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

COVID-19 Clinical Trial

— CORTI-Covid  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04344288
• Other study ID #: 69HCL20_0321
• Secondary ID: 2020-001553-48
• Status: Terminated
• Phase: Phase 2
• Start date: April 21, 2020
• Est. completion date: August 18, 2020

Study information

• Verified date: October 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: August 18, 2020
• Est. primary completion date: August 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• COVID-19
• Pneumonia
• Pneumonia, Viral
• Viral Pneumonia Human Coronavirus

Intervention

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)

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.

Locations

Country	Name	City	State
France	Hôpital Pneumologique et Cardiovasculaire Louis Pradel	Bron
France	CH Annecy-Genevois	Épagny
France	Groupement Hospitalier Nord	Lyon
France	Hôpital Edouard Herriot	Lyon
France	Hôpital St Joseph Saint Luc	Lyon
France	Hôpital St Joseph	Marseille
France	Centre hospitalier Lyon Sud	Pierre-Bénite
France	CHU St Etienne	Saint-Étienne
France	Clinique Charcot	Sainte-Foy-lès-Lyon
France	Clinique des Portes du Sud	Vénissieux
France	CHG Vienne	Vienne
France	Médipôle	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	7 days
Secondary	disease severity assessed on a 7-level ordinal scale	level1: not hospitalized no limited activities, level 7: death	7 days
Secondary	number of patients with a supplemental oxygen use		7 days
Secondary	radiological signs on chest imaging	Reduction of radiological signs on chest imaging	7 days
Secondary	number of patients transferred to intensive care unit		21 days
Secondary	number of patients requiring invasive ventilation		21 days
Secondary	Duration of oxygen therapy	duration on days	21 days
Secondary	number of adverse events induced by corticosteroid treatment		21 days
Secondary	number of patients with infections other than SARS-CoV-2		21 days
Secondary	number of deaths		21 days