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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3345 | Respiratory Training Wiki | 0.58 |
| drug227 | Aerobic training Wiki | 0.58 |
| drug1015 | Computer task questionnaires Wiki | 0.58 |
Navigate: Correlations HPO
There are 3 clinical trials
This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult patients with Coronavirus Disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute respiratory distress syndrome. Patients will be randomly assigned to receive ravulizumab in addition to best supportive care (BSC) (2/3 of the patients) or BSC alone (1/3 of the patients). Best supportive care will consist of medical treatment and/or medical interventions per routine hospital practice.
- This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications. - Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first. - Subjects will be randomized to receiving convalescent plasma or best supportive care. - Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease. - The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study.
Description: The hospitalization rate will be summarized by frequency (%) and compared between the Treatment and Control arms by Mantel-Haenszel test.
Measure: Hospitalization Rate Time: 10 DaysDescription: The time to symptoms resolution is defined as the time in days from therapies initiation to the first documented symptoms resolution as assessed by a local site. Patients whose symptoms are not resolved, or result in death, or lost follow-up on the designed follow-up date, will be censored on that date.
Measure: Time to symptoms resolution Time: 2 MonthsDescription: Overall survival (OS) will be defined as the time in days from study entry to death. Patients who are alive on the date of closing follow-up will be censored on that date.
Measure: Overall survival Time: 2 MonthsDescription: Univariate test will be performed in terms of identifying the association between exploratory objective and the hospitalization rate, Mantel-Haenszel test for categorical variables, and t-test or its non-parametric version for the continuous variables based on the normalized of the data.
Measure: Plasma product's cytokine level assessment Time: Day 0Description: Safety assessment will be performed on infusion day for the Treatment group (immediately post infusion), and for all patients on randomization day +3 and +7 days (by telephone, closest business day is acceptable), +2 weeks (+/- 3 days), +4 weeks (+/- 3 days).
Measure: Rates of adverse events associated with convalescent plasma infusion. Time: Day 3 and 7, Weeks 2 and 4Plasma, the supernatant part of blood, contains a variety of different proteins, including immunoglobulins. These proteins, also called antibodies, are directed to previous foreign infecting organisms, such as virus, bacteria or parasites. Patients recovering from SARS-Cov-2 infection may develop protective antibodies which can prevent reinfection with the same agent or similar organisms with shared molecular structures. Those antibodies may be transferred to other patients through collection of such convalescent plasma from recovered donors and its transfusion to ill patients. In this research, the primary hypothesis is that those antibodies can exert passive immunization and help ameliorate symptoms from COVID-19 (Coronavirus Disease 2019), resulting in higher clinical improvement rates at day 28, especially when administered early in the infection course.
Description: Improvement of 2 points from randomization in a 6-point ordinal severity scale (6 points, death; 5 points, hospitalization plus extracorporeal membrane oxygenation (ECMO) or invasive mechanical ventilation; 4 points, hospitalization plus noninvasive ventilation or high-flow supplemental oxygen; 3 points, hospitalization plus supplemental oxygen (not high-flow or noninvasive ventilation); 2 points, hospitalization with no supplemental oxygen; 1 point, hospital discharge)
Measure: Clinical improvement Time: 28 daysDescription: Proportions of individuals classified in each 6-point ordinal scale strata
Measure: 6-point ordinal scale proportion at 14 days Time: 14 days from randomizationDescription: Proportions of individuals classified in each 6-point ordinal scale strata
Measure: 6-point ordinal scale proportion at 28 days Time: 28 days from randomizationDescription: Death from any cause after randomization
Measure: Overall mortality Time: 14 daysDescription: Death from any cause after randomization
Measure: Overall mortality Time: 28 daysDescription: Days free of respiratory support during follow up
Measure: Days alive and free of respiratory support (DAFOR28) Time: 28 daysDescription: Duration of invasive ventilatory support (for those who received mechanical ventilation)
Measure: Mechanical ventilation Time: 28 daysDescription: PaO2/FiO2 ratio at 7 days of follow up
Measure: PaO2/FiO2 ratio Time: At the 7th day of randomizationDescription: Time from randomization to hospital discharge (for 28-day survivors)
Measure: Hospital stay Time: 28 daysDescription: LDH (U/L)
Measure: Lactate Dehydrogenase Time: Randomization day, Day 3, Day 7 and Day 14Description: Troponin I (pg/mL)
Measure: Troponin I Time: Randomization day, Day 3, Day 7 and Day 14Description: CRP (mg/L)
Measure: C Reactive Protein Time: Randomization day, Day 3, Day 7 and Day 14Description: D-Dimers (mcg/mL)
Measure: D-Dimers Time: Randomization day, Day 3, Day 7 and Day 14Description: Fibrinogen (mg/dL)
Measure: Fibrinogen Time: Randomization day, Day 3, Day 7 and Day 14Description: PT (seconds)
Measure: Prothrombin Time (PT) Time: Randomization day, Day 3, Day 7 and Day 14Description: APTT (seconds)
Measure: Activated Partial Thromboplastin Time (APTT) Time: Randomization day, Day 3, Day 7 and Day 14Description: TNF-Alfa (pg/mL)
Measure: Tumor Necrosis Factor Alfa (TNF-Alfa) Time: Randomization day, Day 3, Day 7 and Day 14Description: IL-6 (pg/mL)
Measure: Interleukin-6 (IL-6) Time: Randomization day, Day 3, Day 7 and Day 14Description: Nasal and Oropharyngeal Swab RT-PCR
Measure: RT-PCR Time: At the 7th day of randomization (or at hospital discharge if earlier than 7 days)Description: SOFA score at 7 days of randomization (ranges from 0 to 24, prognosis worsens with higher score values)
Measure: Sequential Organ Failure Assessment (SOFA) score Time: At the 7th day of randomizationDescription: Change in NEWS 2 from randomization at 7 days and 14 days (ranges from 0 to 20, prognosis worsens with higher score values)
Measure: National Early Warning Score 2 (NEWS) 2 Time: 7 and 14 days of randomizationDescription: CTCAE grade 3-4 events during follow up
Measure: Safety and Adverse Events Time: 28 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