Corticosteroids During Covid-19 Viral Pneumonia Related to SARS-Cov-2 Infection
Status:
Terminated
Trial end date:
2020-08-18
Target enrollment:
Participant gender:
Summary
Infection with the SARS-Cov-2 virus, responsible of severe acute respiratory distress
syndrome (SARS), is an emerging infectious disease called Covid-19 and declared as pandemic
by the World Health Organization on March 11, 2020. This pandemic is responsible of
significant mortality. In France, several thousand patients are hospitalized in intensive
care units, and their number continues to increase. Mortality during Covid-19 is mainly
linked to acute respiratory distress syndrome, which frequency is estimated in France to
occur in 6% of infected patients. Comorbidities such as cardiovascular conditions, obesity
and diabetes increase susceptibility to severe forms of Covid-19 and associated mortality.
Therapeutic management has three components: symptomatic management, including supplementary
oxygen therapy and in case of respiratory distress mechanical ventilation; the antiviral
approach; and immunomodulation, aiming at reducing inflammation associated with viral
infection, which is considered to take part in severe presentations of the disease.
During Covid-19 viral pneumonia related to SARS-COv-2, there is a significant release of
pro-inflammatory cytokines in the acute phase of viral infection, which could participate in
viral pneumonia lesions. In children with less mature immune system than adults, SARS-Cov-2
infection is less severe. The current prevailing assumption is that severe forms of Covid-19
may not only be related to high viral replication, but also to an excessive inflammatory
response favoring acute lung injury and stimulating infection.
The investigators hypothesize that early control of the excessive inflammatory response may
help reducing the risk of acute respiratory distress syndrome.
The investigators will evaluate the benefit, safety and tolerability of corticosteroid
therapy to reduce the rate of subjects hospitalized for Covid-19 viral pneumonia who
experience clinical worsening with a need of high-flow supplemental oxygen supplementation or
transfer in intensive care units for respiratory support.