|drug2926||Routine care (no SARS-CoVSTs) Wiki||1.00|
|drug2429||Partially HLA-matched SARS-CoVSTs Wiki||1.00|
There is one clinical trial.
This is a dose-finding safety trial followed by a randomized pilot trial comparing administration of SARS-CoV2-specific T cells (SARS-CoVSTs) to standard of care treatment in hospitalized patients with COVID19 who are at high risk of requiring mechanical ventilation. The SARS-CoVSTs lines have been made at Baylor College of Medicine from healthy donors who have made a full recovery from COVID19. These cell lines were frozen for later use and will be thawed and used to treat patients who meet the eligibility criteria.
Description: Incidence of ≥ Grade 3 acute GvHD; or Grade 2 acute GvHD persisting beyond 14 days.Measure: Graft versus Host Disease (GvHD) Time: 14 days post infusion or until treatment toxicity resolves
Description: Incidence of ≥ Grade 3 persisting beyond 72 hours and worsens despite treatment. If the first 2 patients treated at any dose level or any 2 consecutively treated patients that receive VSTs during the randomized phase experience grade ≥ 2 CRS that persists for 7 days or is non-responsive to 2 doses of tocilizumab/Anakinra irrespective of attribution.Measure: Cytokine Release Syndrome (CRS) Time: 14 days post infusion or until treatment toxicity resolves
Description: Incidence of ≥ Grade 3 persisting beyond 72 hours and worsens despite treatment. If the first 2 patients treated at any DL or any 2 consecutively treated patients that receive VSTs during the randomized phase experience grade ≥ 2 ICANS that persists for 7 days or is non-responsive to 2 doses of tocilizumab/Anakinra irrespective of attribution.Measure: Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) Time: 14 days or until treatment toxicity resolves
Description: Incidence of any ≥ Grade 3 adverse event related to the T cell product [Treatment-related adverse events (tAE)] within 14 days of the VST infusion and not due to pre-existing conditions as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.Measure: Adverse Events Time: 14 days post infusion or until treatment toxicity resolves
Description: Randomized Trial: Record the daily measurement of clinical response using the WHO Ordinal scale [Scored on a scale from 0 to 8; where 0 = Uninfected and 8 =Dead] or until patient is discharged. The proportion of patients in the treatment arm will be compared to the control arm who have a clinical response by day 7 post-randomization (measured by a decrease in 2 or more points on the WHO scale)Measure: Clinical Response Assessment: World Health Organization (WHO) Ordinal Scale Time: 7 Days or at time of hospital discharge
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