|drug4085||standard concomitant therapy Wiki||0.58|
|drug1016||Descartes 30 Wiki||0.58|
|D012127||Respiratory Distress Syndrome, Newborn NIH||0.05|
There are 3 clinical trials
No optimal antiviral intervention has been yet validated to treat COVID-19 disease. Comorbidities, such as older age, obesity, diabetes, history of cardiovascular diseases are associated with poor prognosis. This study aims to evaluate the efficacy of two experimental antiviral treatments, compared to standard of care (SOC), to prevent clinical worsening, hospitalization or death at day 14 in adults with documented SARS-CoV-2 infection, asymptomatic or with symptoms lasting less than 8 days, and associated comorbidities without any severity criteria of the disease at inclusion. Participants will be randomized to receive SOC alone or SOC + hydroxychloroquine 200 mg three times a day during 10 days or SOC + association of niclosamide 2 g at J1 then 500 mg two times a day with diltiazem 60 mg three times a day during 10 days. Efficacy and tolerance of each treatments will be compared across the three treatment groups during the 28 days of follow-up.
Description: Composite criteriaMeasure: death Time: At day 14
Description: clinical worsening defined by at least one of the NEWS score item > 2 (temperature >39,1°C or<35°C, cardiac rate >111 or ≤40 bpm, respiratory rate > 21 or ≤8 cycles par minute, SaO2 ≤ 93% room air (if its measure is available),need of oxygenMeasure: clinical worsening (composite criteria) Time: At day 14
Description: clinical state as reflected by NEWS scoring, the clinical state of the patient regarding respiratory state as defined by the NEWS scoring systemMeasure: National Early Warning Score (NEWS) Time: at day 3, day 8, day 14 day 28
Description: Number of patients deathMeasure: Mortality Time: at day 14 and at day 28
Randomized open-label multicenter parallel-group study of efficacy and safety of TL-FVP-t vs. standard of care therapy in patients with mild to moderate coronavirus disease (SARS-CoV-2/COVID-19)
Description: To determine the effect of TL-FVP-t vs. SOC on time to clinical improvement. The clinical improvement is defined as reduction on at least 1 score of patient clinical status according to WHO 8-category Ordinal Scale for Clinical Improvement compared to screeningMeasure: Time to clinical improvement Time: through Day 28
Description: To determine the effect of TL-FVP-t vs. SOC on time to viral clearance of SARS-CoV-2 virus as measured by PCR in oropharyngeal samplingMeasure: Time to viral clearance Time: through Day 28
Description: To determine the effect of TL-FVP-t vs. SOC on proportion of subjects (%) with clinical improvement according to WHO 8-category Ordinal Scale for Clinical ImprovementMeasure: Rate of clinical improvement at separate time points Time: Day 7
Description: To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with viral clearance of SARS-CoV-2 virus as measured by PCR in oropharyngeal sampling at separate time pointsMeasure: Rate of viral clearance at separate time points Time: Days 5 and 7
Description: To determine the effect of TL-FVP-t vs. SOC on time to body temperature normalization determined as body temperature < 37°C without antipyretics for at least 48 hours.Measure: Time to body temperature normalization Time: through Day 28
Description: To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with resolution of lung changes on CTMeasure: Rate of resolution of lung changes on CT Time: Day 14
Description: To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with ADR and serious ADRMeasure: Rate of adverse drug reactions (ADR) and serious ADR Time: through Day 28
Description: To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with severe ADRMeasure: Rate of severe ADR Time: through Day 28
Description: To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) discontinued therapy due ADRMeasure: Rate therapy termination due to ADR Time: through Day 28
COVID-19 is a viral respiratory and systemic disease that has been rapidly spreading globally since the first cases were reported in December 2019 and has now become pandemic. The causative agent of COVID-19 was identified as a novel coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, first designated as 2019-nCoV). The disease manifestations of COVID-19 can range from mild, self-resolving respiratory disease to severe pneumonia, ARDS, multiorgan failure, and ultimately death. In early reports, the mortality rate among patients admitted to hospital and with confirmed SARS-CoV-2 infection was reported to be between 4 and 15%. Although the disease can afflict all age groups, elderly patients and patients with underlying comorbidities such as high body mass index, hypertension, diabetes, cardiovascular disease, or cerebrovascular disease are at risk of developing severe disease and dying. There are currently no etiologic treatments for COVID-19, and efforts are underway to identify therapeutics that could be effective in controlling this disease.
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