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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3783 | Sterile normal saline (0.9%) Wiki | 0.71 |
| drug1878 | Ibuprofen Wiki | 0.71 |
Navigate: Correlations HPO
There are 2 clinical trials
To evaluate the safety and efficacy of humanized Meplazumab for Injection in patients infected by 2019-nCoA.
Description: Virological clearance rate using Real-Time PCR in upper and/or lower respiratory tract samples at day 3, day 7 and day 14 respectively.
Measure: 2019 nCoV nucleic acid detection Time: 14 daysDescription: Time (days) from initiation of Meplazumab treatment until normalization of body temperature (≤37℃ axilla)
Measure: Recovery of body temperature Time: 14 daysDescription: Time (days) from initiation of Meplazumab treatment until normalization of resting respiratory rate (≤24/min)
Measure: Recovery of resting respiratory rate Time: 14 daysDescription: Time (days) from initiation of Meplazumab treatment until normalization of SPO2 (>94%)
Measure: Recovery of SPO2 Time: 14 daysDescription: Rate of lung imaging recovery
Measure: Chest CT / chest film changes Time: 28 daysDescription: Rate of PaO2 / FiO2 recovery
Measure: PaO2 / FiO2 Time: 14 daysDescription: Days to reach the isolation release standard
Measure: Time to reach the isolation release standard Time: 28 daysDescription: Rate of CRP, D-Dimer test recovery
Measure: Changes of inflammatory immune status Time: 14 daysThis phase2/3 study will be conducted to evaluate the safety and efficacy of Meplazumab in addition to Standard of Care for the treatment of Corona Virus Disease(COVID) 19 in hospitalized adults
Description: Of at least 2 points (from randomization) on a 6-point ordinal scale, (where sustained improvement is improvement without subsequent worsening), or live discharge from the hospital, whichever comes first. The time to event endpoints, including time to sustained clinical improvement by Day 29 from treatment start date will be compared between the treatment arms stratifying for age group (age <65 years versus ≥65 years) and baseline severity grade, with death handled as competing risk, and the equivalence of cumulative incidence curve will be tested using the Gray's test at the 2-sided alpha level of 0.05. The unstratified cumulative incidence curve will be plotted for each treatment arm. Additionally, Cox regression model will be used to model the sub-distribution hazard ratio (HR) between treatment arms under the Fine and Gray's competing risk framework, with death handed as competing risk; the HR and its 95% Confidence Interval(CI) will be reported.
Measure: Time to sustained clinical improvement Time: Day 1 through Day 29Description: As defined by a sustained improvement of 2 points on a 6-point ordinal scale Analysis of response rate Conduct between the selected dose group and control using Cochran-Mantel-Haenszel (CMH) statistic, stratifying for age group (age <65 years versus ≥65 years), and baseline severity grade, and additional stratification factors if any as determined after evaluation of Stage 1 data. Sensitivity analyses on the response rate Fit the response variable using logistic regression, including treatment, baseline, baseline and treatment interaction, age group (age <65 years versus ≥65 years), and age group and treatment interaction as fixed effects.
Measure: Response rate Time: Day 29Description: Analyze using the same Cochran-Mantel-Haenszel (CMH) test and logistic regression.
Measure: Mortality Time: Day 29Description: Analyze using the same Cochran-Mantel-Haenszel (CMH) test and logistic regression.
Measure: Proportion of subjects alive and discharged without supplemental oxygen Time: Day 29Description: as defined by an improvement of 2 points on a 6-point ordinal scale. Use the same Cochran-Mantel-Haenszel (CMH) test and logistic regression model as in the primary endpoint.
Measure: Response rate Time: Day 2,8 and 15Description: Use the same Cochran-Mantel-Haenszel (CMH) test and logistic regression model as in the primary endpoint.
Measure: Proportion of subjects alive and discharge without supplemental oxygen Time: Day 15 and 57Description: Weight will be obtained on days when investigator drug is administered
Measure: Weight in kilogram Time: Day1 and Day8Description: Blood pressure will be obtained
Measure: Blood pressure in mmHg Time: Day 1 through Day14, Day 15 and 29Description: finger oxygen saturation will be obtained
Measure: saturation in percentage Time: Day 1 through Day14, Day 15 and 29Description: Temperature will be obtained
Measure: Temperature in ℃ Time: Day 1 through Day14, Day 15 and 29Description: Using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals
Measure: 12-lead electrocardiograms (ECGs) Time: Day 1 and 29Description: quantitative Polymerase Chain Reaction(PCR) for COVID 19 in nasopharyngeal swab
Measure: Virologic load Time: Day 1, 3, 5, 8 and 9 or 10, 29 and 57Description: Collection of blood samples for immunogenicity assessments # using validation Anti-body testing assay to test the presence of antidrug antibody
Measure: Antidrug antibody (ADA) titers Time: Day 1, 29, 57 and 84Description: disease-related secondary infection complications, hemolysis, Grade 4 (Common Terminology Criteria for Adverse Events V5 [CTCAE]) neutropenia and lymphopenia, and anaphylactic reactions defined by Clinical Criteria for Diagnosing Anaphylaxis(0); 20% decline in SpO2 between start and end of 1-hr study treatment infusion; ALT or AST >3 x ULN AND TBL >2 x ULN; Evidence of red blood cell (RBC) hemolysis as defined by 2 of the following 3 findings: Anemia that is not due to another obvious cause Increased reticulocyte count that is not explained by an obvious cause Signs of RBC destruction, such as increased lactate dehydrogenase (LDH), low haptoglobin ≤25 mg/dL, increased unconjugated bilirubin.
Measure: Adverse events (AEs) of special interest Time: 84 days (from first dose to the end of study)Description: Use the same Cochran-Mantel-Haenszel (CMH) test and logistic regression model as in the primary endpoint.
Measure: Mortality Time: Day 15 and 57Description: as defined by first day on which 1 of the following 2 categories is achieved using the 6-point ordinal scale： Not hospitalized Hospitalized, not requiring supplemental oxygen
Measure: Time to sustained recovery Time: Day 1 through Day 29Alphabetical 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