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                    <a href="?cresstrial=2355&amp;modal=1&amp;valnames=primary_outcome&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>June 23, 2021, 1:30 a.m.</td>
                <td>usa</td>
                
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        <p class="primary_outcome">
            Number of Subjects with Adverse Events (AEs) post-dosing;Number of Subjects with Adverse Events that Led to Discontinuation or Temporary Suspension of IV Infusion;Number of Subjects with AEs after IV Infusion;Number of Subjects with SAEs after IV Infusion;Pharmacokinetics parameter of apparent terminal elimination half-life after dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of SARS-CoV-2 antibodies plus the additional area extrapolated to infinity (AUC0-inf) after dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to 14 days (AUC0-14d) after dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to 28 days (AUC0-28d) after dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of SARS-CoV-2 antibodies after dose of COVID-HIGIV;Pharmacokinetics parameter of maximum observed concentration (Cmax) of SARS-CoV-2 antibodies observed after dose of COVID-HIGIV;Pharmacokinetics parameter of systemic clearance after dose of COVID-HIGIV;Pharmacokinetics parameter of terminal elimination constant after dose of COVID-HIGIV;Pharmacokinetics parameter of time at which Cmax occurs after dose of COVID-HIGIV;Pharmacokinetics parameter of trough concentration of SARS-CoV-2 antibodies observed 28 days after dose (Cmin28d) of COVID-HIGIV;Pharmacokinetics parameter of volume of distribution after dose of COVID-HIGIV
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        <p class="primary_outcome validated">
            Number of Subjects with Adverse Events (AEs) post-dosing;Number of Subjects with Adverse Events that Led to Discontinuation or Temporary Suspension of IV Infusion;Number of Subjects with AEs after IV Infusion;Number of Subjects with SAEs after IV Infusion;Pharmacokinetics parameter of apparent terminal elimination half-life after dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of SARS-CoV-2 antibodies plus the additional area extrapolated to infinity (AUC0-inf) after dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to 14 days (AUC0-14d) after dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to 28 days (AUC0-28d) after dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of SARS-CoV-2 antibodies after dose of COVID-HIGIV;Pharmacokinetics parameter of maximum observed concentration (Cmax) of SARS-CoV-2 antibodies observed after dose of COVID-HIGIV;Pharmacokinetics parameter of systemic clearance after dose of COVID-HIGIV;Pharmacokinetics parameter of terminal elimination constant after dose of COVID-HIGIV;Pharmacokinetics parameter of time at which Cmax occurs after dose of COVID-HIGIV;Pharmacokinetics parameter of trough concentration of SARS-CoV-2 antibodies observed 28 days after dose (Cmin28d) of COVID-HIGIV;Pharmacokinetics parameter of volume of distribution after dose of COVID-HIGIV
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            <tr class="histvalue-row" histvalueid="76803" class="table-">
                
                <td>Dec. 12, 2020, 12:31 a.m.</td>
                <td>usa</td>
                
                <td class="histvalue-container">
                    

        <p class="primary_outcome">
            Number of Subjects with Adverse Events that Led to Discontinuation or Temporary Suspension of IV Infusion;Pharmacokinetics parameter of volume of distribution after a single dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to 14 days (AUC0-14d) after initial and repeat dose of COVID-HIGIV;Pharmacokinetics parameter of systemic clearance after a single dose of COVID-HIGIV;Number of Subjects with Adverse Events (AEs) post-dosing;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to 28 days (AUC0-28d) after initial and repeat dose of COVID-HIGIV;Pharmacokinetics parameter of apparent terminal elimination half-life after a single dose of COVID-HIGIV;Number of Subjects with SAEs after a Single IV Infusion;Pharmacokinetics parameter of terminal elimination constant after a single dose of COVID-HIGIV;Number of Subjects with AEs after a Single IV Infusion;Number of Subjects with SAEs after a Repeat IV infusion;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to 14 days (AUC0-14d) after a single dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of SARS-CoV-2 antibodies plus the additional area extrapolated to infinity (AUC0-inf) after a single dose of COVID-HIGIV;Number of Subjects with AEs after a Repeat IV Infusion;Pharmacokinetics parameter of trough concentration of SARS-CoV-2 antibodies observed 28 days after a single dose (Cmin28d) of COVID-HIGIV;Pharmacokinetics parameter of maximum observed concentration (Cmax) of SARS-CoV-2 antibodies observed after initial dose and repeat dose of COVID-HIGIV.;Pharmacokinetics parameter of time at which Cmax occurs after a single dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of SARS-CoV-2 antibodies after a single dose of COVID-HIGIV;Pharmacokinetics parameter of maximum observed concentration (Cmax) of SARS-CoV-2 antibodies observed after a single dose of COVID-HIGIV;Pharmacokinetics parameter of time at which Cmax occurs after initial and repeat dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to 28 days (AUC0-28d) after a single dose of COVID-HIGIV;Pharmacokinetics parameter of trough concentration of SARS-CoV-2 antibodies observed 28 days after initial and repeat dose of COVID-HIGIV;Pharmacokinetics parameter of accumulation ratios after repeat dose over initial dose of COVID-HIGIV
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        <p class="primary_outcome validated">
            Number of Subjects with Adverse Events that Led to Discontinuation or Temporary Suspension of IV Infusion;Pharmacokinetics parameter of volume of distribution after a single dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to 14 days (AUC0-14d) after initial and repeat dose of COVID-HIGIV;Pharmacokinetics parameter of systemic clearance after a single dose of COVID-HIGIV;Number of Subjects with Adverse Events (AEs) post-dosing;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to 28 days (AUC0-28d) after initial and repeat dose of COVID-HIGIV;Pharmacokinetics parameter of apparent terminal elimination half-life after a single dose of COVID-HIGIV;Number of Subjects with SAEs after a Single IV Infusion;Pharmacokinetics parameter of terminal elimination constant after a single dose of COVID-HIGIV;Number of Subjects with AEs after a Single IV Infusion;Number of Subjects with SAEs after a Repeat IV infusion;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to 14 days (AUC0-14d) after a single dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of SARS-CoV-2 antibodies plus the additional area extrapolated to infinity (AUC0-inf) after a single dose of COVID-HIGIV;Number of Subjects with AEs after a Repeat IV Infusion;Pharmacokinetics parameter of trough concentration of SARS-CoV-2 antibodies observed 28 days after a single dose (Cmin28d) of COVID-HIGIV;Pharmacokinetics parameter of maximum observed concentration (Cmax) of SARS-CoV-2 antibodies observed after initial dose and repeat dose of COVID-HIGIV.;Pharmacokinetics parameter of time at which Cmax occurs after a single dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of SARS-CoV-2 antibodies after a single dose of COVID-HIGIV;Pharmacokinetics parameter of maximum observed concentration (Cmax) of SARS-CoV-2 antibodies observed after a single dose of COVID-HIGIV;Pharmacokinetics parameter of time at which Cmax occurs after initial and repeat dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to 28 days (AUC0-28d) after a single dose of COVID-HIGIV;Pharmacokinetics parameter of trough concentration of SARS-CoV-2 antibodies observed 28 days after initial and repeat dose of COVID-HIGIV;Pharmacokinetics parameter of accumulation ratios after repeat dose over initial dose of COVID-HIGIV
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Created at	Source	Raw Value	Validated value
June 23, 2021, 1:30 a.m.	usa	Number of Subjects with Adverse Events (AEs) post-dosing;Number of Subjects with Adverse Events that Led to Discontinuation or Temporary Suspension of IV Infusion;Number of Subjects with AEs after IV Infusion;Number of Subjects with SAEs after IV Infusion;Pharmacokinetics parameter of apparent terminal elimination half-life after dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of SARS-CoV-2 antibodies plus the additional area extrapolated to infinity (AUC0-inf) after dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to 14 days (AUC0-14d) after dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to 28 days (AUC0-28d) after dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of SARS-CoV-2 antibodies after dose of COVID-HIGIV;Pharmacokinetics parameter of maximum observed concentration (Cmax) of SARS-CoV-2 antibodies observed after dose of COVID-HIGIV;Pharmacokinetics parameter of systemic clearance after dose of COVID-HIGIV;Pharmacokinetics parameter of terminal elimination constant after dose of COVID-HIGIV;Pharmacokinetics parameter of time at which Cmax occurs after dose of COVID-HIGIV;Pharmacokinetics parameter of trough concentration of SARS-CoV-2 antibodies observed 28 days after dose (Cmin28d) of COVID-HIGIV;Pharmacokinetics parameter of volume of distribution after dose of COVID-HIGIV	Number of Subjects with Adverse Events (AEs) post-dosing;Number of Subjects with Adverse Events that Led to Discontinuation or Temporary Suspension of IV Infusion;Number of Subjects with AEs after IV Infusion;Number of Subjects with SAEs after IV Infusion;Pharmacokinetics parameter of apparent terminal elimination half-life after dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of SARS-CoV-2 antibodies plus the additional area extrapolated to infinity (AUC0-inf) after dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to 14 days (AUC0-14d) after dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to 28 days (AUC0-28d) after dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of SARS-CoV-2 antibodies after dose of COVID-HIGIV;Pharmacokinetics parameter of maximum observed concentration (Cmax) of SARS-CoV-2 antibodies observed after dose of COVID-HIGIV;Pharmacokinetics parameter of systemic clearance after dose of COVID-HIGIV;Pharmacokinetics parameter of terminal elimination constant after dose of COVID-HIGIV;Pharmacokinetics parameter of time at which Cmax occurs after dose of COVID-HIGIV;Pharmacokinetics parameter of trough concentration of SARS-CoV-2 antibodies observed 28 days after dose (Cmin28d) of COVID-HIGIV;Pharmacokinetics parameter of volume of distribution after dose of COVID-HIGIV
Dec. 12, 2020, 12:31 a.m.	usa	Number of Subjects with Adverse Events that Led to Discontinuation or Temporary Suspension of IV Infusion;Pharmacokinetics parameter of volume of distribution after a single dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to 14 days (AUC0-14d) after initial and repeat dose of COVID-HIGIV;Pharmacokinetics parameter of systemic clearance after a single dose of COVID-HIGIV;Number of Subjects with Adverse Events (AEs) post-dosing;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to 28 days (AUC0-28d) after initial and repeat dose of COVID-HIGIV;Pharmacokinetics parameter of apparent terminal elimination half-life after a single dose of COVID-HIGIV;Number of Subjects with SAEs after a Single IV Infusion;Pharmacokinetics parameter of terminal elimination constant after a single dose of COVID-HIGIV;Number of Subjects with AEs after a Single IV Infusion;Number of Subjects with SAEs after a Repeat IV infusion;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to 14 days (AUC0-14d) after a single dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of SARS-CoV-2 antibodies plus the additional area extrapolated to infinity (AUC0-inf) after a single dose of COVID-HIGIV;Number of Subjects with AEs after a Repeat IV Infusion;Pharmacokinetics parameter of trough concentration of SARS-CoV-2 antibodies observed 28 days after a single dose (Cmin28d) of COVID-HIGIV;Pharmacokinetics parameter of maximum observed concentration (Cmax) of SARS-CoV-2 antibodies observed after initial dose and repeat dose of COVID-HIGIV.;Pharmacokinetics parameter of time at which Cmax occurs after a single dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of SARS-CoV-2 antibodies after a single dose of COVID-HIGIV;Pharmacokinetics parameter of maximum observed concentration (Cmax) of SARS-CoV-2 antibodies observed after a single dose of COVID-HIGIV;Pharmacokinetics parameter of time at which Cmax occurs after initial and repeat dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to 28 days (AUC0-28d) after a single dose of COVID-HIGIV;Pharmacokinetics parameter of trough concentration of SARS-CoV-2 antibodies observed 28 days after initial and repeat dose of COVID-HIGIV;Pharmacokinetics parameter of accumulation ratios after repeat dose over initial dose of COVID-HIGIV	Number of Subjects with Adverse Events that Led to Discontinuation or Temporary Suspension of IV Infusion;Pharmacokinetics parameter of volume of distribution after a single dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to 14 days (AUC0-14d) after initial and repeat dose of COVID-HIGIV;Pharmacokinetics parameter of systemic clearance after a single dose of COVID-HIGIV;Number of Subjects with Adverse Events (AEs) post-dosing;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to 28 days (AUC0-28d) after initial and repeat dose of COVID-HIGIV;Pharmacokinetics parameter of apparent terminal elimination half-life after a single dose of COVID-HIGIV;Number of Subjects with SAEs after a Single IV Infusion;Pharmacokinetics parameter of terminal elimination constant after a single dose of COVID-HIGIV;Number of Subjects with AEs after a Single IV Infusion;Number of Subjects with SAEs after a Repeat IV infusion;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to 14 days (AUC0-14d) after a single dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of SARS-CoV-2 antibodies plus the additional area extrapolated to infinity (AUC0-inf) after a single dose of COVID-HIGIV;Number of Subjects with AEs after a Repeat IV Infusion;Pharmacokinetics parameter of trough concentration of SARS-CoV-2 antibodies observed 28 days after a single dose (Cmin28d) of COVID-HIGIV;Pharmacokinetics parameter of maximum observed concentration (Cmax) of SARS-CoV-2 antibodies observed after initial dose and repeat dose of COVID-HIGIV.;Pharmacokinetics parameter of time at which Cmax occurs after a single dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of SARS-CoV-2 antibodies after a single dose of COVID-HIGIV;Pharmacokinetics parameter of maximum observed concentration (Cmax) of SARS-CoV-2 antibodies observed after a single dose of COVID-HIGIV;Pharmacokinetics parameter of time at which Cmax occurs after initial and repeat dose of COVID-HIGIV;Pharmacokinetics parameter of area under the concentration-time curve (AUC) from time 0 to 28 days (AUC0-28d) after a single dose of COVID-HIGIV;Pharmacokinetics parameter of trough concentration of SARS-CoV-2 antibodies observed 28 days after initial and repeat dose of COVID-HIGIV;Pharmacokinetics parameter of accumulation ratios after repeat dose over initial dose of COVID-HIGIV