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                    <a href="?cresstrial=14963&amp;modal=1&amp;valnames=exclusion_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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            <tr class="histvalue-row" histvalueid="346399" class="table-">
                
                <td>Jan. 27, 2021, 1:30 a.m.</td>
                <td>eu</td>
                
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        <p class="exclusion_criteria">
            1. Patients with known or suspected hypersensitivity to hzVSF-v13 or to any of its excipients.
2. Active tuberculosis or suspected active bacterial, fungal, viral, or other infection (besides COVID-19).
3. Anti-rejection or immunomodulatory drugs within the past 3 months.
4. Absolute neutrophil count (ANC) &lt; 1000/µL at screening.
5. Platelet count &lt; 50,000/ µL at screening.
6. ALT or AST &gt; 5 x upper limit of normal (ULN) within 24 hours at screening.
7. Serum creatinine &gt; 2 mg/dL (&gt; 176.8 µmol/L) or estimated creatinine clearance &lt; 30 ml/min measured or calculated by Cockroft Gault equation.
8. Pregnancy or breastfeeding.
9. Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (approved/investigational COVID-19 antivirals and other off-label drugs recommended by local health authorities are permitted).
10. Patients who in the opinion of the treating physician should not participate in this program (ex: severe acute respiratory distress syndrome [ARDS], septicaemia).
1. Pazienti con nota o sospetta ipersensibilità a hzVSF-v13 o ad uno qualsiasi dei suoi eccipienti.
2. Tubercolosi in fase attiva o sospetta infezione batterica, micotica, virale o altra infezione attiva (oltre a COVID-19).
3. Farmaci anti-rigetto o immunomodulanti nei 3 mesi precedenti.
4. Conta assoluta dei neutrofili (Absolute Neutrophil Count – ANC) &lt; 1000/µL allo screening.
5. Conta piastrinica  &lt; 50,000/ µL allo screening.
6. ALT o AST &gt; 5x ULN (Upper Limit of Normal – limite superiore di normalità) entro 24 ore allo screening.
7. Creatinina sierica &gt; 2 mg/dL (&gt; 176.8 µmol/L) o clearance della creatinina &lt; 30 ml/min misurata o calcolata tramite l’equazione di Cockroft Gault.
8. Gravidanza o allattamento.
9. Trattamento con un farmaco sperimentale entro 5 emivite o 30 giorni (a seconda di quale dei due periodi sia più lungo) dalla randomizzazione (sono consentiti antivirali approvati/sperimentali per COVID-19 e altri farmaci off-label raccomandati dalle autorità sanitarie locali).
10.	Pazienti che, a giudizio del medico, non dovrebbero partecipare a questo programma (ad es. sindrome severa da distress respiratorio acuto [Acute Respiratory Distress Syndrome – ARDS], setticemia.
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        <p class="exclusion_criteria validated">
            1. Patients with known or suspected hypersensitivity to hzVSF-v13 or to any of its excipients.
2. Active tuberculosis or suspected active bacterial, fungal, viral, or other infection (besides COVID-19).
3. Anti-rejection or immunomodulatory drugs within the past 3 months.
4. Absolute neutrophil count (ANC) &lt; 1000/µL at screening.
5. Platelet count &lt; 50,000/ µL at screening.
6. ALT or AST &gt; 5 x upper limit of normal (ULN) within 24 hours at screening.
7. Serum creatinine &gt; 2 mg/dL (&gt; 176.8 µmol/L) or estimated creatinine clearance &lt; 30 ml/min measured or calculated by Cockroft Gault equation.
8. Pregnancy or breastfeeding.
9. Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (approved/investigational COVID-19 antivirals and other off-label drugs recommended by local health authorities are permitted).
10. Patients who in the opinion of the treating physician should not participate in this program (ex: severe acute respiratory distress syndrome [ARDS], septicaemia).
1. Pazienti con nota o sospetta ipersensibilità a hzVSF-v13 o ad uno qualsiasi dei suoi eccipienti.
2. Tubercolosi in fase attiva o sospetta infezione batterica, micotica, virale o altra infezione attiva (oltre a COVID-19).
3. Farmaci anti-rigetto o immunomodulanti nei 3 mesi precedenti.
4. Conta assoluta dei neutrofili (Absolute Neutrophil Count – ANC) &lt; 1000/µL allo screening.
5. Conta piastrinica  &lt; 50,000/ µL allo screening.
6. ALT o AST &gt; 5x ULN (Upper Limit of Normal – limite superiore di normalità) entro 24 ore allo screening.
7. Creatinina sierica &gt; 2 mg/dL (&gt; 176.8 µmol/L) o clearance della creatinina &lt; 30 ml/min misurata o calcolata tramite l’equazione di Cockroft Gault.
8. Gravidanza o allattamento.
9. Trattamento con un farmaco sperimentale entro 5 emivite o 30 giorni (a seconda di quale dei due periodi sia più lungo) dalla randomizzazione (sono consentiti antivirali approvati/sperimentali per COVID-19 e altri farmaci off-label raccomandati dalle autorità sanitarie locali).
10.	Pazienti che, a giudizio del medico, non dovrebbero partecipare a questo programma (ad es. sindrome severa da distress respiratorio acuto [Acute Respiratory Distress Syndrome – ARDS], setticemia.
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