Dexamethasone or Tocilizumab for Respiratory Impairment
(IDENTIFY Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new treatments for acute hypoxemic respiratory failure (AHRF), a serious condition where the lungs can't supply enough oxygen to the blood, risking organ failure and death. Researchers aim to determine if treating patients based on specific blood markers can prevent the condition from worsening. Participants will receive either routine care, routine care plus an infusion of Tocilizumab (an immunosuppressive drug), or routine care plus oral Dexamethasone (a corticosteroid). The study seeks individuals who have recently developed new breathing problems and require hospital care. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications to join the trial?
Yes, if you are currently taking systemic steroids, monoclonal antibodies, or other immunosuppressive medications, you cannot participate in the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both Dexamethasone and Tocilizumab have been studied for safety in humans.
For Dexamethasone, studies have found it to be generally well-tolerated. In patients with COVID-19, Dexamethasone was linked to fewer deaths within 28 days compared to those who did not receive the treatment. Another study found that patients on Dexamethasone had better outcomes, such as fewer deaths and less need for ventilators.
Tocilizumab, however, carries a risk of causing infections. Studies have identified infections like colds and breathing problems as the most common issues. One review found that infections were the most frequent cause of death among patients using Tocilizumab. Despite this, it effectively treats certain conditions.
In summary, Dexamethasone is generally safe and helps reduce deaths in patients with breathing issues. Tocilizumab has a risk of infection but works well for its intended conditions. Participants should consider these risks and benefits when deciding about joining the trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they offer new ways to tackle respiratory impairment. Tocilizumab is an antibody that blocks a specific protein involved in inflammation, potentially reducing severe respiratory issues more effectively than traditional anti-inflammatory drugs. Dexamethasone, on the other hand, is a steroid that’s already known for its powerful anti-inflammatory effects, but researchers are analyzing its impact when given in a specific dosage and duration for this condition. These treatments provide hope for quicker and potentially more effective relief compared to standard care options, which often focus on general supportive care and broad-spectrum anti-inflammatory medications.
What evidence suggests that this trial's treatments could be effective for acute hypoxemic respiratory failure?
This trial will compare the effects of Tocilizumab and Dexamethasone on respiratory impairment. Research has shown that Tocilizumab, which participants in this trial may receive, effectively aids patients with severe breathing issues, particularly those caused by COVID-19. It may help reduce the severity of breathing problems. Meanwhile, Dexamethasone, another treatment option in this trial, has been linked to lower death rates and more days without the need for a breathing machine. It helps reduce lung swelling, preventing breathing problems from worsening. Both treatments have demonstrated positive results in alleviating serious breathing issues.12367
Are You a Good Fit for This Trial?
This trial is for adults over 18 who've been hospitalized with new respiratory symptoms like coughing, shortness of breath, or needing extra oxygen within the last two weeks. It's not suitable for those who don't require inpatient care.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard of care, with some receiving additional treatment with Tocilizumab or Dexamethasone based on IL-6 levels
Observation
Participants are observed until discharge or up to 28 days to monitor treatment effects and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a follow-up phone interview
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
- Tocilizumab
Trial Overview
The study tests if monitoring Interleukin-6 levels can guide treatment with Dexamethasone or Tocilizumab to prevent worsening conditions in patients with acute hypoxemic respiratory failure. Participants are divided into three groups: standard care, standard plus Tocilizumab, and standard plus Dexamethasone.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Routine care + single intravenous infusion of tocilizumab at a dose of 4mg/kg of body weight (up to a max 400mg).
Routine care + a 10mg of oral dexamethasone per day for up to 10 days (or until hospital discharge).
Routine care only
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lorenzo delSorbo
Lead Sponsor
Roche Diagnostic Ltd.
Industry Sponsor
Citations
and long-term mortality in hospitalized COVID-19 patients ...
After propensity score matching, dexamethasone treatment was associated with reduced mortality at both 28 days (adjusted HR 0.67, 95% CI 0.46– ...
Effect of Dexamethasone on Days Alive and Ventilator ...
This open label clinical trial compares the effects of dexamethasone vs usual care on the number of days alive and free of mechanical ...
Dexamethasone in Hospitalized Patients with Covid-19
Glucocorticoids may modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death. Methods. In this ...
4.
journals.lww.com
journals.lww.com/md-journal/fulltext/2022/09300/dexamethasone_for_the_treatment_of_acute.1.aspxDexamethasone for the treatment of acute respiratory...
Dexamethasone is an effective and relatively safe treatment for all-cause mortality and ventilator-free status at 28 days in patients with ARDS.
DEXA-ARDS
Outcome · Primary outcome: Number of ventilator free days – significantly greater in the dexamethasone group. 12.3 (SD 9.9) vs 7.5 (SD 9.0) ...
Dexamethasone for the treatment of acute respiratory distress ...
The results showed that patients who received dexamethasone had better outcomes than those who did not, on all-cause mortality and ventilator-free status at 28 ...
Dexamethasone treatment for the acute respiratory distress ...
At 60 days, 29 (21%) patients in the dexamethasone group and 50 (36%) patients in the control group had died (between-group difference −15·3% [–25·9 to −4·9]; p ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.