COVID-19 Clinical Trial
Official title:
Almitrine and Severe COVID-19 Patients in ICU [Almitrine et Patients COVID-19 en Reanimation (French)]
In severe COVID-19 pulmonary failure, the profound hypoxemia is mainly related to pulmonary
vasodilation with altered hypoxic pulmonary vasoconstriction (HPV). Besides prone
positioning, other non-ventilatory strategies may reduce the intrapulmonary shunt. This study
has investigated almitrine, a pharmacological option used in standard care to improve
oxygenation.
A case control series of mechanically ventilated confirmed COVID-19 patients was recorded.
At stable ventilatory settings, consecutive patients received two doses of almitrine (4 and
12 mcg/kg/min) at 30-45 min interval each, and were compared to 7 "control" COVID-matched
patients conventionally treated.
The end-point was the reduction of intra-pulmonary shunt, with an increase in partial
pressure of arterial oxygen (PaO2) and central venous oxygen saturation (ScvO2).
The clinical presentation of COVID-19 disease is heterogenous, ranging from no symptoms to
severe acute respiratory failure (ARF), which may have a poor prognosis. A severe hypoxemia
is associated with preserved respiratory mechanical properties, in particular the pulmonary
system compliance.
The hypoxia during the early phase seems to mainly result from an important
ventilation/perfusion (VA/Q) mismatch associated with an altered pulmonary vasoconstriction.
The "protective" mechanism called hypoxic pulmonary vasoconstriction (HPV) normally reduces
the blood flow in poorly or non-ventilated areas towards aerated zones leading to reduce the
(VA/Q) mismatch. HPV seems poorly functional in COVID-19 severe patients in absence of "cor
pulmonale".
According to the French National agency for Drug Security (ANSM, Paris, France), only iv
almitrine is indicated for hypoxic acute respiratory failure as Drug of Major Therapeutic
Interest. This molecule is a routine option in the treatment strategy of severe hypoxemia.
The investigators studied COVID-19 patients mechanically ventilated at FiO2 1 with a severe
intrapulmonary shunt during their early phase. The emergency conditions and the acute high
inflow of patients to ICU impeded the design of a randomized control trial. To eliminate the
eventuality of a spontaneous evolution of hypoxia, these patients will be compared with
control-matched COVID patients treated conventionally.
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