COVID-19Phase 2/3NCT04340232
Safety and Efficacy of Baricitinib for COVID-19
A Phase 2/3 study testing Baricitinib in people with COVID-19, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study plans to learn more about the effects of a medicine called baricitinib on the progression of COVID-19 (coronavirus disease of 2019), the medical condition caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Baricitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2021to Oct 2021
- Phase
- Phase 2/3
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 - 89 years at time of enrollment
- Hospitalized (or documented plan to hospitalize if patient is in the emergency department) with symptoms suggestive of COVID-19
- Illness of any duration that meets each of the following:
- Evidence of pneumonia, including radiographic infiltrates by imaging (chest x-ray, CT scan, etc.) or clinical assessment (rales/crackles on exam)
- Requires supportive care, including non-invasive supplemental oxygen
- Laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay within 7 days of enrollment
- Understands and agrees to comply with planned study procedures
- Provides informed consent signed by study patient or legally acceptable representative
Who cannot join
- Absolute lymphocyte count is less than 500 cells/mm
- Absolute neutrophil count is less than 1000 cells/mm
- Hemoglobin level is less than 8 g/dL
- Estimated GFR is less than 60 mL/min/1.73 m2
- ALT or AST is over 5 times the upper limit of normal
- Treatment with other JAK inhibitors, OAT3 inhibitors, biologic disease-modifying anti-rheumatic drugs (DMARDs), anti-IL-6 or anti-IL-6R antibodies, or potent immunosuppressants such as azathioprine. and cyclosporine concurrently or within the past 5 days. Note: recent or concurrent treatment with hydroxychloroquine or chloroquine is allowable, as these are 'non-biologic' DMARDs with potential antiviral activity.
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- History of HIV infection and on active immunosuppressant therapy
- Current hematological or solid organ malignancy and on active immunosuppressant therapy
- Active tuberculosis (TB) infection or known or suspected systemic bacterial or fungal infection
- Pregnancy or breast feeding
- Known allergy to baricitinib
- In the opinion of the investigator, they are unlikely to survive for >48 hours from screening
- Any physical examination findings and/or history of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study
- Additional Exclusion Criteria for Phase 2 only:
- Invasive oxygen supplementation, including mechanical ventilation and extracorporeal membrane oxygenation (ECMO)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado, Denver
Aurora, Colorado, 80045
About this study
This study plans to learn more about the effects of a medicine called baricitinib on the progression of COVID-19 (coronavirus disease of 2019), the medical condition caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Baricitinib is FDA-approved for the treatment of rheumatoid arthritis, an autoimmune condition. This study intends to define the impact of baricitinib on the severity and progression of COVID-19. This drug might to lower the hyperinflammation caused by the virus, which would prevent damage to the lungs and possibly other organs.
The study will recruit patients who have been diagnosed with COVID-19.
The goal is to recruit 80 patients.
Read the detailed description
This is an adaptive Phase 2/3 clinical trial, with a focus on the assessment of safety in the first 20 participants (Phase 2), followed by a much broader assessment of efficacy, while continuing to monitor safety, in an additional 60 participants (Phase 3, total participants across Phase 2/3 n=80). Both phases are single arm, open label, and occur at a single site at the University of Colorado Hospital (UCH). Data from participants in this study will be compared with data from other COVID-19 patients not receiving baricitinib. Study participants will receive 2 mg/day of baricitinib for 14 days and will be followed for up to 29 days.
- Conditions
- COVID-19
- Being tested
- Baricitinib
- Keywords
- JAK inhibitor, SARS-CoV-2, inflammation, cytokine release syndrome
- Medical subject headings
- COVID-19, Inflammation, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaricitinibDrug
Subjects will receive a 2 mg oral dose of baricitinib.
| Study group | Role | What they receive |
|---|---|---|
| Baricitinib Arm | Experimental | This study is an Adaptive Phase 2/3 trial designed to test the safety (Phase 2) and efficacy (Phase 2 and 3) of baricitinib to treat COVID-19. Phase 2 consists of a single-arm, open-label assignment of 20 participants receiving 2 mg baricitinib once daily for 14 days. Phase 3 consists of a single-arm, open-label assignment of 60 additional participants receiving baricitinib at the same dose. In both phases, participants will be monitored daily while hospitalized for 29 days, or until discharge, whichever occurs first. Participants who are discharged will be followed up with via phone on Day 15 and Day 29. Receives: Drug: Baricitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 2: Cumulative incidence of Grade 3 and 4 adverse events (AEs)
Description: Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening. AEs will be collected and graded daily and cumulative incidence will be reported.
Measured: Day 0 (screening) through Day 29
Phase 2: Cumulative incidence of serious adverse events (SAEs)
Description: An SAE is defined as an AE that is life-threatening or results in death, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. SAEs will be collected and graded daily and cumulative incidence will be reported.
Measured: Day 0 (screening) through Day 29
Phase 2: Changes in white blood cell count (CBC) through Day 15
Safety assessment via standard blood chemistry and metabolic panels will be performed daily as recommended by participant's physician as standard of care (SOC). Mean changes from baseline to Day 15 will be reported.
Measured: Day 1 to Day 15
Phase 2: Changes in hemoglobin through Day 15
Measured: Day 1 to Day 15
Phase 2: Changes in platelets through Day 15
Measured: Day 1 to Day 15
Phase 2: Changes in creatinine through Day 15
Measured: Day 1 to Day 15
Phase 2: Changes in glucose through Day 15
Measured: Day 1 to Day 15
Phase 2: Changes in prothrombin time (PT) through Day 15
Measured: Day 1 to Day 15
Phase 2: Changes in total bilirubin through Day 15
Measured: Day 1 to Day 15
Phase 2: Changes in ALT through Day 15
Measured: Day 1 to Day 15
Phase 2: Changes in AST through Day 15
Measured: Day 1 to Day 15
Phase 2: Changes in white blood cell count (CBC) through End of Study (EOS)
Safety assessment via standard blood chemistry and metabolic panels will be performed daily as recommended by participant's physician as SOC. Mean changes from baseline to EOS will be reported.
Measured: Day through Day 29 or hospital discharge, whichever is first
Phase 2: Changes in hemoglobin through End of Study (EOS)
Measured: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 2: Changes in platelets through End of Study (EOS)
Measured: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 2: Changes in creatinine through End of Study (EOS)
Measured: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 2: Changes in glucose through End of Study (EOS)
Measured: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 2: Changes in prothrombin time (PT) though End of Study (EOS)
Measured: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 2: Changes in total bilirubin through End of Study (EOS)
Measured: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 2: Changes in ALT through End of Study (EOS)
Measured: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 2: Changes in AST through End of Study (EOS)
Measured: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Percentage of patients reporting each severity on an 8-point ordinal scale at Day 15
The 8-point ordinal scale described below, where a lower score indicates a worse outcome, will be performed daily or as recommended by participant's physician as SOC. The percent of participants scored at each severity will be reported on Day 15.
The 8-point ordinal scale is as follows:
- Death
- Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
- Hospitalized, on non-invasive ventilation or high flow oxygen devices
- Hospitalized, requiring supplemental oxygen
- Hospitalized, not requiring supplemental oxygen, requiring ongoing medical care (COVID-19 related or otherwise)
- Hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care
- Not hospitalized, limitation on activities and/or requiring home oxygen
- Not hospitalized, no limitations on activities
Measured: Day 15
Secondary outcomes (37)
Phase 2: Change in the 8-point ordinal scale
The 8-point ordinal scale described above will be assessed using MR data collected as SOC or follow-up phone call on Day 29, where a lower score indicates a worse outcome. Mean changes from baseline to Day 29 will be reported.
Measured: Day 1 to Day 29
Phase 2: Change in National Early Warning Score (NEWS)
The NEWS is a cumulative score (range: 0 - 20) based on 7 clinical parameters as depicted below and discriminates patients at risk of poor outcomes. A higher score indicates a higher risk. The assessment will be calculated daily using MR data collected as SOC. Mean changes from baseline to End of Study (Day 29 or discharge) will be reported.
Measured: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Change in the 8-point ordinal scale
The 8-point ordinal scale described above will be assessed daily using MR data collected as SOC or follow-up phone call, where a lower score indicates a worse outcome. Mean changes from baseline to Day 29 will be reported.
Measured: Day 1 to Day 29
Phase 3: Change in National Early Warning Score (NEWS)
The NEWS is a cumulative score (range: 0 - 20) based on 7 clinical parameters as depicted below and discriminates patients at risk of poor outcomes. A higher score indicates a higher risk. The assessment will be calculated daily using MR data collected as SOC. Mean changes from baseline to End of Study (Day 29 or discharge) will be reported.
Measured: Day 1 to Day 29 or hospital discharge, whichever is first
Phase 3: Time to an improvement of one category using the 8-point ordinal scale
The 8-point ordinal scale described above will be assessed daily using MR data collected as SOC, where a lower score indicates a worse outcome. Mean time in days to a one-category improvement will be reported.
Measured: Day 1 to Day 29 or hospital discharge, whichever is first
Phase 3: Time to an improvement of two categories using the 8-point ordinal scale
The 8-point ordinal scale described above will be assessed daily, where a lower score indicates a worse outcome. Mean time in days to a two-category improvement will be reported.
Measured: Day 1 to Day 29 or hospital discharge, whichever is first
Phase 3: Time to discharge or to a NEWS ≤2 and maintained for 24 hours, whichever occurs first
The NEWS will be calculated daily. Mean time in days to achieve a score of ≤2 and maintain this score for at least 24 hours OR to be discharged from the hospital, whichever occurs first, will be reported. A higher score indicates a higher risk. End of study is defined as day 29 or discharge, whichever occurs first.
Measured: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Cumulative incidence of Grade 3 and 4 adverse events (AEs)
Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening. AEs will be collected and graded daily and cumulative incidence will be reported.
Measured: Day 0 (screening) through Day 29
Phase 3: Cumulative incidence of serious adverse events (SAEs)
An SAE is defined as an AE that is life-threatening or results in death, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. SAEs will be collected and graded daily and cumulative incidence will be reported.
Measured: Day 0 (screening) through Day 29
Phase 3: Duration of hospitalization
The mean duration of hospitalization will be reported, measured in days.
Measured: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Duration of new oxygen use
The mean duration of new oxygen use will be reported, measured in days.
Measured: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Duration of new ventilator or ECMO use
The mean duration of new ventilator or ECMO use will be reported, measured in days.
Measured: Day 1 to Day 29 or hospital discharge, whichever is first
Phase 3: Incidence of discontinuation or temporary suspension of drug for any reason
The incidence of interruption of baricitinib treatment, along with mean duration and reasons for the interruptions, will be reported.
Measured: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Incidence of new oxygen use
The incidence of new oxygen use will be reported.
Measured: Day 1 to Day 29 or hospital discharge, whichever is first
Phase 3: Incidence of new ventilator use
The incidence of new ventilator or ECMO use will be reported.
Measured: Day 1 to Day 29 or hospital discharge, whichever is first
Phase 3: Number of oxygen free days
The mean number of days patients are free from use of oxygen will be reported.
Measured: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Number of ventilator or ECMO free days
The mean number of days patients are free from use of a ventilator or ECMO will be reported.
Measured: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: 14 day mortality rate
The rate of participant death from Day 1 through Day 15 will be reported.
Measured: Day 1 through Day 15
Phase 3: 28 day mortality rate
The rate of participant death from Day 1 through Day 29 will be reported.
Measured: Day 1 through Day 29
Phase 3: Changes in white blood cell count (CBC) through Day 15
Measured: Day 1 to Day 15
Phase 3: Changes in hemoglobin through Day 15
Measured: Day 1 to Day 15
Phase 3: Changes in platelets through Day 15
Measured: Day 1 to Day 15
Phase 3: Changes in creatinine through Day 15
Measured: Day 1 to Day 15
Phase 3: Changes in glucose through Day 15
Measured: Day 1 to Day 15
Phase 3: Changes in prothrombin time (PT) through Day 15
Measured: Day 1 to Day 15
Phase 3: Changes in total bilirubin through Day 15
Measured: Day 1 to Day 15
Phase 3: Changes in ALT through Day 15
Measured: Day 1 to Day 15
Phase 3: Changes in AST through Day 15
Measured: Day 1 to Day 15
Phase 3: Changes in white blood cell count (CBC) through End of Study (EOS)
Safety assessment via standard blood chemistry and metabolic panels will be performed daily as recommended by participant's physician as SOC. Mean changes from baseline to EOS will be reported.
Measured: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Changes in hemoglobin through End of Study (EOS)
Measured: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Changes in platelets through End of Study (EOS)
Measured: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Changes in creatinine through End of Study (EOS)
Measured: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Changes in glucose through End of Study (EOS)
Measured: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Changes in prothrombin time (PT) though End of Study (EOS)
Measured: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Changes in total bilirubin through End of Study (EOS)
Measured: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Changes in ALT through End of Study (EOS)
Measured: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Changes in AST through End of Study (EOS)
Measured: Day 1 through Day 29 or hospital discharge, whichever is first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study startMar 2021 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionOct 2021 (estimated)
Why it stopped: Could not make FDA required changes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm, open label, single site study. Data from participants in this study with data from other COVID-19 patients not receiving baricitinib.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joaquin Espinosa, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340232
- Sponsor's protocol ID
- 20-0738
- Status last verified
- Mar 2021
- First submitted
- 3 Apr 2020
- Last updated
- 8 Mar 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be made available for all primary outcome measures.
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Baricitinib for COVID-19
- ClinicalTrials.gov ID
- NCT04340232
- Acronym / sponsor ID
- 20-0738
- Conditions
- COVID-19
- Keywords
- JAK inhibitor, SARS-CoV-2, inflammation, cytokine release syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Could not make FDA required changes
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 9 Apr 2020 (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.
This study plans to learn more about the effects of a medicine called baricitinib on the progression of COVID-19 (coronavirus disease of 2019), the medical condition caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Baricitinib is FDA-approved for the treatment of rheumatoid arthritis, an autoimmune condition. This study intends to define the impact of baricitinib on the severity and progression of COVID-19. This drug might to lower the hyperinflammation caused by the virus, which would prevent damage to the lungs and possibly other organs.
The study will recruit patients who have been diagnosed with COVID-19.
The goal is to recruit 80 patients.
Detailed description
This is an adaptive Phase 2/3 clinical trial, with a focus on the assessment of safety in the first 20 participants (Phase 2), followed by a much broader assessment of efficacy, while continuing to monitor safety, in an additional 60 participants (Phase 3, total participants across Phase 2/3 n=80). Both phases are single arm, open label, and occur at a single site at the University of Colorado Hospital (UCH). Data from participants in this study will be compared with data from other COVID-19 patients not receiving baricitinib. Study participants will receive 2 mg/day of baricitinib for 14 days and will be followed for up to 29 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm, open label, single site study. Data from participants in this study with data from other COVID-19 patients not receiving baricitinib.
| Arm | Type | Receives |
|---|---|---|
| Baricitinib Arm | Experimental | Drug: BaricitinibThis study is an Adaptive Phase 2/3 trial designed to test the safety (Phase 2) and efficacy (Phase 2 and 3) of baricitinib to treat COVID-19. Phase 2 consists of a single-arm, open-label assignment of 20 participants receiving 2 mg baricitinib once daily for 14 days. Phase 3 consists of a single-arm, open-label assignment of 60 additional participants receiving baricitinib at the same dose. In both phases, participants will be monitored daily while hospitalized for 29 days, or until discharge, whichever occurs first. Participants who are discharged will be followed up with via phone on Day 15 and Day 29. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female aged 18 - 89 years at time of enrollment
- Hospitalized (or documented plan to hospitalize if patient is in the emergency department) with symptoms suggestive of COVID-19
- Illness of any duration that meets each of the following:
- Laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay within 7 days of enrollment
- Understands and agrees to comply with planned study procedures
Key exclusion criteria (15 listed)
- Absolute lymphocyte count is less than 500 cells/mm
- Absolute neutrophil count is less than 1000 cells/mm
- Hemoglobin level is less than 8 g/dL
- Estimated GFR is less than 60 mL/min/1.73 m2
- ALT or AST is over 5 times the upper limit of normal
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 |
|---|---|---|
| BaricitinibSubjects will receive a 2 mg oral dose of baricitinib. | Drug | Baricitinib Arm |
Primary outcome
Phase 2: Cumulative incidence of Grade 3 and 4 adverse events (AEs)
Time frame: Day 0 (screening) through Day 29
Description: Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening. AEs will be collected and graded daily and cumulative incidence will be reported.
Phase 2: Cumulative incidence of serious adverse events (SAEs)
Time frame: Day 0 (screening) through Day 29
Description: An SAE is defined as an AE that is life-threatening or results in death, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. SAEs will be collected and graded daily and cumulative incidence will be reported.
Phase 2: Changes in white blood cell count (CBC) through Day 15
Time frame: Day 1 to Day 15
Safety assessment via standard blood chemistry and metabolic panels will be performed daily as recommended by participant's physician as standard of care (SOC). Mean changes from baseline to Day 15 will be reported.
Phase 2: Changes in hemoglobin through Day 15
Time frame: Day 1 to Day 15
Phase 2: Changes in platelets through Day 15
Time frame: Day 1 to Day 15
Phase 2: Changes in creatinine through Day 15
Time frame: Day 1 to Day 15
Phase 2: Changes in glucose through Day 15
Time frame: Day 1 to Day 15
Phase 2: Changes in prothrombin time (PT) through Day 15
Time frame: Day 1 to Day 15
Phase 2: Changes in total bilirubin through Day 15
Time frame: Day 1 to Day 15
Phase 2: Changes in ALT through Day 15
Time frame: Day 1 to Day 15
Phase 2: Changes in AST through Day 15
Time frame: Day 1 to Day 15
Phase 2: Changes in white blood cell count (CBC) through End of Study (EOS)
Time frame: Day through Day 29 or hospital discharge, whichever is first
Safety assessment via standard blood chemistry and metabolic panels will be performed daily as recommended by participant's physician as SOC. Mean changes from baseline to EOS will be reported.
Phase 2: Changes in hemoglobin through End of Study (EOS)
Time frame: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 2: Changes in platelets through End of Study (EOS)
Time frame: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 2: Changes in creatinine through End of Study (EOS)
Time frame: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 2: Changes in glucose through End of Study (EOS)
Time frame: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 2: Changes in prothrombin time (PT) though End of Study (EOS)
Time frame: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 2: Changes in total bilirubin through End of Study (EOS)
Time frame: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 2: Changes in ALT through End of Study (EOS)
Time frame: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 2: Changes in AST through End of Study (EOS)
Time frame: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Percentage of patients reporting each severity on an 8-point ordinal scale at Day 15
Time frame: Day 15
The 8-point ordinal scale described below, where a lower score indicates a worse outcome, will be performed daily or as recommended by participant's physician as SOC. The percent of participants scored at each severity will be reported on Day 15. The 8-point ordinal scale is as follows: 1. Death 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen, requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care 7. Not hospitalized, limitation on activities and/or requiring home oxygen 8. Not hospitalized, no limitations on activities
37 secondary outcomes
Phase 2: Change in the 8-point ordinal scale
Time frame: Day 1 to Day 29
Phase 2: Change in National Early Warning Score (NEWS)
Time frame: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Change in the 8-point ordinal scale
Time frame: Day 1 to Day 29
Phase 3: Change in National Early Warning Score (NEWS)
Time frame: Day 1 to Day 29 or hospital discharge, whichever is first
Phase 3: Time to an improvement of one category using the 8-point ordinal scale
Time frame: Day 1 to Day 29 or hospital discharge, whichever is first
Phase 3: Time to an improvement of two categories using the 8-point ordinal scale
Time frame: Day 1 to Day 29 or hospital discharge, whichever is first
Phase 3: Time to discharge or to a NEWS ≤2 and maintained for 24 hours, whichever occurs first
Time frame: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Cumulative incidence of Grade 3 and 4 adverse events (AEs)
Time frame: Day 0 (screening) through Day 29
Phase 3: Cumulative incidence of serious adverse events (SAEs)
Time frame: Day 0 (screening) through Day 29
Phase 3: Duration of hospitalization
Time frame: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Duration of new oxygen use
Time frame: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Duration of new ventilator or ECMO use
Time frame: Day 1 to Day 29 or hospital discharge, whichever is first
Phase 3: Incidence of discontinuation or temporary suspension of drug for any reason
Time frame: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Incidence of new oxygen use
Time frame: Day 1 to Day 29 or hospital discharge, whichever is first
Phase 3: Incidence of new ventilator use
Time frame: Day 1 to Day 29 or hospital discharge, whichever is first
Phase 3: Number of oxygen free days
Time frame: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Number of ventilator or ECMO free days
Time frame: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: 14 day mortality rate
Time frame: Day 1 through Day 15
Phase 3: 28 day mortality rate
Time frame: Day 1 through Day 29
Phase 3: Changes in white blood cell count (CBC) through Day 15
Time frame: Day 1 to Day 15
Phase 3: Changes in hemoglobin through Day 15
Time frame: Day 1 to Day 15
Phase 3: Changes in platelets through Day 15
Time frame: Day 1 to Day 15
Phase 3: Changes in creatinine through Day 15
Time frame: Day 1 to Day 15
Phase 3: Changes in glucose through Day 15
Time frame: Day 1 to Day 15
Phase 3: Changes in prothrombin time (PT) through Day 15
Time frame: Day 1 to Day 15
Phase 3: Changes in total bilirubin through Day 15
Time frame: Day 1 to Day 15
Phase 3: Changes in ALT through Day 15
Time frame: Day 1 to Day 15
Phase 3: Changes in AST through Day 15
Time frame: Day 1 to Day 15
Phase 3: Changes in white blood cell count (CBC) through End of Study (EOS)
Time frame: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Changes in hemoglobin through End of Study (EOS)
Time frame: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Changes in platelets through End of Study (EOS)
Time frame: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Changes in creatinine through End of Study (EOS)
Time frame: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Changes in glucose through End of Study (EOS)
Time frame: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Changes in prothrombin time (PT) though End of Study (EOS)
Time frame: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Changes in total bilirubin through End of Study (EOS)
Time frame: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Changes in ALT through End of Study (EOS)
Time frame: Day 1 through Day 29 or hospital discharge, whichever is first
Phase 3: Changes in AST through End of Study (EOS)
Time frame: Day 1 through Day 29 or hospital discharge, whichever is first
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 8 Mar 2021.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be made available for all primary outcome measures.
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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.
Joaquin Espinosa, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Baricitinib in people with COVID-19, run by University of Colorado, Denver 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 8 inclusion and 15 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 8 Mar 2021. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Phase 2: Cumulative incidence of Grade 3 and 4 adverse events (AEs) (time frame: Day 0 (screening) through Day 29). The study lists 21 primary outcomes in all. 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 8 Mar 2021.