|drug2997||SLEDD with a L-MOD Wiki||0.58|
|D002318||Cardiovascular Diseases NIH||0.11|
|D011024||Pneumonia, Viral NIH||0.07|
There are 3 clinical trials
The investigators plan to evaluate a strategy of chemoprophylaxis with hydroxyloquine (HCQ) against COVID-19 infection in patients diagnosed with an immunomediated inflammatory disease who are following a treatment with biological agents and / or Jak inhibitors. The strategy will be carried out through a randomised double blind, placebo-controlled clinical trial and will assess comparative rates of infection (prevalence, incidence), severity including mortality, impact on clínical course of the primary diseases and toxicity. Such evaluation will require prospective surveillance to assess the different end-points. Drug interventions in this protocol will follow the Spanish law about off-label use of medicines.
Description: number of new cases divided by number of persons-time at riskMeasure: Incidence rate of new COVID-19 cases in both arms Time: From day 14 after start of treatment up to the end of follow-up: week 27
Description: percentage of cases of COVID 19Measure: Prevalence of COVID-19 cases in both arms Time: 27 weeks after the beginning of the study
Description: Case fatality rate (CFR): the proportion of diagnosed cases of COVID 19 that lead to deathMeasure: Mortality rate secondary to COVID-19 cases in both groups Time: 27 weeks after the beginning of the study
Description: percentage of patients who need admission in an ICU due to COVID 19 infectionMeasure: Intensive Care Unit (CU) admission rate secondary to COVID-19 cases in both groups Time: 27 weeks after the beginning of the study
Description: Presence and type of adverse events at this point.Measure: Adverse events Time: 12 weeks after the start of treatment
Description: Proportion of participants that drop out of studyMeasure: Adverse events Time: 27 weeks after the beginning of the study
Infection with the SARS-Cov-2 virus, responsible of severe acute respiratory distress syndrome (SARS), is an emerging infectious disease called Covid-19 and declared as pandemic by the World Health Organization on March 11, 2020. This pandemic is responsible of significant mortality. In France, several thousand patients are hospitalized in intensive care units, and their number continues to increase. Mortality during Covid-19 is mainly linked to acute respiratory distress syndrome, which frequency is estimated in France to occur in 6% of infected patients. Comorbidities such as cardiovascular conditions, obesity and diabetes increase susceptibility to severe forms of Covid-19 and associated mortality. Therapeutic management has three components: symptomatic management, including supplementary oxygen therapy and in case of respiratory distress mechanical ventilation; the antiviral approach; and immunomodulation, aiming at reducing inflammation associated with viral infection, which is considered to take part in severe presentations of the disease. During Covid-19 viral pneumonia related to SARS-COv-2, there is a significant release of pro-inflammatory cytokines in the acute phase of viral infection, which could participate in viral pneumonia lesions. In children with less mature immune system than adults, SARS-Cov-2 infection is less severe. The current prevailing assumption is that severe forms of Covid-19 may not only be related to high viral replication, but also to an excessive inflammatory response favoring acute lung injury and stimulating infection. The investigators hypothesize that early control of the excessive inflammatory response may help reducing the risk of acute respiratory distress syndrome. The investigators will evaluate the benefit, safety and tolerability of corticosteroid therapy to reduce the rate of subjects hospitalized for Covid-19 viral pneumonia who experience clinical worsening with a need of high-flow supplemental oxygen supplementation or transfer in intensive care units for respiratory support.
Description: SpO2 <90% stabilized at rest and under not more than 5 L / min of supplemental oxygen using medium concentration mask. measured twice at 5-15 min intervalsThe average value of the two measurements will be calculated.Measure: Number of patients with a theoretical respiratory indication for transfer to intensive care unit evaluated by a SpO2 <90% stabilized at rest and under not more than 5 L / min of supplemental oxygen using medium concentration mask. Time: 7 days
Description: level1: not hospitalized no limited activities, level 7: deathMeasure: disease severity assessed on a 7-level ordinal scale Time: 7 days
Description: Reduction of radiological signs on chest imagingMeasure: radiological signs on chest imaging Time: 7 days
Description: duration on daysMeasure: Duration of oxygen therapy Time: 21 days
Current treatment recommendations are based on very limited evidence and reliant on the deployment of pharmacological strategies of doubtful efficacy, high toxicity, and near universal shortages of supply. On a global scale, there is a desperate need for readily available therapeutic options to safely and cost effectively target the hyper-inflammatory state in ICU patients based on management of severe COVID-19 (evidence of acute respiratory distress syndrome). The study team proposes to use slow low-efficiency daily dialysis to provide an extracorporeal circuit to target this cytokine storm using immunomodulation of neutrophils with a novel leucocyte modulatory device (L-MOD) to generate an anti-inflammatory phenotype, but without depletion of circulating factors.
Description: Efficacy will be evaluated by reduction of vasopressor support (converted to norepinephrine dose equivalents) compared to control group.Measure: Efficacy of a L-MOD against controls receiving supportive care in ICU. Time: Through dialysis, on average of 12 hours, two days in a row
Description: Time to ICU and hospital discharge compared to case-matched controlsMeasure: Mortality Time: From date of randomization until the date of death from any cause, whichever came first, assessed up to 2 months
Description: Time to ICU and hospital discharge compared to case-matched controlsMeasure: Hospital Discharge Time: From date of randomization until the date of hospital discharge or death from any cause, whichever came first, assessed up to 2 months
Description: Over the course of the disease white blood cells will be monitored (i.e. neutrophils, macrophages...)Measure: Leukocyte Monitoring Time: Through dialysis, on average of 12 hours, two days in a row and again on day 5 in the ICU
Description: Evolution of the Sequential Organ Failure Assessment (SOFA) score. The SOFA score ranges from 0 to 24. The higher score means the worst outcome.Measure: Sequential Organ Failure Assessment (SOFA) Score Time: From date of randomization until the date of ICU discharge or death from any cause, whichever came first, assessed up to 1 months
Description: intubation length will be recorded (in day)Measure: Intubation length Time: From date of randomization until the date of ICU discharge up to 2 months
Description: Evolution of hsCRP during dialysis treatmentMeasure: Markers of Inflammation Time: Through dialysis, on average of 12 hours, two days in a row and again after day 4 and no later than day 7 in the ICU
Description: Characterization of activated/desactivated leukocyte and macrophage subsets in the bloodMeasure: Leukocytes and Macrophages Time: Through dialysis, on average of 12 hours, two days in a row and again after day 4 and no later than day 7 in the ICU
Description: Myocardial damage will be assessed by troponin measurement (ng/mL)Measure: Myocardial damage Time: From date of randomization until the date of ICU discharge up to 2 months
Description: Renal recovery will be assessed by serum creatinin measurement (micromol/L)Measure: Renal recovery Time: From date of randomization until the date of ICU discharge up to 2 months
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