Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 1:24 AM
NCT ID:
NCT04418193
Eligibility Criteria:
Inclusion Criteria:
* Adult patients (18+)
* Infection with COVID-19 diagnosed by positive RT-PCR SARS-CoV-2 or, if not performed, by thorax CT-scan suggesting viral pneumonia of peripheral predominance in a clinically significant context.
* Diagnosed within the previous 48 hours.
* Having at least one of the following two risk factors for complications:
* age ≥75 years old
* Peripheral oxygen saturation (SpO2) ≤ 94% while breathing ambient air, or a partial oxygen pressure (PaO2) to fraction of inspired oxygen (FiO2) ratio ≤ 300 mmHg.
* Patients affiliated with or benefitting from a social security scheme
* Written and signed consent of the patient or a relative or, if not possible, emergency inclusion procedure
* Electrocardiogram showing absence of QT prolongation greater than 440 ms in men and 460 ms in women.
* Patient that can't or don't want to participate to a randomized clinical trial
Exclusion Criteria:
* Age below 18-year of age
* Negative RT-PCR SARS-CoV-2
* Peripheral capillary oxygen saturation less than or equal to 94% (SpO2≤94%) despite oxygen therapy greater than or equal to 3 L/min (≥ 3 L/min)
* Organ failure requiring admission to a resuscitation or high dependency unit
* Comorbidity that is life-threatening in the short-term (life expectancy \<3 months)
* Any reason that makes follow-up at day 28 impossible
* Current treatment with hydroxychloroquine or hydroxychloroquine plus azithromycin
* Absolute contraindication to treatment with hydroxychloroquine (known hypersensitivity, concomitant treatment with risk of torsades de pointe) or azithromycin (known hypersensitivity to azithromycin, erythromycin, other macrolide, ketolide, in association with rye ergot alkaloids, cisapride, colchicine or severe hepatic failure)
* glucose-6-phosphate dehydrogenase (G6PD) known deficit
* Porphyria
* Hypokaliemia \< 3.5 mmol/L
* Electrocardiogram showing corrected QT prolongation greater than 440 ms in men and 460 ms in women
* Child C liver cirrhosis
* Chronic kidney failure with estimated glomerular filtration rate (GFR) ≤ 30 ml/min
* Pregnant, lactating or parturient women
* Patient included in a randomized clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT04418193
Study Brief:
Protocol Section:
NCT04418193