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Corticosteroids During Covid-19 Viral Pneumonia Related to SARS-Cov-2 Infection (CORTI-Covid)

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ClinicalTrials.gov Identifier: NCT04344288
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Infection with the SARS-Cov-2 virus, responsible of severe acute respiratory distress syndrome (SARS), is an emerging infectious disease called Covid-19 and declared as pandemic by the World Health Organization on March 11, 2020. This pandemic is responsible of significant mortality. In France, several thousand patients are hospitalized in intensive care units, and their number continues to increase. Mortality during Covid-19 is mainly linked to acute respiratory distress syndrome, which frequency is estimated in France to occur in 6% of infected patients. Comorbidities such as cardiovascular conditions, obesity and diabetes increase susceptibility to severe forms of Covid-19 and associated mortality. Therapeutic management has three components: symptomatic management, including supplementary oxygen therapy and in case of respiratory distress mechanical ventilation; the antiviral approach; and immunomodulation, aiming at reducing inflammation associated with viral infection, which is considered to take part in severe presentations of the disease.

During Covid-19 viral pneumonia related to SARS-COv-2, there is a significant release of pro-inflammatory cytokines in the acute phase of viral infection, which could participate in viral pneumonia lesions. In children with less mature immune system than adults, SARS-Cov-2 infection is less severe. The current prevailing assumption is that severe forms of Covid-19 may not only be related to high viral replication, but also to an excessive inflammatory response favoring acute lung injury and stimulating infection.

The investigators hypothesize that early control of the excessive inflammatory response may help reducing the risk of acute respiratory distress syndrome.

The investigators will evaluate the benefit, safety and tolerability of corticosteroid therapy to reduce the rate of subjects hospitalized for Covid-19 viral pneumonia who experience clinical worsening with a need of high-flow supplemental oxygen supplementation or transfer in intensive care units for respiratory support.


Condition or disease Intervention/treatment Phase
Viral Pneumonia Human Coronavirus COVID-19 Drug: Prednisone Other: Control group Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Corticosteroids During Covid-19 Viral Pneumonia Related to SARS-Cov-2 Infection
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia Steroids
Drug Information available for: Prednisone

Arm Intervention/treatment
Experimental: Prednisone group
Prednisone during 10 days after randomization
Drug: Prednisone
The experimental group will receive oral prednisone during 10 days (0.75 mg/kg/day during 5 days then 20 mg/day during 5 more days)

Control group Other: Control group
The control group will receive standard of care according to the international recommendations and practices of the investigational site. No corticosteroid therapy can be prescribed in this group.




Primary Outcome Measures :
  1. Number of patients with a theoretical respiratory indication for transfer to intensive care unit evaluated by a SpO2 <90% stabilized at rest and under not more than 5 L / min of supplemental oxygen using medium concentration mask. [ Time Frame: 7 days ]
    SpO2 <90% stabilized at rest and under not more than 5 L / min of supplemental oxygen using medium concentration mask. measured twice at 5-15 min intervalsThe average value of the two measurements will be calculated.


Secondary Outcome Measures :
  1. disease severity assessed on a 7-level ordinal scale [ Time Frame: 7 days ]
    level1: not hospitalized no limited activities, level 7: death

  2. number of patients with a supplemental oxygen use [ Time Frame: 7 days ]
  3. radiological signs on chest imaging [ Time Frame: 7 days ]
    Reduction of radiological signs on chest imaging

  4. number of patients transferred to intensive care unit [ Time Frame: 21 days ]
  5. number of patients requiring invasive ventilation [ Time Frame: 21 days ]
  6. Duration of oxygen therapy [ Time Frame: 21 days ]
    duration on days

  7. number of adverse events induced by corticosteroid treatment [ Time Frame: 21 days ]
  8. number of patients with infections other than SARS-CoV-2 [ Time Frame: 21 days ]
  9. number of deaths [ Time Frame: 21 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Age ≥ 18 years old,
  • Hospitalization for COVID-19 infection confirmed by RT-PCR or other virological method,
  • Peripheral saturation by pulse oximeter SpO2 ≤ 94% in ambient air measured twice at 5-15 min intervals, or PaO2 / FiO2 <300 mmHg,
  • Abnormalities on the chest x-ray or CT scan suggestive of viral pneumonia,
  • Signed informed consent by the patient.

Exclusion Criteria:

  • Covid-19 infection with first symptoms lasting for more than 9 days according to the patient's interview; D1 of symptoms is defined by the first day with fever, cough, shortness of breath, and / or chills related to Covid-19 infection;
  • Patients with primary or secondary immune deficiency, including: HIV, chronic hematological disease, solid organ transplant, ongoing immunosuppressive therapy,
  • Long-term corticosteroid therapy defined by a prescription of more than 10 mg/d (prednisone equivalent),
  • Suspected or confirmed infection with bacteria, fungal agents or viruses (in addition to Covid-19),
  • Known contraindication to systemic corticosteroids,
  • Systolic blood pressure <80 mmHg,
  • SpO2 <90% under 5 L / min of oxygen using medium concentration mask, or higher oxygen requirements,
  • Patient on long-term oxygen therapy,
  • Ongoing mechanical ventilation,
  • Ongoing septic shock ongoing,
  • Ongoing multi-organ failure ongoing,
  • Participating in other COVID-19 therapeutic clinical trial
  • Pregnant or breast-feeding woman (oral diagnosis),
  • No affiliation or beneficiary of health insurance,

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): NCT04344288


Contacts
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Contact: Vincent COTTIN, Pr 4 27 85 77 00 ext +33 vincent.cottin@chu-lyon.fr
Contact: Marielle BUISSON 33 4 72 11 50 11 ext +33 marielle.buisson01@chu-lyon.fr

Locations
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France
Hôpital Pneumologique et Cardiovasculaire Louis Pradel Recruiting
Bron, France
Contact: Vincent COTTIN       vincent.cottin@chu-lyon.fr   
Contact: Marie GROUSSAUD       marie.groussaud@chu-lyon.fr   
Groupement Hospitalier Nord Not yet recruiting
Lyon, France
Contact: Gilles DEVOUASSOUX         
Principal Investigator: Gilles DEVOUASSOUX         
Groupement Hospitalier Nord Not yet recruiting
Lyon, France
Contact: Yvan JAMILLOUX         
Principal Investigator: Yvan JAMILLOUX         
Hôpital Edouard Herriot Not yet recruiting
Lyon, France
Contact: Arnaud HOT         
Principal Investigator: Arnaud HOT         
Hôpital St Joseph Saint Luc Recruiting
Lyon, France
Contact: Sylvie VUILLERMOZ-BLAC         
Contact       svuillermoz@ch-stjoseph-stluc-lyon.fr   
Principal Investigator: Sylvie VUILLERMOZ-BLAC         
Hôpital St Joseph Not yet recruiting
Marseille, France
Contact: Boris BIENVENU         
Principal Investigator: Boris BIENVENU         
Centre hospitalier Lyon Sud Not yet recruiting
Pierre-Bénite, France
Contact: Sébastien COURAUD         
Principal Investigator: Sébastien COURAUD         
Centre hospitalier Lyon Sud Not yet recruiting
Pierre-Bénite, France
Contact: Isabelle DURIEU         
Principal Investigator: Isabelle DURIEU         
CHU St Etienne Not yet recruiting
Saint-Étienne, France
Contact: Isabelle COURT-FORTUNE         
Principal Investigator: Isabelle COURT-FORTUNE         
Clinique Charcot Not yet recruiting
Sainte-Foy-lès-Lyon, France
Contact: Fabrice PIEGAY         
Principal Investigator: Fabrice PIEGAY         
CHG Vienne Not yet recruiting
Vienne, France
Contact: Henri AUSSEDAT         
Principal Investigator: Henri AUSSEDAT         
Médipôle Not yet recruiting
Villeurbanne, France
Contact: Yassine HAMMOU         
Principal Investigator: Yassine HAMMOU         
Clinique des Portes du Sud Not yet recruiting
Vénissieux, France
Contact: Clément DEUDON         
Principal Investigator: Clément DEUDON         
CH Annecy-Genevois Not yet recruiting
Épagny, France
Contact: Stéphane HOMINAL         
Principal Investigator: Stéphane HOMINAL         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Jean-François MORNEX Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04344288    
Other Study ID Numbers: 69HCL20_0321
2020-001553-48 ( EudraCT Number )
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: April 20, 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
Keywords provided by Hospices Civils de Lyon:
Pneumology
viral pneumology
SARS-Cov-2
COVID 19
Prednisone
Additional relevant MeSH terms:
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Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents