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

• ClinicalTrials.gov Identifier: NCT04451174
• Recruitment Status: Terminated
• First Posted: June 30, 2020
• Last Update Posted: June 3, 2021
• Sponsor: University of Chile
• Information provided by (Responsible Party): Mauricio Salinas, University of Chile

Study Description

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.

Condition or disease	Intervention/treatment	Phase
COVID-19	Drug: Prednisone	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia (PREDCOVID)
• Actual Study Start Date: June 23, 2020
• Actual Primary Completion Date: January 30, 2021
• Actual Study Completion Date: January 30, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment; Prednisone 40 mg days 1 to 4. Then Prednisone 20 mg days 5 to 8.	Drug: Prednisone; Prednisone 40 mg days 1 to 4. Then, prednisone 20 mg days 5 to 8.
No Intervention: Control

Outcome Measures

Primary Outcome Measures :

1. Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation or All-cause Death by Day 28 [ Time Frame: 28 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Chile

Hospital Santiago Oriente

Santiago, Peñalolen, Chile, 7930124

Sponsors and Collaborators

University of Chile

Investigators

• Principal Investigator: Mauricio Salinas, MD; University of Chile

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Mauricio Salinas, Mauricio Salinas MD, University of Chile
• ClinicalTrials.gov Identifier: NCT04451174
• Other Study ID Numbers: 2092
• First Posted: June 30, 2020
• Last Update Posted: June 3, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)
• Time Frame: starting 6 months after publication

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Pneumonia; Respiratory Tract Infections; Infections; Pneumonia, Viral; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Prednisone; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents