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

inclusion criteria: the subject must satisfy the following criteria for entry into the study: 1. male or female, aged 18 years and above. 2. provide informed consent prior to any study specific procedure being conducted; for older patients who lack mental or physical capacity, next of kin or legal guardians will be allowed to provide consent on their behalf. this consent can be obtained remotely by telephone to the next of kin, or by a doctor with relevant experience in covid-19 disease not directly involved in the study acting as the patient's advocate and then subsequently informing the next of kin (eg by a telephone call also offering them an opportunity to review and agree the icf with them; the patient may then continue in the study or withdraw at a later date if the next of kin subsequently decides to withdraw consent). 3. positive local approved test to confirm diagnosis of sars-cov-2 within 7 days prior to baseline. 4. classified as moderate or severe based on the modified who/nih baseline severity criteria. moderate: evidence of lower respiratory disease by clinical assessment (e.g. signs or symptoms of lung infection) or by chest x-ray/ct/ultrasound imaging (e.g. viral pneumonia, lung infiltrates) and a saturation of oxygen (sao2) ≥ 94% on room air at sea level. severe: respiratory frequency \>30 bpm, sao2 \< 94% on room air at sea level, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (pao2/fio2) \< 300 mmhg, or lung infiltrates \>50%. 5. hospitalised or attended the hospital ed due to clinical and/or virological diagnosis of sars-cov-2; subsequent follow up after screening may be carried out in hospital (hospitalised) or at a covid-19 hospital op clinic as clinically indicated at the investigator's discretion. where it is not possible for the subject to attend a hospital op clinic, then providing a suitably trained healthcare professional (eg part of the clinical research team) as directed by the investigator, is available to visit the subject at home to conduct the necessary clinical and sao2 assessments and blood tests, subsequent assessments post-hospitalisation or ed visit may be conducted at the subject's home.

inclusion criteria: the subject must satisfy the following criteria for entry into the study: 1. male or female, aged 18 years and above. 2. provide informed consent prior to any study specific procedure being conducted; for older patients who lack mental or physical capacity, next of kin or legal guardians will be allowed to provide consent on their behalf. this consent can be obtained remotely by telephone to the next of kin, or by a doctor with relevant experience in covid-19 disease not directly involved in the study acting as the patient's advocate and then subsequently informing the next of kin (eg by a telephone call also offering them an opportunity to review and agree the icf with them; the patient may then continue in the study or withdraw at a later date if the next of kin subsequently decides to withdraw consent). 3. positive local approved test to confirm diagnosis of sars-cov-2 within 7 days prior to baseline. 4. classified as moderate or severe based on the modified who/nih baseline severity criteria. moderate: evidence of lower respiratory disease by clinical assessment (e.g. signs or symptoms of lung infection) or by chest x-ray/ct/ultrasound imaging (e.g. viral pneumonia, lung infiltrates) and a saturation of oxygen (sao2) ≥ 94% on room air at sea level. severe: respiratory frequency \>30 bpm, sao2 \< 94% on room air at sea level, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (pao2/fio2) \< 300 mmhg, or lung infiltrates \>50%. 5. hospitalised or attended the hospital ed due to clinical and/or virological diagnosis of sars-cov-2; subsequent follow up after screening may be carried out in hospital (hospitalised) or at a covid-19 hospital op clinic as clinically indicated at the investigator's discretion. where it is not possible for the subject to attend a hospital op clinic, then providing a suitably trained healthcare professional (eg part of the clinical research team) as directed by the investigator, is available to visit the subject at home to conduct the necessary clinical and sao2 assessments and blood tests, subsequent assessments post-hospitalisation or ed visit may be conducted at the subject's home.

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

inclusion criteria: the subject must satisfy the following criteria for entry into the study: male or female, aged 18 years and above. provide informed consent prior to any study specific procedure being conducted; for older patients who lack mental or physical capacity, next of kin or legal guardians will be allowed to provide consent on their behalf. this consent can be obtained remotely by telephone to the next of kin, or by a doctor with relevant experience in covid-19 disease not directly involved in the study acting as the patient's advocate and then subsequently informing the next of kin (eg by a telephone call also offering them an opportunity to review and agree the icf with them; the patient may then continue in the study or withdraw at a later date if the next of kin subsequently decides to withdraw consent). positive local approved test to confirm diagnosis of sars-cov-2 within 7 days prior to baseline. classified as moderate or severe based on the modified who/nih baseline severity criteria. moderate: evidence of lower respiratory disease by clinical assessment (e.g. signs or symptoms of lung infection) or by chest x-ray/ct/ultrasound imaging (e.g. viral pneumonia, lung infiltrates) and a saturation of oxygen (sao2) ≥ 94% on room air at sea level. severe: respiratory frequency >30 bpm, sao2 < 94% on room air at sea level, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (pao2/fio2) < 300 mmhg, or lung infiltrates >50%. hospitalised or attended the hospital ed due to clinical and/or virological diagnosis of sars-cov-2; subsequent follow up after screening may be carried out in hospital (hospitalised) or at a covid-19 hospital op clinic as clinically indicated at the investigator's discretion. where it is not possible for the subject to attend a hospital op clinic, then providing a suitably trained healthcare professional (eg part of the clinical research team) as directed by the investigator, is available to visit the subject at home to conduct the necessary clinical and sao2 assessments and blood tests, subsequent assessments post-hospitalisation or ed visit may be conducted at the subject's home.

inclusion criteria: the subject must satisfy the following criteria for entry into the study: male or female, aged 18 years and above. provide informed consent prior to any study specific procedure being conducted; for older patients who lack mental or physical capacity, next of kin or legal guardians will be allowed to provide consent on their behalf. this consent can be obtained remotely by telephone to the next of kin, or by a doctor with relevant experience in covid-19 disease not directly involved in the study acting as the patient's advocate and then subsequently informing the next of kin (eg by a telephone call also offering them an opportunity to review and agree the icf with them; the patient may then continue in the study or withdraw at a later date if the next of kin subsequently decides to withdraw consent). positive local approved test to confirm diagnosis of sars-cov-2 within 7 days prior to baseline. classified as moderate or severe based on the modified who/nih baseline severity criteria. moderate: evidence of lower respiratory disease by clinical assessment (e.g. signs or symptoms of lung infection) or by chest x-ray/ct/ultrasound imaging (e.g. viral pneumonia, lung infiltrates) and a saturation of oxygen (sao2) ≥ 94% on room air at sea level. severe: respiratory frequency >30 bpm, sao2 < 94% on room air at sea level, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (pao2/fio2) < 300 mmhg, or lung infiltrates >50%. hospitalised or attended the hospital ed due to clinical and/or virological diagnosis of sars-cov-2; subsequent follow up after screening may be carried out in hospital (hospitalised) or at a covid-19 hospital op clinic as clinically indicated at the investigator's discretion. where it is not possible for the subject to attend a hospital op clinic, then providing a suitably trained healthcare professional (eg part of the clinical research team) as directed by the investigator, is available to visit the subject at home to conduct the necessary clinical and sao2 assessments and blood tests, subsequent assessments post-hospitalisation or ed visit may be conducted at the subject's home.

Nov. 3, 2020, 11:31 p.m. usa

inclusion criteria: the subject must satisfy the following criteria for entry into the study: 1. male or female, aged 18 years and above. 2. provide informed consent prior to any study specific procedure being conducted; for older patients who lack mental or physical capacity, next of kin or legal guardians will be allowed to provide consent on their behalf. this consent can be obtained remotely by telephone to the next of kin, or by a doctor with relevant experience in covid-19 disease not directly involved in the study acting as the patient's advocate and then subsequently informing the next of kin (eg by a telephone call also offering them an opportunity to review and agree the icf with them; the patient may then continue in the study or withdraw at a later date if the next of kin subsequently decides to withdraw consent). 3. positive local approved test to confirm diagnosis of sars-cov-2 within 7 days prior to baseline. 4. classified as moderate or severe based on the modified who/nih baseline severity criteria. moderate: evidence of lower respiratory disease by clinical assessment (e.g. signs or symptoms of lung infection) or by chest x-ray/ct/ultrasound imaging (e.g. viral pneumonia, lung infiltrates) and a saturation of oxygen (sao2) ≥ 94% on room air at sea level. severe: respiratory frequency >30 bpm, sao2 < 94% on room air at sea level, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (pao2/fio2) < 300 mmhg, or lung infiltrates >50%. 5. hospitalised or attended the hospital ed due to clinical and/or virological diagnosis of sars-cov-2; subsequent follow up after screening may be carried out in hospital (hospitalised) or at a covid-19 hospital op clinic as clinically indicated at the investigator's discretion. where it is not possible for the subject to attend a hospital op clinic, then providing a suitably trained healthcare professional (eg part of the clinical research team) as directed by the investigator, is available to visit the subject at home to conduct the necessary clinical and sao2 assessments and blood tests, subsequent assessments post-hospitalisation or ed visit may be conducted at the subject's home.

inclusion criteria: the subject must satisfy the following criteria for entry into the study: 1. male or female, aged 18 years and above. 2. provide informed consent prior to any study specific procedure being conducted; for older patients who lack mental or physical capacity, next of kin or legal guardians will be allowed to provide consent on their behalf. this consent can be obtained remotely by telephone to the next of kin, or by a doctor with relevant experience in covid-19 disease not directly involved in the study acting as the patient's advocate and then subsequently informing the next of kin (eg by a telephone call also offering them an opportunity to review and agree the icf with them; the patient may then continue in the study or withdraw at a later date if the next of kin subsequently decides to withdraw consent). 3. positive local approved test to confirm diagnosis of sars-cov-2 within 7 days prior to baseline. 4. classified as moderate or severe based on the modified who/nih baseline severity criteria. moderate: evidence of lower respiratory disease by clinical assessment (e.g. signs or symptoms of lung infection) or by chest x-ray/ct/ultrasound imaging (e.g. viral pneumonia, lung infiltrates) and a saturation of oxygen (sao2) ≥ 94% on room air at sea level. severe: respiratory frequency >30 bpm, sao2 < 94% on room air at sea level, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (pao2/fio2) < 300 mmhg, or lung infiltrates >50%. 5. hospitalised or attended the hospital ed due to clinical and/or virological diagnosis of sars-cov-2; subsequent follow up after screening may be carried out in hospital (hospitalised) or at a covid-19 hospital op clinic as clinically indicated at the investigator's discretion. where it is not possible for the subject to attend a hospital op clinic, then providing a suitably trained healthcare professional (eg part of the clinical research team) as directed by the investigator, is available to visit the subject at home to conduct the necessary clinical and sao2 assessments and blood tests, subsequent assessments post-hospitalisation or ed visit may be conducted at the subject's home.

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

inclusion criteria: the subject must satisfy the following criteria for entry into the study: 1. male or female, aged 18 to 85 years. 2. provided informed consent prior to any study specific procedure being conducted. 3. virological or sereological diagnosis of sars-cov-2. 4. evidence of viral pneumonia (either ct scan or chest ultrasonogram). 5. oxygen saturation at rest in ambient air ≤ 94%. 6. pao2/fio2 <300mmhg without oxygen inhalation 7. fever defined as temperature ≥ 36.6°c armpit, ≥ 37.2°c oral, ≥ 37.8°c rectal.

inclusion criteria: the subject must satisfy the following criteria for entry into the study: 1. male or female, aged 18 to 85 years. 2. provided informed consent prior to any study specific procedure being conducted. 3. virological or sereological diagnosis of sars-cov-2. 4. evidence of viral pneumonia (either ct scan or chest ultrasonogram). 5. oxygen saturation at rest in ambient air ≤ 94%. 6. pao2/fio2 <300mmhg without oxygen inhalation 7. fever defined as temperature ≥ 36.6°c armpit, ≥ 37.2°c oral, ≥ 37.8°c rectal.