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 volume 22, Article number: 92 (2021)
To evaluate the efficacy of early treatment with prednisone to decrease the progression of COVID-19 pneumonia.
This is a pragmatic, non-blinded, randomized, two arms, parallel trial.
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.
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 signed
Previous steroid use for more than 48 hours.
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.
Participation in another trial.
Intervention and comparator
Prednisone 40 mg days 1 to 4. Then Prednisone 20 mg days 5 to 8. Usual care defined by the attending physician.
No intervention. Usual care defined by the attending physician.
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 ventilation
Special emphasis will be placed on observing the following serious adverse events
Deterioration of the glycemic profile that requires the use of insulin
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 reason
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).
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.
Protocol version 2.0., approved October 2, 2020.
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.
Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia (PREDCOVID). Registration number NCT04451174. Date of trial registration: June 26, 2020.
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.
Availability of data and materials
Data will be available from the author on reasonable request. Please contact firstname.lastname@example.org
I certify that this trial has received ethical approval from the referred ethical committee.
Consent to participate is mandatory for all participants in this trial
The study is not funded.
Ethics approval and consent to participate
Approved by the Scientific Ethical Committee of the Servicio de Salud Metropolitano Oriente on June 16, 2020 under the title “Uso precoz de corticoides en pacientes hospitalizados con enfermedad moderada por COVID -19 (PREDCOVID)”.
Consent for publication
The authors declare that they have no competing interest
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Cite this article
Salinas, M., Andino, P., Palma, L. et al. 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 22, 92 (2021). https://doi.org/10.1186/s13063-021-05046-6
- Randomised controlled trial
- pragmatic clinical trial