|drug1162||Electrocardiogram, telemetry, echocardiogram, laboratory values Wiki||1.00|
There is one clinical trial.
The aim of this study is to test Cenicriviroc (CVC) as a means to reduce the severity of the lung disease COVID-19 caused by an infection with SARS-CoV-2. The safety of CVC, when administered to COVID-19 patients, will also be assessed. Furthermore, the clinical trial aims to answer the question of whether patients with pre-existing conditions, who have an increased risk of severe COVID-19 progression, benefit more and particularly from CVC. CVC is an orally available dual inhibitor of the chemokine receptors CCR2 and CCR5, which is expected to reduce (hyper-) inflammation in COVID-19. The main goal of the study is to determine whether CVC helps increase the number of patients who are symptom-free and not hospitalized after 14 days compared to a placebo. Approximately 66.7% of the patients enrolled in the study will receive CVC and 33.3% will get an optically identical pill (placebo). Subjects will be assessed daily while hospitalized. Discharged patients will be asked to attend study visits at Days 8, 15, 22, and 29 and 85. All subjects will undergo a series of clinical, safety, and laboratory assessments. Blood samples and oropharyngeal (OP) swabs will be obtained on Day 1; 3, 5 (while hospitalized); and Day 8, 15 and 29 (if able to return to clinic or still hospitalized). The presence of anti-SARS-CoV-2 antibodies will be determined on Days 29 and 85.
Description: The Primary Endpoint will be the subject's responder status defined by achieving a score of "1" or "2" (discharged from hospital e.g.) on Day 15 on the following 7-point scale: Not hospitalized, no limitations on activities; Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high-flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO (Extracorporeal membrane oxygenation); Death.Measure: Subject´s Responder status (score on the 7-point ordinal scale on Day 15) Time: 14 days after enrollment (Day 15)
Description: 7-point ordinal scale to be assessed on Day 15 (and Day 1 for baseline comparison), analyses of ordinal change of 2 or more, compared with baseline ordinal change of 1 or more, compared with baselineMeasure: Evaluation of change in clinical condition based on the 7-point ordinal scale Time: day of enrollment and 15 days after enrollment
Description: 7-point ordinal scale assessed on: Days 8, 22, 29 (and Day 1 for baseline comparison), analyses of: Responder status (achieving a score of a "1" or a "2") ordinal change of 2 or more, compared with baseline ordinal change of 1 or more, compared with baselineMeasure: Evaluation of change in clinical condition based on the 7-point ordinal scale and Responder Status Time: day of enrollment, 8 days, 22 days and 29 days after enrollment
Description: Analysis of: Length of time spent in the ICU (days) Length of time spent in the hospital (days) Days alive and out of hospital through Day 29 Days free of endotracheal tube-based ventilation through Day 29Measure: Hospital resource utilization comparison Time: 29 days after enrollment, 85 days after enrollment
Data processed on January 01, 2021.
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