Trial NCT04343729
Publication Prado Jeronimo CM, Clin Infect Dis (2020) (published paper)
Dates: 2020-04-08 to 2020-06-16
Funding: Public/non profit (Superintendencia da Zona Franca de Manaus, Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior, Departamento de Ciencia e Tecnologia/Ministerio da Saude, Ministerio da Ciencia, Tecnologia e Inovacoes, Conselho Nacional de Desenvolvimento Cientifico e Tecnologico, Fundacao de Amparo a Pesquisa do Estado do Amazonas)
Conflict of interest: No

Methods
RCT
Blinding: double blinding
Location : Single center / Brazil
Follow-up duration (days): 28
Inclusion criteria
  • Hospitalized 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.
Exclusion criteria
  • Patients 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
0.5 mg/kg IV twice daily for 5 days
Control
Placebo

Participants
Randomized
participants :
Placebo=207
Methylprednisolone=209
Characteristics of participants
N= 416
Mean age : NR
271 males
Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=*
Number of vaccinated participants: NR
Primary outcome
In the register
Mortality rate at day 28
In the report
28-day mortality
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing willing stated in the publication:
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.