COVIDPhase 2NCT07196306
Subcutaneous Sarilumab vs Placebo in Hospitalized Patients With Respiratory Distress Caused by COVID 19
A Phase 2 study testing Sarilumab 200 MG/1.14 ML Subcutaneous Solution in people with COVID and COVID-19, run by BayCare Health System at 3 sites in United States.
Trial summary
Studying the efficacy of IL-6 inhibition utilizing single or double dose subcutaneous administration of Sarilumab in patients with severe respiratory distress caused by COVID19 regarding improvement in oxygen demands and other clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, COVID-19, Corona Virus Infection
- What is being tested?
- Sarilumab 200 MG/1.14 ML Subcutaneous Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 May 2020to 15 Oct 2020
- Phase
- Phase 2
- 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
- Confirmed COVID-19 via centralized RT-PCR testing for SARS-CoV2 infection performed at BayCare Health System Laboratory or associated and accredited laboratory.
- Subjects must be hospitalized.
- Document fever of 100.4 F or more during hospitalization and prior to enrollment.
- Evidence of abnormal chest imaging chest x-ray or CT.
- Moderate to severe respiratory distress requiring oxygen supplementation as defined by criteria listed below.
- "Oxygen saturation (Sao2) of 92% or less on room air or a ratio of the partial pressure of oxygen (Pao2) to the fraction of inspired oxygen (Fio2) of less than 200 mm Hg, on ventilator settings that include PEEP ≥5 cm H2O".
- Subjects may have active co-infection with other respiratory pathogens.
- Males and non-pregnant females at least 18 years of age.
Who cannot join
- The subject or Legally Authorized Representative is unable to provide consent in person or by phone.
- The subject is participating in any other clinical trial for treatment of COVID 19 or any other treatment related clinical trial for a concurrent disease. No plans for additional COVID trials.
- The subject does not meet criteria for moderate to severe respiratory distress.
- The presence of any of the following lab abnormalities. ANC <2000/mm3, Platelet count <50,000/mm3, ALT/AST >6x ULN
- Prior utilization of any IL-6 inhibitors or receptor antagonists at any time in patient's life, JAK inhibitors, DMARDS(Except Hydroxychloroquine), long term, chronic steroid use (more than 6 months) or mTOR inhibitors.
- The subject has history of organ or bone marrow transplant.
- History of active or incompletely treated Tuberculosis (TB).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Morton Plant Hospital
Clearwater, Florida, 33756
St. Anthony's Hospital
St. Petersburg, Florida, 33705
St. Joseph's Hospital
Tampa, Florida, 33614
About this study
Official title: Study of Subcutaneous Sarilumab vs Placebo in Hospitalized Patients With Respiratory Distress Caused by COVID 19
Studying the efficacy of IL-6 inhibition utilizing single or double dose subcutaneous administration of Sarilumab in patients with severe respiratory distress caused by COVID19 regarding improvement in oxygen demands and other clinical outcomes.
Read the detailed description
At the time of writing this protocol, there does not exist any strategy to treat acute respiratory distress syndrome associated with COVID-19. Due to the overwhelming health crisis facing a large portion of the population, and due to lack of standardization or clinical approach to management of severe respiratory failure short of standard of care with oxygenation and supportive measures, we elected to embark on this study to evaluate the role of IL-6 stimulating the immune system and the effect of inhibiting signal propagation on clinical outcome.
For this study, Sarilumab, an FDA approved IL-6 receptor antagonist, currently used for severe rheumatoid arthritis, has been selected. The dose and administration of therapy used for the study conforms to the current FDA recommendation for the primary use of Sarilumab.
- Conditions
- COVID, COVID-19, Corona Virus Infection
- Being tested
- Sarilumab 200 MG/1.14 ML Subcutaneous Solution, Placebo
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sarilumab 200 MG/1.14 ML Subcutaneous SolutionDrug
At the time of enrollment, the intervention arm subjects are administered single or double dose of study drug while the placebo arm subjects are administered the placebo drug (normal saline). Subjects will be assigned to the intervention or placebo arm in random order.
PlaceboDrug
Normal saline 0.9% 1.14 mL Subcutaneous x 1 or 2 dose(s)
| Study group | Role | What they receive |
|---|---|---|
| Sarilumab | Experimental | 200 mg in 1.14 mL Subcutaneous x 1 or 2 dose(s) Receives: Drug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution |
| Placebo | Placebo comparator | Normal saline 0.9% 1.14 mL Subcutaneous x 1 or 2 dose(s) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical outcome improvement
Time from randomization to improvement in oxygenation. Improvement in oxygenation is defined as SpO2/FiO2 improvement by 100 or greater.
Measured: Time to improvement up to 28 days
Secondary outcomes (18)
Time to improvement in oxygenation
Time from randomization to no requirement of any oxygen supplementation with Oxygen saturation of > =92% at rest.
Measured: Time to improvement up to 28 days
The number of patients with a need for intubation
Measured: Up to 28 days
Time on ventilator
Measured: Up to 28 days
Fever resolution
A continuous period at least 48 hours without a recorded temperature equal or more than 100.4 F.
Measured: Up to 28 days
Hemodynamic improvement to normal range
Heart rate
Measured: Up to 28 days
Improvement or normalization in CBC
CBC with differential
Measured: At 48 hours post intervention up to 28 days
Time to objective improvement noted on chest imaging
Measured: Up to 28 days
Time from randomization to hospital discharge
Measured: Up to 28 days
Death
Measured: Up to 28 days
Hemodynamic improvement to normal range
Respiratory rate
Measured: Up to 28 days
Improvement or normalization in CMP
Comprehensive Metabolic Panel
Measured: At 48 hours post intervention up to 28 days
Improvement or normalization in LDH
LDH
Measured: At 48 hours post intervention up to 28 days
Improvement or normalization in Lactic Acid
Lactic Acid
Measured: At 48 hours post intervention up to 28 days
Improvement or normalization in Procalcitonin
Procalcitonin
Measured: At 48 hours post intervention up to 28 days
Improvement or normalization in Ferritin
Ferritin
Measured: At 48 hours post intervention up to 28 days
Improvement or normalization in CRP
CRP
Measured: At 48 hours post intervention up to 28 days
Improvement or normalization in D-Dimer
D-Dimer
Measured: At 48 hours post intervention up to 28 days
Improvement or normalization in IL-6
IL-6
Measured: At 48 hours post intervention up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start7 May 2020
- Primary completion31 Aug 2020
- Study completion15 Oct 2020
Why it stopped: no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BayCare Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danielle Mauck, BA, Study director, BayCare Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196306
- Sponsor's protocol ID
- 1
- Status last verified
- Sep 2025
- First submitted
- 7 May 2020
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Subcutaneous Sarilumab vs Placebo in Hospitalized Patients With Respiratory Distress Caused by COVID 19
- ClinicalTrials.gov ID
- NCT07196306
- Acronym / sponsor ID
- 1
- Conditions
- COVID, COVID-19, Corona Virus Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BayCare Health SystemUniversity, hospital or other
- Study start
- 7 May 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 29 Sep 2025 (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.
Studying the efficacy of IL-6 inhibition utilizing single or double dose subcutaneous administration of Sarilumab in patients with severe respiratory distress caused by COVID19 regarding improvement in oxygen demands and other clinical outcomes.
Detailed description
At the time of writing this protocol, there does not exist any strategy to treat acute respiratory distress syndrome associated with COVID-19. Due to the overwhelming health crisis facing a large portion of the population, and due to lack of standardization or clinical approach to management of severe respiratory failure short of standard of care with oxygenation and supportive measures, we elected to embark on this study to evaluate the role of IL-6 stimulating the immune system and the effect of inhibiting signal propagation on clinical outcome.
For this study, Sarilumab, an FDA approved IL-6 receptor antagonist, currently used for severe rheumatoid arthritis, has been selected. The dose and administration of therapy used for the study conforms to the current FDA recommendation for the primary use of Sarilumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarilumab | Experimental | Drug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution200 mg in 1.14 mL Subcutaneous x 1 or 2 dose(s) |
| Placebo | Placebo comparator | Drug: PlaceboNormal saline 0.9% 1.14 mL Subcutaneous x 1 or 2 dose(s) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Confirmed COVID-19 via centralized RT-PCR testing for SARS-CoV2 infection performed at BayCare Health System Laboratory or associated and accredited laboratory.
- Subjects must be hospitalized.
- Document fever of 100.4 F or more during hospitalization and prior to enrollment.
- Evidence of abnormal chest imaging chest x-ray or CT.
- Moderate to severe respiratory distress requiring oxygen supplementation as defined by criteria listed below.
Key exclusion criteria (7 listed)
- The subject or Legally Authorized Representative is unable to provide consent in person or by phone.
- The subject is participating in any other clinical trial for treatment of COVID 19 or any other treatment related clinical trial for a concurrent disease. No plans for additional COVID trials.
- The subject does not meet criteria for moderate to severe respiratory distress.
- The presence of any of the following lab abnormalities. ANC <2000/mm3, Platelet count <50,000/mm3, ALT/AST >6x ULN
- Prior utilization of any IL-6 inhibitors or receptor antagonists at any time in patient's life, JAK inhibitors, DMARDS(Except Hydroxychloroquine), long term, chronic steroid use (more than 6 months) or mTOR inhibitors.
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 |
|---|---|---|
| Sarilumab 200 MG/1.14 ML Subcutaneous SolutionAt the time of enrollment, the intervention arm subjects are administered single or double dose of study drug while the placebo arm subjects are administered the placebo drug (normal saline). Subjects will be assigned to the intervention or placebo arm in random order. | Drug | Sarilumab |
| PlaceboNormal saline 0.9% 1.14 mL Subcutaneous x 1 or 2 dose(s) | Drug | Placebo |
Primary outcome
Time to clinical outcome improvement
Time frame: Time to improvement up to 28 days
Time from randomization to improvement in oxygenation. Improvement in oxygenation is defined as SpO2/FiO2 improvement by 100 or greater.
18 secondary outcomes
Time to improvement in oxygenation
Time frame: Time to improvement up to 28 days
The number of patients with a need for intubation
Time frame: Up to 28 days
Time on ventilator
Time frame: Up to 28 days
Fever resolution
Time frame: Up to 28 days
Hemodynamic improvement to normal range
Time frame: Up to 28 days
Improvement or normalization in CBC
Time frame: At 48 hours post intervention up to 28 days
Time to objective improvement noted on chest imaging
Time frame: Up to 28 days
Time from randomization to hospital discharge
Time frame: Up to 28 days
Death
Time frame: Up to 28 days
Hemodynamic improvement to normal range
Time frame: Up to 28 days
Improvement or normalization in CMP
Time frame: At 48 hours post intervention up to 28 days
Improvement or normalization in LDH
Time frame: At 48 hours post intervention up to 28 days
Improvement or normalization in Lactic Acid
Time frame: At 48 hours post intervention up to 28 days
Improvement or normalization in Procalcitonin
Time frame: At 48 hours post intervention up to 28 days
Improvement or normalization in Ferritin
Time frame: At 48 hours post intervention up to 28 days
Improvement or normalization in CRP
Time frame: At 48 hours post intervention up to 28 days
Improvement or normalization in D-Dimer
Time frame: At 48 hours post intervention up to 28 days
Improvement or normalization in IL-6
Time frame: At 48 hours post intervention up to 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Danielle Mauck, BA study director
BayCare Health System
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sarilumab 200 MG/1.14 ML Subcutaneous Solution in people with COVID and COVID-19, run by BayCare Health System at 3 sites 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 8 inclusion and 7 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: withdrawn, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 clinical outcome improvement (time frame: Time to improvement up to 28 days). 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 29 Sep 2025.