Coronavirus
Conditions
Keywords
2019 novel Coronavirus, SARS-CoV-2, 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.
Interventions
BIOLOGICALConvalescent Plasma
Anti-SARS-CoV-2 convalescent plasma obtained from patients identified as having recovered from COVID-19 with neutralizing antibody titers \>1:64.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RNA in SARS-CoV-2 | 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 | 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 | 90 days after transfusion | Total number of subject deaths. |
| Hospital Length of Stay (LOS) | 90 days after transfusion | The total number of days subjects were admitted to the hospital. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Type of respiratory support | 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 | 90 days after transfusion or until hospital discharge (whichever comes first) | The total number of days subjects required respiratory support. |
Outcome results
None listed