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                    <a href="?cresstrial=15291&amp;modal=1&amp;valnames=exclusion_criteria&amp;order=created_at">Created at</a>
                </th>
                <th scope="col">Source</th>
                
                <th scope="col">Raw Value</th>
                <th scope="col">Validated value</th>
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        <tbody>
            
            <tr class="histvalue-row" histvalueid="363606" class="table-">
                
                <td>Jan. 18, 2022, 1 a.m.</td>
                <td>eu</td>
                
                <td class="histvalue-container">
                    

        <p class="exclusion_criteria">
            Master Protocol Number 2.0 dated 1 Nov 2021:
Participants are excluded from the study if any of the following general exclusion criteria apply:
GE1.	Anticipated transfer to another non-trial hospital within 72 hours
Additional exclusion criteria, included prohibited medication, confounding trials and details on contraception and pregnancy are given in the intervention-specific sub-protocols.
Baricitinib specific protocol v.2.0 dated 1 Nov 2021:
GE1.	Anticipated transfer to another non-trial hospital within 72 hours.
In addition, participants are excluded from being eligible for the intervention cohort if any of the additional specific exclusion (SE) criteria below apply:
 	SE-01. Patients receiving Janus kinase (JAK) inhibitors (including baricitinib) for any indication at screening.
 	SE-20. Have received tocilizumab of sarilumab for any indication 4 weeks prior to screening.
Note: Tocilizumab as rescue therapy will be allowed in patients with clinical progression after inclusion, see section 6.8 concomitant medication. If tocilizumab or other immunosuppressive rescue therapy is started, IMP should be discontinued.
 	SE-21. Patients with recent changes in immunosuppressive therapy that could interfere with the potential effect of baricitinib.
-	Recipients of bone marrow transplant or solid organ transplant last 6 months, or with transplant rejection last 6 months, should not be included.
-	Organ transplant recipients receiving triple immunosuppression can only be included if the anti-metabolite (mycophenolic acid or mTOR inhibitor) has been temporarily discontinued per clinical practice. IMP should be discontinued once triple immunosuppression is restarted.
 	SE-22. Any medical condition that in the opinion of the investigator poses an inacceptable risk of serious infection or aggravation of the medical condition by participating in the trial.
Note: Patients with acute leukemia or history of lymphoma should not be included. Cancer patients under active treatment, HIV positive individuals with detectable HIV-RNA, or other patient group associated with high risk of serious infection or aggravation of the medical condition should only be included if, in the judgement of the investigator, the potential benefit outweighs the potential risk.
 	SE-03. Have received dexamethasone 6 mg daily (or alternative regimens with equivalent of corticosteroids) for more than 4 days prior to screening as part of SoC for severe/critical COVID-19
 	SE-04. Had COVID-related symptoms &gt; 21 days or hospitalized &gt; 7 days.
 	SE-05. Strong inhibitors of organic anion transporter 3 [OAT3] (e.g., probenecid) that cannot be discontinued at study entry.
 	SE-07. Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study (until day 90 (+/- 14 days)).
Note: Use of non-live (inactivated) vaccinations, including COVID-19 vaccinations, is allowed for all participants.
 	SE-08. Are using or will use extracorporeal blood purification (EBP) device to remove proinflammatory cytokines from the blood such as a cytokine absorption or filtering device, for example, CytoSorb®.
 	SE-09. Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required).
 	SE-10. Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product.
 	SE-12. Have a history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) within 12 weeks prior to randomization or have a history of recurrent (&gt;1) VTE (DVT/PE).
 	SE-13. Neutropenia (absolute neutrophil count &lt;1000 cells/microliters).
 	SE-14. Lymphopenia (absolute lymphocyte count &lt;200 cells/microliters).
 	SE-15. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) &gt;5 times ULN.
 	SE-16. Subjects with estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease [MDRD]) &lt;15 millilitre/minute/1.73 meters squared are excluded.
Note: Subjects with eGFR 15-30 are excluded unless in the opinion of the PI, the potential benefit of participation outweighs the potential risk of study participation.
 	SE-17. Known hypersensitivity to baricitinib or any of its excipients.
 	SE-18. Are pregnant or breastfeeding, or intend to become pregnant or breastfeed during the study.
Note: Women of child bearing potential (WOCBP) can only be included based on a negative pregnancy test and WOCBP must comply with requirements regarding highly effective contraception. Refer to section 10.1 for contraception requirements.
 	SE-19 Participation in any therapeutic clinical trials investigating immunomodulators for COVID-19
        </p>
    

                </td>
                <td class="histvalue-container">
                    

        <p class="exclusion_criteria validated">
            Master Protocol Number 2.0 dated 1 Nov 2021:
Participants are excluded from the study if any of the following general exclusion criteria apply:
GE1.	Anticipated transfer to another non-trial hospital within 72 hours
Additional exclusion criteria, included prohibited medication, confounding trials and details on contraception and pregnancy are given in the intervention-specific sub-protocols.
Baricitinib specific protocol v.2.0 dated 1 Nov 2021:
GE1.	Anticipated transfer to another non-trial hospital within 72 hours.
In addition, participants are excluded from being eligible for the intervention cohort if any of the additional specific exclusion (SE) criteria below apply:
 	SE-01. Patients receiving Janus kinase (JAK) inhibitors (including baricitinib) for any indication at screening.
 	SE-20. Have received tocilizumab of sarilumab for any indication 4 weeks prior to screening.
Note: Tocilizumab as rescue therapy will be allowed in patients with clinical progression after inclusion, see section 6.8 concomitant medication. If tocilizumab or other immunosuppressive rescue therapy is started, IMP should be discontinued.
 	SE-21. Patients with recent changes in immunosuppressive therapy that could interfere with the potential effect of baricitinib.
-	Recipients of bone marrow transplant or solid organ transplant last 6 months, or with transplant rejection last 6 months, should not be included.
-	Organ transplant recipients receiving triple immunosuppression can only be included if the anti-metabolite (mycophenolic acid or mTOR inhibitor) has been temporarily discontinued per clinical practice. IMP should be discontinued once triple immunosuppression is restarted.
 	SE-22. Any medical condition that in the opinion of the investigator poses an inacceptable risk of serious infection or aggravation of the medical condition by participating in the trial.
Note: Patients with acute leukemia or history of lymphoma should not be included. Cancer patients under active treatment, HIV positive individuals with detectable HIV-RNA, or other patient group associated with high risk of serious infection or aggravation of the medical condition should only be included if, in the judgement of the investigator, the potential benefit outweighs the potential risk.
 	SE-03. Have received dexamethasone 6 mg daily (or alternative regimens with equivalent of corticosteroids) for more than 4 days prior to screening as part of SoC for severe/critical COVID-19
 	SE-04. Had COVID-related symptoms &gt; 21 days or hospitalized &gt; 7 days.
 	SE-05. Strong inhibitors of organic anion transporter 3 [OAT3] (e.g., probenecid) that cannot be discontinued at study entry.
 	SE-07. Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study (until day 90 (+/- 14 days)).
Note: Use of non-live (inactivated) vaccinations, including COVID-19 vaccinations, is allowed for all participants.
 	SE-08. Are using or will use extracorporeal blood purification (EBP) device to remove proinflammatory cytokines from the blood such as a cytokine absorption or filtering device, for example, CytoSorb®.
 	SE-09. Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required).
 	SE-10. Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product.
 	SE-12. Have a history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) within 12 weeks prior to randomization or have a history of recurrent (&gt;1) VTE (DVT/PE).
 	SE-13. Neutropenia (absolute neutrophil count &lt;1000 cells/microliters).
 	SE-14. Lymphopenia (absolute lymphocyte count &lt;200 cells/microliters).
 	SE-15. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) &gt;5 times ULN.
 	SE-16. Subjects with estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease [MDRD]) &lt;15 millilitre/minute/1.73 meters squared are excluded.
Note: Subjects with eGFR 15-30 are excluded unless in the opinion of the PI, the potential benefit of participation outweighs the potential risk of study participation.
 	SE-17. Known hypersensitivity to baricitinib or any of its excipients.
 	SE-18. Are pregnant or breastfeeding, or intend to become pregnant or breastfeed during the study.
Note: Women of child bearing potential (WOCBP) can only be included based on a negative pregnancy test and WOCBP must comply with requirements regarding highly effective contraception. Refer to section 10.1 for contraception requirements.
 	SE-19 Participation in any therapeutic clinical trials investigating immunomodulators for COVID-19
        </p>
        
    
                </td>
            </tr>
            
            <tr class="histvalue-row" histvalueid="357185" class="table-">
                
                <td>Aug. 15, 2021, 8:07 p.m.</td>
                <td>eu</td>
                
                <td class="histvalue-container">
                    

        <p class="exclusion_criteria">
            Master Protocol Number 1.1 dated 07 April 2021:
Participants are excluded from the study if any of the following general exclusion criteria apply:
GE1.	Anticipated transfer to another non-trial hospital within 72 hours
Additional exclusion criteria, included prohibited medication, confounding trials and details on contraception and pregnancy are given in the intervention-specific sub-protocols.
Baricitinib specific protocol v. 1.1 dated 07 April 2021:
GE1. Anticipated transfer to another non-trial hospital within 72 hours.
In addition, participants are excluded from being eligible for the intervention cohort if any of the additional specific exclusion (SE) criteria below apply:
  SE-01. Receiving cytotoxic or biologic treatments (such as tumour necrosis factor [TNF] inhibitors, anti-interleukin-1 [IL-1, e.g. anakinra], anti-IL-6 [e.g. tocilizumab or sarilumab], T-cell or B-cell targeted therapies (e.g. rituximab), interferon, or Janus kinase (JAK) inhibitors (including baricitinib) for any indication at study entry.
o Note: A washout period is required prior to screening
  SE-02. Have received high dose corticosteroids at doses &gt;20 mg prednisone (or prednisone equivalent) per day administered for ≥14 consecutive days in the month prior to study entry.
  SE-03. Have received dexamethasone 6 mg once daily for more than 4 days prior to screening as part of SoC for severe/critical COVID-19
  SE-04. Had COVID-related symptoms &gt; 14 days or hospitalized &gt; 7 days.
o Note: If hospitalized early in the disease and then progressing after &gt;7 days of hospitalization, the patient could still be included if COVID-related symptoms had a duration &lt; 14 days.
  SE-05. Strong inhibitors of organic anion transporter 3 [OAT3], (e.g. probenecid) that cannot be discontinued at study entry.
  SE-06. Have received neutralizing antibodies for COVID-19, except if receiving such treatment as part of EU SolidAct part A after disease progression.
  SE-07. Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study (until day 90 (+/- 14 days)).
o Note: Use of non-live (inactivated) vaccinations, including COVID-19 vaccinations, is allowed for all participants.
  SE-08. Are using or will use extracorporeal blood purification (EBP) device to remove proinflammatory cytokines from the blood such as a cytokine absorption or filtering device, for example, CytoSorb®.
  SE-09. Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required).
  SE-10. Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product.
o Note: Immunocompromised patients, patients with a chronic medical condition, or those taking a medication that cannot be discontinued at enrolment, who, in the judgment of the investigator, are at increased risk for serious infections or other safety concerns should be excluded. However, well treated HIV infection with normal CD4+ T cell count and undetectable HIV-RNA is not an exclusion criterion per se.
  SE-11. Current diagnosis of active malignancy that, in the opinion of the investigator, could constitute a risk when taking investigational product.
o Note: although this risk is established from long term use of baricitinib, and probably does not pose the same risk in short term use for COVID-19, particular attention should be paid, as reflected in the list of adverse events of special interest
  SE-12. Have a history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) within 12 weeks prior to randomization or have a history of recurrent (&gt;1) VTE (DVT/PE).
  SE-13. Neutropenia (absolute neutrophil count &lt;1000 cells/microliters).
  SE-14. Lymphopenia (absolute lymphocyte count &lt;200 cells/microliters).
  SE-15. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) &gt;5 times ULN.
  SE-16. Subjects with estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease [MDRD]) &lt;15 millilitre/minute/1.73 meters squared are excluded.
o Note: Subjects with eGFR 15-30 are excluded unless in the opinion of the PI, the potential benefit of participation outweighs the potential risk of study participation.
  SE-17. Known hypersensitivity to baricitinib or any of its excipients.
  SE-18. Are pregnant, or intend to become pregnant or breastfeed during the study.
o Note: Women of child bearing potential (WOCBP) can only be included based on a negative pregnancy test and WOCBP must comply with requirements regarding highly effective contraception. Refer to section 10.1 for contraception requirements.
  SE-19 Participation in any therapeutic clinical trials investigating immunomodulators for COVID-19
        </p>
    

                </td>
                <td class="histvalue-container">
                    

        <p class="exclusion_criteria validated">
            Master Protocol Number 1.1 dated 07 April 2021:
Participants are excluded from the study if any of the following general exclusion criteria apply:
GE1.	Anticipated transfer to another non-trial hospital within 72 hours
Additional exclusion criteria, included prohibited medication, confounding trials and details on contraception and pregnancy are given in the intervention-specific sub-protocols.
Baricitinib specific protocol v. 1.1 dated 07 April 2021:
GE1. Anticipated transfer to another non-trial hospital within 72 hours.
In addition, participants are excluded from being eligible for the intervention cohort if any of the additional specific exclusion (SE) criteria below apply:
  SE-01. Receiving cytotoxic or biologic treatments (such as tumour necrosis factor [TNF] inhibitors, anti-interleukin-1 [IL-1, e.g. anakinra], anti-IL-6 [e.g. tocilizumab or sarilumab], T-cell or B-cell targeted therapies (e.g. rituximab), interferon, or Janus kinase (JAK) inhibitors (including baricitinib) for any indication at study entry.
o Note: A washout period is required prior to screening
  SE-02. Have received high dose corticosteroids at doses &gt;20 mg prednisone (or prednisone equivalent) per day administered for ≥14 consecutive days in the month prior to study entry.
  SE-03. Have received dexamethasone 6 mg once daily for more than 4 days prior to screening as part of SoC for severe/critical COVID-19
  SE-04. Had COVID-related symptoms &gt; 14 days or hospitalized &gt; 7 days.
o Note: If hospitalized early in the disease and then progressing after &gt;7 days of hospitalization, the patient could still be included if COVID-related symptoms had a duration &lt; 14 days.
  SE-05. Strong inhibitors of organic anion transporter 3 [OAT3], (e.g. probenecid) that cannot be discontinued at study entry.
  SE-06. Have received neutralizing antibodies for COVID-19, except if receiving such treatment as part of EU SolidAct part A after disease progression.
  SE-07. Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study (until day 90 (+/- 14 days)).
o Note: Use of non-live (inactivated) vaccinations, including COVID-19 vaccinations, is allowed for all participants.
  SE-08. Are using or will use extracorporeal blood purification (EBP) device to remove proinflammatory cytokines from the blood such as a cytokine absorption or filtering device, for example, CytoSorb®.
  SE-09. Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required).
  SE-10. Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product.
o Note: Immunocompromised patients, patients with a chronic medical condition, or those taking a medication that cannot be discontinued at enrolment, who, in the judgment of the investigator, are at increased risk for serious infections or other safety concerns should be excluded. However, well treated HIV infection with normal CD4+ T cell count and undetectable HIV-RNA is not an exclusion criterion per se.
  SE-11. Current diagnosis of active malignancy that, in the opinion of the investigator, could constitute a risk when taking investigational product.
o Note: although this risk is established from long term use of baricitinib, and probably does not pose the same risk in short term use for COVID-19, particular attention should be paid, as reflected in the list of adverse events of special interest
  SE-12. Have a history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) within 12 weeks prior to randomization or have a history of recurrent (&gt;1) VTE (DVT/PE).
  SE-13. Neutropenia (absolute neutrophil count &lt;1000 cells/microliters).
  SE-14. Lymphopenia (absolute lymphocyte count &lt;200 cells/microliters).
  SE-15. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) &gt;5 times ULN.
  SE-16. Subjects with estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease [MDRD]) &lt;15 millilitre/minute/1.73 meters squared are excluded.
o Note: Subjects with eGFR 15-30 are excluded unless in the opinion of the PI, the potential benefit of participation outweighs the potential risk of study participation.
  SE-17. Known hypersensitivity to baricitinib or any of its excipients.
  SE-18. Are pregnant, or intend to become pregnant or breastfeed during the study.
o Note: Women of child bearing potential (WOCBP) can only be included based on a negative pregnancy test and WOCBP must comply with requirements regarding highly effective contraception. Refer to section 10.1 for contraception requirements.
  SE-19 Participation in any therapeutic clinical trials investigating immunomodulators for COVID-19
        </p>
        
    
                </td>
            </tr>
            
        </tbody>
    </table>
</div>
Created at	Source	Raw Value	Validated value
Jan. 18, 2022, 1 a.m.	eu	Master Protocol Number 2.0 dated 1 Nov 2021: Participants are excluded from the study if any of the following general exclusion criteria apply: GE1. Anticipated transfer to another non-trial hospital within 72 hours Additional exclusion criteria, included prohibited medication, confounding trials and details on contraception and pregnancy are given in the intervention-specific sub-protocols. Baricitinib specific protocol v.2.0 dated 1 Nov 2021: GE1. Anticipated transfer to another non-trial hospital within 72 hours. In addition, participants are excluded from being eligible for the intervention cohort if any of the additional specific exclusion (SE) criteria below apply: SE-01. Patients receiving Janus kinase (JAK) inhibitors (including baricitinib) for any indication at screening. SE-20. Have received tocilizumab of sarilumab for any indication 4 weeks prior to screening. Note: Tocilizumab as rescue therapy will be allowed in patients with clinical progression after inclusion, see section 6.8 concomitant medication. If tocilizumab or other immunosuppressive rescue therapy is started, IMP should be discontinued. SE-21. Patients with recent changes in immunosuppressive therapy that could interfere with the potential effect of baricitinib. - Recipients of bone marrow transplant or solid organ transplant last 6 months, or with transplant rejection last 6 months, should not be included. - Organ transplant recipients receiving triple immunosuppression can only be included if the anti-metabolite (mycophenolic acid or mTOR inhibitor) has been temporarily discontinued per clinical practice. IMP should be discontinued once triple immunosuppression is restarted. SE-22. Any medical condition that in the opinion of the investigator poses an inacceptable risk of serious infection or aggravation of the medical condition by participating in the trial. Note: Patients with acute leukemia or history of lymphoma should not be included. Cancer patients under active treatment, HIV positive individuals with detectable HIV-RNA, or other patient group associated with high risk of serious infection or aggravation of the medical condition should only be included if, in the judgement of the investigator, the potential benefit outweighs the potential risk. SE-03. Have received dexamethasone 6 mg daily (or alternative regimens with equivalent of corticosteroids) for more than 4 days prior to screening as part of SoC for severe/critical COVID-19 SE-04. Had COVID-related symptoms > 21 days or hospitalized > 7 days. SE-05. Strong inhibitors of organic anion transporter 3 [OAT3] (e.g., probenecid) that cannot be discontinued at study entry. SE-07. Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study (until day 90 (+/- 14 days)). Note: Use of non-live (inactivated) vaccinations, including COVID-19 vaccinations, is allowed for all participants. SE-08. Are using or will use extracorporeal blood purification (EBP) device to remove proinflammatory cytokines from the blood such as a cytokine absorption or filtering device, for example, CytoSorb®. SE-09. Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required). SE-10. Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product. SE-12. Have a history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) within 12 weeks prior to randomization or have a history of recurrent (>1) VTE (DVT/PE). SE-13. Neutropenia (absolute neutrophil count <1000 cells/microliters). SE-14. Lymphopenia (absolute lymphocyte count <200 cells/microliters). SE-15. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times ULN. SE-16. Subjects with estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease [MDRD]) <15 millilitre/minute/1.73 meters squared are excluded. Note: Subjects with eGFR 15-30 are excluded unless in the opinion of the PI, the potential benefit of participation outweighs the potential risk of study participation. SE-17. Known hypersensitivity to baricitinib or any of its excipients. SE-18. Are pregnant or breastfeeding, or intend to become pregnant or breastfeed during the study. Note: Women of child bearing potential (WOCBP) can only be included based on a negative pregnancy test and WOCBP must comply with requirements regarding highly effective contraception. Refer to section 10.1 for contraception requirements. SE-19 Participation in any therapeutic clinical trials investigating immunomodulators for COVID-19	Master Protocol Number 2.0 dated 1 Nov 2021: Participants are excluded from the study if any of the following general exclusion criteria apply: GE1. Anticipated transfer to another non-trial hospital within 72 hours Additional exclusion criteria, included prohibited medication, confounding trials and details on contraception and pregnancy are given in the intervention-specific sub-protocols. Baricitinib specific protocol v.2.0 dated 1 Nov 2021: GE1. Anticipated transfer to another non-trial hospital within 72 hours. In addition, participants are excluded from being eligible for the intervention cohort if any of the additional specific exclusion (SE) criteria below apply: SE-01. Patients receiving Janus kinase (JAK) inhibitors (including baricitinib) for any indication at screening. SE-20. Have received tocilizumab of sarilumab for any indication 4 weeks prior to screening. Note: Tocilizumab as rescue therapy will be allowed in patients with clinical progression after inclusion, see section 6.8 concomitant medication. If tocilizumab or other immunosuppressive rescue therapy is started, IMP should be discontinued. SE-21. Patients with recent changes in immunosuppressive therapy that could interfere with the potential effect of baricitinib. - Recipients of bone marrow transplant or solid organ transplant last 6 months, or with transplant rejection last 6 months, should not be included. - Organ transplant recipients receiving triple immunosuppression can only be included if the anti-metabolite (mycophenolic acid or mTOR inhibitor) has been temporarily discontinued per clinical practice. IMP should be discontinued once triple immunosuppression is restarted. SE-22. Any medical condition that in the opinion of the investigator poses an inacceptable risk of serious infection or aggravation of the medical condition by participating in the trial. Note: Patients with acute leukemia or history of lymphoma should not be included. Cancer patients under active treatment, HIV positive individuals with detectable HIV-RNA, or other patient group associated with high risk of serious infection or aggravation of the medical condition should only be included if, in the judgement of the investigator, the potential benefit outweighs the potential risk. SE-03. Have received dexamethasone 6 mg daily (or alternative regimens with equivalent of corticosteroids) for more than 4 days prior to screening as part of SoC for severe/critical COVID-19 SE-04. Had COVID-related symptoms > 21 days or hospitalized > 7 days. SE-05. Strong inhibitors of organic anion transporter 3 [OAT3] (e.g., probenecid) that cannot be discontinued at study entry. SE-07. Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study (until day 90 (+/- 14 days)). Note: Use of non-live (inactivated) vaccinations, including COVID-19 vaccinations, is allowed for all participants. SE-08. Are using or will use extracorporeal blood purification (EBP) device to remove proinflammatory cytokines from the blood such as a cytokine absorption or filtering device, for example, CytoSorb®. SE-09. Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required). SE-10. Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product. SE-12. Have a history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) within 12 weeks prior to randomization or have a history of recurrent (>1) VTE (DVT/PE). SE-13. Neutropenia (absolute neutrophil count <1000 cells/microliters). SE-14. Lymphopenia (absolute lymphocyte count <200 cells/microliters). SE-15. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times ULN. SE-16. Subjects with estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease [MDRD]) <15 millilitre/minute/1.73 meters squared are excluded. Note: Subjects with eGFR 15-30 are excluded unless in the opinion of the PI, the potential benefit of participation outweighs the potential risk of study participation. SE-17. Known hypersensitivity to baricitinib or any of its excipients. SE-18. Are pregnant or breastfeeding, or intend to become pregnant or breastfeed during the study. Note: Women of child bearing potential (WOCBP) can only be included based on a negative pregnancy test and WOCBP must comply with requirements regarding highly effective contraception. Refer to section 10.1 for contraception requirements. SE-19 Participation in any therapeutic clinical trials investigating immunomodulators for COVID-19
Aug. 15, 2021, 8:07 p.m.	eu	Master Protocol Number 1.1 dated 07 April 2021: Participants are excluded from the study if any of the following general exclusion criteria apply: GE1. Anticipated transfer to another non-trial hospital within 72 hours Additional exclusion criteria, included prohibited medication, confounding trials and details on contraception and pregnancy are given in the intervention-specific sub-protocols. Baricitinib specific protocol v. 1.1 dated 07 April 2021: GE1. Anticipated transfer to another non-trial hospital within 72 hours. In addition, participants are excluded from being eligible for the intervention cohort if any of the additional specific exclusion (SE) criteria below apply: SE-01. Receiving cytotoxic or biologic treatments (such as tumour necrosis factor [TNF] inhibitors, anti-interleukin-1 [IL-1, e.g. anakinra], anti-IL-6 [e.g. tocilizumab or sarilumab], T-cell or B-cell targeted therapies (e.g. rituximab), interferon, or Janus kinase (JAK) inhibitors (including baricitinib) for any indication at study entry. o Note: A washout period is required prior to screening SE-02. Have received high dose corticosteroids at doses >20 mg prednisone (or prednisone equivalent) per day administered for ≥14 consecutive days in the month prior to study entry. SE-03. Have received dexamethasone 6 mg once daily for more than 4 days prior to screening as part of SoC for severe/critical COVID-19 SE-04. Had COVID-related symptoms > 14 days or hospitalized > 7 days. o Note: If hospitalized early in the disease and then progressing after >7 days of hospitalization, the patient could still be included if COVID-related symptoms had a duration < 14 days. SE-05. Strong inhibitors of organic anion transporter 3 [OAT3], (e.g. probenecid) that cannot be discontinued at study entry. SE-06. Have received neutralizing antibodies for COVID-19, except if receiving such treatment as part of EU SolidAct part A after disease progression. SE-07. Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study (until day 90 (+/- 14 days)). o Note: Use of non-live (inactivated) vaccinations, including COVID-19 vaccinations, is allowed for all participants. SE-08. Are using or will use extracorporeal blood purification (EBP) device to remove proinflammatory cytokines from the blood such as a cytokine absorption or filtering device, for example, CytoSorb®. SE-09. Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required). SE-10. Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product. o Note: Immunocompromised patients, patients with a chronic medical condition, or those taking a medication that cannot be discontinued at enrolment, who, in the judgment of the investigator, are at increased risk for serious infections or other safety concerns should be excluded. However, well treated HIV infection with normal CD4+ T cell count and undetectable HIV-RNA is not an exclusion criterion per se. SE-11. Current diagnosis of active malignancy that, in the opinion of the investigator, could constitute a risk when taking investigational product. o Note: although this risk is established from long term use of baricitinib, and probably does not pose the same risk in short term use for COVID-19, particular attention should be paid, as reflected in the list of adverse events of special interest SE-12. Have a history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) within 12 weeks prior to randomization or have a history of recurrent (>1) VTE (DVT/PE). SE-13. Neutropenia (absolute neutrophil count <1000 cells/microliters). SE-14. Lymphopenia (absolute lymphocyte count <200 cells/microliters). SE-15. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times ULN. SE-16. Subjects with estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease [MDRD]) <15 millilitre/minute/1.73 meters squared are excluded. o Note: Subjects with eGFR 15-30 are excluded unless in the opinion of the PI, the potential benefit of participation outweighs the potential risk of study participation. SE-17. Known hypersensitivity to baricitinib or any of its excipients. SE-18. Are pregnant, or intend to become pregnant or breastfeed during the study. o Note: Women of child bearing potential (WOCBP) can only be included based on a negative pregnancy test and WOCBP must comply with requirements regarding highly effective contraception. Refer to section 10.1 for contraception requirements. SE-19 Participation in any therapeutic clinical trials investigating immunomodulators for COVID-19	Master Protocol Number 1.1 dated 07 April 2021: Participants are excluded from the study if any of the following general exclusion criteria apply: GE1. Anticipated transfer to another non-trial hospital within 72 hours Additional exclusion criteria, included prohibited medication, confounding trials and details on contraception and pregnancy are given in the intervention-specific sub-protocols. Baricitinib specific protocol v. 1.1 dated 07 April 2021: GE1. Anticipated transfer to another non-trial hospital within 72 hours. In addition, participants are excluded from being eligible for the intervention cohort if any of the additional specific exclusion (SE) criteria below apply: SE-01. Receiving cytotoxic or biologic treatments (such as tumour necrosis factor [TNF] inhibitors, anti-interleukin-1 [IL-1, e.g. anakinra], anti-IL-6 [e.g. tocilizumab or sarilumab], T-cell or B-cell targeted therapies (e.g. rituximab), interferon, or Janus kinase (JAK) inhibitors (including baricitinib) for any indication at study entry. o Note: A washout period is required prior to screening SE-02. Have received high dose corticosteroids at doses >20 mg prednisone (or prednisone equivalent) per day administered for ≥14 consecutive days in the month prior to study entry. SE-03. Have received dexamethasone 6 mg once daily for more than 4 days prior to screening as part of SoC for severe/critical COVID-19 SE-04. Had COVID-related symptoms > 14 days or hospitalized > 7 days. o Note: If hospitalized early in the disease and then progressing after >7 days of hospitalization, the patient could still be included if COVID-related symptoms had a duration < 14 days. SE-05. Strong inhibitors of organic anion transporter 3 [OAT3], (e.g. probenecid) that cannot be discontinued at study entry. SE-06. Have received neutralizing antibodies for COVID-19, except if receiving such treatment as part of EU SolidAct part A after disease progression. SE-07. Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study (until day 90 (+/- 14 days)). o Note: Use of non-live (inactivated) vaccinations, including COVID-19 vaccinations, is allowed for all participants. SE-08. Are using or will use extracorporeal blood purification (EBP) device to remove proinflammatory cytokines from the blood such as a cytokine absorption or filtering device, for example, CytoSorb®. SE-09. Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required). SE-10. Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product. o Note: Immunocompromised patients, patients with a chronic medical condition, or those taking a medication that cannot be discontinued at enrolment, who, in the judgment of the investigator, are at increased risk for serious infections or other safety concerns should be excluded. However, well treated HIV infection with normal CD4+ T cell count and undetectable HIV-RNA is not an exclusion criterion per se. SE-11. Current diagnosis of active malignancy that, in the opinion of the investigator, could constitute a risk when taking investigational product. o Note: although this risk is established from long term use of baricitinib, and probably does not pose the same risk in short term use for COVID-19, particular attention should be paid, as reflected in the list of adverse events of special interest SE-12. Have a history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) within 12 weeks prior to randomization or have a history of recurrent (>1) VTE (DVT/PE). SE-13. Neutropenia (absolute neutrophil count <1000 cells/microliters). SE-14. Lymphopenia (absolute lymphocyte count <200 cells/microliters). SE-15. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times ULN. SE-16. Subjects with estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease [MDRD]) <15 millilitre/minute/1.73 meters squared are excluded. o Note: Subjects with eGFR 15-30 are excluded unless in the opinion of the PI, the potential benefit of participation outweighs the potential risk of study participation. SE-17. Known hypersensitivity to baricitinib or any of its excipients. SE-18. Are pregnant, or intend to become pregnant or breastfeed during the study. o Note: Women of child bearing potential (WOCBP) can only be included based on a negative pregnancy test and WOCBP must comply with requirements regarding highly effective contraception. Refer to section 10.1 for contraception requirements. SE-19 Participation in any therapeutic clinical trials investigating immunomodulators for COVID-19