Name (Synonyms) | Correlation | |
---|---|---|
drug265 | Azithromycin 250 MG Oral Capsule Wiki | 0.58 |
drug2922 | non-RAS blocking antihypertensives Wiki | 0.58 |
drug518 | Candesartan Wiki | 0.58 |
drug338 | Best standard of care Wiki | 0.58 |
drug2516 | Thromboprophylaxis Wiki | 0.58 |
drug2023 | Ramipril 2.5 MG Oral Capsule Wiki | 0.58 |
drug2952 | placebo for clazakizumab Wiki | 0.58 |
drug1305 | LAU-7b Wiki | 0.58 |
drug541 | ChAdOx1 MERS Wiki | 0.41 |
drug566 | Chloroquine or Hydroxychloroquine Wiki | 0.33 |
drug1108 | Hydroxychloroquine Sulfate 200 MG [Plaquenil] Wiki | 0.33 |
drug2105 | Rivaroxaban Wiki | 0.33 |
drug1368 | Lopinavir/Ritonavir Wiki | 0.33 |
drug576 | Clazakizumab Wiki | 0.26 |
drug1853 | Placebo oral tablet Wiki | 0.11 |
Name (Synonyms) | Correlation | |
---|---|---|
D019337 | Hematologic Neoplasms NIH | 0.22 |
D009369 | Neoplasms, NIH | 0.13 |
D013577 | Syndrome NIH | 0.06 |
D018352 | Coronavirus Infections NIH | 0.05 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0001909 | Leukemia HPO | 0.16 |
HP:0002664 | Neoplasm HPO | 0.13 |
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 60