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

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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

Tracking Information
First Submitted Date  ICMJE June 26, 2020
First Posted Date  ICMJE June 30, 2020
Last Update Posted Date June 3, 2021
Actual Study Start Date  ICMJE June 23, 2020
Actual Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2020)
Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation or All-cause Death by Day 28 [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia
Official Title  ICMJE Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia (PREDCOVID)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE Drug: Prednisone
Prednisone 40 mg days 1 to 4. Then, prednisone 20 mg days 5 to 8.
Study Arms  ICMJE
  • Experimental: Treatment
    Prednisone 40 mg days 1 to 4. Then Prednisone 20 mg days 5 to 8.
    Intervention: Drug: Prednisone
  • No Intervention: Control
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 30, 2021)
60
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2020)
184
Actual Study Completion Date  ICMJE January 30, 2021
Actual Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04451174
Other Study ID Numbers  ICMJE 2092
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: starting 6 months after publication
Responsible Party Mauricio Salinas, University of Chile
Study Sponsor  ICMJE University of Chile
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mauricio Salinas, MD University of Chile
PRS Account University of Chile
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP