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

NCT04344288 | Terminated Phase 2 DMC

• 2 other identifiers: 69HCL20_03212020-001553-48
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 12

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

Keywords

Pneumology; viral pneumology; SARS-Cov-2; COVID 19; Prednisone

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (9)

• disease severity assessed on a 7-level ordinal scale

  7 days

• number of patients with a supplemental oxygen use

  7 days

• radiological signs on chest imaging

  7 days

• number of patients transferred to intensive care unit

  21 days

• number of patients requiring invasive ventilation

  21 days

Study Arms (2)

Prednisone group

EXPERIMENTAL

Prednisone during 10 days after randomization

Drug: Prednisone

Control group

OTHER

Other: Control group

Interventions

Prednisone 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)

Prednisone group

Control group 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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (12)

Hôpital Pneumologique et Cardiovasculaire Louis Pradel

Bron, France

Location

CH Annecy-Genevois

Épagny, France

Location

Groupement Hospitalier Nord

Lyon, France

Location

Hôpital Edouard Herriot

Lyon, France

Location

Hôpital St Joseph Saint Luc

Lyon, France

Location

Hôpital St Joseph

Marseille, France

Location

Centre hospitalier Lyon Sud

Pierre-Bénite, France

Location

CHU St Etienne

Saint-Etienne, France

Location

Clinique Charcot

Sainte-Foy-lès-Lyon, France

Location

Clinique des Portes du Sud

Vénissieux, France

Location

CHG Vienne

Vienne, France

Location

Médipôle

Villeurbanne, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Prednisone; Control Groups

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jean-François MORNEX

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 14, 2020
• Study Start: April 21, 2020
• Primary Completion: August 18, 2020
• Study Completion: August 18, 2020
• Last Updated: October 26, 2020

Record last verified: 2020-10

Locations

FR (12)