Created at Source Raw Value Validated value
Oct. 14, 2021, 1:55 p.m. eu

The goals of this study are to assess the safety and efficacy of a single infusion of hIVIG in preventing further progression related to COVID-19 when administered early after diagnosis and symptom onset (if symptomatic), with a further aim to concurrently assess for more rapid resolution of illness and restoration of health status to the pre-illness state. There is as yet no consensus on the optimal endpoint for determining clinical benefit from COVID-19 therapies in the ambulatory care setting, including the constituent elements of the endpoint and the timing of its assessment after a given treatment. The primary endpoint is the participant’s clinical status through Day 7, as defined by five mutually exclusive categories on an ordinal scale: 1. Asymptomatic and no limitations in usual activity due to COVID-19 2. Mild COVID-19 illness or minor limitations to usual activity 3. Moderate COVID-19 illness and major limitations to usual activity 4. Severe COVID-19 or other serious disease manifestation 5. Critical illness from COVID-19 or Death

The goals of this study are to assess the safety and efficacy of a single infusion of hIVIG in preventing further progression related to COVID-19 when administered early after diagnosis and symptom onset (if symptomatic), with a further aim to concurrently assess for more rapid resolution of illness and restoration of health status to the pre-illness state. There is as yet no consensus on the optimal endpoint for determining clinical benefit from COVID-19 therapies in the ambulatory care setting, including the constituent elements of the endpoint and the timing of its assessment after a given treatment. The primary endpoint is the participant’s clinical status through Day 7, as defined by five mutually exclusive categories on an ordinal scale: 1. Asymptomatic and no limitations in usual activity due to COVID-19 2. Mild COVID-19 illness or minor limitations to usual activity 3. Moderate COVID-19 illness and major limitations to usual activity 4. Severe COVID-19 or other serious disease manifestation 5. Critical illness from COVID-19 or Death