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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
---|---|---|
drug298 | Artemesia annua Wiki | 0.71 |
drug2703 | Pulmonary Vascular Permeability Index Wiki | 0.71 |
drug363 | Azinc Wiki | 0.71 |
Navigate: Correlations HPO
There are 2 clinical trials
Hydroxychloroquine, a derivative of chloroquine (an antimalarial drug) with a weak immunosuppressive effect, is prescribed by some teams alone or in combination with azithromycin. No randomized controlled trials have demonstrated its efficacy, particularly in primary care in the early stages of the disease. However, currently available data suggest better efficacy if treatment is given early in the disease, before symptoms worsen. To date, the majority of COVID-19 patients treated in outpatient care, particularly in general practice, represent the majority of COVID-19 patients. It is essential to evaluate, in primary care, the efficacy and safety of hydroxychloroquine combined with azithromycin in Covid-19 patients in order to be able to implement this therapeutic strategy as soon as the first symptoms appear. We realize a randomized, controlled, open superiority trial, in 2 parallel groups (ratio 1:1).The main objective is to assess the efficacy of Hydroxychloroquine combined with azithromycin in COVID-19 patients in primary care, in add-on to standard of care, on unfavorable outcome defined by the onset of at least one of the following between D0 and D14: hospitalization, death or percutaneous O² saturation ≤ 92% in ambient air.
Description: Unfavorable outcome defined by the onset of at least one of the following between randomization and day 14: hospitalization, death or percutaneous O² saturation ≤ 92% in ambient air
Measure: Rate of patients with occurrence of an unfavorable outcome between randomization and day 14 Time: between randomization and day14Description: Ancillary virological study : evolution of viral load between day 0 and day 14, measured by the threshold cycle,Ct, with PCR on naso-pharyngeal swab
Measure: Primary outcome of ancillary virological study : evolution of viral load between day 0 and day 14 Time: between day 0 and day 14Description: Unfavorable outcome defined by the onset of at least one of the following between randomization and day 28: hospitalization, death or percutaneous O² saturation ≤ 92% in ambient air
Measure: Rate of patients with occurrence of an unfavorable outcome between randomization and day 28 Time: between randomization and day 28Description: Time to resolution of all COVID-19 symptoms : no COVID symptom for at least 48 hours without symptomatic treatment in previous 24 hours
Measure: The time to resolution of all COVID symptoms at day 14 Time: day 14Description: Time to resolution of all COVID-19 symptoms : no COVID symptom for at least 48 hours without symptomatic treatment in previous 24 hours
Measure: The time to resolution of all COVID symptoms atday 28 Time: day 28Description: Clinical status on a 7-point ordinal scale : 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 ECMO; Death.
Measure: Clinical status at day 14 Time: day 14Description: Clinical status on a 7-point ordinal scale : 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 ECMO; Death.
Measure: Clinical status at day 28 Time: day 28Description: Ancillary virological study : rate of patients with negative viral load at PCR on naso pharyngeal swab at day 8
Measure: Ancillary virological study : rate of patients with negative viral load at day 8 Time: day 8Description: Ancillary virological study : rate of patients with negative viral load at PCR on naso pharyngeal swab at day 14
Measure: Ancillary virological study : rate of patients with negative viral load at day 14 Time: day 14This is a multi-arm, phase II trial for rapid efficacy and toxicity assessment of multiple therapies immediately after COVID19 positive testing in high-risk individuals. Therapies include stand-alone or combination treatment with hydroxychloroquine, azithromycin, ivermectin, or camostat mesilate, artemesia annua. The hypothesis of this study is that the addition of agents that inhibit viral entry or replication of SARS-CoV-2 virus replication in will be devoid of additional moderate to severe toxicities, will prevent clinical deterioration, and will improve viral clearance in high risk individuals.
Description: Proportion of patients experiencing clinical deterioration. Clinical deterioration is defined as a less than a 2-point change from the initial COVID 7-Point Ordinal Outcomes Scale within 14 days from the study start. This scale ranges from 1-7. Lower scores indicate worse outcomes (death); higher scores indicate fewer symptoms and better outcomes.
Measure: Clinical Deterioration Time: 14 daysDescription: The change in (clearance of) viral RNA will be measured by PCR testing at days 1, 14, 28, and 40 days.
Measure: Change in Viral Load Time: 40 daysDescription: Percentage of patients that experience severe respiratory or other organ failure.
Measure: Rate of Organ Failure Time: 28 daysDescription: Percentage of patients requiring ICU admission or ventilation.
Measure: Progression to ICU Care or Ventilation Time: 28 daysDescription: Clinical status will be assessed using the COVID 7-Point Ordinal Outcomes Scale. This scale ranges from 1-7. Lower scores indicate worse outcomes; higher scores indicate fewer symptoms and better outcomes.
Measure: Change in Clinical Status Time: 14 daysDescription: Percentage of patients who have died by day 14.
Measure: Mortality Time: 14 daysDescription: Percentage of patients experiencing severe adverse events, defined as grade 3 non-hematologic or greater by DMID Toxicity Scale for Determining Severity of Adverse Events.
Measure: Rate of severe adverse events Time: 14 daysDescription: Number of days patients do not require oxygen supplementation.
Measure: Oxygen-free days Time: 28 daysDescription: Number of days patients do not require mechanical ventilation.
Measure: Ventilator-free days Time: 28 daysDescription: Number of days patients do not require vasopressor treatment.
Measure: Vasopressor-free days Time: 28 daysDescription: Number of days patients do not require ICU services.
Measure: ICU-free days Time: 28 daysDescription: Number of days patients do not require hospitalization.
Measure: Hospital-free days Time: 28 daysDescription: Proportion of patients meeting Hy's law criteria.
Measure: Patients meeting Hy's Law criteria Time: 28 daysDescription: Proportion of patients with changes in the following liver function tests: Any ALT or AST ≥ 5 x ULN; any AST or ALT ≥ 3 x ULN together with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash and/or eosinophilia (eosinophil percent or count above the ULN); Persistent ALT ≥ 3 x ULN for a period of more than 4 weeks
Measure: Liver Function Time: 28 daysDescription: Proportion of patients with significant changes in ECG findings, including heart rate, ECG intervals (PR, QTcB, QTcF), conduction changes, or abnormalities including severe QTc prolongation of > 500 ms.
Measure: Heart Function 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