Created at Source Raw Value Validated value
March 11, 2022, 3:30 p.m. oms

1. Male or female age &gt,=18 and &lt,=75 years of age at the time of informed consent. 2. Willing and able to provide written informed consent/assent for the trial. 3. Healthy subjects in close contact with confirmed COVID-19 case(s) or subjects with mild or asymptomatic COVID-19. a. Healthy subjects in close contact with confirmed COVID-19 case(s) i. With exposure to confirmed COVID-19 case(s) within 96 hours (refer to the definition of healthy subjects in close contact with confirmed COVID-19 case[s]), ii. Negative reverse transcriptase-polymerase chain reaction (RT-PCR) test for SARS-CoV-2 infection, with the sample collected at screening, iii. Have no previous confirmed COVID-19 diagnosis, iv. Without symptoms of respiratory infection, including fever, cough, fatigue, anorexia, shortness of breath, myalgias, sore throat, nasal congestion, headache, gastrointestinal symptoms, loss of smell (anosmia), loss of taste (ageusia), or other symptoms associated with COVID-19, AND v. With stable health status, as judged by the investigator and determined by physical examination, vital signs, medical history, and laboratory tests at screening. b. Subjects with mild or asymptomatic COVID-19 i. Meeting the criteria of mild or asymptomatic COVID-19, Note: - Asymptomatic or presymptomatic infection: Individuals who test positive for SARS-CoV-2 by virologic testing using a molecular diagnostic (e.g., PCR) or antigen test, but have no symptoms. - Mild disease: Individuals who have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain) and saturation of oxygen (SpO2) &gt,=90% on room air at sea level, without shortness of breath, dyspnea, or abnormal chest imaging. ii. Positive RT-PCR test for SARS-CoV-2 infection, with the sample collected at screening or within 72 hours prior to screening, AND iii. Without evidence of viral pneumonia or hypoxia. 4. Women of childbearing potential must have a negative pregnancy test result at screening. 5. Males and females who are fertile must adhere to contraception requirements for the duration of the study. 6. Non-participation in any other clinical trials during the study period.

1. Male or female age &gt,=18 and &lt,=75 years of age at the time of informed consent. 2. Willing and able to provide written informed consent/assent for the trial. 3. Healthy subjects in close contact with confirmed COVID-19 case(s) or subjects with mild or asymptomatic COVID-19. a. Healthy subjects in close contact with confirmed COVID-19 case(s) i. With exposure to confirmed COVID-19 case(s) within 96 hours (refer to the definition of healthy subjects in close contact with confirmed COVID-19 case[s]), ii. Negative reverse transcriptase-polymerase chain reaction (RT-PCR) test for SARS-CoV-2 infection, with the sample collected at screening, iii. Have no previous confirmed COVID-19 diagnosis, iv. Without symptoms of respiratory infection, including fever, cough, fatigue, anorexia, shortness of breath, myalgias, sore throat, nasal congestion, headache, gastrointestinal symptoms, loss of smell (anosmia), loss of taste (ageusia), or other symptoms associated with COVID-19, AND v. With stable health status, as judged by the investigator and determined by physical examination, vital signs, medical history, and laboratory tests at screening. b. Subjects with mild or asymptomatic COVID-19 i. Meeting the criteria of mild or asymptomatic COVID-19, Note: - Asymptomatic or presymptomatic infection: Individuals who test positive for SARS-CoV-2 by virologic testing using a molecular diagnostic (e.g., PCR) or antigen test, but have no symptoms. - Mild disease: Individuals who have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain) and saturation of oxygen (SpO2) &gt,=90% on room air at sea level, without shortness of breath, dyspnea, or abnormal chest imaging. ii. Positive RT-PCR test for SARS-CoV-2 infection, with the sample collected at screening or within 72 hours prior to screening, AND iii. Without evidence of viral pneumonia or hypoxia. 4. Women of childbearing potential must have a negative pregnancy test result at screening. 5. Males and females who are fertile must adhere to contraception requirements for the duration of the study. 6. Non-participation in any other clinical trials during the study period.