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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3191 | Questionaire Wiki | 0.50 |
| drug3049 | Povidone-Iodine Nasal Spray and Gargle Wiki | 0.35 |
| drug3728 | Standard of Care Wiki | 0.08 |
Navigate: Correlations HPO
There are 4 clinical trials
Opaganib, a sphingosine kinase-2 (SphK2) inhibitor, has been broadly tested in Phase I/II studies. Extensive nonclinical data indicates both anti-viral and anti-inflammatory activity via selective SphK2 inhibition which may prove beneficial for treating COVID-19 infection and resulting pneumonia. This proof of concept study will take place in the US and will enroll about 40 hospitalized patients diagnosed with COVID-19 infection who have developed pneumonia and require supplemental oxygen. Half of the patients, i.e. 20 patients, will receive opaganib in addition to standard of care for 14 days. The other 20 will receive matching placebo (capsules that do not contain the medication) in addition to standard of care. Study drug will be administered every day for 14 days, twice each day, unless the patient has been discharged from the hospital without requiring supplemental oxygen, in which case study drug will only be administered for 10 days. All participants will be followed up for 4 weeks after their last dose of study drug.
Description: Measurement of the oxygen requirement
Measure: Evaluation of the total oxygen requirement (area under the curve) using daily supplemental oxygen flow (L/min) over 14 days Time: Every day from day 1 to day 14 of treatmentDescription: Measurement of the oxygen requirement
Measure: Evaluation of the time to 50% reduction from baseline in supplemental oxygen based on oxygen flow in L/min Time: Every day from day 1 to day 14 of treatmentDescription: Measurement of temperature
Measure: Evaluation of the proportion of afebrile patients at Day 14 Time: From screening phase and every day from day 1 to day 14 of treatmentDescription: Nasopharyngeal or oropharyngeal swab for SARS-CoV-2
Measure: Evaluation of the time to negative swabs for SARS-CoV-2 by PCR Time: From screening phase and every day from day 1 to day 14 of treatment and at the end of the 4 weeks follow-up after the end of treatmentDescription: Nasopharyngeal or oropharyngeal swab for SARS-CoV-2
Measure: Evaluation of the proportion of patients with negative swabs for SARS-CoV-2 by PCR at Day 14 Time: From screening phase and every day from day 1 to day 14 of treatment and at the end of the 4 weeks follow-up after the end of treatmentDescription: Evaluation the proportion of patients, with at least one measurement of fever at baseline (defined as temperature >38.0 C[100.4 F]), who are afebrile (defined as temperature <37.2C [99 F]) at Day 14
Measure: Evaluation the proportion of patients, with at least one measurement of fever at baseline who are afebrile at Day 14 Time: From screening phase and every day from day 1 to day 14 of treatmentShaare-Zedek Medical Center is a tertiary academic hospital in Jerusalem, Israel. On March 2020, a dramatic increase in the number of COVID-19 cases were diagnosed in Jerusalem. RedHill Biopharma, Ltd. offered opaganib under compassionate use for the treatment of COVID-19 patients. Eligible patients were those hospitalized with COVID-19 confirmed by a reverse-transcriptase-polymerase-chain-reaction assay. Patients received opaganib and Standard of Care. For the purpose of this study, the opaganib and Standard of Care patient group was compared to a group of patients that received only Standard of Care. Opaganib is an investigational drug under development and not approved for commercial distribution.
A phase 2/3 multi-center randomized, double-blind, parallel arm, placebo- controlled study in Adult Subjects Hospitalized with Severe SARS-CoV-2 Positive Pneumonia to determine the potential of opaganib to improve and/or stabilize the clinical status of the patient.
Description: To compare the proportion of patients requiring intubation and mechanical ventilation by Day 14 between subjects taking opaganib and those on placebo.
Measure: Intubation and mechanical ventilation Time: 14 daysDescription: Compare scores of subjects taking opaganib and those on placebo, lower scores indicate improvement.
Measure: WHO Ordinal Scale for Clinical Improvement with a scale ranging from 8 down to 0 Time: 14 daysDescription: To compare the time to intubation and mechanical ventilation between subjects taking opaganib and those on placebo.
Measure: Time to intubation and mechanical ventilation Time: 14 daysDescription: To compare the time to low oxygen flow via nasal cannula e.g. from high oxygen flow via nasal cannula or CPAP, if high oxygen flow is not an available option between subjects taking opaganib and those on placebo.
Measure: Time to low oxygen flow via nasal cannula Time: 14 daysDescription: To compare the proportion of patients no longer requiring supplemental oxygen for at least 24 hours by Day 14 between subjects taking opaganib and those on placebo.
Measure: Supplemental oxygen requirement Time: 14 daysDescription: To compare the total oxygen requirement (area under the curve) using daily supplemental oxygen flow (L/min) over 14 days (Day 1 to Day 14) between subjects taking opaganib and those on placebo.
Measure: Total daily oxygen requirement Time: 14 daysDescription: To compare the time to two consecutive negative swabs for SARS-CoV-2 by PCR between subjects taking opaganib and those on placebo.
Measure: Time to negative swabs for SARS-CoV-2 Time: 14 daysDescription: To compare the proportion of patients with two consecutive negative swabs for SARS-CoV-2 by PCR at Day 14 between subjects taking opaganib and those on placebo.
Measure: Negative swabs for SARS-CoV-2 at day 14 Time: 14 daysDescription: To compare the proportion of patients, with at least one measurement of fever at baseline (defined as temperature >38.0 C [100.4 F]), who are afebrile (defined as temperature <37.2C [99 F]) at Day 14 between subjects taking opaganib and those on placebo.
Measure: Fever Time: 14 daysDescription: To compare mortality 30 days post-baseline between subjects taking opaganib and those taking placebo
Measure: Mortality Time: 30 days post baselineDescription: To compare the number of adverse events in patients with severe COVID-19 pneumonia between subjects taking opaganib and subjects taking placebo
Measure: Adverse events Time: Up to 14 days and at the end of the 4 weeks follow-up after the end of treatmentDescription: To compare the change in the systemic marker of inflammation, D-dimer, over the treatment period between subjects taking opaganib and those on placebo.
Measure: Inflammatory markers - D-dimer Time: 14 daysDescription: To compare the change in the systemic marker of inflammation, cardiac troponin, over the treatment period between subjects taking opaganib and those on placebo.
Measure: Inflammatory markers - cardiac troponin Time: 14 daysDescription: To compare the change in the systemic marker of inflammation, C-reactive protein [CRP], over the treatment period between subjects taking opaganib and those on placebo.
Measure: Inflammatory markers - C-reactive protein Time: 14 daysDescription: To compare the change in the systemic marker of inflammation lactate dehydrogenase [LDH] over the treatment period between subjects taking opaganib and those on placebo.
Measure: Inflammatory markers - lactate dehydrogenase Time: 14 daysDescription: To compare the change in the systemic marker of inflammation ferritin over the treatment period between subjects taking opaganib and those on placebo.
Measure: Inflammatory markers - ferritin Time: 14 daysPatients diagnosed with COVID-19 infection will be offered treatment with Opaganib, 500 mg Q12 hours. Opaganib will be continuously administered for up to 2 weeks, until discharged on room air (if earlier than 2 weeks).
Description: To determine the time to breathing room air (off of supplemental oxygen) after the start of opaganib treatment.
Measure: Time to breathing room air Time: Up to 2 weeksDescription: All adverse events will be graded according to the revised NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE version 5.0). If an AE is not listed in the NCI-CTCAE v.5.0, then the Investigator will use the terms: mild, moderate, severe, life-threatening, or death to describe the maximum intensity of the AE.
Measure: Adverse Event Grading and Coding Time: Up to 2 weeksAlphabetical 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