SARS-CoV InfectionPhase 2MetCOVIDNCT04343729
Methylprednisolone in the Treatment of Patients With Signs of Severe Acute Respiratory Syndrome in Covid-19
A Phase 2 study testing Methylprednisolone Sodium Succinate in people with SARS-CoV Infection and Severe Acute Respiratory Syndrome (SARS) Pneumonia, run by Fundação de Medicina Tropical Dr. Heitor Vieira Dourado at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV Infection, Severe Acute Respiratory Syndrome (SARS) Pneumonia
- What is being tested?
- Methylprednisolone Sodium Succinate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 416 participants
- Where
- 1 siteBrazil
- Study dates
- 18 Apr 2020to 20 Oct 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspected cases of COVID-19, from clinical and radiological data, during the pandemic;
- 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);
- SpO2 ≤ 94% in room air OR in use supplementary oxygen OR under invasive mechanical ventilation
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz
Manaus, Amazonas, 69093-415
About this study
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.
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).
- Being tested
- Methylprednisolone Sodium Succinate, Placebo solution
- Keywords
- SARS-CoV-2, Covid-19, Corticosteroid, Severe Acute Respiratory Syndrome (SARS) Pneumonia, Coronavirus, methylprednisolone
- Medical subject headings
- Severe Acute Respiratory Syndrome, Pneumonia, COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone Sodium SuccinateDrug
Also called methylprednisolone
injectable solution at a dose of 0.5mg/kg
Placebo solutionDrug
Also called placebo
injectable saline solution
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone | Active comparator | 0.5mg/kg injectable methylprednisolone sodium succinate, twice daily, for 5 days. Receives: Drug: Methylprednisolone Sodium Succinate |
| Placebo | Placebo comparator | Saline solution, twice daily, for 5 days. Injectable. Receives: Drug: Placebo solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate at day 28
Mortality rate on day 28, after randomization
Measured: on day 28, after randomization
Secondary outcomes (3)
Mortality rate on days 7, 14 and 28
Proportion of patient that died on days 7, 14 and 28.
Measured: after randomization, up to 28 days.
Incidence of orotracheal intubation
proportion of patients requiring orotracheal intubation
Measured: after randomization, up to 7 days.
Change in oxygenation index
Proportion of patients with oxygenation index (PaO2 / FiO2) < 100 in 7 days.
Measured: after randomization, up to 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start18 Apr 2020
- Primary completion16 Jun 2020
- Study completion20 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343729
- Sponsor's protocol ID
- CAEE: 30615920.2.0000.0005
- Acronym
- MetCOVID
- Status last verified
- Jul 2021
- First submitted
- 9 Apr 2020
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all patient data will be shared after study publication
Publications
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.
PubMed 34917633Jeronimo 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.
PubMed 32785710
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04343729
- Acronym / sponsor ID
- MetCOVID / CAEE: 30615920.2.0000.0005
- Keywords
- SARS-CoV-2, Covid-19, Corticosteroid, Severe Acute Respiratory Syndrome (SARS) Pneumonia, Coronavirus, methylprednisolone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Fundação de Medicina Tropical Dr. Heitor Vieira DouradoUniversity, hospital or other
- Study start
- 18 Apr 2020 (actual)
- Primary completion
- 16 Jun 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone | Active comparator | Drug: Methylprednisolone Sodium Succinate0.5mg/kg injectable methylprednisolone sodium succinate, twice daily, for 5 days. |
| Placebo | Placebo comparator | Drug: Placebo solutionSaline solution, twice daily, for 5 days. Injectable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Suspected cases of COVID-19, from clinical and radiological data, during the pandemic;
- 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);
- SpO2 ≤ 94% in room air OR in use supplementary oxygen OR under invasive mechanical ventilation
Key exclusion criteria (6 listed)
- History of hypersensitivity to MPS;
- People living with HIV and AIDS;
- Chronic use of corticosteroids or immunosuppressive agents;
- Pregnancy or breastfeeding;
- Decompensated cirrhosis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolone Sodium SuccinateAlso: methylprednisoloneinjectable solution at a dose of 0.5mg/kg | Drug | Methylprednisolone |
| Placebo solutionAlso: placeboinjectable saline solution | Drug | Placebo |
Primary outcome
Mortality rate at day 28
Time frame: on day 28, after randomization
Mortality rate on day 28, after randomization
3 secondary outcomes
Mortality rate on days 7, 14 and 28
Time frame: after randomization, up to 28 days.
Incidence of orotracheal intubation
Time frame: after randomization, up to 7 days.
Change in oxygenation index
Time frame: after randomization, up to 7 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Derived from this study: PubMed 34917633Barros 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.
- Derived from this study: PubMed 32785710Jeronimo 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.
- Individual participant dataSharing planned: Yes. all patient data will be shared after study publication
Related trials for SARS-CoV Infection
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Not yet recruiting
Effect of MxA Guidance on Antiviral Treatment in Respiratory Viral Infections
Respiratory Viral Infections, Influenza
Recruiting
Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.
COVID-19, Long COVID
Active, not recruiting
SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel Following mRNA COVID-19 Vaccination
SARS-CoV Infection
Active, not recruiting
Clinical Validation of the NowFuture Digital Flu / COVID Test in Anterior Nasal Samples for Over-the-Counter (OTC) Use in Australia
SARS CoV 2 Infection, Influenza A Virus Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methylprednisolone Sodium Succinate in people with SARS-CoV Infection and Severe Acute Respiratory Syndrome (SARS) Pneumonia, run by Fundação de Medicina Tropical Dr. Heitor Vieira Dourado at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate at day 28 (time frame: on day 28, after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04343729, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.