COVID19Phase 3TRONCHERNCT04361032
Assessment of Efficacy and Safety of Tocilizumab Compared to DefeROxamine, Associated With Standards Treatments in COVID-19 (+) Patients Hospitalized In Intensive Care in Tunisia
A Phase 3 study testing Tocilizumab Injection and Deferoxamine in people with COVID19 and Intensive Care Unit, run by Abderrahmane Mami Hospital at 1 site in Tunisia.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID19, Intensive Care Unit
- What is being tested?
- Tocilizumab Injection and Deferoxamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteTunisia
- Study dates
- 4 Sep 2020to 4 Oct 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Chokri Jeribi, Dr contact
Tunisia1 site
Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana
Aryanah
Chokri Jeribi, Dr, +21627870563, eshmouncompany@eshmoun.com.tn
About this study
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
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.
Read the detailed 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)
- Conditions
- COVID19, Intensive Care Unit
- Being tested
- Tocilizumab Injection, Deferoxamine
- Keywords
- Deferoxamine, Tocilizumab
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tocilizumab InjectionDrug
Also called ROACTEMRA
Tocilizumab (LOC) (8mg/ kg per day) (1 injection per infusion). Only on the 1st day (D0)
DeferoxamineDrug
Also called DESFERAL
Deferoxamine (Desferal 500 mg, powder, and solvent for IV solution for injection)
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab | Experimental | ROACTEMRA: (8mg/ kg per day) (1 injection per infusion) Receives: Drug: Tocilizumab Injection |
| Deferoxamine | Active comparator | DESFERAL: 500 mg, powder, and solvent for IV solution Receives: Drug: Deferoxamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 90 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start4 Sep 2020 (estimated)
- Primary completion4 Sep 2020 (estimated)
- Study completion4 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abderrahmane Mami Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eshmoun Clinical Research Center, Datametrix
- Responsible party
- Principal investigator, Dr Jalila Ben Khelil, Abderrahmane Mami Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361032
- Sponsor's protocol ID
- ECC2020-06
- Acronym
- TRONCHER
- Status last verified
- Aug 2020
- First submitted
- 22 Apr 2020
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04361032
- Acronym / sponsor ID
- TRONCHER / ECC2020-06
- Conditions
- COVID19, Intensive Care Unit
- Keywords
- Deferoxamine, Tocilizumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Abderrahmane Mami HospitalUniversity, hospital or other
- Collaborators
- Eshmoun Clinical Research Center, Datametrix
- Study start
- 4 Sep 2020 (estimated)
- Primary completion
- 4 Sep 2020 (estimated)
- Study completion
- 4 Oct 2020 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab | Experimental | Drug: Tocilizumab InjectionROACTEMRA: (8mg/ kg per day) (1 injection per infusion) |
| Deferoxamine | Active comparator | Drug: DeferoxamineDESFERAL: 500 mg, powder, and solvent for IV solution |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tocilizumab InjectionAlso: ROACTEMRATocilizumab (LOC) (8mg/ kg per day) (1 injection per infusion). Only on the 1st day (D0) | Drug | Tocilizumab |
| DeferoxamineAlso: DESFERALDeferoxamine (Desferal 500 mg, powder, and solvent for IV solution for injection) | Drug | Deferoxamine |
Primary outcome
the mortality rate
Time frame: 90 day
* 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for COVID19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chokri Jeribi, Dr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tocilizumab Injection and Deferoxamine in people with COVID19 and Intensive Care Unit, run by Abderrahmane Mami Hospital at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eshmoun Clinical Research Centre (0021627870563, eshmouncompany@eshmoun.com.tn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the mortality rate (time frame: 90 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2020.