Clinical trial NCT04343729: Methylprednisolone in the Treatment of Patients With Signs of Severe Acute Respiratory Syndrome in Covid-19
Official title: Efficacy of Injectable Methylprednisolone Sodium Succinate in the Treatment of Patients With Signs of Severe Acute Respiratory Syndrome Under the New Coronavirus (SARS-CoV2): a Phase IIb, Randomized, Double-blind, Placebo-controlled, Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: SARS-CoV Infection
Severe Acute Respiratory Syndrome (SARS) Pneumonia
Keywords: SARS-CoV-2
Covid-19
Corticosteroid
Severe Acute Respiratory Syndrome (SARS) Pneumonia
Coronavirus
methylprednisolone
Lead sponsor: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double-blind, randomized, placebo-controlled, phase IIb clinical trial to assess the efficacy of injectable methylprednisolone sodium succinate (MP) in patients with severe acute respiratory syndrome (SARS) in COVID-19 infection. A total of 416 individuals of both sexes, aged over 18 years old, with symptoms suggestive or confirmed diagnosis of severe acute respiratory syndrome (SARS), hospitalized at the Hospital and Pronto-Socorro Delphina Rinaldi Abdel Aziz (HPSDRAA), with clinical and radiological findings suggestive of SARS-CoV2 infection, will be randomized at a 1:1 ration to receive either MP (0.5mg/kg of weight, twice daily, for 5 days) or placebo (saline solution, twice daily, for 5 days).


Eligibility criteria: Inclusion Criteria:

1. Suspected cases of COVID-19, from clinical and radiological data, during the pandemic;
2. Adult aged 18 years or older, at the time of inclusion (children under 18 will not be included due to the recognized lower lethality in previous published studies, and the difficulty of consent in the context of an emergency in public health);
3. SpO2 ≤ 94% in room air OR in use supplementary oxygen OR under invasive mechanical ventilation

Exclusion Criteria:

1. History of hypersensitivity to MPS;
2. People living with HIV and AIDS;
3. Chronic use of corticosteroids or immunosuppressive agents;
4. Pregnancy or breastfeeding;
5. Decompensated cirrhosis;
6. Chronic renal failure.

Primary outcomes:
measure: Mortality rate at day 28
timeFrame: on day 28, after randomization
Secondary outcomes:
measure: Mortality rate on days 7, 14 and 28
timeFrame: after randomization, up to 28 days.
measure: Incidence of orotracheal intubation
timeFrame: after randomization, up to 7 days.
measure: Change in oxygenation index
timeFrame: after randomization, up to 7 days.
Other outcomes:
measure: Spirometry (exploratory outcome)
timeFrame: 120 days after randomization
measure: Spirometry (exploratory outcome)
timeFrame: 120 days after randomization
measure: Spirometry (exploratory outcome)
timeFrame: 120 days after randomization
measure: Spirometry (exploratory outcome)
timeFrame: 120 days after randomization
measure: Spirometry (exploratory outcome)
timeFrame: 120 days after randomization
Locations:
city: Manaus
country: Brazil
facility: Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz
state: Amazonas
Study officials:
References:
citation: Barros CMSS, Freire RS, Frota E, Rezende Santos AG, Farias MEL, Rodrigues MGA, Silva BM, Prado Jeronimo CM, Netto RLA, Silva Borba MG, Baia-da-Silva D, Brito-Sousa JD, Xavier MS, Araujo-Alexandre MA, Sampaio VS, Melo GC, Areas GT, Hajjar LA, Monteiro WM, Gomes Naveca F, Costa FTM, Val FFA, Lacerda MVG; Metcovid team. Short-Course of Methylprednisolone Improves Respiratory Functional Parameters After 120 Days in Hospitalized COVID-19 Patients (Metcovid Trial): A Randomized Clinical Trial. Front Med (Lausanne). 2021 Nov 30;8:758405. doi: 10.3389/fmed.2021.758405. eCollection 2021.
citation: Jeronimo CMP, Farias MEL, Val FFA, Sampaio VS, Alexandre MAA, Melo GC, Safe IP, Borba MGS, Netto RLA, Maciel ABS, Neto JRS, Oliveira LB, Figueiredo EFG, Oliveira Dinelly KM, de Almeida Rodrigues MG, Brito M, Mourao MPG, Pivoto Joao GA, Hajjar LA, Bassat Q, Romero GAS, Naveca FG, Vasconcelos HL, de Araujo Tavares M, Brito-Sousa JD, Costa FTM, Nogueira ML, Baia-da-Silva DC, Xavier MS, Monteiro WM, Lacerda MVG; Metcovid Team. Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With Coronavirus Disease 2019 (COVID-19; Metcovid): A Randomized, Double-blind, Phase IIb, Placebo-controlled Trial. Clin Infect Dis. 2021 May 4;72(9):e373-e381. doi: 10.1093/cid/ciaa1177.