Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia (PREDCOVID)
Primary Purpose
COVID-19
Status
Terminated
Phase
Phase 3
Locations
Chile
Study Type
Interventional
Intervention
Prednisone
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
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.
Sites / Locations
- Hospital Santiago Oriente
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Control
Arm Description
Prednisone 40 mg days 1 to 4. Then Prednisone 20 mg days 5 to 8.
Outcomes
Primary Outcome Measures
Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation or All-cause Death by Day 28
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04451174
Brief Title
Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia
Acronym
PREDCOVID
Official Title
Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia (PREDCOVID)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
Corticosteroid use approval
Study Start Date
June 23, 2020 (Actual)
Primary Completion Date
January 30, 2021 (Actual)
Study Completion Date
January 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Prednisone 40 mg days 1 to 4. Then Prednisone 20 mg days 5 to 8.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone 40 mg days 1 to 4. Then, prednisone 20 mg days 5 to 8.
Primary Outcome Measure Information:
Title
Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation or All-cause Death by Day 28
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauricio Salinas, MD
Organizational Affiliation
University of Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Santiago Oriente
City
Santiago
State/Province
Peñalolen
ZIP/Postal Code
7930124
Country
Chile
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
starting 6 months after publication
Citations:
PubMed Identifier
33499887
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.
Results Reference
derived
Learn more about this trial
Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia
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