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

NCT ID: NCT04344288

Last Updated: 2020-10-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-21
• Study Completion Date: 2020-08-18

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.

Conditions

Viral Pneumonia Human Coronavirus; COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prednisone group

Prednisone during 10 days after randomization

Group Type: EXPERIMENTAL

Prednisone

Intervention Type: DRUG

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

Group Type: OTHER

Control group

Intervention Type: OTHER

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.

Interventions

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)

Intervention Type: DRUG

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.

Intervention Type: OTHER

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,

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-François MORNEX

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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-Etienne, , France

Clinique Charcot

Sainte-Foy-lès-Lyon, , France

Clinique des Portes du Sud

Vénissieux, , France

CHG Vienne

Vienne, , France

Médipôle

Villeurbanne, , France

Countries

France

Other Identifiers

2020-001553-48

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

69HCL20_0321

Identifier Type: -

Identifier Source: org_study_id