Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3262 | Ramipril 2.5 MG Oral Capsule Wiki | 0.58 |
| drug424 | Azithromycin 250 MG Oral Capsule Wiki | 0.58 |
| drug2080 | LAU-7b Wiki | 0.58 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D000073436 | Microvascular Rarefaction NIH | 0.58 |
| D019337 | Hematologic Neoplasms NIH | 0.20 |
| D009369 | Neoplasms, NIH | 0.10 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0001909 | Leukemia HPO | 0.15 |
| HP:0002664 | Neoplasm HPO | 0.10 |
Navigate: Correlations HPO
There are 3 clinical trials
In this study we propose to treat 560 patients with ramipril or placebo for 14 days. After an initial evaluation for COVID-19 status, medical history, and symptom assessment, patients will receive either 2.5 mg/day of ramipril or placebo. Patients' symptoms and study endpoints will be monitored at regular intervals. After 14 days, patients will undergo a laboratory assessment and an end-of-treatment follow-up visit at day 28. The primary endpoints of successful therapy will be improved survival, reductions in ICU admissions, and/or reductions in use of mechanical ventilator support.
Description: The major primary outcome to be evaluated is improving a composite outcome of mortality or need for ICU admission or ventilator use within a 14-day window.
Measure: Composite of mortality or need for ICU admission or ventilator use Time: 14 daysThe primary objective of this phase 2, multicentric, placebo-controlled double-blind, randomized study is to evaluate the efficacy of the combination of hydroxychloroquine and azithromycine on the viral load drop at day 5 among patients with COVID-19 and hematological malignancies.
Description: Locally evaluated rate of viral response. Favorable response is defined as (1) complete response : negative PCR (absence of detectable signal with a minimum of 40 cycles) or (2) major response : detectable signal but with an increased number of cycles > or egal to 10 compared to initial PCR. Response failure is defined as (1) minor response : detectable signal but with an increased number of cycles < 10 compared to initial PCR or (2) stabilisation or worsening of the viral load.
Measure: Evaluation of the efficacy of hydroxychloroquine and azithromyncine on the viral load drop at day 5. Time: 5 days of treatmentDescription: Duration of fever - duration of respiratory symptoms (cough, dyspnea) - duration of other COVID-19 related symptoms (digestive symptoms, ageusia, anosmia)
Measure: Clinical evolution Time: up to 3 monthsDescription: Less or equal to 94% oxygen saturation - need to initiate oxygenotherapy - occurrence of respiratory distress - patient transfer in intensive care unit - need of mechanical ventilation - occurrence of non-respiratory organ failure - occurrence of septic shock
Measure: Proportion of patients progressing to a severe form Time: up to 3 monthsDescription: Date and cause of death
Measure: Mortality Time: up to 1 and 3 monthsDescription: SARS-CoV-2 viral load by PCR on nasopharyngeal swab at day 10 (if positive at day 5) : rate of negativation and comparison of number of cycles with previous samples
Measure: Evaluation of viral load drop Time: at day 10Description: Frequence and causality of all-grade cardiac adverse events - frequence and causality of grade > 1 adverse events for other adverse events - frequence and causality of serious adverse events (CTCAE v5)
Measure: Tolerance of study treatment Time: up to 3 monthsDescription: Collection of serum to realize serological tests
Measure: Evaluation of the seroconversion Time: at inclusion, day 10, day 30 and day 90 after treatmentDescription: Phenotypic and functional study of NK lymphocytes at inclusion, Retrospective analysis on frozen cells.
Measure: NK immunological study Time: at day 10 and day 30 after treatmentDescription: Duration of hospitalisation (conventional, intensive care, reanimation)
Measure: Hospitalisation duration Time: up to 3 monthsDescription: Patient follow-up during 3 months : hematological status and associated therapy
Measure: Impact of the study treatment on the treatment of the hematological disease Time: up to 3 monthsDescription: ECG (using connected machine to allow monitoring at home)
Measure: Monitoring of the QT space Time: at inclusion, day 2, day 5, day 10Description: Dosage of residual concentration of azithromycine and hydroxychloroquine.
Measure: Dosage of residual concentration of azithromycine and hydroxychloroquine. Time: at day 5 and day 10Description: Phenotypic and functional study of T lymphocytes at inclusion, Retrospective analysis on frozen cells.
Measure: T immunological study Time: at day 10 and day 30 after treatmentA randomized, double-blind, placebo-controlled Phase 2 Study of LAU-7b against confirmed COVID-19 Disease in hospitalized patients at a higher risk of complications.
Description: 7-point ordinal scale, a higher score is worse than a low score. Not hospitalized, no limitations on activities; Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation; Death.
Measure: Health status of the patient on the 7-point ordinal scale (World Health Organization) compared to placebo Time: On Day 14Description: This will be assessed through monitoring and probing
Measure: The safety of LAU-7b therapy will be assessed through the monitoring of treatment emergent adverse events, compared to placebo Time: From baseline to Day 29Description: This will be assessed through daily health status scoring using the 7-point ordinal scale
Measure: Rate of COVID-19 disease-related aggravation, depicted by a change from baseline in the ordinal scale score of at least one category, compared to placebo Time: From baseline to Day 29Description: This will be assessed through daily health status scoring using the 7-point ordinal scale
Measure: Rate of COVID-19 disease-related transfer to intensive care unit, depicted by a change from baseline in the ordinal scale score to categories 5 or 6, compared to placebo Time: From baseline to Day 29Description: This will be assessed through daily health status scoring using the 7-point ordinal scale
Measure: Rate of COVID-19 disease-related transfer to mechanical ventilation, depicted by a change from baseline in the ordinal scale score to category 6, compared to placebo Time: From baseline to Day 29Description: This will be assessed through Days 14 and 29 health status scoring using the 7-point ordinal scale
Measure: Rate of COVID-19 disease-related death, depicted by a change from baseline in the ordinal scale score to category 7 Time: On Days 14 and 29Description: 7-point ordinal scale, a higher score is worse than a low score. Not hospitalized, no limitations on activities; Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation; Death.
Measure: Health status of the patient on the 7-point ordinal scale (World Health Organization), compared to placebo Time: On Day 29Description: This will be assessed through daily health status scoring using the 7-point ordinal scale
Measure: Mean change from baseline of the ordinal scale patient health status as a function of assessment time, compared to placebo Time: From baseline to Day 29Description: This will be assessed through daily health status scoring using the 7-point ordinal scale
Measure: Time to an improvement of one category on the ordinal scale patient health status, compared to placebo Time: From baseline to Day 29Description: This will be assessed through daily health status scoring using the 7-point ordinal scale
Measure: Time to recovery, defined here as the time to reach categories 2 or 1 on the ordinal scale patient health status (first occurrence if more than once), compared to placebo Time: From baseline to Day 29Description: This will be assessed through daily health status scoring using the 7-point ordinal scale
Measure: Time to mechanical ventilation, defined here as time to reach category 6 on the ordinal scale patient health status, compared to placebo Time: From baseline to Day 29Description: This will be assessed through daily health status scoring using the 7-point ordinal scale
Measure: Time to death, defined here as a tim to reach category 7 on the ordinal scale patient health status, censored to Day 29 if it happens later than Day 29, compared to placebo Time: From baseline to Day 29Description: Monitoring of the hospitalization
Measure: Duration of hospitalization (days) within the study period Days 1-29, compared to placebo Time: From baseline to Day 29Description: This will be assessed through serial oropharyngeal swabs for SARS-CoV-2 viral detection
Measure: Time to attain an undetectable viral load through oropharyngeal swabs done at specified times, compared to placebo Time: On Days 1, 5, 8, 12 and 14Description: This will be assessed through questionnaire filling, in person or remotely
Measure: The change from baseline in the score obtained on the EQ-5D-5L quality-of-life survey Time: On Days 1, 14, 29 and 60Alphabetical 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