Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia (PREDCOVID)
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation or All-cause Death by Day 28
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Treatment
Prednisone 40 mg days 1 to 4. Then Prednisone 20 mg days 5 to 8.
Intervention: Prednisone (Drug)
Outcomes
Primary Outcomes
Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation or All-cause Death by Day 28
Time Frame: 28 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Mauricio Salinas
Mauricio Salinas MD
University of Chile