Created at Source Raw Value Validated value
March 9, 2021, 12:31 a.m. usa

- receipt of any blood product in past 120 days. - psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance. - confirmed or self-reported presumed covid-19, with symptoms that began more than 5 days prior to enrollment, and sars-cov-2 pcr positive sample that was collected more than 7 days prior to anticipated infusion for an asymptomatic participant or more than 10 days prior to anticipated infusion for a patient with mild symptoms at screening. - symptoms consistent with covid---19 infection that are more than mild (as defined above) at time of screening. - symptoms consistent with covid---19 infection that are more than mild at time of screening. - history of allergic reaction to transfusion blood products - inability to complete infusion of the product within 48 hours after randomization. - resident of a long term or skilled nursing facility - known prior diagnosis of immunoglobulin a (iga) deficiency - oxygen saturation that is < 95% at the screening visit - on supplemental oxygen at time of enrollment - participation in another clinical trial of anti-viral agent(s) for covid-19 - receipt of any covid-19 vaccine, either as part of a clinical research trial or through routine service delivery.

- receipt of any blood product in past 120 days. - psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance. - confirmed or self-reported presumed covid-19, with symptoms that began more than 5 days prior to enrollment, and sars-cov-2 pcr positive sample that was collected more than 7 days prior to anticipated infusion for an asymptomatic participant or more than 10 days prior to anticipated infusion for a patient with mild symptoms at screening. - symptoms consistent with covid---19 infection that are more than mild (as defined above) at time of screening. - symptoms consistent with covid---19 infection that are more than mild at time of screening. - history of allergic reaction to transfusion blood products - inability to complete infusion of the product within 48 hours after randomization. - resident of a long term or skilled nursing facility - known prior diagnosis of immunoglobulin a (iga) deficiency - oxygen saturation that is < 95% at the screening visit - on supplemental oxygen at time of enrollment - participation in another clinical trial of anti-viral agent(s) for covid-19 - receipt of any covid-19 vaccine, either as part of a clinical research trial or through routine service delivery.

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

group b: sars-cov-2 pcr positive but asymptomatic or mild symptoms at screening - receipt of any blood product in past 120 days. - psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance. - confirmed or self-reported presumed covid-19 at least one week before index case first became ill with covid-19. - symptoms consistent with covid---19 infection that are more than mild (as defined above) at time of screening. subjects who report fever (tmax > 100.4 f) are not eligible for enrollment. - symptoms that have worsened in the period between screening and enrollment such that the subject is deemed to be medical unstable on the day of planned enrollment. - history of allergic reaction to transfusion blood products - inability to complete infusion of the product within 48 hours after randomization. - pregnancy (or planning for pregnancy in next three months) or breastfeeding. - resident of a long term or skilled nursing facility - known prior diagnosis of immunoglobulin a (iga) deficiency - oxygen saturation that is < 95% at the screening visit - participation in another clinical trial of anti-viral agent(s) for covid-19 group c: sars-cov-2 pcr negative (uninfected) at time of screening - receipt any blood product in past 120 days. - psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principle investigator, would affect subject safety and/or compliance. - confirmed or self-reported presumed covid-19 at least one week before index case first became ill with covid-19. - symptoms consistent with severe covid-19 infection that are more than mild (as defined above) at time of screening. subjects who report fever (tmax > 100.4 f) are not eligible for enrollment. - symptoms that have worsened in the period between screening and enrollment such that the subject is deemed to be medically unstable on the day of planned enrollment. - laboratory evidence of sars-cov-2 infection (i.e. rt-pcr) at time of screening - history of allergic reaction to blood products - inability to complete infusion of the product within 48 hours after randomization. - pregnancy (or planning for pregnancy in next three months) or breastfeeding. - resident of a long term or skilled nursing facility - known history of immunoglobulin a (iga) deficiency - oxygen saturation that is < 95% at the screening visit - participation in another clinical trial of anti-viral agent(s) for covid-19

group b: sars-cov-2 pcr positive but asymptomatic or mild symptoms at screening - receipt of any blood product in past 120 days. - psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance. - confirmed or self-reported presumed covid-19 at least one week before index case first became ill with covid-19. - symptoms consistent with covid---19 infection that are more than mild (as defined above) at time of screening. subjects who report fever (tmax > 100.4 f) are not eligible for enrollment. - symptoms that have worsened in the period between screening and enrollment such that the subject is deemed to be medical unstable on the day of planned enrollment. - history of allergic reaction to transfusion blood products - inability to complete infusion of the product within 48 hours after randomization. - pregnancy (or planning for pregnancy in next three months) or breastfeeding. - resident of a long term or skilled nursing facility - known prior diagnosis of immunoglobulin a (iga) deficiency - oxygen saturation that is < 95% at the screening visit - participation in another clinical trial of anti-viral agent(s) for covid-19 group c: sars-cov-2 pcr negative (uninfected) at time of screening - receipt any blood product in past 120 days. - psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principle investigator, would affect subject safety and/or compliance. - confirmed or self-reported presumed covid-19 at least one week before index case first became ill with covid-19. - symptoms consistent with severe covid-19 infection that are more than mild (as defined above) at time of screening. subjects who report fever (tmax > 100.4 f) are not eligible for enrollment. - symptoms that have worsened in the period between screening and enrollment such that the subject is deemed to be medically unstable on the day of planned enrollment. - laboratory evidence of sars-cov-2 infection (i.e. rt-pcr) at time of screening - history of allergic reaction to blood products - inability to complete infusion of the product within 48 hours after randomization. - pregnancy (or planning for pregnancy in next three months) or breastfeeding. - resident of a long term or skilled nursing facility - known history of immunoglobulin a (iga) deficiency - oxygen saturation that is < 95% at the screening visit - participation in another clinical trial of anti-viral agent(s) for covid-19