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History of Changes for Study: NCT04325672
Convalescent Plasma to Limit Coronavirus Associated Complications
Latest version (submitted April 6, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 26, 2020 None (earliest Version on record)
2 April 6, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT04325672
Submitted Date:  March 26, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: 20-002864
Brief Title: Convalescent Plasma to Limit Coronavirus Associated Complications
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
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2020
Overall Status: Not yet recruiting
Study Start: April 1, 2020
Primary Completion: December 31, 2022 [Anticipated]
Study Completion: December 31, 2022 [Anticipated]
First Submitted: March 26, 2020
First Submitted that
Met QC Criteria:
March 26, 2020
First Posted: March 27, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
March 26, 2020
Last Update Posted: March 27, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Mayo Clinic
Responsible Party: Principal Investigator
Investigator: Michael J. Joyner, M.D.
Official Title: Principal Investigator
Affiliation: Mayo Clinic
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.
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.
Open or close this module Conditions
Conditions: Coronavirus
Keywords: 2019 novel Coronavirus
SARS-CoV-2
COVID-19
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 20 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Shelly Roberts, RN
Telephone: 507-255-2807
Email: roberts.shelly@mayo.edu
Study Officials: Michael Joyner, MD
Principal Investigator
Mayo Clinic
Locations: United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links: Description: Mayo Clinic Clinical Trials
Available IPD/Information:

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