Convalescent Plasma to Limit Coronavirus Associated Complications

Coronavirus Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04325672
• Other study ID #: 20-002864
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RNA in SARS-CoV-2	Change in RNA levels of SARS-CoV-2 from nasopharyngeal using RT-PCR (reverse transcriptase polymerase chain reaction) across time.	Days 0, 1, 3, 7, 14, 28, 60 and 90 after transfusion
Primary	ICU Admissions	Total number of subjects to be admitted to the ICU after the anti-SARS-CoV-2 convalescent plasma transfusion.	90 days after transfusion
Primary	Hospital Mortality	Total number of subject deaths.	90 days after transfusion
Primary	Hospital Length of Stay (LOS)	The total number of days subjects were admitted to the hospital.	90 days after transfusion
Secondary	Type of respiratory support	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.	90 days after transfusion or until hospital discharge (whichever comes first)
Secondary	Duration of respiratory support	The total number of days subjects required respiratory support.	90 days after transfusion or until hospital discharge (whichever comes first)

External Links

•   Mayo Clinic Clinical Trials