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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Terminated

CT.gov ID

NCT04344288

Collaborator

(none)

Enrollment

Locations

Arms

3.9

Actual Duration (Months)

0.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

11 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

Actual Study Start Date :

Apr 21, 2020

Actual Primary Completion Date :

Aug 18, 2020

Actual Study Completion Date :

Aug 18, 2020

Arms and Interventions

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)
Other: 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.

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)

Other: 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.

Outcome Measures

Primary Outcome Measures

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. [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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,

Contacts and Locations

Locations

	Site	City	Country
1	Hôpital Pneumologique et Cardiovasculaire Louis Pradel	Bron	France
2	Groupement Hospitalier Nord	Lyon	France
3	Hôpital Edouard Herriot	Lyon	France
4	Hôpital St Joseph Saint Luc	Lyon	France
5	Hôpital St Joseph	Marseille	France
6	Centre hospitalier Lyon Sud	Pierre-Bénite	France
7	CHU St Etienne	Saint-Étienne	France
8	Clinique Charcot	Sainte-Foy-lès-Lyon	France
9	CHG Vienne	Vienne	France
10	Médipôle	Villeurbanne	France
11	Clinique des Portes du Sud	Vénissieux	France
12	CH Annecy-Genevois	Épagny	France