|drug899||Coronavirus Disease 2019 Wiki||1.00|
|drug2097||Nafamostat Mesilate Wiki||0.45|
|drug3132||Standard care Wiki||0.33|
There is one clinical trial.
COVID-19 is a community acquired pneumonia caused by infection with a novel coronavirus, SARS CoV2 and is a serious condition with high mortality in hospitalised patients, for which there is no currently approved treatment other than supportive care. Urgent investigation of potential treatments for this condition is required. This protocol describes an overarching and adaptive trial designed to provide safety, pharmacokinetic (PK)/ pharmacodynamic (PD) information and exploratory biological surrogates of efficacy which may support further development and deployment of candidate therapies in larger scale trials of COVID-19 positive patients receiving normal standard of care. Given the spectrum of clinical disease, community based infected patients or hospitalised patients can be included. Products requiring parenteral administration will only be investigated in hospitalised patients. Patients will be divided into cohorts, a) community b) hospitalised patients with new changes on a chest x-ray (CXR) or a computed tomography (CT) scan or requiring supplemental oxygen and c) hospitalised requiring assisted ventilation. Participants may be recruited from all three of these cohorts, depending on the experimental therapy, its route of administration and mechanism of action. The relevant cohort(s) for any given therapy will be detailed in the therapy-specific appendix. Candidate therapies can be added to the protocol and previous candidates removed from further investigation as evidence emerges. The trial will be monitored by an independent Data Monitoring Committee (DMC) to ensure patient safety. Each candidate cohort will include a small cohort of patients randomised to candidate therapy or existing standard of care management dependent on disease stage at entry. Cohort numbers will be defined in the protocol appendices. This is a Phase IIa experimental medicine trial and as such formal sample size calculations are not appropriate.
Description: Measure vital signs (blood pressure/heart rate/temperature and respiratory rate)Measure: The safety of the candidate therapies in COVID-19 patients by measuring physiological changes in the circulatory and respiratory system. Time: Up to 16 days post treatment
Description: Record number of participants With treatment-related adverse eventsMeasure: The safety of the candidate therapies in COVID-19 patients by recording the number of treatment related adverse events. Time: Up to 90 days post treatment
Description: Measure maximum plasma concentration [Cmax] in blood samples.Measure: Measuring the PK of the proposed trial treatments in COVID-19 patients. Time: 6 months
Description: Change in expression or activity of coagulation markers in serial blood samples taken before, during and after treatment.Measure: Measure a change in the expression of key coagulation biomarkers in the blood of COVID-19 patients during and after treatment period. Time: 6 months
Description: Change in expression or activity of inflammatory cytokines in serial blood samples taken before, during and after treatment.Measure: Measure a change in the expression of key cytokines in the blood of COVID-19 patients during and after treatment period. Time: 6 months
Description: Record changes in National Early Warning Score (NEWS) 2 score. Scale is from 0-20, with a higher number indicating a higher risk of morbidity.Measure: To evaluate the improvement or deteroriation of patients in each treatment arm. Time: 16 days
Description: Duration (days) of oxygen useMeasure: To evaluate the number of oxygen-free days. Time: 16 days
Description: Duration (days) of ventilationMeasure: To evaluate incidence of any form of new ventilation use. Time: 16 days
Description: Duration of ventilation-free days. • Incidence of any form of new ventilation use and duration (days) of new ventilation use.Measure: To evaluate ventilator-free days Time: 16 days
Description: SpO2/FiO2, measured daily from randomisation to Day 15, hospital discharge, or deathMeasure: Change in the ratio of the oxygen saturation to fraction of inspired oxygen concentration (SpO2/FiO2) Time: 16 days
Description: Qualitative and quantitative polymerase chain reaction (PCR) determination of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in oropharyngeal/nasal/saliva swab while hospitalised on Days 1, 3, 5, 8, 11, 15.Measure: To evaluate SARS-CoV-2 viral load. Time: 15 days
Description: Duration of total hospital stay • Duration to discharge following treatmentMeasure: To evaluate time to discharge Time: 16 days
Description: Record requirement for renal dialysis or haemofiltrationMeasure: To evaluate the use of renal dialysis or haemofiltration for each treatment arm. Time: 16 days
Data processed on December 13, 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