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

NCT04451174 | Terminated Phase 3

• 1 other identifier: 2092
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation or All-cause Death by Day 28

  28 days

Study Arms (2)

Treatment

EXPERIMENTAL

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

Drug: Prednisone

Control

NO INTERVENTION

Interventions

Prednisone DRUG

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

Treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Hospital Santiago Oriente

Santiago, Peñalolen, 7930124, Chile

Location

Related Publications (1)

• 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.

  PMID: 33499887 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Mauricio Salinas, MD

  University of Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mauricio Salinas MD

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: June 30, 2020
• Study Start: June 23, 2020
• Primary Completion: January 30, 2021
• Study Completion: January 30, 2021
• Last Updated: June 3, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: starting 6 months after publication

Locations

CL (1)