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

Tracking Information

• First Submitted Date: June 26, 2020
• First Posted Date: June 30, 2020
• Last Update Posted Date: June 3, 2021
• Actual Study Start Date: June 23, 2020
• Actual Primary Completion Date: January 30, 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: COVID-19

Intervention

Drug: Prednisone

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

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: May 30, 2021): 60
• Original Estimated Enrollment (submitted: June 26, 2020): 184
• Actual Study Completion Date: January 30, 2021
• Actual Primary Completion Date: January 30, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Chile

Administrative Information

• NCT Number: NCT04451174
• Other Study ID Numbers: 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

• 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

• Current Responsible Party: Mauricio Salinas, University of Chile
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Chile
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Chile
• Verification Date: May 2021