Clinical trial NCT04344288: Corticosteroids During Covid-19 Viral Pneumonia Related to SARS-Cov-2 Infection
Official title: Corticosteroids During Covid-19 Viral Pneumonia Related to SARS-Cov-2 Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Viral Pneumonia Human Coronavirus
COVID-19
Keywords: Pneumology
viral pneumology
SARS-Cov-2
COVID 19
Prednisone
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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,

Primary outcomes:
measure: 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.
timeFrame: 7 days
Secondary outcomes:
measure: disease severity assessed on a 7-level ordinal scale
timeFrame: 7 days
measure: number of patients with a supplemental oxygen use
timeFrame: 7 days
measure: radiological signs on chest imaging
timeFrame: 7 days
measure: number of patients transferred to intensive care unit
timeFrame: 21 days
measure: number of patients requiring invasive ventilation
timeFrame: 21 days
measure: Duration of oxygen therapy
timeFrame: 21 days
measure: number of adverse events induced by corticosteroid treatment
timeFrame: 21 days
measure: number of patients with infections other than SARS-CoV-2
timeFrame: 21 days
measure: number of deaths
timeFrame: 21 days
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Pneumologique et Cardiovasculaire Louis Pradel
city: Lyon
country: France
facility: Groupement Hospitalier Nord
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Lyon
country: France
facility: Hôpital St Joseph Saint Luc
city: Marseille
country: France
facility: Hôpital St Joseph
city: Pierre-Bénite
country: France
facility: Centre hospitalier Lyon Sud
city: Saint-Étienne
country: France
facility: CHU St Etienne
city: Sainte-Foy-lès-Lyon
country: France
facility: Clinique Charcot
city: Vienne
country: France
facility: CHG Vienne
city: Villeurbanne
country: France
facility: Médipôle
city: Vénissieux
country: France
facility: Clinique des Portes du Sud
city: Épagny
country: France
facility: CH Annecy-Genevois
Study officials:
affiliation: Hospices Civils de Lyon
name: Jean-François MORNEX
role: PRINCIPAL_INVESTIGATOR
References: