|D018352||Coronavirus Infections NIH||0.04|
There is one clinical trial.
This is a first-in-human study, Phase 1, randomized, placebo-controlled, double blinded study that will be conducted in 2 parts.
Description: Incidence of abnormal vital signs and abnormal laboratory valuesMeasure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) Time: 21 days
Description: Collection of all adverse eventsMeasure: Rate and type of adverse events during and after infusion of OPT101 or placebo Time: 48 hours
Description: Continuous telemetry monitoringMeasure: Incidence of vital signs Time: 48 hours
Description: Blood laboratory results and iStat results onsiteMeasure: Incidence of abnormal laboratory values Time: 21 days
Description: DMC and Safety and TolerabilityMeasure: Definition of maximum tolerated (MTD) single and repeated doses of OPT101 Time: 48 hours
Description: PK samples will be taken at 8 time points during the infusionMeasure: Determine pharmacokinetic (PK) Parameters (AUC0-t, Cmax, CL/F, t1/2) Time: 8 hours
Description: Anti-drug antibodies will be collected 2 times during studyMeasure: Development of anti-drug antibodies after 1 or more infusions Time: 2 weeks- 1 prior to infusion and day 15
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