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DEXamethasone EARLY Administration in Hospitalized Patients With Covid-19 Pneumonia (EARLYDEXCoV2)

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ClinicalTrials.gov Identifier: NCT04836780
Recruitment Status : Not yet recruiting
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Collaborators:
Fundación para la Investigación e Innovación Biomédica del Hospital Universitario Infanta Leonor
Kern Pharma, S.L.
Information provided by (Responsible Party):
Hospital Universitario Infanta Leonor

Brief Summary:

The aim of this study is to evaluate the efficacy of dexamethasone in hospitalized adults with COVID-19 pneumonia who do not require supplementary oxygen on admission, but have high risk of developing acute respiratory distress syndrome (ARDS).

This is a prospective, multicenter, phase 4, parallel-group, randomized and controlled trial that is open-label to investigators, participants and clinical outcome assessors.

Eligible participants include adults (age 18 years or older), diagnosed with SARS-CoV-2 infection, evidence of infiltrates on chest radiography or computerized tomography, peripheral capillary oxygen saturation ≥94% and 22 breaths per minute breathing room air, and high risk of developing ARDS defined by a lactate dehydrogenase higher than 245 U/L, C-Reactive Protein higher than 100 mg/L, and absolute lymphocytes lower than 800 cells/µL. Eligible participants will meet two of the three before analytical criteria associated with severe COVID-19. Patients will provide written informed consent. Exclusion criteria include patients with a history of allergy to dexamethasone, pregnant or lactating women, oral or inhaled corticosteroids treatment within 15 days before randomization, immunosuppressive agent or cytotoxic drug therapy within 30 days before randomization, neutropenia <1000 cells/µL, human immunodeficiency virus infection with CD4 cell counts <500 cells within 90 days after randomization, dementia, chronic liver disease defined by ALT or AST ≥5 times the upper limit of normal, chronic kidney injury defined by a glomerular filtration rate ≤30 ml/min, hemodialysis or peritoneal dialysis, uncontrolled infection, and patients who are already enrolled in another clinical trial.

Study participants will be randomized in a 1:1 ratio to receive dexamethasone base 6 mg once daily for seven days or standard of care.

The primary endpoint is to prevent of development of moderate ARDS. Based on the Berlin criteria, moderate ARDS is defined by a PaO2/FiO2 ratio >100 mmHg and ≤200 mmHg.

Study participants will be randomized in a 1:1 ratio to receive dexamethasone versus standard of care using a randomization platform. Included participants will be hospitalized at the time of randomization.

The study will be undertaken at Infanta Leonor-Virgen de la Torre University Hospital, Enfermera Isabel Zendal Emergency Hospital, and Infanta Cristina Hospital, Madrid, Spain.


Condition or disease Intervention/treatment Phase
COVID-19 Acute Respiratory Distress Syndrome Pneumonia, Viral Drug: Dexamethasone Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a prospective, multicentre, phase 3, parallel-group, randomized and controlled trial that is open-label to investigators, participants and clinical outcome assessors
Masking: None (Open Label)
Masking Description: The study participants and the clinicians who will evaluate post-treatment outcomes will be known to group assignment. The clinical research team will not be blinded to group assignment
Primary Purpose: Prevention
Official Title: DEXamethasone EARLY Administration in Hospitalized Patients With Covid-19 Pneumonia and High Risk of Developing Acute Respiratory Distress Syndrome
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021


Arm Intervention/treatment
Experimental: Dexamethasone
Dexamethasone base 6 mg once daily for seven days
Drug: Dexamethasone
Dexamethasone base 6 mg once daily for seven days
Other Name: Dexametasona kern pharma solution for injection 4 mg/ml

Active Comparator: Standard of care
Standard care therapy
Drug: Dexamethasone
Dexamethasone base 6 mg once daily for seven days
Other Name: Dexametasona kern pharma solution for injection 4 mg/ml




Primary Outcome Measures :
  1. The primary trial outcome is the development of moderate-severe ARDS [ Time Frame: 7 days ]
    Based on the Berlin criteria, moderate ARDS is defined by a PaO2/FiO2 ratio >100 mmHg and ≤200 mmHg. According to The American College of Chest Physicians patients with a PaO2/FiO2 ratio around 200 mmHg requiring supplemental oxygen in nasal cannula at 3 L/min (FiO2 0.30) for a SpO2 of 91-92%. The collected data as outcome measure will be general vital sign, Sequential Organ Failure Assessment (SOFA) score, the clinical status of the patient using the ordinal scale of the WHO, SpO2, partial pressure of arterial oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio calculated from SpO2/FiO2, blood routine tests and chest radiography. Concomitant drugs and adverse event monitoring will be collected. Data will measure during admission. Participants will schedule for a follow-up visit on the 30 and 90th day to track their long-term prognosis, clinical status and sequelae.


Secondary Outcome Measures :
  1. All-cause mortality for 28 days after randomization [ Time Frame: 28 days ]
    All-cause mortality for 28 days after randomization

  2. Intensive Care Unit (ICU) or Intermediate Respiratory Care Unit (IRCU) transfer for 28 days after randomization [ Time Frame: 28 days ]
    Intensive Care Unit (ICU) or Intermediate Respiratory Care Unit (IRCU) transfer for 28 days after randomization

  3. Clinical status of the patient using the ordinal scale of the WHO [ Time Frame: 7 days ]
    The World Health Organization COVID-19 ordinal scale represents intensity of medical intervention, with higher scores for interventions more burdensome for the patient, and highest score for death. Minimum value = 1, and maximum value = 8

  4. Sequential Organ Failure Assessment (SOFA) score on admission, and 4 and 7 days after randomization [ Time Frame: 7 days ]
    The Sequential Organ Failure Assessment score is a simple and objective score that allows for calculation of both the number and the severity of organ dysfunction in six organ systems (respiratory, coagulatory, liver, cardiovascular, renal, and neurologic). The SOFA score can be used to determine level of organ dysfunction and mortality risk. Higher scores for interventions more burdensome for the patient, and highest score for death. Minimum value = 0, and maximum value = 24

  5. Hospital length of stay [ Time Frame: Number of days between admission date and discharge ]
    Hospital length of stay in days. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 90 days.

  6. Respiratory support at hospital discharge [ Time Frame: At hospital discharge ]
    Suplementary oxygen at hospital discharge up to 90 days

  7. All-cause readmission rate for 3 months after randomization [ Time Frame: 3 months ]
    All-cause readmission rate for 3 months after randomization



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:

  • Adults (age 18 years or older).
  • Diagnosed with SARS-CoV-2 infection by Polymerase Chain Reaction or rapid antigen test on upper respiratory tract (nasopharyngeal and oropharyngeal) specimens.
  • Evidence of infiltrates on chest radiography or computerized tomography.
  • Peripheral capillary oxygen saturation (SpO2) ≥94% and <22 breaths per minute (bpm) breathing room air.
  • High risk of developing ARDS defined by a lactate dehydrogenase higher than 245 U/L, C-Reactive Protein higher than 100 mg/L, and absolute lymphocytes lower than 800 cells/µL. Eligible participants will meet two of the three before analytical criteria associated with severe COVID-19.
  • Patients will provide written informed consent or who have a legally authorized representative available to do so. In these exceptional circumstances and following the recommendations of the Spanish Agency of Medicines and Medical Devices, the National Competent Authority of clinical trials, during the coronavirus crisis to avoid the risk of contagion, consent will be possible to obtained orally in the presence of at least one impartial witness.

Exclusion Criteria:

  • Patients with a history of allergy to dexamethasone.
  • Pregnant or lactating women.
  • Oral or inhaled corticosteroids treatment within 15 days before randomization.
  • Immunosuppressive agent or cytotoxic drug therapy within 30 days before randomization.
  • Neutropenia <1000 cells/µL.
  • Human immunodeficiency virus infection with CD4 cell counts <500 cells within 90 days after randomization.
  • Dementia.
  • Chronic liver disease defined by ALT or AST ≥5 times the upper limit of normal.
  • Chronic kidney injury defined by a glomerular filtration rate ≤30 ml/min, hemodialysis or peritoneal dialysis.
  • Uncontrolled infection.
  • Patients who are already enrolled in another clinical trial.

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): NCT04836780


Locations
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Spain
Hospital Universitario Infanta Leonor
Madrid, Spain, 28031
Contact: Anabel Franco Moreno, MD, PhD    +34 911 91 80 00    afranco278@hotmail.com   
Principal Investigator: Anabel Franco Moreno, MD, PhD         
Principal Investigator: Juan Torres Macho, MD, PhD         
Sponsors and Collaborators
Hospital Universitario Infanta Leonor
Fundación para la Investigación e Innovación Biomédica del Hospital Universitario Infanta Leonor
Kern Pharma, S.L.
Publications of Results:
WHO/2019-nCoV/Corticosteroids/2020.1

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Responsible Party: Hospital Universitario Infanta Leonor
ClinicalTrials.gov Identifier: NCT04836780    
Other Study ID Numbers: EARLY-DEX Covid-19
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Hospital Universitario Infanta Leonor:
COVID-19 pneumonia
Acute respiratory distress syndrome
Prevention
Randomised controlled trial
Dexamethasone
Additional relevant MeSH terms:
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Pneumonia, Viral
Pneumonia
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Virus Diseases
Dexamethasone
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