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                    <a href="?cresstrial=15318&amp;modal=1&amp;valnames=inclusion_criteria&amp;order=created_at">Created at</a>
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                <th scope="col">Source</th>
                
                <th scope="col">Raw Value</th>
                <th scope="col">Validated value</th>
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                <td>Aug. 17, 2021, 8:30 p.m.</td>
                <td>eu</td>
                
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        <p class="inclusion_criteria">
            Master Protocol Number: 1.1 dated 07 April 2021:
Participants are eligible to be included in the study only if all the following general inclusion (GI) criteria apply:
GI1. &gt;= 18 years of age
GI2. Laboratory-confirmed SARS-CoV-2 infection (new infection or reinfection) as determined by PCR not more than 9 days old
GI3. Admitted to hospital
GI4. Informed consent by the participant or legally authorized representative.
GI5A: Moderate disease state defined as hospitalised patients without oxygen therapy or oxygen by mask or nasal prongs needed, or
GI5B: Severe/critical disease state defined as fulfilliing at least one of the following criteria:
1.	SpO2&lt;90% on room air, or
2.	SpO2 90-94% with a downwards trend and/or signs of respiratory distress*, or
3.	Need of oxygen by NIV (CPAP, BIPAP), high flow or non-rebreather mask, or
4.	Need of mechanical ventilation/ECMO
*persistently increased respiratory rate, use of accessory muscles, inability to complete full sentences. Clinical judgement must be applied to determine whether a low oxygen saturation is indicative of disease progression or severity or is habitual for a given patient (i.e., with underlying chronic lung disease).
NIV=non-invasive ventilation. CPAP= Continuous Positive Airway Pressure, BPAP= Bi-level Positive Airway Pressure, ECMO = Extracorporeal membrane oxygenation.
Additional inclusion criteria are given in the intervention-specific sub-protocols.
Baricitinib specific protocol v. 1.1 dated 07 April 2021:
All participants must be eligible according to the master protocol inclusion criteria (SolidAct Part B).
Only the general inclusion criteria (GI) for severe/critical COVID-19 are applicable:
GI1.	&gt;=18 years of age
GI2.	Laboratory-confirmed SARS-CoV-2 infection (new infection or reinfection) as determined by PCR in any specimen not more than 9 days old
GI3.	Admitted to hospital
GI4.	Informed consent by the participant or legally authorized representative.
GI5B: Severe/critical disease state defined as fulfilling at least one of the following criteria:
1.	SpO2&lt;90% on room air, or
2.	SpO2 90-94% with a downwards trend and/or signs of respiratory distress*, or
3.	Need of oxygen by NIV (CPAP, BIPAP), high flow or non-rebreather mask, or
4.	Need of mechanical ventilation/ECMO
*persistently increased respiratory rate, use of accessory muscles, inability to complete full sentences. Clinical judgement must be applied to determine whether a low oxygen saturation is indicative of disease progression or severity or is habitual for a given patient (i.e., with underlying chronic lung disease).
NIV=non-invasive ventilation. CPAP= Continuous Positive Airway Pressure, BPAP= Bi-level Positive Airway Pressure, ECMO = extracorporeal membrane oxygenation.
Master Protocol Number: 1.1 dated 07 April 2021:
1.	Età &gt;=18 anni
2.	Infezione da SARS-CoV-2 (nuova infezione o reinfezione) determinata tramite analisi con PCR in qualsiasi campione biologico prelevato non oltre i 9 giorni.
3.	Ricovero in ospedale
4.	Firma del consenso informato del paziente o del suo rappresentante legale autorizzato.
5.	Stato della malattia severo/critico determinato da almeno uno dei seguenti parametri:
6.	SpO2&lt;90%
7.	SpO2 90-94% con un chiaro trend in calo associato a distress dei parametri respiratori.
8.	Necessità di ossigeno attraverso ventilazione non invasiva (CPAP, BIPAP)
9.	Necessità di ventilazione meccanica con ossigeno terapia
Baricitinib specific protocol v. 1.1 dated 07 April 2021:
1.	Età &gt;=18 anni
2.	Infezione da SARS-CoV-2 (nuova infezione o reinfezione) determinata tramite analisi con PCR in qualsiasi campione biologico prelevato non oltre i 9 giorni.
3.	Ricovero in ospedale
4.	Firma del consenso informato del paziente o del suo rappresentante legale autorizzato.
5.	Stato della malattia severo/critico determinato da almeno uno dei seguenti parametri:
6.	SpO2&lt;90%
7.	SpO2 90-94% con un chiaro trend in calo associato a distress dei parametri respiratori.
8.	Necessità di ossigeno attraverso ventilazione non invasiva (CPAP, BIPAP)
9.	Necessità di ventilazione meccanica con ossigeno terapia
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                </td>
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        <p class="inclusion_criteria validated">
            Master Protocol Number: 1.1 dated 07 April 2021:
Participants are eligible to be included in the study only if all the following general inclusion (GI) criteria apply:
GI1. &gt;= 18 years of age
GI2. Laboratory-confirmed SARS-CoV-2 infection (new infection or reinfection) as determined by PCR not more than 9 days old
GI3. Admitted to hospital
GI4. Informed consent by the participant or legally authorized representative.
GI5A: Moderate disease state defined as hospitalised patients without oxygen therapy or oxygen by mask or nasal prongs needed, or
GI5B: Severe/critical disease state defined as fulfilliing at least one of the following criteria:
1.	SpO2&lt;90% on room air, or
2.	SpO2 90-94% with a downwards trend and/or signs of respiratory distress*, or
3.	Need of oxygen by NIV (CPAP, BIPAP), high flow or non-rebreather mask, or
4.	Need of mechanical ventilation/ECMO
*persistently increased respiratory rate, use of accessory muscles, inability to complete full sentences. Clinical judgement must be applied to determine whether a low oxygen saturation is indicative of disease progression or severity or is habitual for a given patient (i.e., with underlying chronic lung disease).
NIV=non-invasive ventilation. CPAP= Continuous Positive Airway Pressure, BPAP= Bi-level Positive Airway Pressure, ECMO = Extracorporeal membrane oxygenation.
Additional inclusion criteria are given in the intervention-specific sub-protocols.
Baricitinib specific protocol v. 1.1 dated 07 April 2021:
All participants must be eligible according to the master protocol inclusion criteria (SolidAct Part B).
Only the general inclusion criteria (GI) for severe/critical COVID-19 are applicable:
GI1.	&gt;=18 years of age
GI2.	Laboratory-confirmed SARS-CoV-2 infection (new infection or reinfection) as determined by PCR in any specimen not more than 9 days old
GI3.	Admitted to hospital
GI4.	Informed consent by the participant or legally authorized representative.
GI5B: Severe/critical disease state defined as fulfilling at least one of the following criteria:
1.	SpO2&lt;90% on room air, or
2.	SpO2 90-94% with a downwards trend and/or signs of respiratory distress*, or
3.	Need of oxygen by NIV (CPAP, BIPAP), high flow or non-rebreather mask, or
4.	Need of mechanical ventilation/ECMO
*persistently increased respiratory rate, use of accessory muscles, inability to complete full sentences. Clinical judgement must be applied to determine whether a low oxygen saturation is indicative of disease progression or severity or is habitual for a given patient (i.e., with underlying chronic lung disease).
NIV=non-invasive ventilation. CPAP= Continuous Positive Airway Pressure, BPAP= Bi-level Positive Airway Pressure, ECMO = extracorporeal membrane oxygenation.
Master Protocol Number: 1.1 dated 07 April 2021:
1.	Età &gt;=18 anni
2.	Infezione da SARS-CoV-2 (nuova infezione o reinfezione) determinata tramite analisi con PCR in qualsiasi campione biologico prelevato non oltre i 9 giorni.
3.	Ricovero in ospedale
4.	Firma del consenso informato del paziente o del suo rappresentante legale autorizzato.
5.	Stato della malattia severo/critico determinato da almeno uno dei seguenti parametri:
6.	SpO2&lt;90%
7.	SpO2 90-94% con un chiaro trend in calo associato a distress dei parametri respiratori.
8.	Necessità di ossigeno attraverso ventilazione non invasiva (CPAP, BIPAP)
9.	Necessità di ventilazione meccanica con ossigeno terapia
Baricitinib specific protocol v. 1.1 dated 07 April 2021:
1.	Età &gt;=18 anni
2.	Infezione da SARS-CoV-2 (nuova infezione o reinfezione) determinata tramite analisi con PCR in qualsiasi campione biologico prelevato non oltre i 9 giorni.
3.	Ricovero in ospedale
4.	Firma del consenso informato del paziente o del suo rappresentante legale autorizzato.
5.	Stato della malattia severo/critico determinato da almeno uno dei seguenti parametri:
6.	SpO2&lt;90%
7.	SpO2 90-94% con un chiaro trend in calo associato a distress dei parametri respiratori.
8.	Necessità di ossigeno attraverso ventilazione non invasiva (CPAP, BIPAP)
9.	Necessità di ventilazione meccanica con ossigeno terapia
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