COVID-19Phase 2NCT04321993
Treatment of Moderate to Severe Coronavirus Disease (COVID-19) in Hospitalized Patients
A Phase 2 study testing Baricitinib (janus kinase inhibitor), Remdesivir (antiviral) + barictinib (janus kinase inhibitor) and Remdesivir (antiviral) in people with COVID-19, run by Lisa Barrett at 1 site in Canada.
Trial summary
Investigational medications adjunct to clinical standard of care treatment will be assessed to evaluate safety and effectiveness as an anti-COVID-19 treatment. All hospitalized persons with moderate to severe COVID-19 disease that meet eligibility criteria will be offered participation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Baricitinib (janus kinase inhibitor), Remdesivir (antiviral) + barictinib (janus kinase inhibitor) and Remdesivir (antiviral)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 363 participants
- Where
- 1 siteCanada
- Study dates
- 17 Apr 2020to Apr 2024
- 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
- 18 years or older
- Moderate to severe COVID-19 associated disease as defined by the WHO
- Willing and able to provide informed consent prior to performing study procedures
- Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay
- Illness of any duration, and at least one of the following: Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤ 94% on room air, or Require mechanical ventilation and/or supplemental oxygen.
- Normal potassium, magnesium, and calcium levels pre-therapy when used in agents at risk of QT prolongation
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- Patients will be further distinguished based on their disease severity into one of two categories:
- Moderate and severe, not critical disease: patients with SpO2 ≤ 94% on room air, and those who require supplemental oxygen
- Severe, critical disease: patients with critical illness requiring ICU-level care including requiring mechanical ventilation or ECMO, and/or end organ dysfunction as seen in sepsis/septic shock.
Who cannot join
- Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
- Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment Medication specific Exclusion
- Baricitinib:
- Contraindicated for patients with known hypersensitivity to baricitinib or to any of the excipients.
- Prior untreated latent tuberculosis
- Any individuals with TB risk factors will not be enrolled in the baricitinib arm of the study.
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- Presence of active viral hepatitis C or B
- People with a clinical history of invasive or active fungal infection
- People with a clinical history of active CMV disease in the last year
- Patients who are pregnant or breastfeeding
- Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <15)
- Tocilizumab:
- Known hypersensitivity to tocilizumab or any of its components
- Prior untreated latent tuberculosis
- Any individuals with TB risk factors will not be enrolled in the tocilizumab arm of the study.
- Presence of active viral hepatitis C or B
- People with a clinical history of invasive or active fungal infection
- People with a clinical history of active CMV disease in the last year
- CRP<75 mg/L
- SpO2 ≥ 92% on room air
- Remdesivir:
- Known hypersensitivity to remdesivir or any of its components
- Weight below 40 kg
- SpO2 ≥ 94% on room air
- Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30)
Trial locations and contacts
1 site in 1 country.
About this study
Investigational medications adjunct to clinical standard of care treatment will be assessed to evaluate safety and effectiveness as an anti-COVID-19 treatment. All hospitalized persons with moderate to severe COVID-19 disease that meet eligibility criteria will be offered participation.
- Conditions
- COVID-19
- Being tested
- Baricitinib (janus kinase inhibitor), Remdesivir (antiviral) + barictinib (janus kinase inhibitor), Remdesivir (antiviral), Tocilizumab (interleukin 6 inhibitor)
- Keywords
- COVID, coronavirus, SARS-CoV-2
- 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.
Baricitinib (janus kinase inhibitor)Drug
Baricitinib will be administered as 4 mg po daily for 14 days or until hospital discharge, whichever is sooner.
Remdesivir (antiviral) + barictinib (janus kinase inhibitor)Drug
Remdesivir will be administered as a loading dose of 200 mg IV over one hour on day 1 followed by 100 mg IV daily over one hour on days 2-5 (with a possibility to extend to up to 10 days total).
Baricitinib will be administered as 4 mg po daily for 14 days or until hospital discharge, whichever is sooner.
Remdesivir (antiviral)Drug
Remdesivir will be administered as a loading dose of 200 mg IV over one hour on day 1 followed by 100 mg IV daily over one hour on days 2-5 (with a possibility to extend to up to 10 days total).
Tocilizumab (interleukin 6 inhibitor)Drug
Tocilizumab will be administered as a single IV infusion over one hour. Dosage will be 8 mg/kg total bodyweight up to a maximum of 800 mg.
| Study group | Role | What they receive |
|---|---|---|
| Baricitinib | Experimental | Moderate and severe, not critical disease Receives: Drug: Baricitinib (janus kinase inhibitor) |
| Remdesivir | Experimental | Moderate and severe, not critical disease Receives: Drug: Remdesivir (antiviral) |
| Remdesivir + baricitinib | Experimental | Moderate and severe, not critical disease Receives: Drug: Remdesivir (antiviral) + barictinib (janus kinase inhibitor) |
| Tocilizumab | Experimental | Severe, critical disease Receives: Drug: Tocilizumab (interleukin 6 inhibitor) |
| Clinical standard of care | No intervention | Moderate and severe, not critical disease AND severe, critical disease as applicable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical status of subject at day 15 (on a 7 point ordinal scale).
- Not hospitalized, no limitations on activities
- Not hospitalized, limitation on activities;
- Hospitalized, not requiring supplemental oxygen;
- Hospitalized, requiring supplemental oxygen;
- Hospitalized, on non-invasive ventilation or high flow oxygen devices;
- Hospitalized, on invasive mechanical ventilation or ECMO;
- Death.
Measured: Up to 15 days
Secondary outcomes (13)
Status on an ordinal scale assessed daily while hospitalized and on days 15 and 29 and 180.
- Not hospitalized, no limitations on activities
- Not hospitalized, limitation on activities;
- Hospitalized, not requiring supplemental oxygen;
- Hospitalized, requiring supplemental oxygen;
- Hospitalized, on non-invasive ventilation or high flow oxygen devices;
- Hospitalized, on invasive mechanical ventilation or ECMO;
- Death.
Measured: Up to 180 days
Length of time to clinical improvement
Time to clinical improvement is defined as the time to normalization of respiratory rate, fever, and oxygen saturation, and alleviation of cough within 72 hours.
Measured: Up to 29 days
Number of participants with normal pulmonary function and normal O2 saturation on days 11, 15 and 29
Measured: Up to 29 days
Number of participants that developed Acute Respiratory Distress Syndrome (ARDS) after treatment
Measured: Up to 24 weeks
Length of time to clinical progression
Time to clinical progression, defined as the time to death, mechanical ventilation, or ICU admission
Measured: Up to 29 days
Cause of death (if applicable)
Measured: Up to 24 weeks
Sequential Organ Failure Assessment (SOFA) score, daily while hospitalized and on days 15 and 29. (Initial, highest, deltas and mean)
Measured: Up to 29 days
Length of time to normalization of fever
Fever normalization as defined by: Temperature < 36.6 °C armpit, < 37.2 °C oral, or < 37.8 °C rectal sustained for minimum 24 hours
Measured: Up to 29 days
Length of time to normalization of oxygen saturation
Oxygen normalization as defined by: peripheral capillary oxygen saturation (Sp02) > 94% sustained minimum 24 hours.
Measured: Up to 29 days
Duration of supplemental oxygen (if applicable)
Measured: Up to 29 days
Duration of mechanical ventilation (if applicable)
Measured: Up to 29 days
Duration of hospitalization
Measured: Up to 29 days
Adverse events
Measured: Up to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start17 Apr 2020
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lisa Barrett
- Sponsor type
- University, hospital or other
- Collaborators
- Nova Scotia Health Authority, Dalhousie University
- Responsible party
- Sponsor-investigator, Lisa Barrett, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321993
- Sponsor's protocol ID
- SAIL-004
- Status last verified
- Sep 2023
- First submitted
- 24 Mar 2020
- Last updated
- 18 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Moderate to Severe Coronavirus Disease (COVID-19) in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT04321993
- Acronym / sponsor ID
- SAIL-004
- Conditions
- COVID-19
- Keywords
- COVID, coronavirus, SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Lisa BarrettUniversity, hospital or other
- Collaborators
- Nova Scotia Health Authority, Dalhousie University
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 26 Mar 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.
Investigational medications adjunct to clinical standard of care treatment will be assessed to evaluate safety and effectiveness as an anti-COVID-19 treatment. All hospitalized persons with moderate to severe COVID-19 disease that meet eligibility criteria will be offered participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Baricitinib | Experimental | Drug: Baricitinib (janus kinase inhibitor)Moderate and severe, not critical disease |
| Remdesivir | Experimental | Drug: Remdesivir (antiviral)Moderate and severe, not critical disease |
| Remdesivir + baricitinib | Experimental | Drug: Remdesivir (antiviral) + barictinib (janus kinase inhibitor)Moderate and severe, not critical disease |
| Tocilizumab | Experimental | Drug: Tocilizumab (interleukin 6 inhibitor)Severe, critical disease |
| Clinical standard of care | No intervention | –Moderate and severe, not critical disease AND severe, critical disease as applicable |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years or older
- Moderate to severe COVID-19 associated disease as defined by the WHO
- Willing and able to provide informed consent prior to performing study procedures
- Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay
- Illness of any duration, and at least one of the following: Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤ 94% on room air, or Require mechanical ventilation and/or supplemental oxygen.
Key exclusion criteria (25 listed)
- Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
- Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment Medication specific Exclusion
- Contraindicated for patients with known hypersensitivity to baricitinib or to any of the excipients.
- Prior untreated latent tuberculosis
- Any individuals with TB risk factors will not be enrolled in the baricitinib arm of the study.
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 |
|---|---|---|
| Baricitinib (janus kinase inhibitor)Baricitinib will be administered as 4 mg po daily for 14 days or until hospital discharge, whichever is sooner. | Drug | Baricitinib |
| Remdesivir (antiviral) + barictinib (janus kinase inhibitor)Remdesivir will be administered as a loading dose of 200 mg IV over one hour on day 1 followed by 100 mg IV daily over one hour on days 2-5 (with a possibility to extend to up to 10 days total). Baricitinib will be administered as 4 mg po daily for 14 days or until hospital discharge, whichever is sooner. | Drug | Remdesivir + baricitinib |
| Remdesivir (antiviral)Remdesivir will be administered as a loading dose of 200 mg IV over one hour on day 1 followed by 100 mg IV daily over one hour on days 2-5 (with a possibility to extend to up to 10 days total). | Drug | Remdesivir |
| Tocilizumab (interleukin 6 inhibitor)Tocilizumab will be administered as a single IV infusion over one hour. Dosage will be 8 mg/kg total bodyweight up to a maximum of 800 mg. | Drug | Tocilizumab |
Primary outcome
Clinical status of subject at day 15 (on a 7 point ordinal scale).
Time frame: Up to 15 days
1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6. Hospitalized, on invasive mechanical ventilation or ECMO; 7. Death.
13 secondary outcomes
Status on an ordinal scale assessed daily while hospitalized and on days 15 and 29 and 180.
Time frame: Up to 180 days
Length of time to clinical improvement
Time frame: Up to 29 days
Number of participants with normal pulmonary function and normal O2 saturation on days 11, 15 and 29
Time frame: Up to 29 days
Number of participants that developed Acute Respiratory Distress Syndrome (ARDS) after treatment
Time frame: Up to 24 weeks
Length of time to clinical progression
Time frame: Up to 29 days
Cause of death (if applicable)
Time frame: Up to 24 weeks
Sequential Organ Failure Assessment (SOFA) score, daily while hospitalized and on days 15 and 29. (Initial, highest, deltas and mean)
Time frame: Up to 29 days
Length of time to normalization of fever
Time frame: Up to 29 days
Length of time to normalization of oxygen saturation
Time frame: Up to 29 days
Duration of supplemental oxygen (if applicable)
Time frame: Up to 29 days
Duration of mechanical ventilation (if applicable)
Time frame: Up to 29 days
Duration of hospitalization
Time frame: Up to 29 days
Adverse events
Time frame: Up to 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Baricitinib (janus kinase inhibitor), Remdesivir (antiviral) + barictinib (janus kinase inhibitor) and Remdesivir (antiviral) in people with COVID-19, run by Lisa Barrett at 1 site in Canada.
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 9 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 18 Sep 2023. 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 Canada. 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?
Results are not available in the source record.
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?
Clinical status of subject at day 15 (on a 7 point ordinal scale). (time frame: Up to 15 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 18 Sep 2023.