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Efficacy and Safety of Corticosteroids in Oxygen-dependent Patients With COVID-19 Pneumonia (CORTICOVIDHUGO)

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ClinicalTrials.gov Identifier: NCT04359511
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

Brief Summary:

To date, there is no efficient therapeutics to prevent or treat COVID-19 related pulmonary failure. Corticosteroids (CS) could be a helpful therapeutic. Retrospective reports suggested survival improvement in patients with acute respiratory distress syndrome (ARDS). CT scan for COVID19 hospitalized patients showed sometimes unusual aspects of pneumonia, suggestive of an organizing phase of diffuse alveolar damage (DAD).

We hypothesize that, in the context of alveolar aggression induced by COVID-19, CT scan could help to individualize patients with a high probability of pulmonary organizing process who could benefit from CS treatment.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: Prednisone Drug: Hydrocortisone Phase 3

Detailed Description:
"Severe acute respiratory syndrome" coronavirus 2 (SARS-Cov-2) is a new coronavirus that induces pneumonia called Corona Virus Disease- 19 (COVID-19), an infected 1.5 million people worldwide and caused the more than 85,000 patients died. COVID-19 usually comes in the form of viral pneumonia but with the peculiarities of a risk frequent worsening towards acute respiratory distress syndrome (ARDS) and a usual duration of oxygen dependence in fragile patients by their age or their comorbidities. To date, there is no therapy effective in preventing or treating COVID-19. Drug identification is a major concern and a public health emergency. Retrospective study (Wu 2020) highlighted improved survival in COVID-19 patients with acute ARDS and treated with corticosteroids (CS). So even in the absence of evidence of effectiveness, the SCs are used for COVID-19 oxygen-dependent patients or with an ARDS. However, their benefit / risk remains debated (Russel 2020). On histological samples of COVID-19, diffuse alveolar damage (DAD) has been especially observed (Hanley 2020). DAD is described histologically in an exudative phase, an organizational phase and a irreversible fibrotic phase (Hughes 2017). SC could have an effect beneficial by limiting the exudative / inflammatory phase but also that organization whose histological and CT aspects are sometimes indistinguishable from organized pneumonia, a form of pulmonary repair aberrant very corticosensitive (Travis 2013). Chest scans performed in the face of the persistence or worsening of oxygen dependence beyond the 7th day of COVID-19 symptoms, could help discern indirect complications (pulmonary embolism, exacerbation of COPD, bacterial superinfection, etc.) of an unfavorable course COVID-19 (by displaying an aspect suggesting DAD in particular during the organization phase). We hypothesize that, in the context of COVID-19, the SCs may be beneficial in patients with CT scans thoracic images suggestive of DAD either at the exudative phase or at the pulmonary organization phase.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Corticosteroids in Oxygen-dependent Patients With COVID-19 Pneumonia in Grand Ouest Interregion France
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia Steroids

Arm Intervention/treatment
Experimental: corticosteroid + Optimized Standard of Care
  • prednisone 0.7 mg/kg/day for 10 days, administered orally, once a day, or
  • hydrocortisone hemisuccinate 3.5 mg/kg/day by continuous infusion for 10 days, administered by IV route if the patient cannot take drugs by oral route,

    • standard of care
Drug: Prednisone
prednisone 0.7 mg/kg/d (PO)

Drug: Hydrocortisone
hémisuccinate d'hydrocortisone 3,5 mg/kg/jour (IV)

No Intervention: Optimized Standard of Care
standard of care



Primary Outcome Measures :
  1. Clinical improvement defined by the improvement of 2 points on a 7-category ordinal scale, at 14 days. [ Time Frame: 14 days ]

    The 7-category ordinal scale is as follow:

    1. Not hospitalized with resumption of usual activities
    2. Not hospitalized, but unable to resume usual activities
    3. Hospitalized, not requiring O2
    4. Hospitalized, requiring O2 from 1 to 5 l/min
    5. Hospitalized, requiring O2 >6 l/min, nasal high-flow O2, non-invasive mechanical ventilation, or both
    6. Hospitalized, requiring ECMO, invasive mechanical ventilation, or both
    7. Death.


Secondary Outcome Measures :
  1. Proportion of patients free of oxygen at day 14 and 28 [ Time Frame: 14 and 28 days ]
  2. Proportion of patients discharged alive from hospital at day 14 and 28 [ Time Frame: 14 and 28 days ]
  3. Time to discharge for patients alive [ Time Frame: 28 days ]
  4. Proportion of patients that were hospitalized to ICU or who died at day 14 and 28 [ Time Frame: 14 and 28 days ]
  5. 14 and 28 day mortality rate [ Time Frame: 14 and 28 days ]
  6. The time until weaning from oxygen therapy [ Time Frame: 28 days ]
  7. The proportion of patients with clinical degradation of at least 1 point on the ordinal scale to 7 categories on D14 and D28 [ Time Frame: 14 and 28 days ]


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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:

  • Adult patients ≥ 18 years old,
  • Hospitalized with a proven diagnosis of COVID-19 (SARS-CoV-2 positive in RTPCR), in medicine or in intensive care.
  • With a need for oxygen therapy ≥ 2 l / min to maintain a Sp02> 92% or a need for oxygen therapy to maintain a PaO2 / FiO2> 300 mmHg (for intubated patients).
  • With a chest scanner at least 7 days after the onset of symptoms, and whose centralized interpretation shows a CT scan aspect suggestive of intense and predominant DAD which can explain the patient's oxygen dependence.
  • Signature of a free, written and informed consent by the patient, or the person of trust
  • Affiliate or beneficiary of a social security scheme.

Exclusion Criteria:

  • Patients already treated by CS for a chronic disease.
  • Patients with a known contraindication to SC, such as hypersensitivity.
  • Patients at risk of dying within 48 hours.
  • Pregnant or breastfeeding women.
  • Patients under guardianship, curatorship, safeguard of justice.
  • Poor understanding of the French language.

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): NCT04359511


Contacts
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Contact: pascal magro, MD +33247473787 pascal.magro@univ-tours.fr
Contact: sylvain marchand-adam, MD, PhD +33247473787 s.marchandadam@univ-tours.fr

Sponsors and Collaborators
University Hospital, Tours
Investigators
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Principal Investigator: LOUIS BERNARD, MD, PhD CHRU DE TOURS
Principal Investigator: JOUNEAU STEPHANE, MD, PhD Rennes University Hospital
Principal Investigator: MAILLOT FRANCOIS, MD CHRU DE TOURS
Principal Investigator: LIOGER BERTRAND, MD CH DE BLOIS
Principal Investigator: GOUPIL FRANCOIS, MD CH Le Mans
Principal Investigator: RABUT Thi- Tuyet Hong, MD CH DE CHARTRES
Principal Investigator: POPA Mihai, MD CH DE RDREUX
Principal Investigator: MOREL HUGUES, MD CHR ORLEANS
Principal Investigator: GUY TIPHAINE, MD CH DE VANNES
Principal Investigator: LEMMENS BRUNO, MD CH AMBOISE
Principal Investigator: BAZIN YANN, MD CH SAINT MALO
Principal Investigator: ROY XAVIER, MD CH DE CHATEAUROUX
Principal Investigator: PECQUERIAUX OLIVIER, MD CH DE BOURGES
Principal Investigator: MARCHAND ADAM Sylvain, MD, PhD CHRU DE TOURS
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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT04359511    
Other Study ID Numbers: CORTI-COVID-19-HUGO
DR200136 ( Registry Identifier: Sponsor ID )
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: April 2020
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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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Prednisone
Hydrocortisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents