Covid19Phase 3NCT04673162
Evaluation of the Efficacy of High Doses of Methylprednisolone in SARS-CoV2 ( COVID-19) Pneumonia Patients
A Phase 3 study of Covid19, run by Azienda USL Reggio Emilia - IRCCS at 20 sites in Italy.
Trial summary
This double blind, randomized study is aiming to evaluate the efficacy of three doses (1gr/day) of methylpredisolone added to standard therapy in patients, with documented COVID-19 pneumonia, requiring hospitalization but not mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 20 sitesItaly
- Study dates
- 17 Dec 2020to 12 Jul 2021
- Phase
- Phase 3
- 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
- age = 18 years;
- Informed consent for participation in the study and for data processing;
- Molecular diagnosis with Polymerase Chain Reaction (PCR) test of Sars-CoV2 infection;
- Hospitalization in a specialist ward for Covid-19 patient care (eg., Infectious Diseases, Pulmonology or Internal Medicine);
- Need for supplemental oxygen in any delivery mode with the exception of invasive mechanical ventilation;
- PaO2 / FiO2 between 100 and 300 mmHg.
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- Clinical / instrumental diagnosis (high resolution chest CT scan or chest x-ray or lung ultrasound) of interstitial pneumonia for no more than three days;
- Serum CRP greater than 5 mg / dL;
- Interval from onset of SARS-CoV2 infection symptoms to randomization> 5 days-
Who cannot join
- Invasive mechanical ventilation;
- Presence of shock or concomitant organ failure that requires admission to the Intensive Care Unit;
- Pregnancy or breastfeeding;
- Severe heart or kidney failure;
- Known hypersensitivity to methylprednisolone, to dexamethasone or to an exception;
- Diabetes not compensated according to the doctor's judgment;
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- Other clinical conditions that contraindicate Methylprednisolone and cannot be treated or resolved according to the doctor's judgment;
- Steroid bolus therapy in the week prior to enrollment for the study;
- Enrollment in another clinical trial;
- Patient already randomized in this study-
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Italy20 sites
SOC di Pneumologia, Az. Osp. S. Antonio e Biagio e C. Arrigo
Alessandria, 15121
UO di Pneumologia, Ospedale San Donato
Arezzo, 52100
UO di Malattie Infettive, Policlinico Sant'Orsola Malpighi
Bologna, 40138
UO di Pneumologia e Terapia Intensiva Respiratoria, Policlinico Sant' Orsola Malpighi
Bologna, 40138
Reparto di Malattie Infettive, Comprensorio Sanitario di Bolzano- Az. Sanitaria Alto Adige
Bolzano, 39100
SOC di Malattie Infettive, ASST di Cremona
Cremona, 26100
SOC di Malattie Infettive, AOU Careggi
Florence, 50134
UOC di Pneumologia, IRCCS Ospedale Policlinico San Martino
Genova, 16132
SC di Malattie Infettive,Ospedale Sant'Andrea - Az. Sociosanitaria Ligure 5
La Spezia, 19121
UO Malattie Infettive, Azienda Ospedaliera Universitaria- Policlinico di Modena
Modena, 41124
UO Clinica Pneumologica - Ospedale "San Gerardo" - ASST di Monza
Monza, 20900
UO Terapia Anestesia e Rianimazione - Ospedale "San Gerardo" - ASST di Monza
Monza, 20900
UO di Malattie Infettive, Ospedale Guglielmo da Saliceto - AUSL di Piacenza
Piacenza, 29100
UO di Pneumologia, Ospedale Guglielmo da Saliceto - AUSL di Piacenza
Piacenza, 29100
SOC di Malattie Infettive - AUSL-IRCCS di Reggio Emilia
Reggio Emilia, 42123
SOC di Pneumologia - AUSL-IRCCS di Reggio Emilia
Reggio Emilia, 42123
SOC di Reumatologia, AUSL- IRCCS di Reggio Emilia
Reggio Emilia, 42123
UO di Malattie Infettive, Azienda Sociosanitaria Ligure 1
Sanremo, Imperia, 18038
UOC di Malattie Infettive - Azienda Unità Locale Socio Sanitaria n. 2
Treviso, 31100
UO di Pneumologia, Azienda Ospedaliera Universitaria Integrata
Verona, 37126
About this study
Official title: A Randomized, Multicentre, Double-blind Study to Evaluate the Efficacy of High-dose Administration of Methylprednisolone in Addition to Standard Treatment, in SARS-CoV2 (COVID-19) Pneumonia Patients
This double blind, randomized study is aiming to evaluate the efficacy of three doses (1gr/day) of methylpredisolone added to standard therapy in patients, with documented COVID-19 pneumonia, requiring hospitalization but not mechanical ventilation.
Read the detailed description
Patients recently hospitalized for the treatment of documented COVID-19 pneumonia who do not require invasive ventilation will be randomized (1:1) to receive current standard treatment, which may include desamethasone and oxygen, with methylprenisolone 1gr daily iv for 3 consecutive days or standard treatment alone.
Efficacy measures will be time to recovery (discharge from hospital), invasive ventilation prevention and survival.
Patients safety will be evaluated throughout the all study period.
- Conditions
- Covid19
- Being tested
- Methylprednisolone, Placebo
- Keywords
- Covid19, Methylprednisolone
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone, PlaceboDrug
Also called Standard treatment
iv administration
| Study group | Role | What they receive |
|---|---|---|
| A SOC plus MP | Experimental | Standard treatment (currently desamethasone 6mg/daily for 10 days) plus Methylprednisolone 1gr daily iv on days 1,2,3 Receives: Drug: Methylprednisolone, Placebo |
| B SOC plus Pb | Active comparator | Standard treatment (currently desamethasone 6mg/daily for 10 days) plus Placebo Receives: Drug: Methylprednisolone, Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospitalization
the interval between randomization and discharge from the hospital without the need for supplemental oxygen
Measured: 30 days since randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start17 Dec 2020
- Primary completion21 Apr 2021
- Study completion12 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, multicentric, double blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Massimo Costantini, MD, Study chair, AUSL-IRCCS di Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673162
- Sponsor's protocol ID
- RCT-MP-COVID-19
- Status last verified
- Dec 2020
- First submitted
- 16 Dec 2020
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Salvarani C, Massari M, Costantini M, Merlo DF, Mariani GL, Viale P, Nava S, Guaraldi G, Dolci G, Boni L, Savoldi L, Bruzzi P, Turra C, Catanoso M, Marata AM, Barbieri C, Valcavi A, Franzoni F, Cavuto S, Mazzi G, Corsini R, Trapani F, Bartoloni A, Barisione E, Barbieri C, Burastero GJ, Pan A, Inojosa W, Scala R, Burattini C, Luppi F, Codeluppi M, Tarek KE, Cenderello G, Salio M, Foti G, Dongilli R, Bajocchi G, Negri EA, Ciusa G, Fornaro G, Bassi I, Zammarchi L, Aloe T, Facciolongo N. Intravenous methylprednisolone pulses in hospitalised patients with severe COVID-19 pneumonia: a double-blind, randomised, placebo-controlled trial. Eur Respir J. 2022 Oct 20;60(4):2200025. doi: 10.1183/13993003.00025-2022. Print 2022 Oct.
PubMed 35361632
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicentre, Double-blind Study to Evaluate the Efficacy of High-dose Administration of Methylprednisolone in Addition to Standard Treatment, in SARS-CoV2 (COVID-19) Pneumonia Patients
- ClinicalTrials.gov ID
- NCT04673162
- Acronym / sponsor ID
- RCT-MP-COVID-19
- Conditions
- Covid19
- Keywords
- Covid19, Methylprednisolone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 21 Apr 2021 (actual)
- Study completion
- 12 Jul 2021 (actual)
- First posted
- 17 Dec 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 double blind, randomized study is aiming to evaluate the efficacy of three doses (1gr/day) of methylpredisolone added to standard therapy in patients, with documented COVID-19 pneumonia, requiring hospitalization but not mechanical ventilation.
Detailed description
Patients recently hospitalized for the treatment of documented COVID-19 pneumonia who do not require invasive ventilation will be randomized (1:1) to receive current standard treatment, which may include desamethasone and oxygen, with methylprenisolone 1gr daily iv for 3 consecutive days or standard treatment alone.
Efficacy measures will be time to recovery (discharge from hospital), invasive ventilation prevention and survival.
Patients safety will be evaluated throughout the all study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, multicentric, double blind
| Arm | Type | Receives |
|---|---|---|
| A SOC plus MP | Experimental | Drug: Methylprednisolone, PlaceboStandard treatment (currently desamethasone 6mg/daily for 10 days) plus Methylprednisolone 1gr daily iv on days 1,2,3 |
| B SOC plus Pb | Active comparator | Drug: Methylprednisolone, PlaceboStandard treatment (currently desamethasone 6mg/daily for 10 days) plus Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- age = 18 years;
- Informed consent for participation in the study and for data processing;
- Molecular diagnosis with Polymerase Chain Reaction (PCR) test of Sars-CoV2 infection;
- Hospitalization in a specialist ward for Covid-19 patient care (eg., Infectious Diseases, Pulmonology or Internal Medicine);
- Need for supplemental oxygen in any delivery mode with the exception of invasive mechanical ventilation;
Key exclusion criteria (10 listed)
- Invasive mechanical ventilation;
- Presence of shock or concomitant organ failure that requires admission to the Intensive Care Unit;
- Pregnancy or breastfeeding;
- Severe heart or kidney failure;
- Known hypersensitivity to methylprednisolone, to dexamethasone or to an exception;
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, PlaceboAlso: Standard treatmentiv administration | Drug | A SOC plus MP, B SOC plus Pb |
Primary outcome
Length of hospitalization
Time frame: 30 days since randomisation
the interval between randomization and discharge from the hospital without the need for supplemental oxygen
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 23 May 2022.
- Derived from this study: PubMed 35361632Salvarani C, Massari M, Costantini M, Merlo DF, Mariani GL, Viale P, Nava S, Guaraldi G, Dolci G, Boni L, Savoldi L, Bruzzi P, Turra C, Catanoso M, Marata AM, Barbieri C, Valcavi A, Franzoni F, Cavuto S, Mazzi G, Corsini R, Trapani F, Bartoloni A, Barisione E, Barbieri C, Burastero GJ, Pan A, Inojosa W, Scala R, Burattini C, Luppi F, Codeluppi M, Tarek KE, Cenderello G, Salio M, Foti G, Dongilli R, Bajocchi G, Negri EA, Ciusa G, Fornaro G, Bassi I, Zammarchi L, Aloe T, Facciolongo N. Intravenous methylprednisolone pulses in hospitalised patients with severe COVID-19 pneumonia: a double-blind, randomised, placebo-controlled trial. Eur Respir J. 2022 Oct 20;60(4):2200025. doi: 10.1183/13993003.00025-2022. Print 2022 Oct.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Massimo Costantini, MD study chair
AUSL-IRCCS di Reggio Emilia
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Covid19, run by Azienda USL Reggio Emilia - IRCCS at 20 sites in Italy.
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 9 inclusion and 10 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 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Italy. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Length of hospitalization (time frame: 30 days since randomisation). 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 NCT04673162, which also lists 1 linked publication.
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 23 May 2022.