Covid19Phase 2SOBINCT04603742
Anakinra, COVID-19, Cytokine Storm
A Phase 2 study testing Anakinra and 0.9% Saline in people with Covid19 and Cytokine Storm, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The clinical syndrome associated with infection of the Coronavirus Disease 2019 (COVID-19) is notable for its variable clinical expression. Infection and transmission of the virus by asymptomatic individuals have been noted and represent one end of the clinical spectrum, while multi-organ failure, particularly… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Covid19, Cytokine Storm, Mechanical Ventilation Complication
- What is being tested?
- Anakinra and 0.9% Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2021to Sep 2022
- Phase
- Phase 2
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An IRB approved written Informed Consent Form (ICF) is signed and dated by the subject or legal representative.
- The subject or legal representative must be considered capable of understanding the study procedures to provide consent for participation according to the judgment of the Investigator.
- Molecular diagnosis of SARS-CoV-2 infection within 14 days of screening assessment.
- Radiographic evidence of pneumonia by either chest X-ray or computerized tomography (CT) scan of the chest if collected as part of the standard of care.
- Age between 18-89 years of age at the screening visit.
- The subject must fulfill the inclusion criteria for CSS:
Show all 18Show fewer
- Fever documented ≥ 38 ˚C (from the time of admission to the hospital), or historical fever (patient-reported).
- AND
- Respiratory failure defined as:
- i.Requiring supplemental O2 of ≥ 4 L nasal cannula or more to maintain an O2 saturation ≥ 92%, within 36 hours of the requirement for that level of O2.24 (Individuals on continuous positive airway pressure (CPAP) or high flow nasal cannula will be allowed)
- AND
- Ferritin > 1000 ng/mL at the time of screening.
- Not requiring mechanical ventilation or ECMO at Screening and Baseline Assessments.
- ANC must be > 1 x 10^9/L before randomization
- Platelet count must be ≥ 50 x 10^9/L before randomization.
- Negative pregnancy test before randomization (women of childbearing age only).
- GFR ≥ 30 mL/min based on the Modification of Diet in Renal Disease equation.
- Subjects participating in studies for convalescent plasma or anticoagulation protocol for COVID-19 will be included as long as these are also open-label.
Who cannot join
- The subject is not expected to survive for more than 48 hours from screening, in the opinion of the investigator.
- Subjects participating in studies for COVID-19 with immunomodulating drugs, will be excluded. See Section 4.3.1 for drugs or investigational drugs for COVID-19 not allowed in this study.
- Subject is currently participating in another study with an investigational drug. Participation in observational studies is allowed.
- Known hypersensitivity to anakinra or E. coli derived proteins.
- Existence of other evidence that can explain pneumonia including but not limited to: Influenza A virus, Influenza B virus, bacterial pneumonia, fungal pneumonia, or mycobacterial infection.
- Known or suspected active TB including those incompletely treated, or known latent TB not adequately treated.
Show all 25Show fewer
- Known or suspected active TB including those incompletely treated.
- Exclude patients with known latent TB including those incompletely treated (patient reported).
- Known human immunodeficiency virus (HIV) infection.
- Culture confirmed active bacterial infection requiring antibiotic therapy.
- Subjects who are: do not intubate (DNI) and/or do not resuscitate (DNR) will not be allowed in the study.
- Subjects already on mechanical ventilation or on extracorporeal membrane oxygenation (ECMO).
- Subjects with Eastern Co-operative Oncology Group (ECOG)/WHO system score ≥ 3 before their hospital admission.
- Subjects with past or current lymphoproliferative disorder requiring current medical treatment (e.g., chemotherapy, radiotherapy) for these conditions.
- Current or past history of a solid tumor including breast or prostate cancer requiring current medical treatment.
- Subjects receiving other immunosuppressants.
- Use of the following medications within 6 months of randomization:
- Tumor necrosis factor inhibitors
- Chronic IL-1 use such as canakinumab or anakinra.
- IL-6 inhibitors: Use of any IL-6
- Janus kinase inhibitors
- Bruton's tyrosine kinase inhibitor
- C-C Chemokine receptor type 5
- Disease-modifying anti-rheumatic drugs (DMARD), which include cyclosporine, tacrolimus, cyclophosphamide, mycophenolic acid, mycophenolate, penicillamine, azathioprine, methotrexate.
- Rituximab and abatacept
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anakinra in Adults With Severe COVID-19 and Features of Cytokine Storm Syndrome: A Randomized, Double-blind, Placebo-controlled Trial
The clinical syndrome associated with infection of the Coronavirus Disease 2019 (COVID-19) is notable for its variable clinical expression. Infection and transmission of the virus by asymptomatic individuals have been noted and represent one end of the clinical spectrum, while multi-organ failure, particularly pulmonary failure, and death represent the most severe end of the clinical spectrum. In a recent study published from the investigator's institution about the first 393 patients with COVID-19, 77.1% had a fever, a mechanism driven by IL-1. This suggests that there may be an excess release of IL-1 present.
Cytokine storm syndrome (CSS) has been observed in patients with COVID-19 and has been proposed to contribute to the acute pulmonary failure that occurs. In distinct clinical settings, macrophage activation syndrome, elevated levels of pro-inflammatory cytokines, including IL-1, IL-6, and others, as well as elevations in laboratory indicators, including ferritin, CRP, d-dimer, and lymphopenia, have been observed. IL-1 production is induced in response to inflammatory stimuli and mediates various physiologic responses including inflammatory and immunological responses. Anakinra, a recombinant IL-1 receptor antagonist, has shown promise in treating CSS. It inhibits both IL-1-alpha and IL-1-beta. It is an FDA approved medication used in rheumatoid arthritis (RA) and Cryopyrin-Associated Periodic Syndromes (CAPS). Anakinra's ability to inhibit both IL-1 subtypes and short half-life makes it favorable to some experts. In the investigator's case-series, using anakinra in patients with COVID-19 showed promising in preventing the need for mechanical ventilation, and mortality subsequently.
This study will determine the efficacy of anakinra, an interleukin (IL) -1 receptor blocker, in reducing the need for mechanical ventilation and/or 28-day mortality among patients with COVID-19 who have features of CSS and severe respiratory failure. The investigators will test the hypothesis that the proportion of subjects with COVID-19, features of CSS, and severe respiratory failure (World Health Organization (WHO) category 4 or 5) alive and without having required mechanical ventilation at day 28 from randomization will be 18% higher among those that receive anakinra compared to those that receive a placebo. A secondary hypothesis is that the number of subjects alive at 60-days will be higher amongst those who receive anakinra compared to those who receive a placebo.
- Conditions
- Covid19, Cytokine Storm, Mechanical Ventilation Complication
- Being tested
- Anakinra, 0.9% Saline
- Keywords
- Anakinra, Covid19, Mechanical Ventilation, Cytokine Storm
- Medical subject headings
- COVID-19, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnakinraDrug
Also called Anakinra IV
100 mg of Anakinra will be mixed with 100 mL of 0.9% saline solution for IV administration.
0.9% SalineDrug
Also called Saline IV
The placebo preparation will consist of a 100 mL of 0.9% saline solution without the addition of anakinra.
| Study group | Role | What they receive |
|---|---|---|
| Anakinra IV | Experimental | Patients in the intervention arm will receive anakinra IV (N=85) 4 times a day for 7 days. The investigator will follow up with patients for up to 60 days. Receives: Drug: Anakinra |
| Normal Saline IV | Placebo comparator | Patients in the placebo arm will receive normal saline IV (N=85) 4 times a day for 7 days. The investigator will follow up with patients for up to 60 days. Receives: Drug: 0.9% Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects alive without having required mechanical ventilation
This will be measured among subjects with COVID-19, features of CSS, and severe respiratory failure (WHO category 4 or 5) who are alive and without having required mechanical ventilation 28 days post randomization.
Measured: 28 days post randomization
Secondary outcomes (3)
60-day mortality
Mortality of participants will be compared between those that received anakinra and those that did not.
Measured: 60 days post randomization
Patient Hospitalization
The number of days of hospitalization in the anakinra group compared to placebo after randomization up to day 28.
Measured: 28 days post randomization
Patient Mechanical Ventilation
The number of days with supplemental oxygen, with noninvasive ventilation or high-flow oxygen at day 28 after randomization in the anakinra group compared to placebo.
Measured: 28 days post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study startDec 2021 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionSep 2022 (estimated)
Why it stopped: Funding did not go through
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a phase II double-blind, placebo-controlled, multicentered trial. Patients in the intervention arm will receive anakinra IV (N=85) 4 times a day for 7 days. The placebo arm will receive normal saline IV (N=85) 4 times a day for 7 days. The investigators will follow up with patients for up to 60 days.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Orphan Biovitrum
- Responsible party
- Sponsor
- Investigators
- Iris Y Navarro-Millan, MD, MSPH, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603742
- Sponsor's protocol ID
- 20-07022396
- Acronym
- SOBI
- Status last verified
- Jan 2022
- First submitted
- 21 Oct 2020
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fu L, Wang B, Yuan T, Chen X, Ao Y, Fitzpatrick T, Li P, Zhou Y, Lin YF, Duan Q, Luo G, Fan S, Lu Y, Feng A, Zhan Y, Liang B, Cai W, Zhang L, Du X, Li L, Shu Y, Zou H. Clinical characteristics of coronavirus disease 2019 (COVID-19) in China: A systematic review and meta-analysis. J Infect. 2020 Jun;80(6):656-665. doi: 10.1016/j.jinf.2020.03.041. Epub 2020 Apr 10.
PubMed 32283155Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
PubMed 32007143Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
PubMed 32031570Goyal P, Choi JJ, Pinheiro LC, Schenck EJ, Chen R, Jabri A, Satlin MJ, Campion TR Jr, Nahid M, Ringel JB, Hoffman KL, Alshak MN, Li HA, Wehmeyer GT, Rajan M, Reshetnyak E, Hupert N, Horn EM, Martinez FJ, Gulick RM, Safford MM. Clinical Characteristics of Covid-19 in New York City. N Engl J Med. 2020 Jun 11;382(24):2372-2374. doi: 10.1056/NEJMc2010419. Epub 2020 Apr 17. No abstract available.
PubMed 32302078Dinarello CA. The history of fever, leukocytic pyrogen and interleukin-1. Temperature (Austin). 2015 Apr 14;2(1):8-16. doi: 10.1080/23328940.2015.1017086. eCollection 2015 Jan-Mar.
PubMed 27226996WHO. Coronavirus disease (COVID-19) Therapeutic Trial Synopsis. 2020; https://www.who.int/blueprint/priority-diseases/key-action/COVID19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf. Accessed May 8, 2020, 2020.
Navarro-Millan I, Sattui SE, Lakhanpal A, Zisa D, Siegel CH, Crow MK. Use of Anakinra to Prevent Mechanical Ventilation in Severe COVID-19: A Case Series. Arthritis Rheumatol. 2020 Dec;72(12):1990-1997. doi: 10.1002/art.41422. Epub 2020 Nov 4.
PubMed 32602262
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anakinra in Adults With Severe COVID-19 and Features of Cytokine Storm Syndrome: A Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04603742
- Acronym / sponsor ID
- SOBI / 20-07022396
- Conditions
- Covid19, Cytokine Storm, Mechanical Ventilation Complication
- Keywords
- Anakinra, Covid19, Mechanical Ventilation, Cytokine Storm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding did not go through
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Swedish Orphan Biovitrum
- Study start
- Dec 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 27 Oct 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 clinical syndrome associated with infection of the Coronavirus Disease 2019 (COVID-19) is notable for its variable clinical expression. Infection and transmission of the virus by asymptomatic individuals have been noted and represent one end of the clinical spectrum, while multi-organ failure, particularly pulmonary failure, and death represent the most severe end of the clinical spectrum. In a recent study published from the investigator's institution about the first 393 patients with COVID-19, 77.1% had a fever, a mechanism driven by IL-1. This suggests that there may be an excess release of IL-1 present.
Cytokine storm syndrome (CSS) has been observed in patients with COVID-19 and has been proposed to contribute to the acute pulmonary failure that occurs. In distinct clinical settings, macrophage activation syndrome, elevated levels of pro-inflammatory cytokines, including IL-1, IL-6, and others, as well as elevations in laboratory indicators, including ferritin, CRP, d-dimer, and lymphopenia, have been observed. IL-1 production is induced in response to inflammatory stimuli and mediates various physiologic responses including inflammatory and immunological responses. Anakinra, a recombinant IL-1 receptor antagonist, has shown promise in treating CSS. It inhibits both IL-1-alpha and IL-1-beta. It is an FDA approved medication used in rheumatoid arthritis (RA) and Cryopyrin-Associated Periodic Syndromes (CAPS). Anakinra's ability to inhibit both IL-1 subtypes and short half-life makes it favorable to some experts. In the investigator's case-series, using anakinra in patients with COVID-19 showed promising in preventing the need for mechanical ventilation, and mortality subsequently.
This study will determine the efficacy of anakinra, an interleukin (IL) -1 receptor blocker, in reducing the need for mechanical ventilation and/or 28-day mortality among patients with COVID-19 who have features of CSS and severe respiratory failure. The investigators will test the hypothesis that the proportion of subjects with COVID-19, features of CSS, and severe respiratory failure (World Health Organization (WHO) category 4 or 5) alive and without having required mechanical ventilation at day 28 from randomization will be 18% higher among those that receive anakinra compared to those that receive a placebo. A secondary hypothesis is that the number of subjects alive at 60-days will be higher amongst those who receive anakinra compared to those who receive a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study is a phase II double-blind, placebo-controlled, multicentered trial. Patients in the intervention arm will receive anakinra IV (N=85) 4 times a day for 7 days. The placebo arm will receive normal saline IV (N=85) 4 times a day for 7 days. The investigators will follow up with patients for up to 60 days.
| Arm | Type | Receives |
|---|---|---|
| Anakinra IV | Experimental | Drug: AnakinraPatients in the intervention arm will receive anakinra IV (N=85) 4 times a day for 7 days. The investigator will follow up with patients for up to 60 days. |
| Normal Saline IV | Placebo comparator | Drug: 0.9% SalinePatients in the placebo arm will receive normal saline IV (N=85) 4 times a day for 7 days. The investigator will follow up with patients for up to 60 days. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- An IRB approved written Informed Consent Form (ICF) is signed and dated by the subject or legal representative.
- The subject or legal representative must be considered capable of understanding the study procedures to provide consent for participation according to the judgment of the Investigator.
- Molecular diagnosis of SARS-CoV-2 infection within 14 days of screening assessment.
- Radiographic evidence of pneumonia by either chest X-ray or computerized tomography (CT) scan of the chest if collected as part of the standard of care.
- Age between 18-89 years of age at the screening visit.
Key exclusion criteria (25 listed)
- The subject is not expected to survive for more than 48 hours from screening, in the opinion of the investigator.
- Subjects participating in studies for COVID-19 with immunomodulating drugs, will be excluded. See Section 4.3.1 for drugs or investigational drugs for COVID-19 not allowed in this study.
- Subject is currently participating in another study with an investigational drug. Participation in observational studies is allowed.
- Known hypersensitivity to anakinra or E. coli derived proteins.
- Existence of other evidence that can explain pneumonia including but not limited to: Influenza A virus, Influenza B virus, bacterial pneumonia, fungal pneumonia, or mycobacterial infection.
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 |
|---|---|---|
| AnakinraAlso: Anakinra IV100 mg of Anakinra will be mixed with 100 mL of 0.9% saline solution for IV administration. | Drug | Anakinra IV |
| 0.9% SalineAlso: Saline IVThe placebo preparation will consist of a 100 mL of 0.9% saline solution without the addition of anakinra. | Drug | Normal Saline IV |
Primary outcome
Number of subjects alive without having required mechanical ventilation
Time frame: 28 days post randomization
This will be measured among subjects with COVID-19, features of CSS, and severe respiratory failure (WHO category 4 or 5) who are alive and without having required mechanical ventilation 28 days post randomization.
3 secondary outcomes
60-day mortality
Time frame: 60 days post randomization
Patient Hospitalization
Time frame: 28 days post randomization
Patient Mechanical Ventilation
Time frame: 28 days post randomization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Background: PubMed 32283155Fu L, Wang B, Yuan T, Chen X, Ao Y, Fitzpatrick T, Li P, Zhou Y, Lin YF, Duan Q, Luo G, Fan S, Lu Y, Feng A, Zhan Y, Liang B, Cai W, Zhang L, Du X, Li L, Shu Y, Zou H. Clinical characteristics of coronavirus disease 2019 (COVID-19) in China: A systematic review and meta-analysis. J Infect. 2020 Jun;80(6):656-665. doi: 10.1016/j.jinf.2020.03.041. Epub 2020 Apr 10.
- Background: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
- Background: PubMed 32007143Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
- Background: PubMed 32031570Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
- Background: PubMed 32302078Goyal P, Choi JJ, Pinheiro LC, Schenck EJ, Chen R, Jabri A, Satlin MJ, Campion TR Jr, Nahid M, Ringel JB, Hoffman KL, Alshak MN, Li HA, Wehmeyer GT, Rajan M, Reshetnyak E, Hupert N, Horn EM, Martinez FJ, Gulick RM, Safford MM. Clinical Characteristics of Covid-19 in New York City. N Engl J Med. 2020 Jun 11;382(24):2372-2374. doi: 10.1056/NEJMc2010419. Epub 2020 Apr 17. No abstract available.
- Background: PubMed 27226996Dinarello CA. The history of fever, leukocytic pyrogen and interleukin-1. Temperature (Austin). 2015 Apr 14;2(1):8-16. doi: 10.1080/23328940.2015.1017086. eCollection 2015 Jan-Mar.
- BackgroundWHO. Coronavirus disease (COVID-19) Therapeutic Trial Synopsis. 2020; https://www.who.int/blueprint/priority-diseases/key-action/COVID19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf. Accessed May 8, 2020, 2020.
- Background: PubMed 32602262Navarro-Millan I, Sattui SE, Lakhanpal A, Zisa D, Siegel CH, Crow MK. Use of Anakinra to Prevent Mechanical Ventilation in Severe COVID-19: A Case Series. Arthritis Rheumatol. 2020 Dec;72(12):1990-1997. doi: 10.1002/art.41422. Epub 2020 Nov 4.
- 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.
Iris Y Navarro-Millan, MD, MSPH principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anakinra and 0.9% Saline in people with Covid19 and Cytokine Storm, run by Weill Medical College of Cornell University at 1 site in United States.
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 18 inclusion and 25 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: withdrawn, as of the sponsor's last update on 25 Jan 2022. 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 United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
Number of subjects alive without having required mechanical ventilation (time frame: 28 days post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04603742, which also lists 8 linked publications.
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 25 Jan 2022.