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

* prior receipt of sars-cov-2 hivig or convalescent plasma from a person who recovered from covid-19 at any time * prior receipt of standard ivig (not hyperimmune to sars-cov-2) within 45 days * current or predicted imminent (within 24 hours) requirement for any of the following: 1. invasive ventilation 2. non-invasive ventilation 3. extracorporeal membrane oxygenation 4. mechanical circulatory support 5. continuous vasopressor therapy * history of allergy to ivig or plasma products * history of selective iga deficiency with documented presence of anti-iga antibodies * any medical conditions for which receipt of the required volume of intravenous fluid may be dangerous to the patient (includes new york association class iii or iv stage heart failure) * any of the following thrombotic or procoagulant disorders: 1. acute coronary syndromes, cerebrovascular syndromes and pulmonary or deep venous thrombosis within 28 days of randomization 2. history of prothrombin gene mutation 20210, homozygous factor v leiden mutations, antithrombin iii deficiency, protein c deficiency, protein s deficiency or antiphospholipid syndrome * any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments

* prior receipt of sars-cov-2 hivig or convalescent plasma from a person who recovered from covid-19 at any time * prior receipt of standard ivig (not hyperimmune to sars-cov-2) within 45 days * current or predicted imminent (within 24 hours) requirement for any of the following: 1. invasive ventilation 2. non-invasive ventilation 3. extracorporeal membrane oxygenation 4. mechanical circulatory support 5. continuous vasopressor therapy * history of allergy to ivig or plasma products * history of selective iga deficiency with documented presence of anti-iga antibodies * any medical conditions for which receipt of the required volume of intravenous fluid may be dangerous to the patient (includes new york association class iii or iv stage heart failure) * any of the following thrombotic or procoagulant disorders: 1. acute coronary syndromes, cerebrovascular syndromes and pulmonary or deep venous thrombosis within 28 days of randomization 2. history of prothrombin gene mutation 20210, homozygous factor v leiden mutations, antithrombin iii deficiency, protein c deficiency, protein s deficiency or antiphospholipid syndrome * any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments

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

prior receipt of sars-cov-2 hivig or convalescent plasma from a person who recovered from covid-19 at any time prior receipt of standard ivig (not hyperimmune to sars-cov-2) within 45 days current or predicted imminent (within 24 hours) requirement for any of the following: invasive ventilation non-invasive ventilation extracorporeal membrane oxygenation mechanical circulatory support continuous vasopressor therapy history of allergy to ivig or plasma products history of selective iga deficiency with documented presence of anti-iga antibodies any medical conditions for which receipt of the required volume of intravenous fluid may be dangerous to the patient (includes new york association class iii or iv stage heart failure) any of the following thrombotic or procoagulant disorders: acute coronary syndromes, cerebrovascular syndromes and pulmonary or deep venous thrombosis within 28 days of randomization history of prothrombin gene mutation 20210, homozygous factor v leiden mutations, antithrombin iii deficiency, protein c deficiency, protein s deficiency or antiphospholipid syndrome any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments

prior receipt of sars-cov-2 hivig or convalescent plasma from a person who recovered from covid-19 at any time prior receipt of standard ivig (not hyperimmune to sars-cov-2) within 45 days current or predicted imminent (within 24 hours) requirement for any of the following: invasive ventilation non-invasive ventilation extracorporeal membrane oxygenation mechanical circulatory support continuous vasopressor therapy history of allergy to ivig or plasma products history of selective iga deficiency with documented presence of anti-iga antibodies any medical conditions for which receipt of the required volume of intravenous fluid may be dangerous to the patient (includes new york association class iii or iv stage heart failure) any of the following thrombotic or procoagulant disorders: acute coronary syndromes, cerebrovascular syndromes and pulmonary or deep venous thrombosis within 28 days of randomization history of prothrombin gene mutation 20210, homozygous factor v leiden mutations, antithrombin iii deficiency, protein c deficiency, protein s deficiency or antiphospholipid syndrome any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments

Oct. 26, 2020, 11:31 p.m. usa

- prior receipt of sars-cov-2 hivig or convalescent plasma from a person who recovered from covid-19 at any time - prior receipt of standard ivig (not hyperimmune to sars-cov-2) within 45 days - current or predicted imminent (within 24 hours) requirement for any of the following: 1. invasive ventilation 2. non-invasive ventilation 3. extracorporeal membrane oxygenation 4. mechanical circulatory support 5. continuous vasopressor therapy - history of allergy to ivig or plasma products - history of selective iga deficiency with documented presence of anti-iga antibodies - any medical conditions for which receipt of the required volume of intravenous fluid may be dangerous to the patient (includes new york association class iii or iv stage heart failure) - any of the following thrombotic or procoagulant disorders: 1. acute coronary syndromes, cerebrovascular syndromes and pulmonary or deep venous thrombosis within 28 days of randomization 2. history of prothrombin gene mutation 20210, homozygous factor v leiden mutations, antithrombin iii deficiency, protein c deficiency, protein s deficiency or antiphospholipid syndrome - any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments

- prior receipt of sars-cov-2 hivig or convalescent plasma from a person who recovered from covid-19 at any time - prior receipt of standard ivig (not hyperimmune to sars-cov-2) within 45 days - current or predicted imminent (within 24 hours) requirement for any of the following: 1. invasive ventilation 2. non-invasive ventilation 3. extracorporeal membrane oxygenation 4. mechanical circulatory support 5. continuous vasopressor therapy - history of allergy to ivig or plasma products - history of selective iga deficiency with documented presence of anti-iga antibodies - any medical conditions for which receipt of the required volume of intravenous fluid may be dangerous to the patient (includes new york association class iii or iv stage heart failure) - any of the following thrombotic or procoagulant disorders: 1. acute coronary syndromes, cerebrovascular syndromes and pulmonary or deep venous thrombosis within 28 days of randomization 2. history of prothrombin gene mutation 20210, homozygous factor v leiden mutations, antithrombin iii deficiency, protein c deficiency, protein s deficiency or antiphospholipid syndrome - any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments