Status:
TERMINATED
Hydroxychloroquine Versus Placebo in COVID-19 Patients at Risk for Severe Disease
Lead Sponsor:
University Hospital, Angers
Conditions:
Coronavirus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A new human coronavirus responsible for pneumonia, SARS-CoV-2, emerged in China in December 2019 and has spread rapidly. COVID-19, the disease caused by this virus, has a very polymorphous clinical pr...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age ≥ 18 years old
- Symptomatic infection with COVID-19 confirmed by positive RT-PCR SARS-CoV-2 or, failing that, by thorax CT-scan suggesting viral pneumopathy of peripheral predominance in a clinically significant context.
- Diagnosis in the previous two calendar days or, for an asymptomatic patient at the time of virological diagnosis, onset of symptoms in the previous two calendar days.
- Patient having at least one of the following risk factors for developing complications:
- Age ≥75 years old
- Age between 60 and 74 years old and presence of at least one comorbidity among the following: obesity (body mass index ≥ 30 kg/m²), arterial hypertension requiring treatment, diabetes mellitus requiring treatment
- Need for supplemental oxygen to reach a peripheral capillary oxygen saturation of more than 94% (SpO2 \> 94%), or a ratio of partial oxygen pressure to the fraction of inspired oxygen less than or equal to 300 mmHg (PaO2/FiO2 ≤ 300 mmHg).
- Patient affiliated to a social security scheme.
- Written and signed consent of the patient or a relative or emergency inclusion procedure.
- Exclusion criteria
- Last RT-PCR negative for 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 critical or intensive care unit.
- Comorbidity that is life threatening in the short-term (life expectancy \< 3 months)
- Any reason that makes patient follow-up throughout the study impossible
- Current treatment with hydroxychloroquine
- Absolute contraindication to treatment with hydroxychloroquine (known hypersensitivity, retinopathy, concomitant treatment with risk of ventricular disorders, particularly torsades de pointe, known deficit of glucose-6-phosphate dehydrogenase, porphyria)
- Hypokalaemia \< 3.5 mmol/L
- Corrected QT prolongation (QTc ≥ 440 ms in men and 460 ms in women).
- Child-Pugh's class C liver cirrhosis
- Chronic kidney failure with estimated GFR ≤ 30 ml/min, or ≤ 40 ml/min in patients with concomitant treatment with azithromycin
- Women who are pregnant, breastfeeding, or parturient
Exclusion
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2020
Estimated Enrollment :
259 Patients enrolled
Trial Details
Trial ID
NCT04325893
Start Date
April 1 2020
End Date
June 18 2020
Last Update
October 6 2020
Active Locations (47)
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1
CH Agen
Agen, France
2
CHU Amiens
Amiens, France
3
CHU Angers
Angers, France
4
CH Auxerre
Auxerre, France