Methylprednisolone versus dexamethasone in patients with COVID-19
| ISRCTN | ISRCTN44151777 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44151777 |
| Secondary identifying numbers | 47957821.2.0000.5529 |
- Submission date
- 21/01/2022
- Registration date
- 24/01/2022
- Last edited
- 24/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
Since the beginning of the COVID-19 pandemic, corticosteroids have been used to control the inflammatory response. Inflammation is normal in response to injury or infection, but it can be dangerous if it is not controlled.
The present study aims to evaluate the efficacy of early intravenous administration of methylprednisolone in all-cause mortality rates at 28 days after randomization in adult patients with COVID-19.
Who can participate?
Adults over the age of 18, diagnosed with COVID 19 and that needed hospitalization.
What does the study involve?
The intervention group received methylprednisolone associated with the standard treatment for COVID-19, while the control group received dexamethasone associated with the standard treatment for COVID-19.
What are the possible benefits and risks of participating?
The possible risks are the consequences of the disease itself, and the side effects of the corticosteroids that are being used in the study. As a consequence of COVID-19 it is possible to develop thromboembolic events, bleedings, need for ICU, need for respiratory support, death.
Direct benefits to participants are not guaranteed. This is a study to verify the real effectiveness of a medication that is already formally recommended for the treatment of COVID-19.
Where is the study run from?
The MEDEX study is being run by the Núcleo de Pesquisa do Hospital do Rocio (Rocio Hospital Research Center) and takes place at the Hospital do Rocio (Rocio Hospital), in south Brazil.
When is the study starting and how long is it expected to run for?
July 2021 to September 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
1. Dalton Rivabem MD
daltonrivabem@yahoo.com.br
2. Evandro Mariot MD
evandroasm@yahoo.com.br
3. Cesar Dusilek MD
cesardusilek@gmail.com
Contact information
Scientific
Maria Aparecida de Oliveira Street nº 599
Campo Largo - PR - Brazil
CEP: 83601-350
Campo Largo
83601-350
Brazil
 ORCID ID |
0000-0002-7644-747X |
|---|---|
| evandroasm@yahoo.com.br |
Study information
| Study design | Prospective randomized controlled single-center open comparative clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Evaluation of the effectiveness of methylprednisolone versus dexamethasone in patients with COVID-19 |
| Study acronym | MEDEX |
| Study hypothesis | The early administration of methylprednisolone increases the number of days alive and free from mechanical ventilation, and / or reduces the length of hospital stay, in adult patients with moderate or severe acute respiratory syndrome resulting from COVID-19. |
| Ethics approval(s) | Approved 27/07/2021, Brazilian National Research Ethics Committee (Brasília - Distrito Federal - Brazil, North Wing, SRTV 701, Via W 5 Norte, lote D - Edifício PO 700, 3º floor, CEP: 70719-040; + 55 61 3315-5878; conep@saude.gov.br), ref: 47957821.2.0000.5529 |
| Condition | COVID-19 (SARS-CoV-2 infection) |
| Intervention | The study presents two groups. The “Rocio Group” is the intervention group, while the “Recovery Group” is the control group. The intervention group received daily intravenous methylprednisolone for 3 days, followed by a daily dose of 1 mg/kg/day for 7 days. The control group received a daily dose of 6 mg of dexamethasone intravenously for 10 days or until discharge, whichever comes first. Both groups received standard care for critically ill and potential critical patients. The standard care included: follow-up diary by the Assistant Physician in the infirmary unit; Monitoring by the ICU Diarist Physician; monitoring, adjustment of conducts and care of intercurrences by the ICU on-duty Physician (for patients in ICU); continuous hemodynamic and ventilatory monitoring; monitoring of vital data following the ICU routine (for patients in ICU); motor and respiratory physiotherapy; ventilatory support measures, invasive or not; hemodynamic support measures, with or without vasopressors, as medically indicated (for patients in ICU); hydro-electrolyte and acid-base control; medical and general procedures, such as central venous access puncture, closed chest drainage, tracheostomy, among others; use of antimicrobials (antibiotics, antivirals, antifungals, bacteriostatics, etc). according to medical advice; any treatment used adjunct that does not interfere with the evaluation; laboratory routine according to the unit routine and/or medical indication. Follow-up included laboratory data on the third day, on the seventh day, on tenth day of randomization and on discharge day. All patients were followed until day 28 after randomization. The study is a single randomized paired into two equal groups. Randomization took place in the ward the day after hospital admission and was carried out by the research coordinator and informed to the assistant physician. The study is not blinded randomization, however, the statistical analysis of data is blinded. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Methylprednisolone, dexamethasone |
| Primary outcome measure | All-cause mortality rates at 28 days after randomization measured using patient records |
| Secondary outcome measures | Measured using patient records: 1. Length of hospital stay 2. Need or not for referral to the ICU 3. Length of ICU stay between randomization and day 28 4. Time of mechanical ventilation between randomization and day 28 5. Changes in laboratory standards after 72 hours, 7 days and 10 days of randomization |
| Overall study start date | 27/07/2021 |
| Overall study end date | 30/09/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 400 |
| Total final enrolment | 400 |
| Participant inclusion criteria | 1. Age ≥18 years. 2. Confirmed or suspected infection for COVID-19. 3. Need for hospitalization, infirmary or intensive care unit (ICU). 4. Chest tomography with image compatible with COVID-19. |
| Participant exclusion criteria | 1. Known history of allergy to metrilprednisolone. 2. Use of corticosteroids for another condition. 3. Patient's refusal to participate in the study. 4. Pregnant or breastfeeding women. 5. Contraindication to the use of corticosteroids. |
| Recruitment start date | 15/08/2021 |
| Recruitment end date | 20/09/2021 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Campo Largo
83601-350
Brazil
Sponsor information
Hospital/treatment centre
Maria Aparecida de Oliveira nº 599
Campo Largo
83601-350
Brazil
| Phone | +55 4131362515 |
|---|---|
| ouvidoria@hospitaldorocio.com.br |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/04/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2 | 06/07/2021 | 24/01/2022 | No | No |
| Other unpublished results | 24/10/2022 | No | No |
Additional files
Editorial Notes
24/10/2022: A file of unpublished results was uploaded as an additional file.
24/01/2022: Trial's existence confirmed by Brazilian National Research Ethics Committee.
