Created at Source Raw Value Validated value
June 25, 2024, noon usa

* asymptomatic and had prior symptoms from the current infection that have now resolved (for \>24 hours). * asymptomatic and has received a vaccination for covid-19 (≥1 dose). * undergoing evaluation for possible admission to hospital for medical management (this does not include evaluation of possible hospitalization for public health purposes). * evidence of pneumonia and/or hypoxia due to covid-19 (note: chest imaging is not required, but if available it should not show new infiltrates suggestive of pneumonia; hypoxia is defined by new oxygen supplementation or increase above pre-illness level). * prior receipt of immunoglobulin product or passive immune therapy for sars-cov-2 in the past 90 days (i.e., convalescent plasma, sars-cov-2 monoclonal antibodies, or any ivig). * any of the following thrombotic or procoagulant conditions or disorders: 1. acute coronary syndrome, cerebrovascular syndrome, pulmonary embolism, or deep venous thrombosis within 28 days of randomization. 2. prothrombin gene mutation 20210, homozygous factor v leiden mutations, antiphospholipid syndrome, or a deficiency in antithrombin iii, protein c, or protein s. * history of hypersensitivity to blood, plasma or ivig excipients. * known immunoglobulin a (iga) deficiency or anti-iga antibodies. * in the opinion of the investigator, any condition for which participation would not be in the best interest of the participant or that could prevent or confound protocol assessments.

* asymptomatic and had prior symptoms from the current infection that have now resolved (for \>24 hours). * asymptomatic and has received a vaccination for covid-19 (≥1 dose). * undergoing evaluation for possible admission to hospital for medical management (this does not include evaluation of possible hospitalization for public health purposes). * evidence of pneumonia and/or hypoxia due to covid-19 (note: chest imaging is not required, but if available it should not show new infiltrates suggestive of pneumonia; hypoxia is defined by new oxygen supplementation or increase above pre-illness level). * prior receipt of immunoglobulin product or passive immune therapy for sars-cov-2 in the past 90 days (i.e., convalescent plasma, sars-cov-2 monoclonal antibodies, or any ivig). * any of the following thrombotic or procoagulant conditions or disorders: 1. acute coronary syndrome, cerebrovascular syndrome, pulmonary embolism, or deep venous thrombosis within 28 days of randomization. 2. prothrombin gene mutation 20210, homozygous factor v leiden mutations, antiphospholipid syndrome, or a deficiency in antithrombin iii, protein c, or protein s. * history of hypersensitivity to blood, plasma or ivig excipients. * known immunoglobulin a (iga) deficiency or anti-iga antibodies. * in the opinion of the investigator, any condition for which participation would not be in the best interest of the participant or that could prevent or confound protocol assessments.

Nov. 22, 2022, noon usa

asymptomatic and had prior symptoms from the current infection that have now resolved (for >24 hours). asymptomatic and has received a vaccination for covid-19 (≥1 dose). undergoing evaluation for possible admission to hospital for medical management (this does not include evaluation of possible hospitalization for public health purposes). evidence of pneumonia and/or hypoxia due to covid-19 (note: chest imaging is not required, but if available it should not show new infiltrates suggestive of pneumonia; hypoxia is defined by new oxygen supplementation or increase above pre-illness level). prior receipt of immunoglobulin product or passive immune therapy for sars-cov-2 in the past 90 days (i.e., convalescent plasma, sars-cov-2 monoclonal antibodies, or any ivig). any of the following thrombotic or procoagulant conditions or disorders: acute coronary syndrome, cerebrovascular syndrome, pulmonary embolism, or deep venous thrombosis within 28 days of randomization. prothrombin gene mutation 20210, homozygous factor v leiden mutations, antiphospholipid syndrome, or a deficiency in antithrombin iii, protein c, or protein s. history of hypersensitivity to blood, plasma or ivig excipients. known immunoglobulin a (iga) deficiency or anti-iga antibodies. in the opinion of the investigator, any condition for which participation would not be in the best interest of the participant or that could prevent or confound protocol assessments.

asymptomatic and had prior symptoms from the current infection that have now resolved (for >24 hours). asymptomatic and has received a vaccination for covid-19 (≥1 dose). undergoing evaluation for possible admission to hospital for medical management (this does not include evaluation of possible hospitalization for public health purposes). evidence of pneumonia and/or hypoxia due to covid-19 (note: chest imaging is not required, but if available it should not show new infiltrates suggestive of pneumonia; hypoxia is defined by new oxygen supplementation or increase above pre-illness level). prior receipt of immunoglobulin product or passive immune therapy for sars-cov-2 in the past 90 days (i.e., convalescent plasma, sars-cov-2 monoclonal antibodies, or any ivig). any of the following thrombotic or procoagulant conditions or disorders: acute coronary syndrome, cerebrovascular syndrome, pulmonary embolism, or deep venous thrombosis within 28 days of randomization. prothrombin gene mutation 20210, homozygous factor v leiden mutations, antiphospholipid syndrome, or a deficiency in antithrombin iii, protein c, or protein s. history of hypersensitivity to blood, plasma or ivig excipients. known immunoglobulin a (iga) deficiency or anti-iga antibodies. in the opinion of the investigator, any condition for which participation would not be in the best interest of the participant or that could prevent or confound protocol assessments.

Nov. 16, 2021, 6:30 p.m. usa

asymptomatic and had prior symptoms from the current infection that have now resolved (for >24 hours). asymptomatic and has received a vaccination for covid-19 (≥1 dose). undergoing evaluation for possible admission to hospital for medical management (this does not include evaluation of possible hospitalization for public health purposes). evidence of pneumonia and/or hypoxia due to covid-19 (note: chest imaging is not required, but if available it should not show new infiltrates suggestive of pneumonia; hypoxia is defined by new oxygen supplementation or increase above pre-illness level). prior receipt of immunoglobulin product or passive immune therapy for sars-cov-2 in the past 90 days (i.e., convalescent plasma, sars-cov-2 monoclonal antibodies, or any ivig). any of the following thrombotic or procoagulant conditions or disorders: acute coronary syndrome, cerebrovascular syndrome, pulmonary embolism, or deep venous thrombosis within 28 days of randomization. prothrombin gene mutation 20210, homozygous factor v leiden mutations, antiphospholipid syndrome, or a deficiency in antithrombin iii, protein c, or protein s. history of hypersensitivity to blood, plasma or ivig excipients. known iga deficiency or anti-iga antibodies. medical conditions for which receipt of a 300 ml volume of iv fluid from study treatment may pose specific risk to the patient (e.g., decompensated congestive heart failure). in the opinion of the investigator, any condition for which participation would not be in the best interest of the participant or that could prevent or confound protocol assessments.

asymptomatic and had prior symptoms from the current infection that have now resolved (for >24 hours). asymptomatic and has received a vaccination for covid-19 (≥1 dose). undergoing evaluation for possible admission to hospital for medical management (this does not include evaluation of possible hospitalization for public health purposes). evidence of pneumonia and/or hypoxia due to covid-19 (note: chest imaging is not required, but if available it should not show new infiltrates suggestive of pneumonia; hypoxia is defined by new oxygen supplementation or increase above pre-illness level). prior receipt of immunoglobulin product or passive immune therapy for sars-cov-2 in the past 90 days (i.e., convalescent plasma, sars-cov-2 monoclonal antibodies, or any ivig). any of the following thrombotic or procoagulant conditions or disorders: acute coronary syndrome, cerebrovascular syndrome, pulmonary embolism, or deep venous thrombosis within 28 days of randomization. prothrombin gene mutation 20210, homozygous factor v leiden mutations, antiphospholipid syndrome, or a deficiency in antithrombin iii, protein c, or protein s. history of hypersensitivity to blood, plasma or ivig excipients. known iga deficiency or anti-iga antibodies. medical conditions for which receipt of a 300 ml volume of iv fluid from study treatment may pose specific risk to the patient (e.g., decompensated congestive heart failure). in the opinion of the investigator, any condition for which participation would not be in the best interest of the participant or that could prevent or confound protocol assessments.

June 4, 2021, 12:32 a.m. usa

- asymptomatic and had prior symptoms from the current infection that have now resolved (for >24 hours). - asymptomatic and has received a vaccination for covid-19 (≥1 dose). - undergoing evaluation for possible admission to hospital for medical management (this does not include evaluation of possible hospitalization for public health purposes). - evidence of pneumonia and/or hypoxia due to covid-19 (note: chest imaging is not required, but if available it should not show new infiltrates suggestive of pneumonia; hypoxia is defined by new oxygen supplementation or increase above pre-illness level). - prior receipt of immunoglobulin product or passive immune therapy for sars-cov-2 in the past 90 days (i.e., convalescent plasma, sars-cov-2 monoclonal antibodies, or any ivig). - any of the following thrombotic or procoagulant conditions or disorders: 1. acute coronary syndrome, cerebrovascular syndrome, pulmonary embolism, or deep venous thrombosis within 28 days of randomization. 2. prothrombin gene mutation 20210, homozygous factor v leiden mutations, antiphospholipid syndrome, or a deficiency in antithrombin iii, protein c, or protein s. - history of hypersensitivity to blood, plasma or ivig excipients. - known iga deficiency or anti-iga antibodies. - medical conditions for which receipt of a 300 ml volume of iv fluid from study treatment may pose specific risk to the patient (e.g., decompensated congestive heart failure). - in the opinion of the investigator, any condition for which participation would not be in the best interest of the participant or that could prevent or confound protocol assessments.

- asymptomatic and had prior symptoms from the current infection that have now resolved (for >24 hours). - asymptomatic and has received a vaccination for covid-19 (≥1 dose). - undergoing evaluation for possible admission to hospital for medical management (this does not include evaluation of possible hospitalization for public health purposes). - evidence of pneumonia and/or hypoxia due to covid-19 (note: chest imaging is not required, but if available it should not show new infiltrates suggestive of pneumonia; hypoxia is defined by new oxygen supplementation or increase above pre-illness level). - prior receipt of immunoglobulin product or passive immune therapy for sars-cov-2 in the past 90 days (i.e., convalescent plasma, sars-cov-2 monoclonal antibodies, or any ivig). - any of the following thrombotic or procoagulant conditions or disorders: 1. acute coronary syndrome, cerebrovascular syndrome, pulmonary embolism, or deep venous thrombosis within 28 days of randomization. 2. prothrombin gene mutation 20210, homozygous factor v leiden mutations, antiphospholipid syndrome, or a deficiency in antithrombin iii, protein c, or protein s. - history of hypersensitivity to blood, plasma or ivig excipients. - known iga deficiency or anti-iga antibodies. - medical conditions for which receipt of a 300 ml volume of iv fluid from study treatment may pose specific risk to the patient (e.g., decompensated congestive heart failure). - in the opinion of the investigator, any condition for which participation would not be in the best interest of the participant or that could prevent or confound protocol assessments.