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                <th scope="col">
                    <a href="?cresstrial=14591&amp;modal=1&amp;valnames=primary_outcome&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>
            </tr>
        </thead>
        <tbody>
            
            <tr class="histvalue-row" histvalueid="347260" class="table-">
                
                <td>Feb. 12, 2021, 1:30 a.m.</td>
                <td>eu</td>
                
                <td class="histvalue-container">
                    

        <p class="primary_outcome">
            For end-of-part-1 interim analysis:
For safety analysis intended to facilitate recruitment for part 2, time frame – up to 28 days:
Safety and tolerability to BIO101:
• SUSARs, SAEs, AESIs, AEs
• Vital signs
• Safety labs (including testicular biomarkers)
• ECGs
For interim analysis intended to obtain indication of activity of BIO101, time frame – up to 28 days:
Primary:
• Proportion of participants with ‘negative’ events, of either of the following:
o All-cause mortality
o Respiratory failure, defined as any of the following:
- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
- Requiring ECMO
Secondary:
• SpO2/FiO2
• Inflammatory markers including:
o IL 6
o TNFα
o D-dimer
• RAS / MAS biomarkers:
o Angiotensin 2
o Angiotensin 1-7 (Ang (1-7)
o Angiotensin 1-5 (Ang 1-5)
o Angiotensin 1
o Angiotensin-converting enzyme 2(ACE2) levels and activity
For part-2 sample size interim analysis:
For sample size re-assessment for part 2, time frame – up to 28 days:
• Proportion of participants with ‘negative’ events, of either of the following:
o All-cause mortality
o Respiratory failure, defined as any of the following:
- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
- Requiring ECMO
For the final analysis:
Primary, time frame – up to 28 days:
• Proportion of participants with ‘negative’ events, of either of the following:
o All-cause mortality
o Respiratory failure, defined as any of the following:
- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
- Requiring ECMO
        </p>
    

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

        <p class="primary_outcome validated">
            For end-of-part-1 interim analysis:
For safety analysis intended to facilitate recruitment for part 2, time frame – up to 28 days:
Safety and tolerability to BIO101:
• SUSARs, SAEs, AESIs, AEs
• Vital signs
• Safety labs (including testicular biomarkers)
• ECGs
For interim analysis intended to obtain indication of activity of BIO101, time frame – up to 28 days:
Primary:
• Proportion of participants with ‘negative’ events, of either of the following:
o All-cause mortality
o Respiratory failure, defined as any of the following:
- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
- Requiring ECMO
Secondary:
• SpO2/FiO2
• Inflammatory markers including:
o IL 6
o TNFα
o D-dimer
• RAS / MAS biomarkers:
o Angiotensin 2
o Angiotensin 1-7 (Ang (1-7)
o Angiotensin 1-5 (Ang 1-5)
o Angiotensin 1
o Angiotensin-converting enzyme 2(ACE2) levels and activity
For part-2 sample size interim analysis:
For sample size re-assessment for part 2, time frame – up to 28 days:
• Proportion of participants with ‘negative’ events, of either of the following:
o All-cause mortality
o Respiratory failure, defined as any of the following:
- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
- Requiring ECMO
For the final analysis:
Primary, time frame – up to 28 days:
• Proportion of participants with ‘negative’ events, of either of the following:
o All-cause mortality
o Respiratory failure, defined as any of the following:
- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
- Requiring ECMO
        </p>
        
    
                </td>
            </tr>
            
            <tr class="histvalue-row" histvalueid="344791" class="table-">
                
                <td>Dec. 15, 2020, 1:30 a.m.</td>
                <td>eu</td>
                
                <td class="histvalue-container">
                    

        <p class="primary_outcome">
            For end-of-part-1 interim analysis:
For safety analysis intended to facilitate recruitment for part 2, time frame – up to 28 days:
Safety and tolerability to BIO101:
• SUSARs, SAEs, AESIs, AEs
• Vital signs
• Safety labs (including testicular biomarkers)
• ECGs
For interim analysis intended to obtain indication of activity of BIO101, time frame – up to 28 days:
Primary:
• Proportion of participants with ‘negative’ events, of either of the following:
o All-cause mortality
o Respiratory failure, defined as any of the following:
- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
- Requiring ECMO
- Requiring high-flow oxygen
Secondary:
• SpO2/FiO2
• Inflammatory markers including:
o IL 6
o TNFα
o D-dimer
• RAS / MAS biomarkers:
o Angiotensin 2
o Angiotensin-converting enzyme (ACE) levels
For part-2 sample size interim analysis:
For sample size re-assessment for part 2, time frame – up to 28 days:
• Proportion of participants with ‘negative’ events, of either of the following:
o All-cause mortality
o Respiratory failure, defined as any of the following:
- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
- Requiring ECMO
- Requiring high-flow oxygen
For the final analysis:
Primary, time frame – up to 28 days:
• Proportion of participants with ‘negative’ events, of either of the following:
o All-cause mortality
o Respiratory failure, defined as any of the following:
- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
- Requiring ECMO
- Requiring high-flow oxygen
        </p>
    

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

        <p class="primary_outcome validated">
            For end-of-part-1 interim analysis:
For safety analysis intended to facilitate recruitment for part 2, time frame – up to 28 days:
Safety and tolerability to BIO101:
• SUSARs, SAEs, AESIs, AEs
• Vital signs
• Safety labs (including testicular biomarkers)
• ECGs
For interim analysis intended to obtain indication of activity of BIO101, time frame – up to 28 days:
Primary:
• Proportion of participants with ‘negative’ events, of either of the following:
o All-cause mortality
o Respiratory failure, defined as any of the following:
- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
- Requiring ECMO
- Requiring high-flow oxygen
Secondary:
• SpO2/FiO2
• Inflammatory markers including:
o IL 6
o TNFα
o D-dimer
• RAS / MAS biomarkers:
o Angiotensin 2
o Angiotensin-converting enzyme (ACE) levels
For part-2 sample size interim analysis:
For sample size re-assessment for part 2, time frame – up to 28 days:
• Proportion of participants with ‘negative’ events, of either of the following:
o All-cause mortality
o Respiratory failure, defined as any of the following:
- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
- Requiring ECMO
- Requiring high-flow oxygen
For the final analysis:
Primary, time frame – up to 28 days:
• Proportion of participants with ‘negative’ events, of either of the following:
o All-cause mortality
o Respiratory failure, defined as any of the following:
- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
- Requiring ECMO
- Requiring high-flow oxygen
        </p>
        
    
                </td>
            </tr>
            
            <tr class="histvalue-row" histvalueid="334222" class="table-">
                
                <td>Oct. 26, 2020, 7:26 a.m.</td>
                <td>eu</td>
                
                <td class="histvalue-container">
                    

        <p class="primary_outcome">
            For end-of-part-1 interim analysis:
For safety analysis intended to facilitate the decision to begin part 2, time frame – up to 28 days:
Safety and tolerability to BIO101:
• SUSARs, SAEs, AESIs, AEs
• Vital signs
• Safety labs (including testicular biomarkers)
• ECGs
For interim analysis intended to obtain indication of activity of BIO101, time frame – up to 28 days:
Primary:
• Proportion of participants with ‘negative’ events, of either of the following:
o All-cause mortality
o Respiratory failure, defined as any of the following:
- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
- Requiring ECMO
- Requiring high-flow oxygen
Secondary:
• SpO2/FiO2
• Inflammatory markers including:
o IL 6
o TNFα
o D-dimer
• RAS / MAS biomarkers:
o Angiotensin 2
o Angiotensin-converting enzyme (ACE) levels
For part-2 sample size interim analysis:
For sample size re-assessment for part 2, time frame – up to 28 days:
• Proportion of participants with ‘negative’ events, of either of the following:
o All-cause mortality
o Respiratory failure, defined as any of the following:
- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
- Requiring ECMO
- Requiring high-flow oxygen
For the final analysis:
Primary, time frame – up to 28 days:
• Proportion of participants with ‘negative’ events, of either of the following:
o All-cause mortality
o Respiratory failure, defined as any of the following:
- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
- Requiring ECMO
- Requiring high-flow oxygen
        </p>
    

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

        <p class="primary_outcome validated">
            For end-of-part-1 interim analysis:
For safety analysis intended to facilitate the decision to begin part 2, time frame – up to 28 days:
Safety and tolerability to BIO101:
• SUSARs, SAEs, AESIs, AEs
• Vital signs
• Safety labs (including testicular biomarkers)
• ECGs
For interim analysis intended to obtain indication of activity of BIO101, time frame – up to 28 days:
Primary:
• Proportion of participants with ‘negative’ events, of either of the following:
o All-cause mortality
o Respiratory failure, defined as any of the following:
- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
- Requiring ECMO
- Requiring high-flow oxygen
Secondary:
• SpO2/FiO2
• Inflammatory markers including:
o IL 6
o TNFα
o D-dimer
• RAS / MAS biomarkers:
o Angiotensin 2
o Angiotensin-converting enzyme (ACE) levels
For part-2 sample size interim analysis:
For sample size re-assessment for part 2, time frame – up to 28 days:
• Proportion of participants with ‘negative’ events, of either of the following:
o All-cause mortality
o Respiratory failure, defined as any of the following:
- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
- Requiring ECMO
- Requiring high-flow oxygen
For the final analysis:
Primary, time frame – up to 28 days:
• Proportion of participants with ‘negative’ events, of either of the following:
o All-cause mortality
o Respiratory failure, defined as any of the following:
- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
- Requiring ECMO
- Requiring high-flow oxygen
        </p>
        
    
                </td>
            </tr>
            
        </tbody>
    </table>
</div>
Created at	Source	Raw Value	Validated value
Feb. 12, 2021, 1:30 a.m.	eu	For end-of-part-1 interim analysis: For safety analysis intended to facilitate recruitment for part 2, time frame – up to 28 days: Safety and tolerability to BIO101: • SUSARs, SAEs, AESIs, AEs • Vital signs • Safety labs (including testicular biomarkers) • ECGs For interim analysis intended to obtain indication of activity of BIO101, time frame – up to 28 days: Primary: • Proportion of participants with ‘negative’ events, of either of the following: o All-cause mortality o Respiratory failure, defined as any of the following: - Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) - Requiring ECMO Secondary: • SpO2/FiO2 • Inflammatory markers including: o IL 6 o TNFα o D-dimer • RAS / MAS biomarkers: o Angiotensin 2 o Angiotensin 1-7 (Ang (1-7) o Angiotensin 1-5 (Ang 1-5) o Angiotensin 1 o Angiotensin-converting enzyme 2(ACE2) levels and activity For part-2 sample size interim analysis: For sample size re-assessment for part 2, time frame – up to 28 days: • Proportion of participants with ‘negative’ events, of either of the following: o All-cause mortality o Respiratory failure, defined as any of the following: - Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) - Requiring ECMO For the final analysis: Primary, time frame – up to 28 days: • Proportion of participants with ‘negative’ events, of either of the following: o All-cause mortality o Respiratory failure, defined as any of the following: - Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) - Requiring ECMO	For end-of-part-1 interim analysis: For safety analysis intended to facilitate recruitment for part 2, time frame – up to 28 days: Safety and tolerability to BIO101: • SUSARs, SAEs, AESIs, AEs • Vital signs • Safety labs (including testicular biomarkers) • ECGs For interim analysis intended to obtain indication of activity of BIO101, time frame – up to 28 days: Primary: • Proportion of participants with ‘negative’ events, of either of the following: o All-cause mortality o Respiratory failure, defined as any of the following: - Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) - Requiring ECMO Secondary: • SpO2/FiO2 • Inflammatory markers including: o IL 6 o TNFα o D-dimer • RAS / MAS biomarkers: o Angiotensin 2 o Angiotensin 1-7 (Ang (1-7) o Angiotensin 1-5 (Ang 1-5) o Angiotensin 1 o Angiotensin-converting enzyme 2(ACE2) levels and activity For part-2 sample size interim analysis: For sample size re-assessment for part 2, time frame – up to 28 days: • Proportion of participants with ‘negative’ events, of either of the following: o All-cause mortality o Respiratory failure, defined as any of the following: - Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) - Requiring ECMO For the final analysis: Primary, time frame – up to 28 days: • Proportion of participants with ‘negative’ events, of either of the following: o All-cause mortality o Respiratory failure, defined as any of the following: - Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) - Requiring ECMO
Dec. 15, 2020, 1:30 a.m.	eu	For end-of-part-1 interim analysis: For safety analysis intended to facilitate recruitment for part 2, time frame – up to 28 days: Safety and tolerability to BIO101: • SUSARs, SAEs, AESIs, AEs • Vital signs • Safety labs (including testicular biomarkers) • ECGs For interim analysis intended to obtain indication of activity of BIO101, time frame – up to 28 days: Primary: • Proportion of participants with ‘negative’ events, of either of the following: o All-cause mortality o Respiratory failure, defined as any of the following: - Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) - Requiring ECMO - Requiring high-flow oxygen Secondary: • SpO2/FiO2 • Inflammatory markers including: o IL 6 o TNFα o D-dimer • RAS / MAS biomarkers: o Angiotensin 2 o Angiotensin-converting enzyme (ACE) levels For part-2 sample size interim analysis: For sample size re-assessment for part 2, time frame – up to 28 days: • Proportion of participants with ‘negative’ events, of either of the following: o All-cause mortality o Respiratory failure, defined as any of the following: - Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) - Requiring ECMO - Requiring high-flow oxygen For the final analysis: Primary, time frame – up to 28 days: • Proportion of participants with ‘negative’ events, of either of the following: o All-cause mortality o Respiratory failure, defined as any of the following: - Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) - Requiring ECMO - Requiring high-flow oxygen	For end-of-part-1 interim analysis: For safety analysis intended to facilitate recruitment for part 2, time frame – up to 28 days: Safety and tolerability to BIO101: • SUSARs, SAEs, AESIs, AEs • Vital signs • Safety labs (including testicular biomarkers) • ECGs For interim analysis intended to obtain indication of activity of BIO101, time frame – up to 28 days: Primary: • Proportion of participants with ‘negative’ events, of either of the following: o All-cause mortality o Respiratory failure, defined as any of the following: - Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) - Requiring ECMO - Requiring high-flow oxygen Secondary: • SpO2/FiO2 • Inflammatory markers including: o IL 6 o TNFα o D-dimer • RAS / MAS biomarkers: o Angiotensin 2 o Angiotensin-converting enzyme (ACE) levels For part-2 sample size interim analysis: For sample size re-assessment for part 2, time frame – up to 28 days: • Proportion of participants with ‘negative’ events, of either of the following: o All-cause mortality o Respiratory failure, defined as any of the following: - Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) - Requiring ECMO - Requiring high-flow oxygen For the final analysis: Primary, time frame – up to 28 days: • Proportion of participants with ‘negative’ events, of either of the following: o All-cause mortality o Respiratory failure, defined as any of the following: - Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) - Requiring ECMO - Requiring high-flow oxygen
Oct. 26, 2020, 7:26 a.m.	eu	For end-of-part-1 interim analysis: For safety analysis intended to facilitate the decision to begin part 2, time frame – up to 28 days: Safety and tolerability to BIO101: • SUSARs, SAEs, AESIs, AEs • Vital signs • Safety labs (including testicular biomarkers) • ECGs For interim analysis intended to obtain indication of activity of BIO101, time frame – up to 28 days: Primary: • Proportion of participants with ‘negative’ events, of either of the following: o All-cause mortality o Respiratory failure, defined as any of the following: - Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) - Requiring ECMO - Requiring high-flow oxygen Secondary: • SpO2/FiO2 • Inflammatory markers including: o IL 6 o TNFα o D-dimer • RAS / MAS biomarkers: o Angiotensin 2 o Angiotensin-converting enzyme (ACE) levels For part-2 sample size interim analysis: For sample size re-assessment for part 2, time frame – up to 28 days: • Proportion of participants with ‘negative’ events, of either of the following: o All-cause mortality o Respiratory failure, defined as any of the following: - Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) - Requiring ECMO - Requiring high-flow oxygen For the final analysis: Primary, time frame – up to 28 days: • Proportion of participants with ‘negative’ events, of either of the following: o All-cause mortality o Respiratory failure, defined as any of the following: - Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) - Requiring ECMO - Requiring high-flow oxygen	For end-of-part-1 interim analysis: For safety analysis intended to facilitate the decision to begin part 2, time frame – up to 28 days: Safety and tolerability to BIO101: • SUSARs, SAEs, AESIs, AEs • Vital signs • Safety labs (including testicular biomarkers) • ECGs For interim analysis intended to obtain indication of activity of BIO101, time frame – up to 28 days: Primary: • Proportion of participants with ‘negative’ events, of either of the following: o All-cause mortality o Respiratory failure, defined as any of the following: - Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) - Requiring ECMO - Requiring high-flow oxygen Secondary: • SpO2/FiO2 • Inflammatory markers including: o IL 6 o TNFα o D-dimer • RAS / MAS biomarkers: o Angiotensin 2 o Angiotensin-converting enzyme (ACE) levels For part-2 sample size interim analysis: For sample size re-assessment for part 2, time frame – up to 28 days: • Proportion of participants with ‘negative’ events, of either of the following: o All-cause mortality o Respiratory failure, defined as any of the following: - Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) - Requiring ECMO - Requiring high-flow oxygen For the final analysis: Primary, time frame – up to 28 days: • Proportion of participants with ‘negative’ events, of either of the following: o All-cause mortality o Respiratory failure, defined as any of the following: - Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) - Requiring ECMO - Requiring high-flow oxygen