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Trial record 1 of 1 for:    NCT04343729
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Methylprednisolone in the Treatment of Patients With Signs of Severe Acute Respiratory Syndrome in Covid-19 (MetCOVID)

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

Tracking Information
First Submitted Date  ICMJE April 9, 2020
First Posted Date  ICMJE April 13, 2020
Last Update Posted Date July 1, 2020
Actual Study Start Date  ICMJE April 18, 2020
Actual Primary Completion Date June 16, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Methylprednisolone in the Treatment of Patients With Signs of Severe Acute Respiratory Syndrome in Covid-19
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • SARS-CoV Infection
  • Severe Acute Respiratory Syndrome (SARS) Pneumonia
Intervention  ICMJE
  • 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  ICMJE
  • 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]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 29, 2020)
416
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2020)
420
Estimated Study Completion Date  ICMJE September 2020
Actual Primary Completion Date June 16, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04343729
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP