COVID-19Phase 2COVIDOSE-2NCT04479358

Low-dose Tocilizumab Versus Standard of Care in Hospitalized Patients With COVID-19

A Phase 2 study testing Tocilizumab in people with COVID-19, run by University of Chicago at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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: 85 participants
Where: 1 siteUnited States
Study dates: 10 Sep 2020to 10 Feb 2025
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 inpatient service
Hospitalized
Fever, documented in electronic medical record and defined as: T ≥ 38 degrees 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
Concurrent use of vasopressor or inotropic medications
Previous receipt of tocilizumab or another anti-IL6R or IL-6 inhibitor in the year prior.
Known history of hypersensitivity to tocilizumab.
Diagnosis of end-stage liver disease or listed for liver transplant.
Elevation of AST or ALT in excess of 10 times the upper limit of normal.

Show all 65Show fewer

Neutropenia (Absolute neutrophil count < 500/uL).
Thrombocytopenia (Platelets < 50,000/uL).
On active therapy with a Bruton's tyrosine kinase-targeted agent, which include the following:
Acalabrutinib
Ibrutinib
Zanubrutinib
On active therapy with a JAK2-targeted agent, which include the following:
Tofacitinib
Baricitinib
Upadacitinib
Ruxolitinib
Any of the following biologic immunosuppressive agent (and any biosimilar versions thereof) administered in the past 6 months or less::
Abatacept
Adalimumab
Alemtuzumab
Atezolizumab
Belimumab
Blinatumomab
Brentuximab
Certolizumab
Daratumumab
Durvalumab
Eculizumab
Elotuzumab
Etanercept
Gemtuzumab
Golimumab
Ibritumomab
Infliximab
Inotuzumab
Ipilimumab
Ixekizumab
Moxetumomab
Nivolumab
Obinutuzumab
Ocrelizumab
Ofatumumab
Pembrolizumab
Polatuzumab
Rituximab
Rituximab
Sarilumab
Secukinumab
Tocilizumab
Tositumumab
Tremelimumab
Urelumab
Ustekinumab
History of bone marrow transplantation (including chimeric antigen receptor T-cell) or solid organ transplant
Known history of Hepatitis B or Hepatitis C (patients who have completed curative-intent anti-HCV treatments are not excluded from trial)
Positive result on hepatitis B or C screening
Known history of mycobacterium tuberculosis infection at risk for reactivation
Known history of gastrointestinal perforation
Active diverticulitis
Multi-organ failure as determined by primary treating physicians
Any other documented serious, active infection besides COVID-19 - including but not limited to: lobar pneumonia consistent with bacterial infection, bacteremia, culture-negative endocarditis, or current mycobacterial infection - at the discretion of primary treating physicians
Pregnant patients or nursing mothers
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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Chicago Medicine
Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: COVIDOSE-2: A Multi-center, Randomized, Controlled Phase 2 Trial Comparing Early Administration of Low-dose Tocilizumab to Standard of Care in Hospitalized Patients With COVID-19 Pneumonitis Not Requiring Invasive Ventilation

Tocilizumab is an effective treatment for severe coronavirus disease 2019 (Covid-19) pneumonia and related inflammation. Given limited global supplies, clarification of the optimal tocilizumab dose is critical. We conducted an open-label, randomized, controlled trial evaluating two different dose levels of tocilizumab in Covid-19 (40mg and 120mg). Randomization was stratified on remdesivir and corticosteroid at enrollment. The primary outcome was the time to recovery. The key secondary outcome was 28-day mortality.

Read the detailed description

COVID-19's high mortality may be driven by hyperinflammation. Interleukin-6 (IL-6) axis therapies may reduce COVID-19 mortality. Retrospective analyses of tocilizumab in severe to critical COVID-19 patients have demonstrated survival advantage and lower likelihood of requiring invasive ventilation following tocilizumab administration. The majority of patients have 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.

The investigators hypothesized that a dose of tocilizumab significantly lower than the EMA- and FDA-labeled dose (8mg/kg) as well as the emerging standard of care dose (400mg) may be effective in patients with COVID-19 pneumonitis and hyperinflammation. Advantages to the lower dose of tocilizumab may include lower likelihood of secondary bacterial infections as well as extension of this drug's limited supply. The investigators conducted an adaptive single-arm phase 2 trial (NCT04331795) evaluating clinical and biochemical response to low-dose tocilizumab in patients with COVID-19 pneumonitis and hyperinflammation.

This multi-center, prospective, randomized controlled phase 2 trial -- designed as two sub-studies to allow for the possible emergence of data demonstrating the clinical efficacy of tocilizumab 8mg/kg or 400mg -- formally tests the clinical efficacy of low-dose tocilizumab in COVID-19 pneumonia.

Sub-Study A Primary Objective A: To establish whether low-dose tocilizumab reduces the time to clinical recovery in patients with COVID-19 pneumonitis and hyperinflammation, when compared to a tocilizumab-free standard of care.

Hypothesis A: The investigators hypothesize that low-dose tocilizumab, when compared to a tocilizumab-free standard of care, decreases the time to recovery in hospitalized, non-invasively ventilated patients with COVID-19 pneumonitis and hyperinflammation by three days or more.

Sub-Study B Primary Objective B: To establish whether low-dose tocilizumab is near-equivalent to high-dose tocilizumab (400mg or 8 mg/kg) in reducing the time to clinical recovery in patients with COVID-19 pneumonitis and hyperinflammation.

Hypothesis B: The investigators hypothesize that low-dose tocilizumab is near-equivalent to high-dose tocilizumab in reducing the time to clinical recovery in hospitalized, non-invasively ventilated patients with COVID-19 pneumonitis and hyperinflammation.

Conditions: COVID-19
Being tested: Tocilizumab, Standard of Care
Keywords: COVID-19, 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
Also called Tocilizumab 40mg
Tocilizumab 40mg
TocilizumabDrug
Also called Tocilizumab 120mg
Tocilizumab 120mg
Standard of CareOther
Tocilizumab-Free Standard of Care
Standard of CareOther
Tocilizumab 400mg or 8mg/kg

Study groups in NCT04479358
Study group	Role	What they receive
Sub-study A, Tocilizumab-Free Standard of Care	Active comparator	Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive no tocilizumab. Receives: Other: Standard of Care
Sub-study A, Tocilizumab 40mg	Experimental	Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 40mg. Receives: Drug: Tocilizumab
Sub-study A, Tocilizumab 120mg	Experimental	Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 120mg. Receives: Drug: Tocilizumab
Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of Care	Active comparator	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). Receives: Other: Standard of Care
Sub-study B, Tocilizumab 40mg	Experimental	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. Receives: Drug: Tocilizumab
Sub-study B, Tocilizumab 120mg	Experimental	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. Receives: Drug: Tocilizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Recovery
Day of recovery is defined as the first day on which the patient achieves one of the following two categories from a seven-point ordinal scale: 6) Hospitalized, not requiring supplemental oxygen or ongoing medical care or 7) Not hospitalized. Time to recovery is the number of days from randomization to achievement of this status. Note that the ordinal scale is measured once daily, with the patient's worst clinical status during the 24-hour time period (0:00-23:59) being documented.
Measured: 28 days

Secondary outcomes (13)

Achievement of Recovery
This will be defined as the percentage of patients achieving one of the following two categories by day 7: hospitalized but not requiring supplemental oxygen or ongoing medical care or not hospitalized.
Measured: 7 days
Overall Survival
This will be defined as the percentage of patients in a given arm of the study who are alive thirty days following randomization. Patients who are discharged to hospice will be counted as deceased on the day of discharge. Patients who are transitioned to inpatient hospice or inpatient comfort measures only will be counted as deceased on the day of transition.
Measured: 30 days
Hospital Length of Stay
This will be defined as the number of days that pass between the day of a patient's randomization and his or her discharge from the hospital.
Measured: Up to 1 year
Clinical Response: Maximum Temperature (Tmax) Response
Maximum temperature (Tmax) in the 24-hour period immediately following randomization minus the measured Tmax in the 24-hour period immediately preceding randomization.
Measured: 24-hour period immediately preceding randomization and 24-hour period immediately following randomization
Clinical Response: Rate of Non-Elective Invasive Mechanical Ventilation
This will be a binary outcome defined as worsening COVID-19 disease resulting in the use of invasive mechanical ventilation during the course of the patient's COVID-19 infection.
Measured: Up to 28 days
Clinical Response: Duration of Non-Elective Invasive Mechanical Ventilation
This will be a continuous outcome defined by the amount of time between initiation and cessation of non-elective invasive mechanical ventilation.
Measured: Up to 28 days
Clinical Response: Time to Non-Elective Invasive Mechanical Ventilation
This will be a continuous outcome defined by the amount of time between randomization and the initiation of non-elective invasive mechanical ventilation.
Measured: Up to 28 days
Clinical Response: Rate of Vasopressor/Inotrope Utilization
This will be a binary outcome defined as utilization of any vasopressor or inotropic medication.
Measured: Up to 28 days
Clinical Response: 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 medications.
Measured: Up to 28 days
Clinical Response: Time to Vasopressor/Inotrope Utilization
This will be a continuous outcome defined by the amount of time between randomization and the initiation of any vasopressor or inotropic medication.
Measured: Up to 28 days
Clinical Response: Duration of Increased Supplemental Oxygen From Baseline
This will be an ordinal outcome defined by the number of days counted from randomization over which the participant requires supplemental oxygen in excess over 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: 28 days
Biochemical Response: C-reactive Protein Response Rate
Decline in CRP of ≥ 25% in the 27 +/- 3 hours after tocilizumab administration, as compared to pre-treatment baseline.
Measured: Pre-treatment baseline and 27 +/- 3 hours after tocilizumab administration
Safety: Rate of Secondary Infection
This will be defined as the percentage of patients in a study arm who develop serious non-COVID-19 viral, bacterial, or fungal infections (e.g., bloodstream infection, hospital-acquired pneumonia, ventilator-associated pneumonia, opportunistic infection) following randomization and up to the 28-day assessment of overall survival.
Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Sep 202010 Feb 2025

First posted21 Jul 2020
Study start10 Sep 2020
Primary completion1 Mar 2024
Study completion10 Feb 2025

Why it stopped: Lack of recruitment of patients into the trial

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: Randomised
Intervention model: Parallel groups
Model description: Two sub-studies in parallel, each of three arms (maximum).
Masking: None (open label)
Enrolment: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04479358
Sponsor's protocol ID: IRB20-1179
Acronym: COVIDOSE-2
Status last verified: May 2026
First submitted: 13 Jul 2020
Last updated: 8 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data that underlie the results of this article, after de-identification. Sharing period will be 1 month after data are published and available indefinitely thereafter. Researchers who provide methodologically sound proposals for the purposes of achieving stated aims in their proposal will be eligible for data-sharing.

Publications

Strohbehn GW, Reid PD, Ratain MJ. Applied Clinical Pharmacology in a Crisis: Interleukin-6 Axis Blockade and COVID-19. Clin Pharmacol Ther. 2020 Sep;108(3):425-427. doi: 10.1002/cpt.1931. Epub 2020 Jul 4.
PubMed 32488861

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: COVIDOSE-2: A Multi-center, Randomized, Controlled Phase 2 Trial Comparing Early Administration of Low-dose Tocilizumab to Standard of Care in Hospitalized Patients With COVID-19 Pneumonitis Not Requiring Invasive Ventilation
ClinicalTrials.gov ID: NCT04479358
Acronym / sponsor ID: COVIDOSE-2 / IRB20-1179
Conditions: COVID-19
Keywords: COVID-19, Tocilizumab
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of recruitment of patients into the trial
Enrolment: 85 participants (actual)
Lead sponsor: University of ChicagoUniversity, hospital or other
Study start: 10 Sep 2020 (actual)
Primary completion: 1 Mar 2024 (actual)
Study completion: 10 Feb 2025 (actual)
First posted: 21 Jul 2020 (actual)
Results: Posted 5 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6
Model description: Two sub-studies in parallel, each of three arms (maximum).

Arm	Type	Receives
Sub-study A, Tocilizumab-Free Standard of Care	Active comparator	Other: Standard of CarePatient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive no tocilizumab.
Sub-study A, Tocilizumab 40mg	Experimental	Drug: TocilizumabPatient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 40mg.
Sub-study A, Tocilizumab 120mg	Experimental	Drug: TocilizumabPatient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 120mg.
Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of Care	Active comparator	Other: Standard of CarePatient 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).
Sub-study B, Tocilizumab 40mg	Experimental	Drug: TocilizumabPatient 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.
Sub-study B, Tocilizumab 120mg	Experimental	Drug: TocilizumabPatient 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.

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 inpatient service
Hospitalized
Fever, documented in electronic medical record and defined as: T ≥ 38 degrees C by any conventional clinical method (forehead, tympanic, oral, axillary, rectal)
Positive test for active SARS-CoV-2 infection

Key exclusion criteria (65 listed)

Concurrent use of invasive mechanical ventilation
Concurrent use of vasopressor or inotropic medications
Previous receipt of tocilizumab or another anti-IL6R or IL-6 inhibitor in the year prior.
Known history of hypersensitivity to tocilizumab.
Diagnosis of end-stage liver disease or listed for liver transplant.

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
TocilizumabAlso: Tocilizumab 40mgTocilizumab 40mg	Drug	Sub-study A, Tocilizumab 40mg, Sub-study B, Tocilizumab 40mg
TocilizumabAlso: Tocilizumab 120mgTocilizumab 120mg	Drug	Sub-study A, Tocilizumab 120mg, Sub-study B, Tocilizumab 120mg
Standard of CareTocilizumab-Free Standard of Care	Other	Sub-study A, Tocilizumab-Free Standard of Care
Standard of CareTocilizumab 400mg or 8mg/kg	Other	Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of Care

Primary outcome

Time to Recovery
Time frame: 28 days
Day of recovery is defined as the first day on which the patient achieves one of the following two categories from a seven-point ordinal scale: 6) Hospitalized, not requiring supplemental oxygen or ongoing medical care or 7) Not hospitalized. Time to recovery is the number of days from randomization to achievement of this status. Note that the ordinal scale is measured once daily, with the patient's worst clinical status during the 24-hour time period (0:00-23:59) being documented.

13 secondary outcomes

Achievement of Recovery
Time frame: 7 days
Overall Survival
Time frame: 30 days
Hospital Length of Stay
Time frame: Up to 1 year
Clinical Response: Maximum Temperature (Tmax) Response
Time frame: 24-hour period immediately preceding randomization and 24-hour period immediately following randomization
Clinical Response: Rate of Non-Elective Invasive Mechanical Ventilation
Time frame: Up to 28 days
Clinical Response: Duration of Non-Elective Invasive Mechanical Ventilation
Time frame: Up to 28 days
Clinical Response: Time to Non-Elective Invasive Mechanical Ventilation
Time frame: Up to 28 days
Clinical Response: Rate of Vasopressor/Inotrope Utilization
Time frame: Up to 28 days
Clinical Response: Duration of Vasopressor/Inotrope Utilization
Time frame: Up to 28 days
Clinical Response: Time to Vasopressor/Inotrope Utilization
Time frame: Up to 28 days
Clinical Response: Duration of Increased Supplemental Oxygen From Baseline
Time frame: 28 days
Biochemical Response: C-reactive Protein Response Rate
Time frame: Pre-treatment baseline and 27 +/- 3 hours after tocilizumab administration
Safety: Rate of Secondary Infection
Time frame: 28 days

Results and safety

Results posted to the registry on 5 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sub-study A, Tocilizumab-Free Standard of Care	26	26
Sub-study A, Tocilizumab 40mg	25	25
Sub-study A, Tocilizumab 120mg	26	25
Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of Care	3	3
Sub-study B, Tocilizumab 40mg	3	3
Sub-study B, Tocilizumab 120mg	2	1

Primary outcome: Time to Recovery

Time frame: 28 days. Median (95% Confidence Interval). Unit: days

Measure	Sub-study A, Tocilizumab-Free Standard of Care n = 26	Sub-study A, Tocilizumab 40mg n = 25	Sub-study A, Tocilizumab 120mg n = 25	Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of Care n = 3	Sub-study B, Tocilizumab 40mg n = 3	Sub-study B, Tocilizumab 120mg n = 1
Value	5 (4 to 6)	7 (4 to 9)	4 (4 to 5)	7 (2.4 to NA)	6 (4 to NA)	8 (NA to NA)

Population analysed: Note: for confidence intervals below, -9999 and 9999 = Upper or lower limit cannot be estimated due to insufficient number of participants with events.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: 28 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sub-study A, Tocilizumab-Free Standard of Care	0 of 26 (0%)	23 of 26 (88.5%)	1 of 26
Sub-study A, Tocilizumab 40mg	0 of 25 (0%)	22 of 25 (88%)	3 of 25
Sub-study A, Tocilizumab 120mg	0 of 25 (0%)	21 of 25 (84%)	0 of 25
Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of Care	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Sub-study B, Tocilizumab 40mg	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Sub-study B, Tocilizumab 120mg	0 of 1 (0%)	1 of 1 (100%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32488861Strohbehn GW, Reid PD, Ratain MJ. Applied Clinical Pharmacology in a Crisis: Interleukin-6 Axis Blockade and COVID-19. Clin Pharmacol Ther. 2020 Sep;108(3):425-427. doi: 10.1002/cpt.1931. Epub 2020 Jul 4.
Individual participant dataSharing planned: Yes. Individual participant data that underlie the results of this article, after de-identification. Sharing period will be 1 month after data are published and available indefinitely thereafter. Researchers who provide methodologically sound proposals for the purposes of achieving stated aims in their proposal will be eligible for data-sharing.

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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 D Reid, MD, MPH principal investigator

University of Chicago

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 65 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: stopped early, as of the sponsor's last update on 8 Jun 2026. 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 5 Jun 2025). 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?

Time to Recovery (time frame: 28 days). 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 NCT04479358, 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 8 Jun 2026.