Methylprednisolone in the Treatment of Patients With Signs of Severe Acute Respiratory Syndrome in Covid-19

NCT04343729 | Completed Phase 2 DMC

• 1 other identifier: CAEE: 30615920.2.0000.0005
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (1)

• Mortality rate at day 28

  Mortality rate on day 28, after randomization

  on day 28, after randomization

Secondary Outcomes (3)

• Mortality rate on days 7, 14 and 28

  after randomization, up to 28 days.

• Incidence of orotracheal intubation

  after randomization, up to 7 days.

• Change in oxygenation index

  after randomization, up to 7 days.

Other Outcomes (5)

• Spirometry (exploratory outcome)

  120 days after randomization

• Spirometry (exploratory outcome)

  120 days after randomization

• Spirometry (exploratory outcome)

  120 days after randomization

Study Arms (2)

Methylprednisolone

ACTIVE COMPARATOR

0.5mg/kg injectable methylprednisolone sodium succinate, twice daily, for 5 days.

Drug: Methylprednisolone Sodium Succinate

Placebo

PLACEBO COMPARATOR

Saline solution, twice daily, for 5 days. Injectable.

Drug: Placebo solution

Interventions

Methylprednisolone Sodium Succinate DRUG

injectable solution at a dose of 0.5mg/kg

Also known as: methylprednisolone

Methylprednisolone

Placebo solution DRUG

injectable saline solution

Also known as: placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspected cases of COVID-19, from clinical and radiological data, during the pandemic;
• SpO2 ≤ 94% in room air OR in use supplementary oxygen OR under invasive mechanical ventilation

You may not qualify if:

• History of hypersensitivity to MPS;
• People living with HIV and AIDS;
• Chronic use of corticosteroids or immunosuppressive agents;
• Pregnancy or breastfeeding;
• Decompensated cirrhosis;
• Chronic renal failure.

Sponsors & Collaborators

• Fundação de Medicina Tropical Dr. Heitor Vieira Dourado: lead

Study Sites (1)

Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz

Manaus, Amazonas, 69093-415, Brazil

Location

Related Publications (2)

• 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.

  PMID: 34917633 DERIVED

• 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.

  PMID: 32785710 DERIVED

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; Pneumonia; COVID-19; Coronavirus Infections

Interventions

Methylprednisolone Hemisuccinate; Methylprednisolone

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 13, 2020
• Study Start: April 18, 2020
• Primary Completion: June 16, 2020
• Study Completion: October 20, 2020
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: after study publication.
• Access Criteria: upon formal request.

Locations

BR (1)