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Objectives  To evaluate the efficacy of early treatment with prednisone to decrease the progression of COVID-19 pneumonia.    Trial design  This is a pragmatic, non-blinded, randomized, two arms, parallel trial.    Participants  Patients between 18 and 90 years, with COVID-19 pneumonia, confirmed by RT PCR. The setting for the trial is the Hospital Santiago Oriente which is a secondary level hospital with an emergency room, intensive care, and all basic specialties of medicine.  Inclusion Criteria:    18 years or more    COVID-19 confirmed by RT-PCR    Oxygen requirements up to 35% by venturi mask or 5 liters per minute by nasal cannula (approximately FiO2 40%)    Consent form signedExclusion Criteria:    Previous steroid use for more than 48 hours.    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 in another trial.Intervention and comparator  Experimental arm  Prednisone 40 mg days 1 to 4. Then Prednisone 20 mg days 5 to 8. Usual care defined by the attending physician.  Control arm  No intervention. Usual care defined by the attending physician.    Main outcomes  Primary outcome  Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation or All-cause Death by Day 28  Secondary outcomes (followed until day 28).    Time to respiratory deterioration    Incidence of patients requiring mechanical ventilation:    Number of days on mechanical ventilationSpecial emphasis will be placed on observing the following serious adverse events    Deterioration of the glycemic profile that requires the use of insulin    Delirium    Incidence of hospital infections (pneumonia, urinary tract infection, device associated infections)    Cumulative incidence of grade 3 and 4 adverse events (AE).    Interruption or temporary suspension of treatment for any reasonRandomisation  Randomisation in permuted block. Computer generated random numbers in an allocation rate of 1:1. Stata 14.0 was used.  Allocated by the principal investigator (direct communication).    Blinding (masking)  Patients not blinded.  Caregivers not blinded.  Participants not blinded.  Statistician will not know the allocation.    Numbers to be randomised (sample size)  92 patients in each arm.  184 total number of patients.    Trial Status  Protocol version 2.0., approved October 2, 2020.  Trial ongoing.  Recruitment start: June 23, 2020.  Anticipate finish recruiting: November 30, 2020.  The protocol has been submitted before the last patient and last visit. The delay in sending to publication is responsibility of the authors.    Trial registration  Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia (PREDCOVID). Registration number  NCT04451174 . Date of trial registration: June 26, 2020.    Full protocol  The full protocol is attached as an additional file, accessible from the Trials website (Additional file  1 ). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.    Supplementary Information  The online version contains supplementary material available at 10.1186/s13063-021-05046-6.

trials

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