COVID-19 InfectionPhase 3ANACONDANCT04364009
Anakinra for COVID-19 Respiratory Symptoms
A Phase 3 study testing Anakinra plus oSOC and oSOC in people with COVID-19 Infection and ANAKINRA Treatment, run by University Hospital, Tours at 1 site in France.
Trial summary
The main objective of the ANACONDA-COVID-19 trial is to assess the efficacy of Anakinra + optimized Standard of Care (oSOC) as compared to oSOC alone on the condition of patients with COVID-19 infection and worsening respiratory symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Infection, ANAKINRA Treatment, Optimized Standard of Care (oSOC)
- What is being tested?
- Anakinra plus oSOC and oSOC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2020to 3 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female≥ 18 years of age
- Written informed consent of the patient or a proxy
- Ability for participant to comply with the requirements of the study
- Hospitalized patient with COVID-19 defined as
- Positive SARS-CoV2 RT-PCR
- Or typical COVID-19 Radiographic infiltrates on the CT scan (peripheral ground glass without lung cavitation, lymphadenopathy, or pulmonary nodules) other non COVID-19 diagnosis ruled out.
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- Patient with respiratory symptoms and requirement of oxygen therapy as defined:
- Oxygen therapy >= 4L/min to maintain Sp02>92% and respiratory rate >=24/min.
- Or patients under oxygen >= 1L/min and presenting worsening of oxygen requirement defined by an increase of oxygen therapy >= 2L/min to maintain Sp02>92%.
- Inflammatory component C-Reactive Protein ≥ 50mg/L.
- Patients within the first 20 days from the onset of the first COVID-19 symptoms
- Probabilistic antibiotics therapy according to local practice
- Non-inclusion criteria:
- Respiratory failure related to other cause than COVID-19
- Patients requiring mechanical ventilation at inclusion or requiring oxygen therapy equal or more than 11 liters per min to maintain Sp02>92%
- Infectious diseases such as severe bacterial infections, aspergillosis, HIV, active HCV, active HBV, active tuberculosis
- Contra indication to anti-IL1 receptor
- Known hypersensitivity to Anakinra
- Absolute neutrophil count (ANC)< 1500/mm3
- Liver cirrhosis Child-Pugh Score C
- Live or attenuated vaccine in the past 8 weeks
- Pregnant or breast-feeding women
- Patients with either legally protected status or who have been deprived of their freedom
- Patient included in other interventional therapeutic research (e.g. = concurrent participation in French CoVID-19 is accepted)
- Patients who have received previous treatment by anti-IL6R, anti-IL-6, anti-IL1R, anti-IL1 or anti-TNFα within 21 days preceding inclusion
- Absence of Health Insurance
- Existence of any life-threatening co-morbidity or any other medical condition which,in the opinion of the investigator, makes the patient unsuitable for inclusion.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of ANAkinra During Adult " COVID-19 " With Aggravating Respiratory Symptoms: a Multicenter Open-label Controlled Randomized Trial
The main objective of the ANACONDA-COVID-19 trial is to assess the efficacy of Anakinra + optimized Standard of Care (oSOC) as compared to oSOC alone on the condition of patients with COVID-19 infection and worsening respiratory symptoms. Success defined as patient alive and free of invasive mechanical ventilation (IMV) and free of Extracorporeal Membrane Oxygenation (ECMO) at Day 14.
- Being tested
- Anakinra plus oSOC, oSOC
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anakinra plus oSOCDrug
Anakinra plus Optimized Standard of Care (oSOC) on the condition of patients with COVID-19 infection and worsening respiratory symptoms.
The patients will receive intraveinous injection of Anakinra 400mg from Day 1 to Day 3 (two injections of 100 mg each 12 hours) and 200mg the remaining 7 days. The total duration of Anakinra is 10 Days. Efficient dosage of Anakinra as previously described will be continued until Day 10
oSOCDrug
Optimized Standard of Care (oSOC) on the condition of patients with COVID-19 infection and worsening respiratory symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Optimized Standard of Care (oSOC) | Active comparator | The control group will receive optimized standard of care alone, including all treatments authorized for COVID-19 by the French Health Ministry and/or the center COVID-19 therapeutic committees at inclusion and during the follow-up. Receives: Drug: oSOC |
| Anakinra plus Optimized Standard of Care (oSOC) | Experimental | The experimental group will receive Anakinra plus optimized Standard of Care. The patients will receive Intravenous injection (IV) of Anakinra 400mg/day (100mg IV every 6 hours) at Day 1, 2 and 3. From Day 4 to Day 10, the patient will receive IV injection of Anakinra 200mg/day (100mg every 12 hours). The total duration of Anakinra is 10 Days Receives: Drug: Anakinra plus oSOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success
The primary endpoint is treatment success at Day 14, defined as a patient alive and not requiring any of the following: Invasive mechanical ventilation (IMV) or Extracorporeal membrane oxygenation (ECMO).
Measured: After 14 days of treatment
Secondary outcomes (16)
Treatment success
Defined as a patient alive and not requiring any of the following: Invasive mechanical ventilation (IMV) or Extracorporeal membrane oxygenation (ECMO).
Measured: After 3 days, 10 days and 28 days of treatment
OMS progression scale (on a 7 point ordinal scale)
- Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices;6. Hospitalized, on invasive mechanical ventilation or ECMO;7. Death.
Measured: After 3 days, 10 days, 14 days and 28 days of treatment
Overall survival
Overall survival
Measured: After 3 days, 10 days, 14 days and 28 days of treatment
Time to ICU admission
Time to ICU admission
Measured: Up to 28 days
Time to ventilatory support
Time to ventilatory support : extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, non-invasive ventilation, high flow oxygen therapy)
Measured: Up to 28 days
Change in National Early Warning Score (NEW)from baseline to Day 3, Day 10, Day 14 and Day 28
The National Early Warning Score (NEWS) determines the degree of illness of a patient using six physiological findings and one observation. Score from 0 to 20, 0 mean a worse outcome, 20 mean a better outcome
Measured: After 3 days, 10 days, 14 days and 28 days of treatment
Change in inflammatory parameter
C-reactive proteine (mg/L)
Measured: From baseline to Day 3, Day 10, Day 14 and Day 28
Change in inflammatory parameter
ferritin (ng/mL)
Measured: From baseline to Day 3, Day 10, Day 14 and Day 28
Change in inflammatory parameter
lymphocyte count (G/L)
Measured: From baseline to Day 3, Day 10, Day 14 and Day 28
Change in inflammatory parameter
fibrinogen (g/l)
Measured: From baseline to Day 3, Day 10, Day 14 and Day 28
Hospital length of stay
Hospital length of stay
Measured: Up to 28 days
ICU parameter
Need for Vasopressors (yes or no)
Measured: Up to 28 days
ICU parameter
Evolution of SpO2/FIO2 ratio (no unit)
Measured: Up to 28 days
ICU parameter
Evolution of PaO2/FiO2 ratio (no unit)
Measured: Up to 28 days
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Occurrence of serious adverse events during the study, including infection (bacterial, parasitic, mycotic and viral infection), septic shock, Ankanira hypersensitivity, hepatic damages (SGOT/SGPT, alkaline phosphatase, gammaGT) and neutropenia (Blood count).
Measured: Up to 28 days
Predictors of efficacy of Anakinra
The correlation between several of clinical parameters at inclusion (including level of oxygen requirement (saturation), respiratory rate (per min), temperature (°C)…), biological parameters :including, CRP (mg/L), ferritin (µg/L), LDH (UI/L), lymphocyte count (G/L), eosinophil count (G/L), Ddimers (ng/mM), platelet count (G/L), polymorphonuclear count (G/L)...with the primary end point will be explored.
Measured: After 14 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start27 Apr 2020
- Primary completion20 Oct 2020
- Study completion3 Nov 2020
Why it stopped: Efficiency and safety reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- 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
- Model description
- ANACONDA study is a French multicentre, open-label, randomized, controlled superiority trial comparing the administration of optimized standard of care and Anakinra versus optimized standard of care alone in patients hospitalized in a medical unit with COVID-19.
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM CIC-P 1415, University Hospital Center of Tours, Swedish Orphan Biovitrum
- Responsible party
- Sponsor
- Investigators
- Alexandra AUDEMARD-VERGER, MD-PhD, Study director, University Hospital of Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364009
- Sponsor's protocol ID
- ANACONDA-COVID-19
- Other IDs
- 2020-001734-36, DR200111
- Acronym
- ANACONDA
- Status last verified
- Apr 2020
- First submitted
- 17 Apr 2020
- Last updated
- 15 Jan 2021
- 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 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of ANAkinra During Adult " COVID-19 " With Aggravating Respiratory Symptoms: a Multicenter Open-label Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT04364009
- Acronym / sponsor ID
- ANACONDA / ANACONDA-COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Efficiency and safety reasons
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- INSERM CIC-P 1415, University Hospital Center of Tours, Swedish Orphan Biovitrum
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 27 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.
The main objective of the ANACONDA-COVID-19 trial is to assess the efficacy of Anakinra + optimized Standard of Care (oSOC) as compared to oSOC alone on the condition of patients with COVID-19 infection and worsening respiratory symptoms. Success defined as patient alive and free of invasive mechanical ventilation (IMV) and free of Extracorporeal Membrane Oxygenation (ECMO) at Day 14.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- ANACONDA study is a French multicentre, open-label, randomized, controlled superiority trial comparing the administration of optimized standard of care and Anakinra versus optimized standard of care alone in patients hospitalized in a medical unit with COVID-19.
| Arm | Type | Receives |
|---|---|---|
| Optimized Standard of Care (oSOC) | Active comparator | Drug: oSOCThe control group will receive optimized standard of care alone, including all treatments authorized for COVID-19 by the French Health Ministry and/or the center COVID-19 therapeutic committees at inclusion and during the follow-up. |
| Anakinra plus Optimized Standard of Care (oSOC) | Experimental | Drug: Anakinra plus oSOCThe experimental group will receive Anakinra plus optimized Standard of Care. The patients will receive Intravenous injection (IV) of Anakinra 400mg/day (100mg IV every 6 hours) at Day 1, 2 and 3. From Day 4 to Day 10, the patient will receive IV injection of Anakinra 200mg/day (100mg every 12 hours). The total duration of Anakinra is 10 Days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Male or female≥ 18 years of age
- Written informed consent of the patient or a proxy
- Ability for participant to comply with the requirements of the study
- Hospitalized patient with COVID-19 defined as
- Patient with respiratory symptoms and requirement of oxygen therapy as defined:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Anakinra plus oSOCAnakinra plus Optimized Standard of Care (oSOC) on the condition of patients with COVID-19 infection and worsening respiratory symptoms. The patients will receive intraveinous injection of Anakinra 400mg from Day 1 to Day 3 (two injections of 100 mg each 12 hours) and 200mg the remaining 7 days. The total duration of Anakinra is 10 Days. Efficient dosage of Anakinra as previously described will be continued until Day 10 | Drug | Anakinra plus Optimized Standard of Care (oSOC) |
| oSOCOptimized Standard of Care (oSOC) on the condition of patients with COVID-19 infection and worsening respiratory symptoms. | Drug | Optimized Standard of Care (oSOC) |
Primary outcome
Treatment success
Time frame: After 14 days of treatment
The primary endpoint is treatment success at Day 14, defined as a patient alive and not requiring any of the following: Invasive mechanical ventilation (IMV) or Extracorporeal membrane oxygenation (ECMO).
16 secondary outcomes
Treatment success
Time frame: After 3 days, 10 days and 28 days of treatment
OMS progression scale (on a 7 point ordinal scale)
Time frame: After 3 days, 10 days, 14 days and 28 days of treatment
Overall survival
Time frame: After 3 days, 10 days, 14 days and 28 days of treatment
Time to ICU admission
Time frame: Up to 28 days
Time to ventilatory support
Time frame: Up to 28 days
Change in National Early Warning Score (NEW)from baseline to Day 3, Day 10, Day 14 and Day 28
Time frame: After 3 days, 10 days, 14 days and 28 days of treatment
Change in inflammatory parameter
Time frame: From baseline to Day 3, Day 10, Day 14 and Day 28
Change in inflammatory parameter
Time frame: From baseline to Day 3, Day 10, Day 14 and Day 28
Change in inflammatory parameter
Time frame: From baseline to Day 3, Day 10, Day 14 and Day 28
Change in inflammatory parameter
Time frame: From baseline to Day 3, Day 10, Day 14 and Day 28
Hospital length of stay
Time frame: Up to 28 days
ICU parameter
Time frame: Up to 28 days
ICU parameter
Time frame: Up to 28 days
ICU parameter
Time frame: Up to 28 days
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Up to 28 days
Predictors of efficacy of Anakinra
Time frame: After 14 days of treatment
Results and safety
The study was stopped early (reason given: Efficiency and safety reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Alexandra AUDEMARD-VERGER, MD-PhD study director
University Hospital of Tours
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 Anakinra plus oSOC and oSOC in people with COVID-19 Infection and ANAKINRA Treatment, run by University Hospital, Tours at 1 site in France.
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 27 inclusion and 0 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: stopped early, as of the sponsor's last update on 15 Jan 2021. 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 France. 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?
The study was stopped early (reason given: Efficiency and safety reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success (time frame: After 14 days of treatment). 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 15 Jan 2021.