Steroids has shown benefits in COVID19 patients in observational studies. We hypothesized that early use of corticosteroids, low dose, in mild disease, can decrease progression to respiratory failure and death.
We are in the middle of a coronavirus pandemic, facing a large number of infections in
serious cases and an increasing number of deaths in Chile. As of June 11, 2020, there are
154092 cases confirmed by COVID - 19 i and 2648 deaths in our country.
Most patients have mild disease, but older people and those with comorbidities can develop
severe disease that requires hospitalization, some form of ventilatory support, and
eventually intensive care unit admission. The pathophysiology occurs in two different
overlapping phases, the initial pathogen with viral replication, followed by the host's
inflammatory response with varying degrees of severity associated with different clinical
characteristics. The pathological progression in some cases of severe COVID-19 would be
explained by an excess of proinflammatory cytokines, which leads to diffuse alveolar damage,
with the development of acute respiratory distress syndrome (ARDS) and inflammatory
compromise of multiple systems until death.
In the absence of any proven antiviral therapy, current clinical treatment is primarily
supportive care, supplemental oxygen, and mechanical ventilatory support.
Clinical trials have been published and called to demonstrate the usefulness of therapies in
the context of this pandemic.
The role of corticosteroids is not fully defined. Observational studies report better results
in decreasing disease progression in those COVID-19 patients who received corticosteroids
early.
We hypothesize in this study that treatment in mild disease (defined as that requiring
supplemental oxygen, but without the need for ventilatory support) can attenuate the host's
excessive respiratory and systemic inflammatory responses.
The objective of this study is to evaluate the effect of early treatment with prednisone to
decrease the progression of the disease.
Drug: Prednisone
Prednisone 40 mg days 1 to 4. Then, prednisone 20 mg days 5 to 8.
Inclusion Criteria:
- 18 years or more
- COVID-19 confirmed by PCR
- Oxygen requirements until 35 % by venturi mask or 5 lt minutes by nasal cannula
- Consent form signed
Exclusion Criteria:
- Previous steroid use 48 hours or more.
- Pregnancy
- Chronic respiratory failure
- Requirements of mechanical ventilation (invasive or no invasive)
- Chronic liver damage Child Pugh B or C
- Chronic kidney disease stage IV or V.
- Immunosuppressed
- Participation on other trial.
Hospital Santiago Oriente
Santiago, Peñalolen, Chile
Mauricio Salinas, MD, Principal Investigator
University of Chile