Convalescent Plasma to Limit Coronavirus Associated Complications

• ClinicalTrials.gov Identifier: NCT04325672
• Recruitment Status: Withdrawn
• First Posted: March 27, 2020
• Last Update Posted: April 8, 2020
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Michael J. Joyner, M.D., Mayo Clinic

Tracking Information

• First Submitted Date: March 26, 2020
• First Posted Date: March 27, 2020
• Last Update Posted Date: April 8, 2020
• Estimated Study Start Date: April 1, 2020
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 26, 2020)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 26, 2020)

• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Coronavirus

Intervention

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.

Study Arms

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.

Intervention: Biological: Convalescent Plasma

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: April 6, 2020): 0
• Original Estimated Enrollment (submitted: March 26, 2020): 20
• Estimated Study Completion Date: December 31, 2022
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT04325672
• Other Study ID Numbers: 20-002864
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Michael J. Joyner, M.D., Mayo Clinic
• Study Sponsor: Mayo Clinic
• Collaborators: Not Provided

Investigators

• Principal Investigator: Michael Joyner, MD; Mayo Clinic

• PRS Account: Mayo Clinic
• Verification Date: April 2020