Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 p.m. usa

inclusion criteria: hospitalized male or female subject ≥ 18 years of age at time of screening who is being treated for covid-19. subjects must be screened within 48 hours (≤ 48 hours) of hospital admission. has laboratory-confirmed novel coronavirus {sars-cov-2} infection as determined by qualitative polymerase chain reaction (pcr) (reverse transcriptase [rt]-pcr), or other commercial or public health assay approved by regulatory authorities as a diagnostic test for covid-19 in any specimen during the current hospital admission or 96 hours prior to the hospital admission date and prior to randomization (the sars-cov-2 test results must be performed by a hospital laboratory and the documentation available). covid-19 illness (symptoms) of any duration, including both of the following: a) radiographic infiltrates by imaging (chest x-ray, computed tomography (ct) scan, etc.) and/or clinical assessment (evidence of rales/crackles on exam) with peripheral oxygen saturation by pulse oximetry (spo2) <94% on room air; b) any one of the following related to covid-19: i. ferritin > 400 nanogram per milliliter (ng/ml), ii. lactate dehydrogenase (ldh) > 300 units per liter (u/l), iii. d-dimers > reference range, or iv. c-reactive protein (crp) > 40 milligram per liter (mg/l). subject provides informed consent prior to initiation of any study procedures. female subjects of childbearing potential (and males with female partners of childbearing potential) must agree to use of acceptable contraception methods during study (example, oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout the study.

inclusion criteria: hospitalized male or female subject ≥ 18 years of age at time of screening who is being treated for covid-19. subjects must be screened within 48 hours (≤ 48 hours) of hospital admission. has laboratory-confirmed novel coronavirus {sars-cov-2} infection as determined by qualitative polymerase chain reaction (pcr) (reverse transcriptase [rt]-pcr), or other commercial or public health assay approved by regulatory authorities as a diagnostic test for covid-19 in any specimen during the current hospital admission or 96 hours prior to the hospital admission date and prior to randomization (the sars-cov-2 test results must be performed by a hospital laboratory and the documentation available). covid-19 illness (symptoms) of any duration, including both of the following: a) radiographic infiltrates by imaging (chest x-ray, computed tomography (ct) scan, etc.) and/or clinical assessment (evidence of rales/crackles on exam) with peripheral oxygen saturation by pulse oximetry (spo2) <94% on room air; b) any one of the following related to covid-19: i. ferritin > 400 nanogram per milliliter (ng/ml), ii. lactate dehydrogenase (ldh) > 300 units per liter (u/l), iii. d-dimers > reference range, or iv. c-reactive protein (crp) > 40 milligram per liter (mg/l). subject provides informed consent prior to initiation of any study procedures. female subjects of childbearing potential (and males with female partners of childbearing potential) must agree to use of acceptable contraception methods during study (example, oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout the study.

April 6, 2021, 12:31 a.m. usa

inclusion criteria: 1. hospitalized male or female subject ≥ 18 years of age at time of screening who is being treated for covid-19. subjects must be screened within 48 hours (≤ 48 hours) of hospital admission. 2. has laboratory-confirmed novel coronavirus {sars-cov-2} infection as determined by qualitative polymerase chain reaction (pcr) (reverse transcriptase [rt]-pcr), or other commercial or public health assay approved by regulatory authorities as a diagnostic test for covid-19 in any specimen during the current hospital admission or 96 hours prior to the hospital admission date and prior to randomization (the sars-cov-2 test results must be performed by a hospital laboratory and the documentation available). 3. covid-19 illness (symptoms) of any duration, including both of the following: a) radiographic infiltrates by imaging (chest x-ray, computed tomography (ct) scan, etc.) and/or clinical assessment (evidence of rales/crackles on exam) with peripheral oxygen saturation by pulse oximetry (spo2) <94% on room air; b) any one of the following related to covid-19: i. ferritin > 400 nanogram per milliliter (ng/ml), ii. lactate dehydrogenase (ldh) > 300 units per liter (u/l), iii. d-dimers > reference range, or iv. c-reactive protein (crp) > 40 milligram per liter (mg/l). 4. subject provides informed consent prior to initiation of any study procedures. 5. female subjects of childbearing potential (and males with female partners of childbearing potential) must agree to use of acceptable contraception methods during study (example, oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout the study.

inclusion criteria: 1. hospitalized male or female subject ≥ 18 years of age at time of screening who is being treated for covid-19. subjects must be screened within 48 hours (≤ 48 hours) of hospital admission. 2. has laboratory-confirmed novel coronavirus {sars-cov-2} infection as determined by qualitative polymerase chain reaction (pcr) (reverse transcriptase [rt]-pcr), or other commercial or public health assay approved by regulatory authorities as a diagnostic test for covid-19 in any specimen during the current hospital admission or 96 hours prior to the hospital admission date and prior to randomization (the sars-cov-2 test results must be performed by a hospital laboratory and the documentation available). 3. covid-19 illness (symptoms) of any duration, including both of the following: a) radiographic infiltrates by imaging (chest x-ray, computed tomography (ct) scan, etc.) and/or clinical assessment (evidence of rales/crackles on exam) with peripheral oxygen saturation by pulse oximetry (spo2) <94% on room air; b) any one of the following related to covid-19: i. ferritin > 400 nanogram per milliliter (ng/ml), ii. lactate dehydrogenase (ldh) > 300 units per liter (u/l), iii. d-dimers > reference range, or iv. c-reactive protein (crp) > 40 milligram per liter (mg/l). 4. subject provides informed consent prior to initiation of any study procedures. 5. female subjects of childbearing potential (and males with female partners of childbearing potential) must agree to use of acceptable contraception methods during study (example, oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout the study.

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

inclusion criteria: 1. hospitalized male or female subject ≥ 18 years of age at time of screening who is being treated for covid-19. subjects must be screened within 48 hours (≤ 48 hours) of hospital admission. 2. has laboratory-confirmed novel coronavirus {sars-cov-2} infection as determined by qualitative polymerase chain reaction (pcr) (reverse transcriptase [rt]-pcr), or other commercial or public health assay approved by regulatory authorities as a diagnostic test for covid-19 in any specimen during the current hospital admission prior to randomization. 3. covid-19 illness (symptoms) of any duration, including both of the following: a) radiographic infiltrates by imaging (chest x-ray, computed tomography (ct) scan, etc.) and/or clinical assessment (evidence of rales/crackles on exam) with peripheral oxygen saturation by pulse oximetry (spo2) <94% on room air; b) any one of the following related to covid-19: i. ferritin > 400 nanogram per milliliter (ng/ml), ii. lactate dehydrogenase (ldh) > 300 units per liter (u/l), iii. d-dimers > reference range, or iv. c-reactive protein (crp) > 40 milligram per liter (mg/l). 4. subject provides informed consent prior to initiation of any study procedures. 5. female subjects of childbearing potential (and males with female partners of childbearing potential) must agree to use of acceptable contraception methods during study (example, oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout the study.

inclusion criteria: 1. hospitalized male or female subject ≥ 18 years of age at time of screening who is being treated for covid-19. subjects must be screened within 48 hours (≤ 48 hours) of hospital admission. 2. has laboratory-confirmed novel coronavirus {sars-cov-2} infection as determined by qualitative polymerase chain reaction (pcr) (reverse transcriptase [rt]-pcr), or other commercial or public health assay approved by regulatory authorities as a diagnostic test for covid-19 in any specimen during the current hospital admission prior to randomization. 3. covid-19 illness (symptoms) of any duration, including both of the following: a) radiographic infiltrates by imaging (chest x-ray, computed tomography (ct) scan, etc.) and/or clinical assessment (evidence of rales/crackles on exam) with peripheral oxygen saturation by pulse oximetry (spo2) <94% on room air; b) any one of the following related to covid-19: i. ferritin > 400 nanogram per milliliter (ng/ml), ii. lactate dehydrogenase (ldh) > 300 units per liter (u/l), iii. d-dimers > reference range, or iv. c-reactive protein (crp) > 40 milligram per liter (mg/l). 4. subject provides informed consent prior to initiation of any study procedures. 5. female subjects of childbearing potential (and males with female partners of childbearing potential) must agree to use of acceptable contraception methods during study (example, oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout the study.