DEFIBROTIDE AS PREVENTION AND TREATMENT OF RESPIRATORY DISTRESS AND CYTOKINE RELEASE SYNDROME OF COVID-19

Phase 1

• Conditions: COVID-19; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2020-001409-21-ES
• Lead Sponsor: FFIS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-03
• Last Update Posted: 14 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

? Patients of both sexes with an age greater than or equal to 18 years.
? Patients with a diagnosis of SARS-CoV-2 infection confirmed by RT-PCR.
? Patients with grade 4, 5 or 6 clinical status according to the WHO classification.
- Grade 4: Hospitalized patients requiring oxygen therapy.
- Grade 5: Hospitalized patients requiring high-flow oxygen therapy, non-invasive mechanical ventilation, or both.
- Grade 6: Hospitalized patients requiring extracorporeal membrane oxygenation or invasive mechanical ventilation.
? Patients with IL-6 levels equal to or greater than 3 times the value of normality
? Potentially fertile patients should have a negative pregnancy test in serum (beta-HCG) or urine (evaluated between 2 and 1 days prior to administration of the study medication).
? Patients who offer sufficient guarantees of adherence to the protocol.
? Patients who give their written informed consent to participate in the study
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

? Patients with acute bleeding.
? Patients with thrombolytic treatment and anticoagulant treatment at therapeutic doses.
? Patients with an active malignant tumor.
? Patients with severe systemic or neuropsychiatric diseases.
? Patients with hypersensitivity to the active substance or to any of the excipients of the study drug.
? Patients who are participating in other clinical trials.
? Patients with an inability to understand informed consent.
? Pregnant patientsb, in the postpartum period or in the period of active lactation.
Physically fertile patients, UNLESS they are using a highly effective contraceptive method

Study & Design

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