Status:
TERMINATED
Corticosteroids During Covid-19 Viral Pneumonia Related to SARS-Cov-2 Infection
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Viral Pneumonia Human Coronavirus
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 Or...
Eligibility Criteria
Inclusion
- 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
- 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,
Key Trial Info
Start Date :
April 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2020
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04344288
Start Date
April 21 2020
End Date
August 18 2020
Last Update
October 26 2020
Active Locations (12)
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1
Hôpital Pneumologique et Cardiovasculaire Louis Pradel
Bron, France
2
CH Annecy-Genevois
Épagny, France
3
Groupement Hospitalier Nord
Lyon, France
4
Hôpital Edouard Herriot
Lyon, France