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Evaluation of the Efficacy of High Doses of Methylprednisolone in SARS-CoV2 ( COVID-19) Pneumonia Patients

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ClinicalTrials.gov Identifier: NCT04673162
Recruitment Status : Not yet recruiting
First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Azienda Unità Sanitaria Locale Reggio Emilia

Brief 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.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Methylprednisolone, Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, multicentric, double blind
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Placebo controlled
Primary Purpose: Treatment
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
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : June 2021


Arm Intervention/treatment
Experimental: A SOC plus MP
Standard treatment (currently desamethasone 6mg/daily for 10 days) plus Methylprednisolone 1gr daily iv on days 1,2,3
Drug: Methylprednisolone, Placebo
iv administration
Other Name: Standard treatment

Active Comparator: B SOC plus Pb
Standard treatment (currently desamethasone 6mg/daily for 10 days) plus Placebo
Drug: Methylprednisolone, Placebo
iv administration
Other Name: Standard treatment




Primary Outcome Measures :
  1. Length of hospitalization [ Time Frame: 30 days since randomisation ]
    the interval between randomization and discharge from the hospital without the need for supplemental oxygen



Information from the National Library of Medicine

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

Inclusion Criteria:

  1. age = 18 years;
  2. Informed consent for participation in the study and for data processing;
  3. Molecular diagnosis with Polymerase Chain Reaction (PCR) test of Sars-CoV2 infection;
  4. Hospitalization in a specialist ward for Covid-19 patient care (eg., Infectious Diseases, Pulmonology or Internal Medicine);
  5. Need for supplemental oxygen in any delivery mode with the exception of invasive mechanical ventilation;
  6. PaO2 / FiO2 between 100 and 300 mmHg.
  7. Clinical / instrumental diagnosis (high resolution chest CT scan or chest x-ray or lung ultrasound) of interstitial pneumonia for no more than three days;
  8. Serum CRP greater than 5 mg / dL;
  9. Interval from onset of SARS-CoV2 infection symptoms to randomization> 5 days-

Exclusion Criteria:

  1. Invasive mechanical ventilation;
  2. Presence of shock or concomitant organ failure that requires admission to the Intensive Care Unit;
  3. Pregnancy or breastfeeding;
  4. Severe heart or kidney failure;
  5. Known hypersensitivity to methylprednisolone, to dexamethasone or to an exception;
  6. Diabetes not compensated according to the doctor's judgment;
  7. Other clinical conditions that contraindicate Methylprednisolone and cannot be treated or resolved according to the doctor's judgment;
  8. Steroid bolus therapy in the week prior to enrollment for the study;
  9. Enrollment in another clinical trial;
  10. Patient already randomized in this study-

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04673162


Contacts
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Contact: Massimo Costantini, MD +390522296986 massimo.costantini@ausl.re.it

Locations
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Italy
SOC Pneumologia, SOC Malattie Infettive, SOC Reumatologia, Az USL-IRCCS di Reggio Emilia
Reggio Emilia, Italy, 42122
Contact: Massimo Costantini, MD       Massimo.Costantini@ausl.re.it   
Principal Investigator: Nicola Facciolongo, MD         
Principal Investigator: Marco Massari, MD         
Principal Investigator: Carlo Salvarani, MD         
Sponsors and Collaborators
Azienda Unità Sanitaria Locale Reggio Emilia
Investigators
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Study Chair: Massimo Costantini, MD AUSL-IRCCS di Reggio Emilia
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Responsible Party: Azienda Unità Sanitaria Locale Reggio Emilia
ClinicalTrials.gov Identifier: NCT04673162    
Other Study ID Numbers: RCT-MP-COVID-19
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: As soon as the main results have been published
Access Criteria: publication reviewers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Azienda Unità Sanitaria Locale Reggio Emilia:
Covid19
Methylprednisolone
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
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
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents