Assessment of Efficacy and Safety of Tocilizumab Compared to DefeROxamine, Associated With Standards Treatments in COVID-19 (+) Patients Hospitalized In Intensive Care in Tunisia

• Status: Not yet recruiting
• Trial end date: 2020-10-04
• Target enrollment: 0
• Participant gender: All

Summary

Assessment of Efficacy and Safety of Tocilizumab Compared to DefeROxamine, associated with standards treatments in COVID-19 (+) patients, Hospitalized In Intensive care in Tunisia.

Multicentric, comparative, randomized study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abderrahmane Mami Hospital
• Collaborators: Datametrix; Eshmoun Clinical Research Centre
• Treatments: Deferoxamine

Criteria

Inclusion Criteria:

• Patient confirmed COVID19 positive

• Patient with acute respiratory deficiency

• Patient hospitalized in the intensive care unit

• Age >18 years old

• Having given written consent for their participation in the study

Exclusion Criteria:

• Taking Tocilizumab or hydroxychloroquine deferoxamine within one month prior to inclusion (excluding participation in THINC or COVID_2Pro or COVID+PA studies)

• Severe/severe liver failure

• Dialysis patients

• Renal insufficiency (clearance< 30ml/min/1.73m2)

• Allergy to deferoxamine

• Pregnant or breastfeeding woman

• Hypersensitivity to the active substance or any of the excipients of Tocilizumab

• A decrease in blood platelets with previous use of enoxaparin or another heparin drug,

• hemophilia and related diseases,

• stomach or duodenal ulcer