COVID-19Phase 2COVIDOSENCT04331795
Tocilizumab to Prevent Clinical Decompensation in Hospitalized, Non-critically Ill Patients With COVID-19 Pneumonitis
A Phase 2 study testing Tocilizumab in people with COVID-19, run by University of Chicago at 1 site in United States.
Trial summary
Coronavirus disease-2019 (COVID-19) has a quoted inpatient mortality as high as 25%. This high mortality may be driven by hyperinflammation resembling cytokine release syndrome (CRS), offering the hope that therapies targeting the interleukin-6 (IL-6) axis therapies commonly used to treat CRS can be used to reduce… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Tocilizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2020to 5 Jun 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adults ≥ 18 years of age
- Approval from the patient's primary service
- Admitted as an inpatient to University of Chicago Medicine
- Fever, documented in electronic medical record and defined as: T ≥ 38*C by any conventional clinical method (forehead, tympanic, oral, axillary, rectal)
- Positive test for active SARS-CoV-2 infection
- Radiographic evidence of infiltrates on chest radiograph (CXR) or computed tomography (CT)
- Ability to provide written informed consent on the part of the subject or, in the absence of decisional capacity of the subject, an appropriate surrogate (e.g. a legally authorized representative).
Who cannot join
- Concurrent use of invasive mechanical ventilation (patients receiving non-invasive mechanical ventilation [CPAP, BiPap, HHFNC] are eligible)
- Concurrent use of vasopressor or inotropic medications
- Previous receipt of tocilizumab or another anti-IL6R or IL-6 inhibitor.
- Known history of hypersensitivity to tocilizumab.
- Patients who are actively being considered for a study of an antiviral agent that would potentially exclude concurrent enrollment on this study.
- Patients actively receiving an investigational antiviral agent in the context of a clinical research study.
Show all 78Show fewer
- Diagnosis of end-stage liver disease or listed for liver transplant.
- Elevation of AST or ALT in excess of 5 times the upper limit of normal.
- Neutropenia (Absolute neutrophil count < 500/uL).
- Thrombocytopenia (Platelets < 50,000/uL).
- On active therapy with a biologic immunosuppressive agent, which include the following biologics and any biosimilar versions thereof:
- Alemtuzumab
- Blinatumomab
- Brentuximab
- Daratumumab
- Elotuzumab
- Ibritumomab
- Obinutuzumab
- Ofatumumab
- Ocrelizumab
- Rituximab
- Inotuzumab
- Gemtuzumab
- Tositumumab
- Moxetumomab
- Polatuzumab
- Abatacept
- Adalimumab
- Belimumab
- Certolizumab
- Eculizumab
- Etanercept
- Golimumab
- Infliximab
- Ixekizumab
- Rituximab
- Sarilumab
- Secukinumab
- Tocilizumab
- Ustekinumab
- On active therapy with a JAK2-targeted agent, which include the following:
- Tofacitinib
- Baricitinib
- Upadacitinib
- Ruxolitinib
- History of bone marrow transplantation or solid organ transplant.
- Known history of Hepatitis B or Hepatitis C.
- Known history of mycobacterium tuberculosis infection at risk for reactivation.
- Known history of gastrointestinal perforation or active diverticulitis.
- Multi-organ failure as determined by primary treating team
- Any other documented serious, active infection besides COVID-19.
- Pregnant patients
- Patients who are unable to discontinue scheduled antipyretic medications, either as monotherapy (e.g., acetaminophen or ibuprofen [aspirin is acceptable]) or as part of combination therapy (e.g., hydrocodone/acetaminophen, aspirin/acetaminophen/caffeine [Excedrin®])
- CRP < 40 mg/L (or ug/mL)
- Patients will be assigned to Group A if:
- ● C-reactive protein (CRP) ≥ 75 ug/mL
- AND
- Any one of the following criteria are met:
- Previous ICU admission
- Previous non-elective intubation
- Admission for heart failure exacerbation within the past 12 months
- History of percutaneous coronary intervention (PCI)
- History of coronary artery bypass graft (CABG) surgery
- Diagnosis of pulmonary hypertension
- Baseline requirement for supplemental O2
- Diagnosis of interstitial lung disease (ILD)
- Admission for chronic obstructive pulmonary disease (COPD) exacerbation within the past 12 months
- Asthma with use of daily inhaled corticosteroid
- History of pneumonectomy or lobectomy
- History of radiation therapy to the lung
- History of HIV
- Cancer of any stage and receiving active treatment (excluding hormonal therapy)
- Any history of diagnosed immunodeficiency
- End-stage renal disease (ESRD) requiring peritoneal or hemodialysis
- History of cerebrovascular accident with residual, patient-reported neurologic deficit
- BMI >30 kg/m2
- Supplemental O2 requirement > 6L in the 24 hours prior to enrollment and tocilizumab administration
- All other eligible patients assigned to Group B
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medicine
Chicago, Illinois, 60637
About this study
Official title: Early Institution of Tocilizumab Titration in Non-Critical Hospitalized COVID-19 Pneumonitis
Coronavirus disease-2019 (COVID-19) has a quoted inpatient mortality as high as 25%. This high mortality may be driven by hyperinflammation resembling cytokine release syndrome (CRS), offering the hope that therapies targeting the interleukin-6 (IL-6) axis therapies commonly used to treat CRS can be used to reduce COVID-19 mortality. Retrospective analysis of severe to critical COVID-19 patients receiving tocilizumab demonstrated that the majority of patients had rapid resolution (i.e., within 24-72 hours following administration) of both clinical and biochemical signs (fever and CRP, respectively) of hyperinflammation with only a single tocilizumab dose.
Hypotheses:
Read more
- Tocilizumab is effective in decreasing signs, symptoms, and laboratory evidence of COVID-19 pneumonitis in hospitalized, non-critically ill patients with clinical risk factors for clinical decompensation, intensive care utilization, and death.
- Low-dose tocilizumab is effective in decreasing signs, symptoms, and laboratory evidence of COVID-19 pneumonitis in hospitalized, non-critically ill patients with and without clinical risk factors for clinical decompensation, intensive care utilization, and death.
Objectives:
- To establish proof of concept that tocilizumab is effective in decreasing signs, symptoms, and laboratory evidence of COVID-19 pneumonitis in hospitalized, non-critically ill patients with clinical risk factors for clinical decompensation, intensive care utilization, and death, as determined by the clinical outcome of resolution of fever and the biochemical outcome measures of time to CRP normalization for the individual patient and the rate of patients whose CRP normalize.
- To establish proof of concept that low-dose tocilizumab is effective in decreasing signs, symptoms, and laboratory evidence of COVID-19 pneumonitis in hospitalized, non-critically ill patients without clinical risk factors for clinical decompensation, intensive care utilization, and death, as determined by the clinical outcome of resolution of fever and the biochemical outcome measures of time to CRP normalization for the individual patient and the rate of patients whose CRP normalize.
- Conditions
- COVID-19
- Being tested
- 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.
TocilizumabDrug
Group A: Tocilizumab (beginning dose 200mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.
Second dose is provisioned if:
- Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND
- CRP decrease is < 25% at 24 hours following tocilizumab administration and CRP > 40mg/L
TocilizumabDrug
Group B: Low-dose tocilizumab (beginning dose 80mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.
Second dose is provisioned if:
- Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND
- CRP decrease is < 25% at 24 hours following tocilizumab administration and CRP > 40mg/L
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Hospitalized, non-critically ill patients with COVID-19 pneumonitis with risk factors for decompensation Receives: Drug: Tocilizumab |
| Group B | Experimental | Hospitalized, non-critically ill patients with COVID-19 pneumonitis without risk factors for decompensation Receives: Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinical Response in Maximum Temperature (Tmax)
Number of Participants with Clinical Response in Maximum Temperature (Tmax)
Measured: Assessed for the 24 hour period after tocilizumab administration
Number of Participants With Biochemical Response as Determined by CRP Response
Number of Participants with Biochemical Response as determined by CRP Response. Defined as at least 25% decrease in CRP from baseline at least 16 hours after administration of drug.
Measured: Assessed every 24 hours during patient's hospitalization, up to 4 weeks after tocilizumab administration
Secondary outcomes (11)
Overall Survival
28-Day Overall Survival is defined as the status of the patient at the end of 28 days, beginning from the time of the first dose of tocilizumab.
Measured: 28 days
Survival to Hospital Discharge
This will be defined as the percentage of patients who are discharged in stable condition compared to the percentage of patients who die in the hospital. Patients who are discharged to hospice will be excluded from this calculation.
Measured: Hospitalization, up to 4 weeks after tocilizumab administration
Progression of COVID-19 Pneumonitis
This will be a binary outcome defined by worsening COVID-19 pneumonitis resulting in transition from clinical Group A or Group B COVID-19 pneumonitis to critical COVID-19 pneumonitis during the course of the patient's COVID-19 infection. This diagnosis will be determined by treating physicians on the basis of worsening pulmonary infiltrates on chest imaging as well as clinical deterioration marked by persistent fever, rising supplemental oxygen requirement, declining PaO2/FiO2 ratio, and the need for intensive care such as mechanical ventilation or vasopressor/inotrope medication(s).
Measured: Hospitalization, up to 4 weeks after tocilizumab administration
Rate of Non-elective Mechanical Ventilation
This will be a binary outcome defined as worsening COVID-19 disease resulting in the use of non-invasive (BiPap, heated high-flow nasal cannula) or invasive positive pressure ventilation during the course of the patient's COVID-19 infection. For patients admitted to the hospital using non-invasive mechanical ventilation, the utilization of mechanical ventilation will count toward this metric, as well. Calculated as the ratio of the number of patients who require non-invasive or invasive positive pressure ventilation during hospitalization and total number of patients who receive tocilizumab.
Measured: Hospitalization, up to 4 weeks after tocilizumab administration
Duration of Mechanical Ventilation
This will be a continuous outcome defined by the amount of time between initiation and cessation of mechanical ventilation (invasive and non-invasive).
Measured: Hospitalization, up to 4 weeks after tocilizumab administration
Time to Mechanical Ventilation
This will be a continuous outcome defined by the amount of time between tocilizumab dose administration and the initiation of mechanical ventilation. This will be treated as a time-to-event with possible censoring.
Measured: Assessed over hospitalization, up to 4 weeks after tocilizumab administration
Rate of Vasopressor/Inotrope Utilization
This will be a binary outcome defined as utilization of any vasopressor or inotropic medication during the course of the patient's COVID-19 infection. Calculated as the ratio of the number of patients who require vasopressor or inotrope medication during hospitalization and total number of patients who receive tocilizumab.
Measured: Hospitalization, up to 4 weeks after tocilizumab administration
Duration of Vasopressor/Inotrope Utilization
This will be a continuous outcome defined by the amount of time between initiation of first and cessation of last vasopressor or inotrope medication(s).
Measured: Hospitalization, up to 4 weeks after tocilizumab administration
Time to Vasopressor or Inotropic Utilization
This will be a continuous outcome defined by the amount of time between first tocilizumab dose administration and the initiation of vasopressor or inotropic medication(s). This will be treated as a time-to-event with possible censoring.
Measured: Assessed over hospitalization, up to 4 weeks after tocilizumab administration
Number of ICU Days
Number of ICU days is defined as the time period when a patient is admitted to the ICU (defined as the timestamp on the first vital signs collected in an ICU) until they are transferred from the ICU to a non-ICU setting such as a general acute care bed (defined as the timestamp on the first vital signs collected outside an ICU, excepting any "off the floor" vital signs charted from operating rooms or procedure or imaging suites). Death in the ICU will be a competing risk.
Measured: Hospitalization, up to 4 weeks after tocilizumab administration
Duration of Increased Supplemental Oxygen Requirement From Baseline
Duration of increased supplemental oxygen requirement from baseline is defined as the time period (number of days) during which the participant requires supplemental oxygen in excess of his/her baseline supplemental oxygen requirement. The supplemental oxygen requirement is defined as the highest liters-per-minute flow of supplemental oxygen required by the patient each day over the course of the hospitalization.
Measured: Assessed over hospitalization, up to 4 weeks after tocilizumab administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start4 Apr 2020
- Primary completion5 Jun 2020
- Study completion5 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pankti Reid, MD, MPH, Principal investigator, University of Chicago, Department of Medicine, Section of Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331795
- Sponsor's protocol ID
- IRB20-0515
- Acronym
- COVIDOSE
- Status last verified
- May 2022
- First submitted
- 1 Apr 2020
- Last updated
- 9 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Strohbehn GW, Heiss BL, Rouhani SJ, Trujillo JA, Yu J, Kacew AJ, Higgs EF, Bloodworth JC, Cabanov A, Wright RC, Koziol AK, Weiss A, Danahey K, Karrison TG, Edens CC, Bauer Ventura I, Pettit NN, Patel BK, Pisano J, Strek ME, Gajewski TF, Ratain MJ, Reid PD. COVIDOSE: A Phase II Clinical Trial of Low-Dose Tocilizumab in the Treatment of Noncritical COVID-19 Pneumonia. Clin Pharmacol Ther. 2021 Mar;109(3):688-696. doi: 10.1002/cpt.2117. Epub 2020 Dec 10.
PubMed 33210302
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Institution of Tocilizumab Titration in Non-Critical Hospitalized COVID-19 Pneumonitis
- ClinicalTrials.gov ID
- NCT04331795
- Acronym / sponsor ID
- COVIDOSE / IRB20-0515
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 4 Apr 2020 (actual)
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 5 Jun 2020 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Posted 9 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coronavirus disease-2019 (COVID-19) has a quoted inpatient mortality as high as 25%. This high mortality may be driven by hyperinflammation resembling cytokine release syndrome (CRS), offering the hope that therapies targeting the interleukin-6 (IL-6) axis therapies commonly used to treat CRS can be used to reduce COVID-19 mortality. Retrospective analysis of severe to critical COVID-19 patients receiving tocilizumab demonstrated that the majority of patients had rapid resolution (i.e., within 24-72 hours following administration) of both clinical and biochemical signs (fever and CRP, respectively) of hyperinflammation with only a single tocilizumab dose.
Hypotheses:
- Tocilizumab is effective in decreasing signs, symptoms, and laboratory evidence of COVID-19 pneumonitis in hospitalized, non-critically ill patients with clinical risk factors for clinical decompensation, intensive care utilization, and death.
- Low-dose tocilizumab is effective in decreasing signs, symptoms, and laboratory evidence of COVID-19 pneumonitis in hospitalized, non-critically ill patients with and without clinical risk factors for clinical decompensation, intensive care utilization, and death.
Objectives:
- To establish proof of concept that tocilizumab is effective in decreasing signs, symptoms, and laboratory evidence of COVID-19 pneumonitis in hospitalized, non-critically ill patients with clinical risk factors for clinical decompensation, intensive care utilization, and death, as determined by the clinical outcome of resolution of fever and the biochemical outcome measures of time to CRP normalization for the individual patient and the rate of patients whose CRP normalize.
- To establish proof of concept that low-dose tocilizumab is effective in decreasing signs, symptoms, and laboratory evidence of COVID-19 pneumonitis in hospitalized, non-critically ill patients without clinical risk factors for clinical decompensation, intensive care utilization, and death, as determined by the clinical outcome of resolution of fever and the biochemical outcome measures of time to CRP normalization for the individual patient and the rate of patients whose CRP normalize.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: TocilizumabHospitalized, non-critically ill patients with COVID-19 pneumonitis with risk factors for decompensation |
| Group B | Experimental | Drug: TocilizumabHospitalized, non-critically ill patients with COVID-19 pneumonitis without risk factors for decompensation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults ≥ 18 years of age
- Approval from the patient's primary service
- Admitted as an inpatient to University of Chicago Medicine
- Fever, documented in electronic medical record and defined as: T ≥ 38*C by any conventional clinical method (forehead, tympanic, oral, axillary, rectal)
- Positive test for active SARS-CoV-2 infection
Key exclusion criteria (78 listed)
- Concurrent use of invasive mechanical ventilation (patients receiving non-invasive mechanical ventilation [CPAP, BiPap, HHFNC] are eligible)
- Concurrent use of vasopressor or inotropic medications
- Previous receipt of tocilizumab or another anti-IL6R or IL-6 inhibitor.
- Known history of hypersensitivity to tocilizumab.
- Patients who are actively being considered for a study of an antiviral agent that would potentially exclude concurrent enrollment on this study.
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 |
|---|---|---|
| TocilizumabGroup A: Tocilizumab (beginning dose 200mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours. Second dose is provisioned if: 1. Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND 2. CRP decrease is < 25% at 24 hours following tocilizumab administration and CRP > 40mg/L | Drug | Group A |
| TocilizumabGroup B: Low-dose tocilizumab (beginning dose 80mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours. Second dose is provisioned if: 1. Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND 2. CRP decrease is < 25% at 24 hours following tocilizumab administration and CRP > 40mg/L | Drug | Group B |
Primary outcome
Number of Participants With Clinical Response in Maximum Temperature (Tmax)
Time frame: Assessed for the 24 hour period after tocilizumab administration
Number of Participants with Clinical Response in Maximum Temperature (Tmax)
Number of Participants With Biochemical Response as Determined by CRP Response
Time frame: Assessed every 24 hours during patient's hospitalization, up to 4 weeks after tocilizumab administration
Number of Participants with Biochemical Response as determined by CRP Response. Defined as at least 25% decrease in CRP from baseline at least 16 hours after administration of drug.
11 secondary outcomes
Overall Survival
Time frame: 28 days
Survival to Hospital Discharge
Time frame: Hospitalization, up to 4 weeks after tocilizumab administration
Progression of COVID-19 Pneumonitis
Time frame: Hospitalization, up to 4 weeks after tocilizumab administration
Rate of Non-elective Mechanical Ventilation
Time frame: Hospitalization, up to 4 weeks after tocilizumab administration
Duration of Mechanical Ventilation
Time frame: Hospitalization, up to 4 weeks after tocilizumab administration
Time to Mechanical Ventilation
Time frame: Assessed over hospitalization, up to 4 weeks after tocilizumab administration
Rate of Vasopressor/Inotrope Utilization
Time frame: Hospitalization, up to 4 weeks after tocilizumab administration
Duration of Vasopressor/Inotrope Utilization
Time frame: Hospitalization, up to 4 weeks after tocilizumab administration
Time to Vasopressor or Inotropic Utilization
Time frame: Assessed over hospitalization, up to 4 weeks after tocilizumab administration
Number of ICU Days
Time frame: Hospitalization, up to 4 weeks after tocilizumab administration
Duration of Increased Supplemental Oxygen Requirement From Baseline
Time frame: Assessed over hospitalization, up to 4 weeks after tocilizumab administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33210302Strohbehn GW, Heiss BL, Rouhani SJ, Trujillo JA, Yu J, Kacew AJ, Higgs EF, Bloodworth JC, Cabanov A, Wright RC, Koziol AK, Weiss A, Danahey K, Karrison TG, Edens CC, Bauer Ventura I, Pettit NN, Patel BK, Pisano J, Strek ME, Gajewski TF, Ratain MJ, Reid PD. COVIDOSE: A Phase II Clinical Trial of Low-Dose Tocilizumab in the Treatment of Noncritical COVID-19 Pneumonia. Clin Pharmacol Ther. 2021 Mar;109(3):688-696. doi: 10.1002/cpt.2117. Epub 2020 Dec 10.
- 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.
Pankti Reid, MD, MPH principal investigator
University of Chicago, Department of Medicine, Section of Rheumatology
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 Tocilizumab in people with COVID-19, run by University of Chicago 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 7 inclusion and 78 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 9 Jun 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. 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?
Yes. Results are posted in the registry (first posted 9 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Clinical Response in Maximum Temperature (Tmax) (time frame: Assessed for the 24 hour period after tocilizumab administration). The study lists 2 primary outcomes in all. 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 NCT04331795, which also lists 1 linked publication.
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 9 Jun 2022.