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

NCT ID: NCT04451174

Last Updated: 2021-06-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-23
• Study Completion Date: 2021-01-30

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment

Prednisone 40 mg days 1 to 4. Then Prednisone 20 mg days 5 to 8.

Group Type: EXPERIMENTAL

Prednisone

Intervention Type: DRUG

Prednisone 40 mg days 1 to 4. Then, prednisone 20 mg days 5 to 8.

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Prednisone

Prednisone 40 mg days 1 to 4. Then, prednisone 20 mg days 5 to 8.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chile

OTHER

Sponsor Role: lead

Responsible Party

Mauricio Salinas

Mauricio Salinas MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mauricio Salinas, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Locations

Hospital Santiago Oriente

Santiago, Peñalolen, Chile

Countries

Chile

References

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.

Reference Type: DERIVED

PMID: 33499887 (View on PubMed)

Other Identifiers

2092

Identifier Type: -

Identifier Source: org_study_id