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

inclusion criteria: 1. male or non-pregnant female adult ≥18 years of age, but \< 75 years of age at time of enrollment. 2. laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay in any specimen \< 28 days prior to randomization, or person under investigation (pui) of covid-19 with pulmonary infiltrates and elevated ferritin and crp level. 3. acute intermediate-risk pulmonary embolism defined as: * presence of acute pulmonary embolism confirmed by diagnostic imaging (computed tomographic angiography, ventilation-perfusion scan, or invasive pulmonary angiography) and * presence of clot burden with at least one lobar artery involved or bilateral with at least segmental branches or unilateral clot in at least multiple segmental branches. 4. subject (or legally authorized representative) provides written informed consent prior to the performance of any study procedures. 5. in the investigator's judgement, patient has the ability to comply with the study protocol, and understands and agrees to comply with planned tnk bolus versus placebo.

inclusion criteria: 1. male or non-pregnant female adult ≥18 years of age, but \< 75 years of age at time of enrollment. 2. laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay in any specimen \< 28 days prior to randomization, or person under investigation (pui) of covid-19 with pulmonary infiltrates and elevated ferritin and crp level. 3. acute intermediate-risk pulmonary embolism defined as: * presence of acute pulmonary embolism confirmed by diagnostic imaging (computed tomographic angiography, ventilation-perfusion scan, or invasive pulmonary angiography) and * presence of clot burden with at least one lobar artery involved or bilateral with at least segmental branches or unilateral clot in at least multiple segmental branches. 4. subject (or legally authorized representative) provides written informed consent prior to the performance of any study procedures. 5. in the investigator's judgement, patient has the ability to comply with the study protocol, and understands and agrees to comply with planned tnk bolus versus placebo.

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

inclusion criteria: male or non-pregnant female adult ≥18 years of age, but < 75 years of age at time of enrollment. laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay in any specimen < 28 days prior to randomization, or person under investigation (pui) of covid-19 with pulmonary infiltrates and elevated ferritin and crp level. acute intermediate-risk pulmonary embolism defined as: presence of acute pulmonary embolism confirmed by diagnostic imaging (computed tomographic angiography, ventilation-perfusion scan, or invasive pulmonary angiography) and presence of clot burden with at least one lobar artery involved or bilateral with at least segmental branches or unilateral clot in at least multiple segmental branches. subject (or legally authorized representative) provides written informed consent prior to the performance of any study procedures. in the investigator's judgement, patient has the ability to comply with the study protocol, and understands and agrees to comply with planned tnk bolus versus placebo.

inclusion criteria: male or non-pregnant female adult ≥18 years of age, but < 75 years of age at time of enrollment. laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay in any specimen < 28 days prior to randomization, or person under investigation (pui) of covid-19 with pulmonary infiltrates and elevated ferritin and crp level. acute intermediate-risk pulmonary embolism defined as: presence of acute pulmonary embolism confirmed by diagnostic imaging (computed tomographic angiography, ventilation-perfusion scan, or invasive pulmonary angiography) and presence of clot burden with at least one lobar artery involved or bilateral with at least segmental branches or unilateral clot in at least multiple segmental branches. subject (or legally authorized representative) provides written informed consent prior to the performance of any study procedures. in the investigator's judgement, patient has the ability to comply with the study protocol, and understands and agrees to comply with planned tnk bolus versus placebo.

Oct. 27, 2021, 11 a.m. usa

inclusion criteria: 1. male or non-pregnant female adult ≥18 years of age, but < 75 years of age at time of enrollment. 2. laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay in any specimen < 28 days prior to randomization, or person under investigation (pui) of covid-19 with pulmonary infiltrates and elevated ferritin and crp level. 3. acute intermediate-risk pulmonary embolism defined as: - presence of acute pulmonary embolism confirmed by diagnostic imaging (computed tomographic angiography, ventilation-perfusion scan, or invasive pulmonary angiography) and - presence of clot burden with at least one lobar artery involved or bilateral with at least segmental branches or unilateral clot in at least multiple segmental branches. 4. subject (or legally authorized representative) provides written informed consent prior to the performance of any study procedures. 5. in the investigator's judgement, patient has the ability to comply with the study protocol, and understands and agrees to comply with planned tnk bolus versus placebo.

inclusion criteria: 1. male or non-pregnant female adult ≥18 years of age, but < 75 years of age at time of enrollment. 2. laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay in any specimen < 28 days prior to randomization, or person under investigation (pui) of covid-19 with pulmonary infiltrates and elevated ferritin and crp level. 3. acute intermediate-risk pulmonary embolism defined as: - presence of acute pulmonary embolism confirmed by diagnostic imaging (computed tomographic angiography, ventilation-perfusion scan, or invasive pulmonary angiography) and - presence of clot burden with at least one lobar artery involved or bilateral with at least segmental branches or unilateral clot in at least multiple segmental branches. 4. subject (or legally authorized representative) provides written informed consent prior to the performance of any study procedures. 5. in the investigator's judgement, patient has the ability to comply with the study protocol, and understands and agrees to comply with planned tnk bolus versus placebo.

Oct. 27, 2020, 11:31 p.m. usa

inclusion criteria: 1. male or non-pregnant female adult ≥18 years of age, but < 75 years of age at time of enrollment. 2. has laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay in any specimen < 14 days prior to randomization. 3. acute intermediate-risk pulmonary embolism defined as: - presence of acute pulmonary embolism confirmed by diagnostic imaging (computed tomographic angiography, ventilation-perfusion scan, or invasive pulmonary angiography) and - presence of clot burden with at least one lobar artery involved and - abnormal right ventricular (rv) function by echocardiography, and - elevated troponin-i or troponin-t as defined by local lab reference ranges. 4. subject (or legally authorized representative) provides written informed consent prior to the performance of any study procedures. 5. in the investigator's judgement, patient has the ability to comply with the study protocol, and understands and agrees to comply with planned tnk bolus versus placebo.

inclusion criteria: 1. male or non-pregnant female adult ≥18 years of age, but < 75 years of age at time of enrollment. 2. has laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay in any specimen < 14 days prior to randomization. 3. acute intermediate-risk pulmonary embolism defined as: - presence of acute pulmonary embolism confirmed by diagnostic imaging (computed tomographic angiography, ventilation-perfusion scan, or invasive pulmonary angiography) and - presence of clot burden with at least one lobar artery involved and - abnormal right ventricular (rv) function by echocardiography, and - elevated troponin-i or troponin-t as defined by local lab reference ranges. 4. subject (or legally authorized representative) provides written informed consent prior to the performance of any study procedures. 5. in the investigator's judgement, patient has the ability to comply with the study protocol, and understands and agrees to comply with planned tnk bolus versus placebo.

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

inclusion criteria: - subject (or legally authorized representative) provides written informed consent prior to administration of tnk/placebo. - patient has the ability to comply with the study protocol, in the investigator's judgment, and understands and agrees to comply with planned tnk infusion versus placebo. - male or non-pregnant female adult ≥18 years of age, but less than 75 years of age at time of enrollment. - has laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay in any specimen < 10 days prior to randomization. - acute intermediate-risk pulmonary embolism defined as: - presence of acute pulmonary embolism confirmed by diagnostic imaging (computed tomographic angiography, ventilation-perfusion scan, or invasive pulmonary angiography) - either abnormal right ventricular (rv) function by echocardiography and elevated troponin-i/troponin-t

inclusion criteria: - subject (or legally authorized representative) provides written informed consent prior to administration of tnk/placebo. - patient has the ability to comply with the study protocol, in the investigator's judgment, and understands and agrees to comply with planned tnk infusion versus placebo. - male or non-pregnant female adult ≥18 years of age, but less than 75 years of age at time of enrollment. - has laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay in any specimen < 10 days prior to randomization. - acute intermediate-risk pulmonary embolism defined as: - presence of acute pulmonary embolism confirmed by diagnostic imaging (computed tomographic angiography, ventilation-perfusion scan, or invasive pulmonary angiography) - either abnormal right ventricular (rv) function by echocardiography and elevated troponin-i/troponin-t