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

Study Description

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).

Condition or disease	Intervention/treatment	Phase
SARS-CoV Infection; Severe Acute Respiratory Syndrome (SARS) Pneumonia	Drug: Methylprednisolone Sodium Succinate; Drug: Placebo solution	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 416 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: April 18, 2020
• Actual Primary Completion Date: June 16, 2020
• Estimated Study Completion Date: September 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Methylprednisolone; 0.5mg/kg injectable methylprednisolone sodium succinate, twice daily, for 5 days.	Drug: Methylprednisolone Sodium Succinate; injectable solution at a dose of 0.5mg/kg; Other Name: methylprednisolone
Placebo Comparator: Placebo; Saline solution, twice daily, for 5 days. Injectable.	Drug: Placebo solution; injectable saline solution; Other Name: placebo

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. 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.
2. Incidence of orotracheal intubation [ Time Frame: after randomization, up to 7 days. ]
   proportion of patients requiring orotracheal intubation
3. Change in oxygenation index [ Time Frame: after randomization, up to 7 days. ]
   Proportion of patients with oxygenation index (PaO2 / FiO2) < 100 in 7 days.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Brazil

Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz

Manaus, Amazonas, Brazil, 69093-415

Sponsors and Collaborators

Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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]

• Responsible Party: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
• ClinicalTrials.gov Identifier: NCT04343729
• Other Study ID Numbers: CAEE: 30615920.2.0000.0005
• First Posted: April 13, 2020
• Last Update Posted: July 1, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

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

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

Keywords provided by Fundação de Medicina Tropical Dr. Heitor Vieira Dourado:

SARS-CoV-2; Covid-19; Corticosteroid; Severe Acute Respiratory Syndrome (SARS) Pneumonia; Coronavirus; methylprednisolone

Additional relevant MeSH terms:

Severe Acute Respiratory Syndrome; Coronavirus Infections; Pneumonia; Syndrome; Disease; Pathologic Processes; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuroprotective Agents