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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04451174
Recruitment Status : Terminated (Corticosteroid use approval)
First Posted : June 30, 2020
Last Update Posted : June 3, 2021
Sponsor:
Information provided by (Responsible Party):
Mauricio Salinas, University of Chile

Study Description
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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
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Prednisone

Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04451174


Locations
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Chile
Hospital Santiago Oriente
Santiago, Peñalolen, Chile, 7930124
Sponsors and Collaborators
University of Chile
Investigators
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Principal Investigator: Mauricio Salinas, MD University of Chile
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mauricio Salinas, Mauricio Salinas MD, University of Chile
ClinicalTrials.gov Identifier: NCT04451174    
Other Study ID Numbers: 2092
First Posted: June 30, 2020    Key Record Dates
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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