Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1059 | Convalescent anti-SARS-CoV-2 plasma Wiki | 0.58 |
| drug3878 | TD139 Wiki | 0.58 |
| drug1940 | Infusion placebo Wiki | 0.58 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D000860 | Hypoxia NIH | 0.11 |
| D011024 | Pneumonia, Viral NIH | 0.07 |
| D018352 | Coronavirus Infections NIH | 0.06 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0012418 | Hypoxemia HPO | 0.11 |
| HP:0002090 | Pneumonia HPO | 0.03 |
Navigate: Correlations HPO
There are 3 clinical trials
RACONA is a prospective trial that will test the hypothesis that nafamostat can lower lung function deterioration and need for intensive care admission in COVID-19 patients. Design: Adult hospitalized COVID-19 patients will be randomized in a prospective double-blind randomized placebo-controlled study to test the clinical efficacy of nafamostat mesylate (administered intravenously) on top of best standard of care. Primary outcome measures: the time-to-clinical improvement, defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven category ordinal scale or live discharge from the hospital, whichever comes first.
Description: Time-to-clinical improvement (time from randomization to an improvement of two points (from the status at randomization) on a 7 category ordinal scale or live discharge from the hospital, whichever came first.
Measure: Time-to-clinical improvement Time: day 1 until day 28Description: Rate of patients showing improvement of 2 points in 7 category ordinal scale (with 7 points the worst)(PubMed ID: 32187464)
Measure: Responders Time: day 1 until day 28Description: Proportion of patients who will progress to critical illness/death
Measure: Critical or dead patients Time: day 1 until day 28Description: Change in pO2/FiO2 ratio over time
Measure: pO2/FiO2 ratio Time: day 1 until day 28Description: Change Sequential organ failure assessment score (SOFA score) over time. The Score ranges from 0 to 24 (with 24 the worst)(PubMed ID: 11594901)
Measure: SOFA score over time Time: day 1 until day 28Description: Duration of hospitalization in survivors (days)
Measure: Hospitalization Time: day 1 until day 28Description: Number of patients who require ventilation
Measure: Mechanical ventilation Time: day 1 until day 28Description: Duration of ventilation (days)
Measure: Mechanical ventilation duration Time: day 1 until day 28Description: Proportion of patients who develop arrhythmia, or myocardial infarction, or other cardiovascular disease not present at the baseline
Measure: Cardiovascular disease Time: day 1 until day 28COVID-19 is an emerging pandemic disease affecting most countries including Senegal, caused by the new coronavirus (SARS-CoV-2) which was first detected in the city of Wuhan in China in December 2019. A rapid spread of the disease has occurred at a global scale, associated with a mortality rate of 3.4%. The first case in Africa was declared on February 15, 2020 in Egypt and the first case in Senegal was declared on March 2nd, 2020. In this context, the SEN-CoV-Fadj clinical trial aims to evaluate efficacy and safety, among adults, of different therapeutic regimens considered optimal according to current knowledge, as well as available and adapted to Sub-Saharan Africa. This trial is nested into a cohort of confirmed cases of COVID-19 in Senegal aiming to understand the main clinical, biological, virologic and immunological characteristics of the infection. The protocol of the cohort is based and adapted from the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) / World Health Organization (WHO) Clinical Characterisation Protocol (CCP). The Nafamostat mesilate, whose antiviral, anticoagulant an anti-inflammatory activities have been shown, has been eligible for SEN-CoV-Fadj for the treatment of moderate to severe COVID-19 cases.
Description: Real time-PCR (RT-PCR) result of the naso- and oro-pharyngeal sample
Measure: SARS-CoV-2 viral load level Time: Day 7Description: not hospitalized with resumption of normal activities; not hospitalized, but unable to resume normal activities; hospitalization, not requiring supplemental oxygen; hospitalization, requiring supplemental oxygen; hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation; hospitalization, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; death.
Measure: Clinical status on the seven-category ordinal scale Time: through hospitalization, an average of 2 weeksCOVID-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 treatmentDescription: Record number of participants With treatment-related adverse events
Measure: 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 treatmentDescription: Measure maximum plasma concentration [Cmax] in blood samples.
Measure: Measuring the PK of the proposed trial treatments in COVID-19 patients. Time: 6 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 daysDescription: Duration (days) of oxygen use
Measure: To evaluate the number of oxygen-free days. Time: 16 daysDescription: Duration (days) of ventilation
Measure: To evaluate incidence of any form of new ventilation use. Time: 16 daysDescription: 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 daysDescription: SpO2/FiO2, measured daily from randomisation to Day 15, hospital discharge, or death
Measure: Change in the ratio of the oxygen saturation to fraction of inspired oxygen concentration (SpO2/FiO2) Time: 16 daysDescription: 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 daysDescription: Duration of total hospital stay • Duration to discharge following treatment
Measure: To evaluate time to discharge Time: 16 daysDescription: Record requirement for renal dialysis or haemofiltration
Measure: To evaluate the use of renal dialysis or haemofiltration for each treatment arm. Time: 16 daysAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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