Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
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There are 2 clinical trials
In absence of vaccine and medications specifically designed to treat SARS-CoV-2 disease, identifying treatment options is critical at this time to control the disease outbreak. For this, we have designed a phase II trial of efficacy and safety with 3 branches of different combinations of treatment to identify which is the best early treatment option for patients with pneumonia due to SARS-CoV-2 (Covid-19) Identifying treatment options as early as possible is critical to the SARS-CoV-2 outbreak response. Currently, there is no approved vaccine for the disease and the treatments being used are not specifically designed for the SARS-CoV-2 virus, but are different groups of drugs used for other pathologies with mechanisms of action that justify their use because they inhibit entry of the virus into virus cells or proteases. The study aims to compare lopinavir / ritonavir (200 /50), imatinib 400mg, baricitinib 4mg, in combination with hydroxychloroquine 200mg, administered for 7 days in the setting of SARS-CoV-2 pneumonia treatment. Patients who meet inclusion criteria and do not have any exclusion criteria will be randomized to receive open treatment 1:1:1
Description: time from inclusion to improvement by 2 points on the "seven-category ordinal scale" or high, whichever comes first
Measure: time to clinical improvement Time: baseline to day 14Description: number of serious adverse effects and premature discontinuation of treatment
Measure: Safety of treatments Time: through study completion, an average of 1 monthDescription: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Measure: Tolerability of treatments Time: during treatment and up to 30 days after the last treatment doseDescription: Possible biomarkers and genetic markers of susceptibility to SARS-CoV-2 using high-performance techniques with serum DNA from the participants
Measure: Biomarkers and genetic markers of susceptibility to SARS-CoV-2 Time: baselineThere is urgent need of an effective therapy for Covid-19. To date, the best treatment of SARS-CoV-2 infection is unknown. Baricitinib has been identified as potential treatment for 2019-nCoV acute respiratory disease, because of its immunomodulating and hypothesized antiviral activity. This is a multicenter randomized clinical trial that aims to evaluate the efficacy and safety of baricitinib in patients with SARS-CoV2 pneumonia. Patients will be randomized to receive or not baricitinib as adjunctive therapy. All patients will continue to receive the ongoing standard therapy: chloroquine/idrossichloroquine and low-molecular weight heparin (LMWH) eventually associated with ritonavir/lopinavir or darunavir/ritonavir will be allowed for all included patients. The primary endpoint measure is the efficacy of baricitinib in reducing the number of patients requiring invasive ventilation after 7 and 14 days of treatment. Secondary endpoints will be mortality rates and toxicity of baricitinib.
Description: Reduction of the number of patients requiring invasive ventilation
Measure: Need of invasive mechanical ventilation Time: after 7 and 14 days of treatmentDescription: Proportion of any cause deaths
Measure: Mortality Time: 14- and 28-days from randomizationDescription: Days from randomization to invasive mechanical ventilation
Measure: Time to invasive mechanical ventilation Time: 30 daysDescription: Days from randomization to independence from non-invasive mechanical ventilation
Measure: Time to independence from non-invasive mechanical ventilation Time: 30 daysDescription: Days from randomization to independence from oxygen therapy
Measure: Time to independence from oxygen therapy Time: 30 daysDescription: Days from randomization to improvement in oxygenation for at least 48 hours
Measure: Time to improvement in oxygenation for at least 48 hours Time: 30 daysDescription: Days of hospital stay
Measure: Length of hospital stay Time: 30 daysDescription: Days of ICU stay
Measure: Length of ICU stay Time: 30 daysDescription: Changes in pulmonary echography
Measure: Instrumental response Time: 30 daysDescription: Rate of adverse events codified by Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0
Measure: Proportion of adverse events Time: 30 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