Covid19Phase 3STRUCKNCT04724629
Survival TRial Using CytoKines in COVID-19 (STRUCK Trial)
A Phase 3 study testing Ixekizumab, Aldesleukin and Colchicine in people with Covid19, run by University of Sao Paulo at 2 sites in Brazil.
Trial summary
Currently, there are few approved treatments for COVID-19, antiretroviral (remdesivir) and corticoids. With about 15% of COVID-19 patients suffering from severe disease health system will be overwhelmed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Ixekizumab, Aldesleukin and Colchicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesBrazil
- Study dates
- 5 Jan 2021to 30 Jul 2021
- 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
- Positive result in the quantitative real-time PCR (qPCR) test for SARS-CoV-2 in the respiratory tract;
- Pneumonia confirmed by chest imaging and
- Respiratory rate ≥ 24 IRPM (for adults) or
- O2 saturation <93% or
- No improvement in O2 saturation, despite oxygen supply or
- Arterial hypotension; or
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- Changes in capillary filling time; or
- Changes in the level of consciousness; or
- Oliguria;
- IMPORTANT: The presence of increased respiratory rate or desaturation (items "a" and "b") are criteria for hospital admission. Items "c" to "g" are considered criteria for ICU admission
- Following the recommendations of The São Paulo State Health Secretariat, resolution SS-28 of 03-Mar-2020, prepared by the Hospital das Clínicas of Medical School-USP.
Who cannot join
- Age <18 years;
- Refuse to sign the Informed Consent Form;
- Patient's decision that their involvement is not in their interest;
- Severe known liver disease (eg cirrhosis, with aminotransferase levels> 5 times the reference value limit);
- Pregnancy or breastfeeding period;
- Severe bacterial infection;
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- Severe diarrhea;
- Diverticulitis or intestinal perforation;
- Infection known as HIV;
- Presence of one of the following uncontrolled or unstable cardiovascular diseases: stroke, ECG confirmed acute ischemia or myocardial infarction and / or clinically significant dysrhythmia; • Known history of gastrointestinal bleeding, uncontrolled peptic ulcer or uncontrolled duodenal ulcer;
- Known history of hemophilia or other bleeding disorders;
- History of organ transplantation, congenital immunodeficiency;
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Faculdade de Medicina de Ribeirão Preto - USP
Ribeirão Preto, São Paulo
Hospital e Maternidade Christovão da Gama
Santo André, São Paulo, 09030-010
About this study
Official title: Prospective-randomized Adaptive Study, With Active Control to Evaluate the Efficacy and Safety of Interleukin (IL)-17 Inhibitor Treatment Versus Low Doses of IL-2 Versus Indirect IL-6 Inhibitor in Hospitalized Patients With Severe Forms of COVID-19
Currently, there are few approved treatments for COVID-19, antiretroviral (remdesivir) and corticoids. With about 15% of COVID-19 patients suffering from severe disease health system will be overwhelmed. Treatments approaches to inhibit viral replication (antiretroviral and extended spectrum antiviral drugs), such as Remdesivir and Hydroxychloroquine are being used. In severe cases, by CT scans investigators are able to observe that these patients seem to be dying with fibrosis and lung vasculitis. It is hypothesised that targeting vasculitis and lung inflammation secondary to the viral infection may help patients' survival (reducing mortality) and/or decrease time in mechanical ventilators. It is proposed a 4-arm trial, converted to 2 after interim analysis (60 patients for the initial phase, sample size recalculation after initial analysis and 2 arms beyond). In initial phase, IL-6 indirect inhibitor (colchicine), in first arm; IL-17 inhibitor, an innovative target never tested (at this moment) in COVID-19 severe patients, in second study arm. Both approaches (indirect IL-6 and Il-17) are related to modulation of inflammatory immune response. Finally, in third arm, IL-2 low dose. This cytokine was identified as Treg upregulation. Treg levels decrease in hepatitis C virus (HCV) associated vasculitis and increase in vasculitis resolution. In fourth arm, control group, standard of care. Initially, for the first 60 included patients, the study will comprise 4 arms (15 patients per arm, randomization ratio 1:1:1:1). An interim effectiveness and safety analysis at this point will guide the selection of one single treatment strategy (adaptative study) to be carried on after that, comparatively with the control group. The multi-site trial planned enrollment duration of 4-6 months and for each participant will be approximately 4 weeks. This trial will bring complementary data to the global effort in COVID-19 cases resolution.
- Conditions
- Covid19
- Being tested
- Ixekizumab, Aldesleukin, Colchicine, Standard of care (SOC)
- Keywords
- Colchicine, Ixekizumab, Cytokine storm, Lung vasculitis, Recombinant Human Interleukin-2
- 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.
IxekizumabBiological
Also called Taltz
80 mg of IL-17 inhibitor
AldesleukinBiological
Also called Proleukin
1.5 million IU (low-dose) of IL-2
ColchicineDrug
0.5 mg of indirect IL-6 inhibitor
Standard of care (SOC)Drug
Active comparator (Corticoids and antiretrovirals)
| Study group | Role | What they receive |
|---|---|---|
| IL-17 inhibitor (Ixekizumab) | Experimental | Patients will receive study medication Ixekizumab 80 mg per week, (SC) once a week for 4 weeks or until discharge. Receives: Biological: Ixekizumab |
| IL-2 (Aldesleukin) | Experimental | 1.5 million IU per day (SC) for 7 days or until discharge. Patients will receive study medication Aldesleukin 1.5 million IU per day (SC), for 7 days or until discharge. Receives: Biological: Aldesleukin |
| Indirect IL-6 inhibitor (Colchicine) | Experimental | Patients will receive study medication colchicine 0.5 mg every 8 hours for 3 days (PO), followed by 4 weeks (+/-7 days) 0.5 mg twice daily. If a dose is missed, it should not be replaced. Receives: Drug: Colchicine |
| Standard of care | Active comparator | Standard treatment, supplementation of O2 ventilation + standard treatment of the institution, which may include Dexamethasone according to the institutional protocol. Receives: Drug: Standard of care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ordinal scale of seven World Health Organization (WHO) categories of IL-17 inhibitor versus low dose IL-2 versus indirect IL-6 inhibitor (colchicine) versus standard treatment in the treatment of severe COVID-19
proportion of patients with clinical improvement, defined by an increase of two points in the ordinal scale of seven WHO categories
Measured: On the 21st day of study, since inclusion.
Secondary outcomes (7)
Time until independence from oxygen therapy in days
Measured: During the follow-up period (30 days (+/- 2))
Ventilator free days (in days)
Measured: During the follow-up period (30 days (+/- 2))
Assessment of worsening pulmonary involvement, defined as the presence of one of these criteria (absence or presence)
Need to increase the inspired fraction of O2 (FIO2) to keep oxygen saturation stable or the need for mechanical ventilation; b. Increase in the number and / or extension of affected lung areas on chest computed tomography.
Measured: At some point in Day 7, Day 14 and Day 28
In patients who needed mechanical ventilation, time to indicate mechanical ventilation
(calculated in days, from entry into the protocol until orotracheal intubation, up to 45 days)
Measured: Day 0 up to 45 days
Duration of hospitalization, in survivors
In days
Measured: On day 28
Analysis of in-hospital mortality
Measured: Day 0 up to 45 days
Analysis of general mortality
Measured: During the follow-up period (30 days (+/- 2))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start5 Jan 2021
- Primary completion31 Mar 2021
- Study completion30 Jul 2021
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.
- More trials run by University of Sao PauloThe 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
- This is a multicenter, adaptive, open-label, randomized study design (1: 1: 1: 1 ratio), with an active comparator, superiority study, in severe to critical COVID19 subjects.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Science Valley Research Institute
- Responsible party
- Principal investigator, Fernando Bellissimo-Rodrigues, MD, PhD, University of Sao Paulo
- Investigators
- Fernando Rodrigues, MD, PhD, Principal investigator, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto, USP, SP, BrazilEduardo Ramacciotti, MD, PhD, Study chair, Hospital e Maternidade Dr. Christóvão da Gama, Grupo Leforte, Santo André, SP, BrazilLeandro B Agati, PhD, Study director, Hospital Leforte Liberdade, SP, BrazilEsper Kallas, MD, PhD, Study chair, Hospital das Clinicas de Sao Paulo (USP)Renato D Lopes, MD, PhD, Study chair, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724629
- Sponsor's protocol ID
- 402422/2020-1
- Acronym
- STRUCK
- Status last verified
- Jul 2022
- First submitted
- 5 Oct 2020
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective-randomized Adaptive Study, With Active Control to Evaluate the Efficacy and Safety of Interleukin (IL)-17 Inhibitor Treatment Versus Low Doses of IL-2 Versus Indirect IL-6 Inhibitor in Hospitalized Patients With Severe Forms of COVID-19
- ClinicalTrials.gov ID
- NCT04724629
- Acronym / sponsor ID
- STRUCK / 402422/2020-1
- Conditions
- Covid19
- Keywords
- Colchicine, Ixekizumab, Cytokine storm, Lung vasculitis, Recombinant Human Interleukin-2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Science Valley Research Institute
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 26 Jan 2021 (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.
Currently, there are few approved treatments for COVID-19, antiretroviral (remdesivir) and corticoids. With about 15% of COVID-19 patients suffering from severe disease health system will be overwhelmed. Treatments approaches to inhibit viral replication (antiretroviral and extended spectrum antiviral drugs), such as Remdesivir and Hydroxychloroquine are being used. In severe cases, by CT scans investigators are able to observe that these patients seem to be dying with fibrosis and lung vasculitis. It is hypothesised that targeting vasculitis and lung inflammation secondary to the viral infection may help patients' survival (reducing mortality) and/or decrease time in mechanical ventilators. It is proposed a 4-arm trial, converted to 2 after interim analysis (60 patients for the initial phase, sample size recalculation after initial analysis and 2 arms beyond). In initial phase, IL-6 indirect inhibitor (colchicine), in first arm; IL-17 inhibitor, an innovative target never tested (at this moment) in COVID-19 severe patients, in second study arm. Both approaches (indirect IL-6 and Il-17) are related to modulation of inflammatory immune response. Finally, in third arm, IL-2 low dose. This cytokine was identified as Treg upregulation. Treg levels decrease in hepatitis C virus (HCV) associated vasculitis and increase in vasculitis resolution. In fourth arm, control group, standard of care. Initially, for the first 60 included patients, the study will comprise 4 arms (15 patients per arm, randomization ratio 1:1:1:1). An interim effectiveness and safety analysis at this point will guide the selection of one single treatment strategy (adaptative study) to be carried on after that, comparatively with the control group. The multi-site trial planned enrollment duration of 4-6 months and for each participant will be approximately 4 weeks. This trial will bring complementary data to the global effort in COVID-19 cases resolution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a multicenter, adaptive, open-label, randomized study design (1: 1: 1: 1 ratio), with an active comparator, superiority study, in severe to critical COVID19 subjects.
| Arm | Type | Receives |
|---|---|---|
| IL-17 inhibitor (Ixekizumab) | Experimental | Biological: IxekizumabPatients will receive study medication Ixekizumab 80 mg per week, (SC) once a week for 4 weeks or until discharge. |
| IL-2 (Aldesleukin) | Experimental | Biological: Aldesleukin1.5 million IU per day (SC) for 7 days or until discharge. Patients will receive study medication Aldesleukin 1.5 million IU per day (SC), for 7 days or until discharge. |
| Indirect IL-6 inhibitor (Colchicine) | Experimental | Drug: ColchicinePatients will receive study medication colchicine 0.5 mg every 8 hours for 3 days (PO), followed by 4 weeks (+/-7 days) 0.5 mg twice daily. If a dose is missed, it should not be replaced. |
| Standard of care | Active comparator | Drug: Standard of care (SOC)Standard treatment, supplementation of O2 ventilation + standard treatment of the institution, which may include Dexamethasone according to the institutional protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Positive result in the quantitative real-time PCR (qPCR) test for SARS-CoV-2 in the respiratory tract;
- Pneumonia confirmed by chest imaging and
- IMPORTANT: The presence of increased respiratory rate or desaturation (items "a" and "b") are criteria for hospital admission. Items "c" to "g" are considered criteria for ICU admission
- Following the recommendations of The São Paulo State Health Secretariat, resolution SS-28 of 03-Mar-2020, prepared by the Hospital das Clínicas of Medical School-USP.
Key exclusion criteria (12 listed)
- Age <18 years;
- Refuse to sign the Informed Consent Form;
- Patient's decision that their involvement is not in their interest;
- Severe known liver disease (eg cirrhosis, with aminotransferase levels> 5 times the reference value limit);
- Pregnancy or breastfeeding period;
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 |
|---|---|---|
| IxekizumabAlso: Taltz80 mg of IL-17 inhibitor | Biological | IL-17 inhibitor (Ixekizumab) |
| AldesleukinAlso: Proleukin1.5 million IU (low-dose) of IL-2 | Biological | IL-2 (Aldesleukin) |
| Colchicine0.5 mg of indirect IL-6 inhibitor | Drug | Indirect IL-6 inhibitor (Colchicine) |
| Standard of care (SOC)Active comparator (Corticoids and antiretrovirals) | Drug | Standard of care |
Primary outcome
Ordinal scale of seven World Health Organization (WHO) categories of IL-17 inhibitor versus low dose IL-2 versus indirect IL-6 inhibitor (colchicine) versus standard treatment in the treatment of severe COVID-19
Time frame: On the 21st day of study, since inclusion.
proportion of patients with clinical improvement, defined by an increase of two points in the ordinal scale of seven WHO categories
7 secondary outcomes
Time until independence from oxygen therapy in days
Time frame: During the follow-up period (30 days (+/- 2))
Ventilator free days (in days)
Time frame: During the follow-up period (30 days (+/- 2))
Assessment of worsening pulmonary involvement, defined as the presence of one of these criteria (absence or presence)
Time frame: At some point in Day 7, Day 14 and Day 28
In patients who needed mechanical ventilation, time to indicate mechanical ventilation
Time frame: Day 0 up to 45 days
Duration of hospitalization, in survivors
Time frame: On day 28
Analysis of in-hospital mortality
Time frame: Day 0 up to 45 days
Analysis of general mortality
Time frame: During the follow-up period (30 days (+/- 2))
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
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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.
Fernando Rodrigues, MD, PhD principal investigator
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto, USP, SP, Brazil
Eduardo Ramacciotti, MD, PhD study chair
Hospital e Maternidade Dr. Christóvão da Gama, Grupo Leforte, Santo André, SP, Brazil
Leandro B Agati, PhD study director
Hospital Leforte Liberdade, SP, Brazil
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ixekizumab, Aldesleukin and Colchicine in people with Covid19, run by University of Sao Paulo at 2 sites in Brazil.
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 11 inclusion and 12 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: finished, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ordinal scale of seven World Health Organization (WHO) categories of IL-17 inhibitor versus low dose IL-2 versus indirect IL-6 inhibitor (colchicine) versus standard treatment in the treatment of severe COVID-19 (time frame: On the 21st day of study, since inclusion.). 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 28 Jul 2022.