|D045169||Severe Acute Respiratory Syndrome NIH||0.04|
There is one clinical trial.
This is a single arm phase II trial to assess efficacy and confirm safety of infusions of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms,with or without confirmed interstitial COVID-19 pneumonia by chest Xray or CT. A total of 29 eligible subjects will be enrolled to receive anti-SARS-CoV-2 plasma.Outcomes will be compared to hospitalized controls with confirmed COVID-19 disease through retrospective chart review.
Description: Will be done by comparing the admission rate to the ICU between patients who received convalescent plasma and a control group who did not enroll in the study, or receive another experimental therapy.Measure: Transfer to ICU Time: Days 0 - 60
Description: Will be done by comparing the 28 day mortality rate between enrolled subjects and the control group.Measure: 28 day mortality Time: Days 0 - 60
Description: Will be collected from time of enrollment until completion of the study. The adverse events will be evaluated by CTCAE V5.0 and MedDRA.Measure: Cumulative incidence of serious adverse events Time: Days 0 - 60
Description: Will be done by collecting respiratory tract swabs and testing for SARS-CoV-2 positivity.Measure: Rates and duration of SARS-CoV-2 Time: Days 0, 7, 14, and 21
Description: Serum or plasma will be collected and analyzed for SARS-CoV-2 antibody.Measure: Serum of plasma antibody titer to SARS-CoV-2 Time: Days 0, 7, 14, and 28
Description: Blood will be collected and analyzed for cellular and humoral response.Measure: Cellular and humoral immune response Time: Days 0, 7, 14, 28
Description: All days where a supplemental oxygen is needed will be recorded as a concomitant medication and will be subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the supplemental oxygen free days.Measure: Supplemental oxygen free days Time: Days 0-28
Description: All days where a ventilator is needed will be recorded as a concomitant procedure and will be subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the ventilator free days.Measure: Ventilator free days Time: Days 0 - 28
Description: All days where the participant is admitted to the ICU will be recorded and subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the ICU free days.Measure: ICU free days Time: Days 0 - 28
Description: The patient will be evaluated throughout their enrollment in the study. The score will be evaluated to see if the score improved or worsened throughout their admission.Measure: Sequential organ failure assessment score Time: days 0, 1, 4, 7, 14, 21, 28
Description: Concomitant medications will be recorded throughout the patients participation in the study and vasopressors will be recorded, if they are needed.Measure: Need for vasopressors Time: Days 0 - 60
Description: Renal function will be assessed throughout the patients participation in the study. If renal replacement therapy is needed, it will be captured as a concomitant procedure.Measure: Need for renal replacement therapy Time: Days 0 - 60
Description: Respiratory function will be assessed throughout the patients participation in the study. If ECMO is needed, it will be captured as a concomitant procedure.Measure: Need for extracorporeal membrane oxygenation (ECMO) Time: Days 0 - 60
Description: Will be calculated from the date the patient entered the hospital until they were discharged.Measure: Hospital length of stay (LOS) Time: Days 0-60
Description: Will be calculated from the date the patient entered the ICU until they were discharged from the ICU.Measure: ICU LOS Time: days 0 - 60
Description: All adverse events will be recorded and evaluated by CTCAE v.5.0. All grade 3 and 4 AEs will be calculated to determine safety of convalescent plasma.Measure: Grade 3 or 4 Adverse Events (AEs) Time: days 0 - 60
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports