoV2
Convalescent plasma
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases