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Glucocorticoid Therapy in Coronavirus Disease COVID-19 Patients

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ClinicalTrials.gov Identifier: NCT04780581
Recruitment Status : Recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Collaborator:
Instituto de Investigación Biomédica de Salamanca
Information provided by (Responsible Party):
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Brief Summary:
Treatment with glucocorticoids in COVID patients. Low-intervention, phase IV, open-label, randomised, low-intervention clinical trial comparing 2 active treatments.

Condition or disease Intervention/treatment Phase
Corona Virus Infection Drug: Dexamethasone Drug: Methylprednisolone Phase 4

Detailed Description:
The use of high-dose bolus glucocorticoids in the treatment of patients with COVID-19 infection will increase the anti-inflammatory effect without increasing side effects. This will allow a better patient outcome, reducing the number of deaths and the need for intubation or admission to the Intensive Care Unit.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open-label, randomised clinical trial comparing 2 active treatments.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MP3-pulses-COVID-19. Methylprednisolone Pulses Versus Dexamethasone According RECOVERY Protocol in Patients With Pneumonia Due to SARS-COV-2 Coronavirus Infection
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
Active Comparator: RECOVERY
intermediate-dose dexamethasone (6mg/24h - 10 days)
Drug: Dexamethasone
6 mg/24h - 10 days
Other Name: Recovery

Experimental: BOLUS
high-dose methylprednisolone bolus (250mg/4h - 3 days)
Drug: Methylprednisolone
250 mg/ 24h - 3 days
Other Name: Bolus




Primary Outcome Measures :
  1. Mortality rate in COVID-19 patients after high-dose methylprednisolone bolus administration versus mortality rate intermediate-dose dexamethasone pattern (RECOVERY trial) [ Time Frame: 28 days ]
    Mortality rate (percentage)


Secondary Outcome Measures :
  1. Admission in Intensive Unit Care (ICU) [ Time Frame: 28 days ]
    Incidence of ICU admission

  2. Evaluation of respiratory support requirements [ Time Frame: 28 days ]
    • Proportion of patients (number of cases with respiratory support requirement / total number of patients) with non-invasive mechanical ventilation and/or high-flow oxygen requirements.
    • Proportion of patients (number of cases with respiratory support requirement / total number of patients) with invasive mechanical ventilation or intubation requirements.

  3. Days in hospital [ Time Frame: 28 days ]
    Number of days in hospital from the star of the treatment until discharge

  4. Evaluation of presence of adverse events related with use of high dose of glucocorticoids. [ Time Frame: 28 days ]
    • Presence or absence of adverse effects (infections, hyperglycaemia, psychotic states or other adverse effects).
    • Incidence of infections, hyperglycaemia, psychotic states or other adverse effects, if applicable

  5. Evaluation of other immunosuppressors requirements. [ Time Frame: 28 days ]
    Occurrence of use of other immunosuppressors (active substance, dose, duration, if applicable)

  6. Status according to the World Health Organization (WHO) 10-category scale. [ Time Frame: 3 months ]
    Clinical evaluation of patient status according to the WHO 10-category scale.



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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. Over 18 years of age
  2. Inpatient
  3. Diagnosis of SARS-CoV-2 infection confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) or antigen
  4. They present evidence in computerized axial tomography (CT) of pulmonary involvement attributed to the infection by COVID. Patients in whom CT scans are not performed must have suspected pulmonary involvement by clinical examination with simple compatible or suggestive radiology.
  5. Requires supplementary oxygen due to basal saturation ≤ 93% (with ambient O2, 21%)

Exclusion Criteria:

  1. The patient's situation is so serious that the doctor in charge thinks he could die within 24 hours.
  2. At the time of randomisation, patients require one of the following 4 ventilatory supports:

    1. high-flow oxygen devices.
    2. non-invasive mechanical ventilation.
    3. invasive mechanical ventilation.
    4. Extracorporeal membrane oxygenation (ECMO).
  3. The patient is or has been treated in the 2 weeks prior to randomisation with glucocorticoids or inflammation modifying drugs, both conventional (thiopurines, cyclophosphamide, cyclosporine, tacrolimus), leflunomide, methotrexate, mycophenolate mofetil/mycophenolic acid, sulfasalazine, hydroxychloroquine or chloroquine) as synthetics or biologics directed against therapeutic targets (abatacept, belimumab, CD-20, IL1, IL6, Il12. 23, IL-23, Il.17, TNF, integrin α4β7 or Janus kinase inhibitors JAK). Patients who are only on maintenance treatment with doses of steroids less than or equal to 7.5 mg of prednisone or equivalent per day will not be excluded.
  4. The patient is pregnant or breastfeeding.
  5. The patient has a chronic renal disease is stage 4 or 5 (CCr <30 ml/min).
  6. Moderate to severe dementia at the investigator's discretion.
  7. Hypersensitivity to any of the active ingredients or to any of the excipients included in its formulation.
  8. Untreated systemic infections not caused by COVID-19.
  9. Active stomach or duodenal ulcer.
  10. Recent vaccination with live vaccines.
  11. Other infection or disease that explains the lung disorder.
  12. Inability of the patient to understand the study or to sign the informed consent unless consent is delegated to a legal representative.
  13. Active participation in another clinical study in the last 15 days.

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): NCT04780581


Contacts
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Contact: Luis Corral Gudino 983 420400 lcorral@saludcastillayleon.es
Contact: Esperanza López Franco 923 291100 esperanza.lopez@scren.es

Locations
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Spain
Complejo Asistencial Universitario de Burgos Not yet recruiting
Burgos, Spain, 09006
Contact: María López Veloso       mlopezvel@saludcastillayleon.es   
Complejo Asistencial Universitario de León Active, not recruiting
León, Spain, 24071
Complejo Asistencial Universitario de Salamanca Recruiting
Salamanca, Spain, 37007
Contact: José Ignacio Martín González       jmartingo@saludcastillayleon.es   
Hospital Clínico Universitario de Valladolid Not yet recruiting
Valladolid, Spain, 47003
Contact: Iván Cusácovich Torres       icusacovich@saludcastillayleon.es   
Hospital Universitario Río Hortega Recruiting
Valladolid, Spain, 47012
Contact: Luis Corral Gudino       lcorral@saludcastillayleon.es   
Sponsors and Collaborators
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Instituto de Investigación Biomédica de Salamanca
Investigators
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Principal Investigator: Luis Corral Gudino Investigator
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Responsible Party: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
ClinicalTrials.gov Identifier: NCT04780581    
Other Study ID Numbers: MP3-pulses-COVID-19
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Dexamethasone
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
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Neuroprotective Agents
Protective Agents