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Convalescent Plasma to Limit Coronavirus Associated Complications

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04325672
Recruitment Status : Withdrawn (Study stopped due to opening Expanded Access Protocol.)
First Posted : March 27, 2020
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Michael J. Joyner, M.D., Mayo Clinic

Brief Summary:
Researchers are trying to assess the treatment potential and safety of anti-SARS-CoV-2 convalescent plasma in patients with acute respiratory symptoms with confirmed COVID-19.

Condition or disease Intervention/treatment Phase
Coronavirus Biological: Convalescent Plasma Phase 2

Detailed Description:
High titer human convalescent plasma will be extracted from apheresis donations from twenty recently-sick and currently-recovered COVID-19 patients. An open-label, phase 2A clinical trial will then be conducted to administer convalescent plasma to twenty individuals with confirmed cases of COVID-19 to investigate the novel application of convalescent plasma in the treatment strategy of SARS-CoV-2.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Convalescent Plasma to Limit Coronavirus Associated Complications: An Open Label, Phase 2A Study of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Convalescent Plasma Group
Subjects will receive 1-2 units (300-600 mL) of plasma with an anti-SARS-CoV-2 titer of >1:64.
Biological: Convalescent Plasma
Anti-SARS-CoV-2 convalescent plasma obtained from patients identified as having recovered from COVID-19 with neutralizing antibody titers >1:64.




Primary Outcome Measures :
  1. RNA in SARS-CoV-2 [ Time Frame: Days 0, 1, 3, 7, 14, 28, 60 and 90 after transfusion ]
    Change in RNA levels of SARS-CoV-2 from nasopharyngeal using RT-PCR (reverse transcriptase polymerase chain reaction) across time.

  2. ICU Admissions [ Time Frame: 90 days after transfusion ]
    Total number of subjects to be admitted to the ICU after the anti-SARS-CoV-2 convalescent plasma transfusion.

  3. Hospital Mortality [ Time Frame: 90 days after transfusion ]
    Total number of subject deaths.

  4. Hospital Length of Stay (LOS) [ Time Frame: 90 days after transfusion ]
    The total number of days subjects were admitted to the hospital.


Secondary Outcome Measures :
  1. Type of respiratory support [ Time Frame: 90 days after transfusion or until hospital discharge (whichever comes first) ]
    The type of supplemental oxygen support (e.g. nasal cannula, high flow nasal cannula, noninvasive ventilation, intubation and invasive mechanical ventilation, rescue ventilation) of the anti-SARS-CoV-2 convalescent plasma group across time.

  2. Duration of respiratory support [ Time Frame: 90 days after transfusion or until hospital discharge (whichever comes first) ]
    The total number of days subjects required respiratory support.



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:

  • Patients must be 18 years of age or older
  • Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. Patient is willing and able to provide written informed consent and comply with all protocol requirements.
  • Patient agrees to storage of specimens for future testing.

Exclusion Criteria:

  • Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period
  • Receipt of pooled immunoglobulin in past 30 days
  • Contraindication to transfusion or history of prior reactions to transfusion blood products

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): NCT04325672


Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Michael Joyner, MD Mayo Clinic
Additional Information:
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Responsible Party: Michael J. Joyner, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04325672    
Other Study ID Numbers: 20-002864
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 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 Michael J. Joyner, M.D., Mayo Clinic:
2019 novel Coronavirus
SARS-CoV-2
COVID-19
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases