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

COVID19 Clinical Trial

— TRONCHER  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04361032
• Other study ID #: ECC2020-06
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 4, 2020
• Est. completion date: October 4, 2020

Study information

• Verified date: August 2020
• Source: Abderrahmane Mami Hospital
• Contact: Eshmoun Clinical Research Centre
• Phone: 0021627870563
• Email: eshmouncompany[@]eshmoun.com.tn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Arm1 :

• Usual standard treatment*

• Tocilizumab (LOC) (8mg/ kg per day) (1 injection per infusion) a second injection may be considered if necessary, but no more than 800 mg per day. Only on the 1st day (D0)

• Enoxaparin (4000 IU X 2) per day for the duration of hospitalization

VERSUS

Arm 2:

• Usual standard treatment*

• Deferoxamine (Desferal 500 mg, powder, and solvent for IV solution) by electric syringe 40 mg/kg/day 5day/7 without exceeding 5 g per day for 14 days

• Enoxaparin (4000 IU X 2) per day for the duration of hospitalization

Usual standard treatment*: according to the standard practices of each center, apart from the active molecules of the 2 arms and their therapeutic class)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 260
• Est. completion date: October 4, 2020
• Est. primary completion date: September 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID19
• Intensive Care Unit

Intervention

Drug:
• Tocilizumab Injection
Tocilizumab (LOC) (8mg/ kg per day) (1 injection per infusion). Only on the 1st day (D0)
• Deferoxamine
Deferoxamine (Desferal 500 mg, powder, and solvent for IV solution for injection)

Locations

Country	Name	City	State
Tunisia	Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana	Ariana

Sponsors (3)

Lead Sponsor	Collaborator
Abderrahmane Mami Hospital	Datametrix, Eshmoun Clinical Research Centre

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the mortality rate	Evaluate the mortality rate at 90 days.; Evaluate the Intensive Care Unit (ICU) and Hospital Mortality rate at day 90 with date and cause of death (if applicable)	90 day