French hospital started clinical trial of Spironolactone Treatment for ICU patients with COVID-19 suffering from ARDS
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The hospital group in France, Assistance Publique Hopitaux De Marseille is conducting the clinical trial of Losartan and Spironolactone Treatment for ICU Patients With COVID-19 Suffering From ARDS (COVIDANCE).
Coronavirus disease (COVID-19) is a current pandemic infection caused by an RNA virus called Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). Severe forms of COVID-19 are most often responsible for isolated respiratory failure in the form of acute respiratory distress syndrome (ARDS), which accounts for most of the mortality. Angiotensin converting enzyme 2 (ACE2) has been shown to be a co-receptor for the entry of SARS-CoV-2 into cells and is likely to play a prolonged role in the pathogenesis of COVID-19. ACE2 and angiotensin (1-7) have been shown to be protective in a number of different lung lesion models. In a mouse model of acidic lung injury, negative regulation of ACE2 by COVID, the SARS virus responsible for the 2003 SARS outbreak, worsened the lung injury which was improved by treatment with ARBs.
The main expected outcome is an improved prognosis with a decrease in the SOFA severity score at 7 days in resuscitation patients, resulting in an improvement in organ failure.
Actual study start date is September 11, 2020. The researchers expect to complete the study by October 30, 2022.
Adult patients with respiratory distress requiring oxygen support of 6 liters per minute or more with News-Score greater than 6 PCR SARS-CoV-2 positive in a pharyngeal or respiratory specimen can be enroled into this study.
There are a number of conditions that do not allow participation, such as:
- Hypotension justifying treatment with norepinephrine.
- Acute renal failure with a clearance of less than 60ml/min.
- Severe liver failure.
- Intolerance or contraindication to losartan or spironolactone.
The location of the study is as follows (further details can be found here https://ichgcp.net/clinical-trials-registry/NCT04643691) Marseille, France.
