NCT04451174

Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia

Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia (PREDCOVID)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Chile · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Prednisone	Prednisone 40 mg days 1 to 4. Then, prednisone 20 mg days 5 to 8.

Timeline

• Start date: 2020-06-23
• Primary completion: 2021-01-30
• Completion: 2021-01-30
• First posted: 2020-06-30
• Last updated: 2021-06-03

Locations

1 site across 1 country: Chile