Trial NCT04343729
Publication Prado Jeronimo CM, Clin Infect Dis, 2020
Dates: 2020-04-18 to 2020-06-16
Funding: Public/non profit (Superintendência da Zona Franca de Manaus (SUFRAMA), Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES), Departamento de Ciência e Tecnologia/Ministério da Saúde (DECIT), Ministério da Ciência, Tecnologia e Inovações (MCTI), Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq, grant 403253/2020-9), Fundação de Amparo à Pesquisa do Estado do Amazonas (FAPEAM) (PAPAC 005/2019 and Pró-Estado public calls), and Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP))

Methods
RCT
Location : Single center / Brazil
Follow-up duration (days): 28
Inclusion criteriaHospitalized patients were included if they had clinical AND/OR radiological suspicion of COVID-19 (history of fever AND any respiratory symptom, e.g., cough or dyspnea AND/OR ground glass opacity OR pulmonary consolidation on CT scan), aged 18 years or older at the time of inclusion, with SpO2 ≤ 94% at room air OR in use of supplementary oxygen OR under IMV. Children under 18 years of age were not included due to the known lower morbidity/mortality from COVID-19.17
Exclusion criteriaPatients were excluded if they had a history of hypersensitivity to MP, HIV/AIDS, chronic use of corticosteroids or immunosuppressive agents, pregnant or breastfeeding, decompensated cirrhosis or chronic renal failure.
Interventions
Treatment
Methylprednisolone (0,5mg/kg)
Co-Intervention: Standard care
Duration : 5 days
Control
Placebo
Duration : 5 days
Participants
Randomized
416 participants (n1=209 / n2= 207)
Characteristics of participants
N=416
Mean age : 55.5
254 males
Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* Critical: n=*
Primary outcome
In the register
Mortality rate at day 28
In the report
28-day mortality
Documents
avalaible

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing stated

Yes
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
High
General comment In addition to the accepted manuscript, the study registry, protocol and statistical analysis plan was used in data extraction and risk of bias assessment. The study achieved the target sample size reported in the registry. There is no change from the trial registration in the intervention and control treatments. There is no change from the trial registration in the primary outcomes. Some secondary outcomes in the report are not present in the registry. The trial reported mITT analyses in the report and ITT analyses in a supplementary file but not for all outcomes such as time to death.