Prevention of severe respiratory failure in Covid-19

Phase 1

• Conditions: ower respiratory tract infection by Covid-19 at high risk for development of severe respiratory failure; MedDRA version: 20.0Level: LLTClassification code 10035738Term: Pneumonia viral NOSSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001466-11-GR
• Lead Sponsor: Hellenic Institute for the Study of Sepsis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-14
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Age equal to or above 18 years
• Male or female gender
• In case of women, unwillingness to remain pregnant during the study period.
• Written informed consent provided by the patient or by one first-degree relative/spouse in case of patients unable to consent
• Confirmed infection by SARS-CoV-2 virus
• Findings in chest-X-ray or in chest computed tomography compatible with lower respiratory tract infection
• Plasma suPAR =6ng/ml
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

• Age below 18 years
• Denial for written informed consent
• Any stage IV malignancy
• Any do not resuscitate decision
• Presence of respiratory failure
• Any primary immunodeficiency
• Less than 1,500 neutrophils/mm3
• Known allergy to anakinra
• Known allergy to trimethoprim/sulfamehoxazole
• Known G-6PD enzyme deficiency
• Oral or IV intake of corticosteroids at a daily dose equal or greater than 0.4 mg prednisone or greater the last 15 days.
• Any anti-cytokine biological treatment the last one month
• Confirmed pernicious anemia due to folic acid deficiency
• Severe hepatic failure
• Severe renal failure
• Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified