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

• ClinicalTrials.gov Identifier: NCT04343729
• Recruitment Status: Active, not recruiting
• First Posted: April 13, 2020
• Last Update Posted: July 1, 2020
• Sponsor: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
• Information provided by (Responsible Party): Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

Tracking Information

• First Submitted Date: April 9, 2020
• First Posted Date: April 13, 2020
• Last Update Posted Date: July 1, 2020
• Actual Study Start Date: April 18, 2020
• Actual Primary Completion Date: June 16, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 9, 2020)

Mortality rate at day 28 [ Time Frame: on day 28, after randomization ]

Mortality rate on day 28, after randomization

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 17, 2020)

• Mortality rate on days 7, 14 and 28 [ Time Frame: after randomization, up to 28 days. ]
  Proportion of patient that died on days 7, 14 and 28.
• Incidence of orotracheal intubation [ Time Frame: after randomization, up to 7 days. ]
  proportion of patients requiring orotracheal intubation
• Change in oxygenation index [ Time Frame: after randomization, up to 7 days. ]
  Proportion of patients with oxygenation index (PaO2 / FiO2) < 100 in 7 days.

Original Secondary Outcome Measures (submitted: April 9, 2020)

• Proportion of patients with SARS [ Time Frame: after randomization, up to 7 days. ]
  Number of patients with diagnosis of early onset of SARS
• Mortality rate on days 7, 14 and 28 [ Time Frame: after randomization, up to 28 days. ]
  Proportion of patient that died on days 7, 14 and 28.
• Incidence of orotracheal intubation [ Time Frame: after randomization, up to 7 days. ]
  proportion of patients requiring orotracheal intubation
• Change in oxygenation index [ Time Frame: after randomization, up to 7 days. ]
  Proportion of patients with oxygenation index (PaO2 / FiO2) < 100 in 7 days.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• SARS-CoV Infection
• Severe Acute Respiratory Syndrome (SARS) Pneumonia

Intervention

• Drug: Methylprednisolone Sodium Succinate
  injectable solution at a dose of 0.5mg/kg
  Other Name: methylprednisolone
• Drug: Placebo solution
  injectable saline solution
  Other Name: placebo

Study Arms

• Active Comparator: Methylprednisolone
  0.5mg/kg injectable methylprednisolone sodium succinate, twice daily, for 5 days.
  Intervention: Drug: Methylprednisolone Sodium Succinate
• Placebo Comparator: Placebo
  Saline solution, twice daily, for 5 days. Injectable.
  Intervention: Drug: Placebo solution

• Publications *: Jeronimo CMP, Farias MEL, Val FFA, Sampaio VS, Alexandre MAA, Melo GC, Safe IP, Borba MGS, Abreu-Netto RL, Maciel ABS, Neto JRS, Oliveira LB, Figueiredo EFG, Dinelly KMO, Rodrigues MGA, Brito M, Mourão MPG, Pivoto João GA, Hajjar LA, Bassat Q, Romero GAS, Naveca FG, Vasconcelos HL, Tavares MA, Brito-Sousa JD, Costa FTM, Nogueira ML, Baía-da-Silva D, Xavier MS, Monteiro WM, Lacerda MVG; , for the Metcovid Team. Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With COVID-19 (Metcovid): A Randomised, Double-Blind, Phase IIb, Placebo-Controlled Trial. Clin Infect Dis. 2020 Aug 12. pii: ciaa1177. doi: 10.1093/cid/ciaa1177. [Epub ahead of print]

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: June 29, 2020): 416
• Original Estimated Enrollment (submitted: April 9, 2020): 420
• Estimated Study Completion Date: September 2020
• Actual Primary Completion Date: June 16, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT04343729
• Other Study ID Numbers: CAEE: 30615920.2.0000.0005
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: all patient data will be shared after study publication
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: after study publication.
• Access Criteria: upon formal request.

• Responsible Party: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
• Study Sponsor: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
• Verification Date: June 2020