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Monoclonal Antibodies
Low-dose Tocilizumab for COVID-19 (COVIDOSE-2 Trial)
Phase 2
Waitlist Available
Led By Pankti D Reid, MD, MPH
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hospitalized
Fever, documented in electronic medical record and defined as: T ≥ 38 degrees C by any conventional clinical method (forehead, tympanic, oral, axillary, rectal)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
COVIDOSE-2 Trial Summary
This trial found that tocilizumab was an effective treatment for severe Covid-19 pneumonia, with the highest dose having the best results.
Who is the study for?
This trial is for hospitalized adults over 18 with COVID-19, fever, and lung issues seen on X-rays or CT scans. They must have a positive SARS-CoV-2 test and be able to consent. People with severe liver disease, low blood counts, certain drug treatments (like immunosuppressives), other active infections, extreme liver enzyme levels, history of transplants or diverticulitis, those on strong heart drugs or ventilators can't join.Check my eligibility
What is being tested?
The study tests two doses of Tocilizumab (40mg and 120mg) against standard care in patients with severe COVID-19 pneumonia. It's an open-label trial where recovery time is the main goal; survival after 28 days is also tracked. Patients are grouped by whether they're getting remdesivir or steroids too.See study design
What are the potential side effects?
Tocilizumab may cause allergic reactions, elevated liver enzymes, lowered blood cell counts increasing infection risk, digestive tract perforation risks among others. The exact side effects depend on the patient's condition and dose received.
COVIDOSE-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently in the hospital.
Select...
I have had a fever of 38 degrees C or higher.
COVIDOSE-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to Recovery
Secondary outcome measures
Achievement of Recovery
Biochemical Response: C-reactive Protein Response Rate
Clinical Response: Duration of Increased Supplemental Oxygen from Baseline
+10 moreSide effects data
From 2017 Phase 4 trial • 59 Patients • NCT0203447411%
Low ANC
5%
nausea
5%
Inpatient admission
5%
fatigue
5%
agranulocytosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tocilizumab
Placebo
COVIDOSE-2 Trial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: Sub-study B, Tocilizumab 40mgExperimental Treatment1 Intervention
Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 40mg.
Group II: Sub-study B, Tocilizumab 120mgExperimental Treatment1 Intervention
Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 120mg.
Group III: Sub-study A, Tocilizumab 40mgExperimental Treatment1 Intervention
Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 40mg.
Group IV: Sub-study A, Tocilizumab 120mgExperimental Treatment1 Intervention
Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 120mg.
Group V: Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of CareActive Control1 Intervention
Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab dose (400mg or 8mgkg).
Group VI: Sub-study A, Tocilizumab-Free Standard of CareActive Control1 Intervention
Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive no tocilizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tocilizumab
2012
Completed Phase 4
~1840
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,702 Total Patients Enrolled
11 Trials studying COVID-19
35,033 Patients Enrolled for COVID-19
Pankti D Reid, MD, MPHPrincipal InvestigatorUniversity of Chicago
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently in the hospital.I have had Hepatitis B or C but am not currently undergoing treatment.I have had a bone marrow or solid organ transplant.I am 18 years old or older.You have a positive test for an active COVID-19 infection.I can sign the consent form myself or have someone who can do it for me.Your absolute neutrophil count is less than 500 per microliter.I am currently being treated with a medication targeting Bruton's tyrosine kinase.My doctors have diagnosed me with failure of multiple organs.I am currently taking a medication for my condition that targets JAK2.Your AST or ALT levels are higher than 10 times the normal limit.I have end-stage liver disease or am on the liver transplant list.Your platelet count is less than 50,000 per microliter of blood.Your CRP level (a marker of inflammation) is less than 40 mg/L.I have had a fever of 38 degrees C or higher.I have been on biologic immunosuppressive therapy in the last 6 months.I do not have any serious infections other than COVID-19.I currently have active diverticulitis.I am currently taking medication to increase my blood pressure or heart strength.I cannot stop taking fever-reducing medicines like acetaminophen or ibuprofen.You are currently using a machine to help you breathe.I have had a gastrointestinal perforation in the past.You have tested positive for hepatitis B or C.I have a history of tuberculosis that could become active again.You have had a bad reaction to tocilizumab in the past.There are signs of lung infection on your chest X-ray or CT scan.I haven't taken tocilizumab or similar drugs in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of Care
- Group 2: Sub-study B, Tocilizumab 120mg
- Group 3: Sub-study A, Tocilizumab 40mg
- Group 4: Sub-study A, Tocilizumab-Free Standard of Care
- Group 5: Sub-study A, Tocilizumab 120mg
- Group 6: Sub-study B, Tocilizumab 40mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any openings to join this trial?
"Affirmative. Clinicaltrials.gov displays that this trial is presently seeking enrolment, with its initial posting on September 10th 2020 and most recent update occurring on May 11th 2022. The clinical trail has a target of 332 patients at one medical centre."
Answered by AI
For what kinds of conditions is tocilizumab commonly prescribed?
"Tocilizumab is a common treatment for polyarticular juvenile idiopathic arthritis, but it can be utilised to manage other medical issues such as systemic juvenile idiopathic arthritis (sjia), cytokine release syndrome caused by car-t cell therapy and giant cells."
Answered by AI
What potential hazards are associated with Tocilizumab?
"This Phase 2 trial has not yet provided evidence of Tocilizumab's efficacy, but there is existing data that suggests it is relatively safe. Our team at Power assigns a score of 2 to this medication accordingly."
Answered by AI
Have any prior studies made use of Tocilizumab?
"Currently, there are 71 open clinical trials for Tocilizumab with 8 studies in their final stage. Most of these research sites can be found in Poznan and New york; Yet, a total of 1455 locations across the world are carrying out analyses on this drug."
Answered by AI
What is the current capacity of this clinical trial?
"Indeed, clinicaltrials.gov shows that this medical trial is actively seeking participants. It was first posted on September 10th of 2020 and has been recently updated on May 11th 2022. The study requires 332 people to be recruited at a single location."
Answered by AI
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