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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04325672
Other study ID # 20-002864
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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)
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