Clinical trial NCT04451174: Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia
Official title: Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia (PREDCOVID)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: COVID-19
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation or All-cause Death by Day 28
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Santiago Oriente
state: Peñalolen
Study officials:
affiliation: University of Chile
name: Mauricio Salinas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salinas M, Andino P, Palma L, Valencia J, Figueroa E, Ortega J. Early use of corticosteroids in non-critical patients with COVID-19 pneumonia (PREDCOVID): a structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Jan 26;22(1):92. doi: 10.1186/s13063-021-05046-6.