Created at Source Raw Value Validated value
Dec. 22, 2021, 3 a.m. usa

inclusion criteria: subject (or legally authorized representative) provides written informed consent prior to the initiation of any study procedures subject understands and agrees to comply with planned study procedures, including using the diary subject agrees to the collection of nasopharyngeal swabs and venous blood per protocol subject is male or non-pregnant female adult ≥18 years of age at time of consent a. women with a history of menstruation must agree to use two methods of contraception, at least one of which is highly effective, for the duration of the study as well as to undergo additional pregnancy testing during the study subject has a laboratory confirmed sars-cov-2 infection as determined by rt-pcr assay prior to enrollment subject has evidence of either mild or moderate covid-19 illness of less than 7 days from first onset, with minimal baseline symptom severity based on patient-reported fda scoring system defined as follows: subject presents with at least two common symptoms of covid-19 from the following list: stuffy or runny nose, sore throat, cough, low energy or tiredness, muscle or body ache, headache, chills or shivering, feeling hot or feverish, nausea, vomiting, diarrhea, shortness of breath with exertion (without supplemental oxygen requirement) with a score of 2 or higher, impairment in sense of smell or taste with a score of 1 or higher or subject presents with any (i.e., at least one) symptom of covid-19 as defined above and clinical evidence of moderate covid-19 as defined by fda guidance for industry (such as respiratory rate >20 breaths per minute, heart rate >90 beats per minute, with oxygen saturation >93% on room air at sea level) subject presents with high-risk for covid-19-related inflammation determined by at least one comorbidity, including obesity, diabetes, hypertension, stable heart disease, respiratory disease, and/or non-severe fatty liver disease subject's overall health condition is deemed as suitable to fully and safely participate in this trial as determined by the investigator

inclusion criteria: subject (or legally authorized representative) provides written informed consent prior to the initiation of any study procedures subject understands and agrees to comply with planned study procedures, including using the diary subject agrees to the collection of nasopharyngeal swabs and venous blood per protocol subject is male or non-pregnant female adult ≥18 years of age at time of consent a. women with a history of menstruation must agree to use two methods of contraception, at least one of which is highly effective, for the duration of the study as well as to undergo additional pregnancy testing during the study subject has a laboratory confirmed sars-cov-2 infection as determined by rt-pcr assay prior to enrollment subject has evidence of either mild or moderate covid-19 illness of less than 7 days from first onset, with minimal baseline symptom severity based on patient-reported fda scoring system defined as follows: subject presents with at least two common symptoms of covid-19 from the following list: stuffy or runny nose, sore throat, cough, low energy or tiredness, muscle or body ache, headache, chills or shivering, feeling hot or feverish, nausea, vomiting, diarrhea, shortness of breath with exertion (without supplemental oxygen requirement) with a score of 2 or higher, impairment in sense of smell or taste with a score of 1 or higher or subject presents with any (i.e., at least one) symptom of covid-19 as defined above and clinical evidence of moderate covid-19 as defined by fda guidance for industry (such as respiratory rate >20 breaths per minute, heart rate >90 beats per minute, with oxygen saturation >93% on room air at sea level) subject presents with high-risk for covid-19-related inflammation determined by at least one comorbidity, including obesity, diabetes, hypertension, stable heart disease, respiratory disease, and/or non-severe fatty liver disease subject's overall health condition is deemed as suitable to fully and safely participate in this trial as determined by the investigator