Covid 19 Research using Clinical Trials (Home Page)
AzincWiki
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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug389 | Hydroxychloroquine and Azithromycin Wiki | 1.00 |
| drug143 | CAStem Wiki | 1.00 |
Correlated MeSH Terms (7)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D055370 | Lung Injury NIH | 0.32 |
| D011024 | Pneumonia, Viral NIH | 0.17 |
| D055371 | Acute Lung Injury NIH | 0.16 |
| D013577 | Syndrome NIH | 0.15 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.15 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.13 |
| D011014 | Pneumonia NIH | 0.08 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There is one clinical trial.
Clinical Trials
1 Efficacy of Azithromycin-associated Hydroxychloroquine Therapy Given in General Practice in Early-stage Disease in COVID-19 Patients: Randomized Controlled Trial: MG-COVID
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.
NCT04371406 Covid-19 Drug: Hydroxychloroquine and Azithromycin Dietary Supplement: Azinc
Primary Outcomes
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 14Secondary Outcomes
Measure: The all-cause mortality rate at day 14 Time: day 14Measure: The all-cause mortality rate at day 28 Time: day 28
Description: 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 28Measure: The rate of use of mechanical ventilation at day 14 Time: day 14
Measure: The rate of use of mechanical ventilation at day 28 Time: day 28
Measure: The Intensive Care Unit admission rate at day 14 Time: day 14
Measure: The Intensive Care Unit admission rate at day 28 Time: day 28
Measure: Number of days of hospitalization for any cause between day 0 and day 14 Time: between randomization and day 14
Measure: Number of days of hospitalization for any cause between day 0 and day 28 Time: between randomization and day 28
Description: 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 28Measure: The rate of use of oxygen therapy at day 14 Time: between randomization and day 14
Measure: The rate of use of oxygen therapy at day 28 Time: between randomization and day 28
Measure: The rate of use of secondary antibiotic therapy (after day 2) at day 14 Time: between randomization and day 14
Measure: The rate of use of secondary antibiotic therapy (after day 2) at day 28 Time: between randomization and day 28
Description: 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 28Measure: number of serious adverse events at day 14 Time: day 14
Measure: number serious adverse events at day 28 Time: day 28
Measure: number of adverse events at day 14 Time: day 14
Measure: number of adverse events at day 28 Time: day 28
Measure: The rate of patients with treatment withdrawal Time: day 14
Description: 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 14