Status:
WITHDRAWN
Patient Preference Trial for COVID-19 (PPT-COVID)
Lead Sponsor:
Centre Hospitalier Princesse Grace
Conditions:
Coronavirus
Eligibility:
All Genders
18-99 years
Brief Summary
To date no treatment has proven its effectiveness in the caring of patients infected with type 2 Coronavirus. The Centre Hospitalier Princesse Grace (CHPG) has decided to only propose randomized doubl...
Detailed Description
Conduct of the research * Pre-selection / Recruitment It is proposed to participate in the study to patients who cannot or do not wish to participate in a randomized therapeutic trial. * Inclusion pr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 6 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 4 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04418193
Start Date
April 6 2020
End Date
February 4 2021
Last Update
February 9 2021
Active Locations (1)
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1
Centre Hospitalier Princesse Grace
Monaco, Monaco, 98000