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

inclusion criteria: informed consent form signed and dated by participant. men or women >/=18 years of age at the time of signing the informed consent. access to device and internet for televisits. laboratory confirmed sars-cov-2 infection via viral rt-pcr test. the sars-cov-2 diagnostic test will be conducted using, if possible, an fda acceptable product under emergency use authorization (eua) or as cleared by the center for device and radiological health (cdrh). we will have confirmation of the sars-cov-2 testing prior to enrollment. covid-19 patients in generally healthy status without significant medical comorbidities. a treatment window for first dose of up to 10 days from onset of symptoms. outpatients with symptoms of respiratory illness caused by coronavirus 2019 infection as defined below: symptoms of mild illness with covid-19 as defined by the w.h.o. in table 1of the clinical management of covid-19 interim guidance document, may 27, 2020, meeting the case definition for mild covid-19 without evidence of viral pneumonia or hypoxia covid-19 severity score on an 8-point ordinal score =/< 2 as defined by the who 2020. 8. clinically normal resting 12-lead ecg at screening visit or, if abnormal, considered not clinically significant by the principal investigator. 9. normal or clinically insignificant change in the liver (alt, ast) and kidney function (blood creatinine), cbc with differential and clotting factors (pt and ptt). 10. understands and agrees to comply with planned study procedures. 11. women of childbearing potential must agree to use at least one medically accepted method of contraception (e.g., barrier contraceptives [condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], or intrauterine devices) for the duration of the study. 12. background standard of care will be maintained in all treatment arms. off-label use of any other drugs, devices, or interventions that might be used to manage covid-19 need to be discussed with the study medical director.

inclusion criteria: informed consent form signed and dated by participant. men or women >/=18 years of age at the time of signing the informed consent. access to device and internet for televisits. laboratory confirmed sars-cov-2 infection via viral rt-pcr test. the sars-cov-2 diagnostic test will be conducted using, if possible, an fda acceptable product under emergency use authorization (eua) or as cleared by the center for device and radiological health (cdrh). we will have confirmation of the sars-cov-2 testing prior to enrollment. covid-19 patients in generally healthy status without significant medical comorbidities. a treatment window for first dose of up to 10 days from onset of symptoms. outpatients with symptoms of respiratory illness caused by coronavirus 2019 infection as defined below: symptoms of mild illness with covid-19 as defined by the w.h.o. in table 1of the clinical management of covid-19 interim guidance document, may 27, 2020, meeting the case definition for mild covid-19 without evidence of viral pneumonia or hypoxia covid-19 severity score on an 8-point ordinal score =/< 2 as defined by the who 2020. 8. clinically normal resting 12-lead ecg at screening visit or, if abnormal, considered not clinically significant by the principal investigator. 9. normal or clinically insignificant change in the liver (alt, ast) and kidney function (blood creatinine), cbc with differential and clotting factors (pt and ptt). 10. understands and agrees to comply with planned study procedures. 11. women of childbearing potential must agree to use at least one medically accepted method of contraception (e.g., barrier contraceptives [condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], or intrauterine devices) for the duration of the study. 12. background standard of care will be maintained in all treatment arms. off-label use of any other drugs, devices, or interventions that might be used to manage covid-19 need to be discussed with the study medical director.

March 19, 2021, 12:31 a.m. usa

inclusion criteria: 1. informed consent form signed and dated by participant. 2. men or women >/=18 years of age at the time of signing the informed consent. 3. access to device and internet for televisits. 4. laboratory confirmed sars-cov-2 infection via viral rt-pcr test. the sars-cov-2 diagnostic test will be conducted using, if possible, an fda acceptable product under emergency use authorization (eua) or as cleared by the center for device and radiological health (cdrh). we will have confirmation of the sars-cov-2 testing prior to enrollment. 5. covid-19 patients in generally healthy status without significant medical comorbidities. 6. a treatment window for first dose of up to 10 days from onset of symptoms. 7. outpatients with symptoms of respiratory illness caused by coronavirus 2019 infection as defined below: - symptoms of mild illness with covid-19 as defined by the w.h.o. in table 1of the clinical management of covid-19 interim guidance document, may 27, 2020, meeting the case definition for mild covid-19 without evidence of viral pneumonia or hypoxia - covid-19 severity score on an 8-point ordinal score =/< 2 as defined by the who 2020. 8. clinically normal resting 12-lead ecg at screening visit or, if abnormal, considered not clinically significant by the principal investigator. 9. normal or clinically insignificant change in the liver (alt, ast) and kidney function (blood creatinine), cbc with differential and clotting factors (pt and ptt). 10. understands and agrees to comply with planned study procedures. 11. women of childbearing potential must agree to use at least one medically accepted method of contraception (e.g., barrier contraceptives [condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], or intrauterine devices) for the duration of the study. 12. background standard of care will be maintained in all treatment arms. off-label use of any other drugs, devices, or interventions that might be used to manage covid-19 need to be discussed with the study medical director.

inclusion criteria: 1. informed consent form signed and dated by participant. 2. men or women >/=18 years of age at the time of signing the informed consent. 3. access to device and internet for televisits. 4. laboratory confirmed sars-cov-2 infection via viral rt-pcr test. the sars-cov-2 diagnostic test will be conducted using, if possible, an fda acceptable product under emergency use authorization (eua) or as cleared by the center for device and radiological health (cdrh). we will have confirmation of the sars-cov-2 testing prior to enrollment. 5. covid-19 patients in generally healthy status without significant medical comorbidities. 6. a treatment window for first dose of up to 10 days from onset of symptoms. 7. outpatients with symptoms of respiratory illness caused by coronavirus 2019 infection as defined below: - symptoms of mild illness with covid-19 as defined by the w.h.o. in table 1of the clinical management of covid-19 interim guidance document, may 27, 2020, meeting the case definition for mild covid-19 without evidence of viral pneumonia or hypoxia - covid-19 severity score on an 8-point ordinal score =/< 2 as defined by the who 2020. 8. clinically normal resting 12-lead ecg at screening visit or, if abnormal, considered not clinically significant by the principal investigator. 9. normal or clinically insignificant change in the liver (alt, ast) and kidney function (blood creatinine), cbc with differential and clotting factors (pt and ptt). 10. understands and agrees to comply with planned study procedures. 11. women of childbearing potential must agree to use at least one medically accepted method of contraception (e.g., barrier contraceptives [condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], or intrauterine devices) for the duration of the study. 12. background standard of care will be maintained in all treatment arms. off-label use of any other drugs, devices, or interventions that might be used to manage covid-19 need to be discussed with the study medical director.