Created at Source Raw Value Validated value
June 27, 2024, 4 p.m. usa

inclusion criteria: 1. ambulatory male or female outpatients ≥ 18 years of age who have laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection as determined by qualitative pcr (reverse transcriptase (rt)-pcr), or other commercial or public health assay approved by regulatory authorities as a diagnostic test for covid-19 (inclusive of sars-cov-2 antigen testing or other approved rapid testing platforms) in any specimen ≤ 5 days prior to randomized treatment. 2. asymptomatic with no constitutional covid-19 illness (evident symptoms), specifically no fever, cough, shortness of breath, fatigue, anorexia, vomiting/diarrhea, headache that is unrelated to pre-existing conditions (example, migraine), sore throat that is unrelated to other pre-existing medical conditions (example, allergies, gastroesophageal reflux disease), myalgias, olfactory disorders unrelated with previous medical condition, or evidence of pneumonia at screening. 3. pulse oximetry peripheral oxygen saturation (spo2) (oxygen saturation) on room air \> 94% (i.e., 95% to 100%) at screening. 4. national early warning score (news) ≤ 2 points at screening. 5. participant provides informed consent (icf) prior to initiation of any study procedures.

inclusion criteria: 1. ambulatory male or female outpatients ≥ 18 years of age who have laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection as determined by qualitative pcr (reverse transcriptase (rt)-pcr), or other commercial or public health assay approved by regulatory authorities as a diagnostic test for covid-19 (inclusive of sars-cov-2 antigen testing or other approved rapid testing platforms) in any specimen ≤ 5 days prior to randomized treatment. 2. asymptomatic with no constitutional covid-19 illness (evident symptoms), specifically no fever, cough, shortness of breath, fatigue, anorexia, vomiting/diarrhea, headache that is unrelated to pre-existing conditions (example, migraine), sore throat that is unrelated to other pre-existing medical conditions (example, allergies, gastroesophageal reflux disease), myalgias, olfactory disorders unrelated with previous medical condition, or evidence of pneumonia at screening. 3. pulse oximetry peripheral oxygen saturation (spo2) (oxygen saturation) on room air \> 94% (i.e., 95% to 100%) at screening. 4. national early warning score (news) ≤ 2 points at screening. 5. participant provides informed consent (icf) prior to initiation of any study procedures.

Dec. 9, 2022, 4 a.m. usa

inclusion criteria: ambulatory male or female outpatients ≥ 18 years of age who have laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection as determined by qualitative pcr (reverse transcriptase (rt)-pcr), or other commercial or public health assay approved by regulatory authorities as a diagnostic test for covid-19 (inclusive of sars-cov-2 antigen testing or other approved rapid testing platforms) in any specimen ≤ 5 days prior to randomized treatment. asymptomatic with no constitutional covid-19 illness (evident symptoms), specifically no fever, cough, shortness of breath, fatigue, anorexia, vomiting/diarrhea, headache that is unrelated to pre-existing conditions (example, migraine), sore throat that is unrelated to other pre-existing medical conditions (example, allergies, gastroesophageal reflux disease), myalgias, olfactory disorders unrelated with previous medical condition, or evidence of pneumonia at screening. pulse oximetry peripheral oxygen saturation (spo2) (oxygen saturation) on room air > 94% (i.e., 95% to 100%) at screening. national early warning score (news) ≤ 2 points at screening. participant provides informed consent (icf) prior to initiation of any study procedures.

inclusion criteria: ambulatory male or female outpatients ≥ 18 years of age who have laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection as determined by qualitative pcr (reverse transcriptase (rt)-pcr), or other commercial or public health assay approved by regulatory authorities as a diagnostic test for covid-19 (inclusive of sars-cov-2 antigen testing or other approved rapid testing platforms) in any specimen ≤ 5 days prior to randomized treatment. asymptomatic with no constitutional covid-19 illness (evident symptoms), specifically no fever, cough, shortness of breath, fatigue, anorexia, vomiting/diarrhea, headache that is unrelated to pre-existing conditions (example, migraine), sore throat that is unrelated to other pre-existing medical conditions (example, allergies, gastroesophageal reflux disease), myalgias, olfactory disorders unrelated with previous medical condition, or evidence of pneumonia at screening. pulse oximetry peripheral oxygen saturation (spo2) (oxygen saturation) on room air > 94% (i.e., 95% to 100%) at screening. national early warning score (news) ≤ 2 points at screening. participant provides informed consent (icf) prior to initiation of any study procedures.

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

inclusion criteria: ambulatory male or female outpatients ≥ 18 years of age who have laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection as determined by qualitative pcr (reverse transcriptase (rt)-pcr), or other commercial or public health assay approved by regulatory authorities as a diagnostic test for covid-19 (inclusive of sars-cov-2 antigen testing or other approved rapid testing platforms) in any specimen ≤ 5 days prior to randomized treatment. asymptomatic with no constitutional covid-19 illness (evident symptoms), specifically no fever, cough, shortness of breath, fatigue, anorexia, vomiting/diarrhea, headache that is unrelated to pre-existing conditions (example, migraine), sore throat that is unrelated to other pre-existing medical conditions (example, allergies, gastroesophageal reflux disease), myalgias, olfactory disorders unrelated with previous medical condition, or evidence of pneumonia at screening. pulse oximetry peripheral oxygen saturation (spo2) (oxygen saturation) on room air > 94% (i.e., 95% to 100%) at screening. national early warning score (news) ≤ 2 points at screening. subject provides informed consent (icf) prior to initiation of any study procedures.

inclusion criteria: ambulatory male or female outpatients ≥ 18 years of age who have laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection as determined by qualitative pcr (reverse transcriptase (rt)-pcr), or other commercial or public health assay approved by regulatory authorities as a diagnostic test for covid-19 (inclusive of sars-cov-2 antigen testing or other approved rapid testing platforms) in any specimen ≤ 5 days prior to randomized treatment. asymptomatic with no constitutional covid-19 illness (evident symptoms), specifically no fever, cough, shortness of breath, fatigue, anorexia, vomiting/diarrhea, headache that is unrelated to pre-existing conditions (example, migraine), sore throat that is unrelated to other pre-existing medical conditions (example, allergies, gastroesophageal reflux disease), myalgias, olfactory disorders unrelated with previous medical condition, or evidence of pneumonia at screening. pulse oximetry peripheral oxygen saturation (spo2) (oxygen saturation) on room air > 94% (i.e., 95% to 100%) at screening. national early warning score (news) ≤ 2 points at screening. subject provides informed consent (icf) prior to initiation of any study procedures.

July 29, 2021, noon usa

inclusion criteria: 1. ambulatory male or female outpatients ≥ 18 years of age who have laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection as determined by qualitative pcr (reverse transcriptase (rt)-pcr), or other commercial or public health assay approved by regulatory authorities as a diagnostic test for covid-19 (inclusive of sars-cov-2 antigen testing or other approved rapid testing platforms) in any specimen ≤ 5 days prior to randomized treatment. 2. asymptomatic with no constitutional covid-19 illness (evident symptoms), specifically no fever, cough, shortness of breath, fatigue, anorexia, vomiting/diarrhea, headache that is unrelated to pre-existing conditions (example, migraine), sore throat that is unrelated to other pre-existing medical conditions (example, allergies, gastroesophageal reflux disease), myalgias, olfactory disorders unrelated with previous medical condition, or evidence of pneumonia at screening. 3. pulse oximetry peripheral oxygen saturation (spo2) (oxygen saturation) on room air > 94% (i.e., 95% to 100%) at screening. 4. national early warning score (news) ≤ 2 points at screening. 5. subject provides informed consent (icf) prior to initiation of any study procedures.

inclusion criteria: 1. ambulatory male or female outpatients ≥ 18 years of age who have laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection as determined by qualitative pcr (reverse transcriptase (rt)-pcr), or other commercial or public health assay approved by regulatory authorities as a diagnostic test for covid-19 (inclusive of sars-cov-2 antigen testing or other approved rapid testing platforms) in any specimen ≤ 5 days prior to randomized treatment. 2. asymptomatic with no constitutional covid-19 illness (evident symptoms), specifically no fever, cough, shortness of breath, fatigue, anorexia, vomiting/diarrhea, headache that is unrelated to pre-existing conditions (example, migraine), sore throat that is unrelated to other pre-existing medical conditions (example, allergies, gastroesophageal reflux disease), myalgias, olfactory disorders unrelated with previous medical condition, or evidence of pneumonia at screening. 3. pulse oximetry peripheral oxygen saturation (spo2) (oxygen saturation) on room air > 94% (i.e., 95% to 100%) at screening. 4. national early warning score (news) ≤ 2 points at screening. 5. subject provides informed consent (icf) prior to initiation of any study procedures.

May 22, 2021, 12:32 a.m. usa

inclusion criteria: 1. ambulatory male or female outpatients ≥ 30 years of age who have laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection as determined by qualitative pcr (reverse transcriptase (rt)-pcr), or other commercial or public health assay approved by regulatory authorities as a diagnostic test for covid-19 (inclusive of sars-cov-2 antigen testing or other approved rapid testing platforms) in any specimen ≤ 5 days prior to randomized treatment. 2. asymptomatic with no constitutional covid-19 illness (evident symptoms), specifically no fever, cough, shortness of breath, fatigue, anorexia, vomiting/diarrhea, headache that is unrelated to pre-existing conditions (example, migraine), sore throat that is unrelated to other pre-existing medical conditions (example, allergies, gastroesophageal reflux disease), myalgias, olfactory disorders unrelated with previous medical condition, or evidence of pneumonia at screening. 3. pulse oximetry peripheral oxygen saturation (spo2) (oxygen saturation) on room air > 94% (i.e., 95% to 100%) at screening. 4. national early warning score (news) ≤ 2 points at screening. 5. subject provides informed consent (icf) prior to initiation of any study procedures.

inclusion criteria: 1. ambulatory male or female outpatients ≥ 30 years of age who have laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection as determined by qualitative pcr (reverse transcriptase (rt)-pcr), or other commercial or public health assay approved by regulatory authorities as a diagnostic test for covid-19 (inclusive of sars-cov-2 antigen testing or other approved rapid testing platforms) in any specimen ≤ 5 days prior to randomized treatment. 2. asymptomatic with no constitutional covid-19 illness (evident symptoms), specifically no fever, cough, shortness of breath, fatigue, anorexia, vomiting/diarrhea, headache that is unrelated to pre-existing conditions (example, migraine), sore throat that is unrelated to other pre-existing medical conditions (example, allergies, gastroesophageal reflux disease), myalgias, olfactory disorders unrelated with previous medical condition, or evidence of pneumonia at screening. 3. pulse oximetry peripheral oxygen saturation (spo2) (oxygen saturation) on room air > 94% (i.e., 95% to 100%) at screening. 4. national early warning score (news) ≤ 2 points at screening. 5. subject provides informed consent (icf) prior to initiation of any study procedures.

April 22, 2021, 12:31 a.m. usa

inclusion criteria: 1. ambulatory male or female outpatients ≥ 50 years of age who have laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection as determined by qualitative pcr (reverse transcriptase (rt)-pcr), or other commercial or public health assay approved by regulatory authorities as a diagnostic test for covid-19 (inclusive of sars-cov-2 antigen testing or other approved rapid testing platforms) in any specimen ≤ 5 days prior to randomized treatment. 2. asymptomatic with no constitutional covid-19 illness (evident symptoms), specifically no fever, cough, shortness of breath, fatigue, anorexia, vomiting/diarrhea, headache that is unrelated to pre-existing conditions (example, migraine), sore throat that is unrelated to other pre-existing medical conditions (example, allergies, gastroesophageal reflux disease), myalgias, olfactory disorders unrelated with previous medical condition, or evidence of pneumonia at screening. 3. pulse oximetry peripheral oxygen saturation (spo2) (oxygen saturation) on room air > 94% (i.e., 95% to 100%) at screening. 4. national early warning score (news) ≤ 2 points at screening. 5. subject provides informed consent (icf) prior to initiation of any study procedures.

inclusion criteria: 1. ambulatory male or female outpatients ≥ 50 years of age who have laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection as determined by qualitative pcr (reverse transcriptase (rt)-pcr), or other commercial or public health assay approved by regulatory authorities as a diagnostic test for covid-19 (inclusive of sars-cov-2 antigen testing or other approved rapid testing platforms) in any specimen ≤ 5 days prior to randomized treatment. 2. asymptomatic with no constitutional covid-19 illness (evident symptoms), specifically no fever, cough, shortness of breath, fatigue, anorexia, vomiting/diarrhea, headache that is unrelated to pre-existing conditions (example, migraine), sore throat that is unrelated to other pre-existing medical conditions (example, allergies, gastroesophageal reflux disease), myalgias, olfactory disorders unrelated with previous medical condition, or evidence of pneumonia at screening. 3. pulse oximetry peripheral oxygen saturation (spo2) (oxygen saturation) on room air > 94% (i.e., 95% to 100%) at screening. 4. national early warning score (news) ≤ 2 points at screening. 5. subject provides informed consent (icf) prior to initiation of any study procedures.