| Is your age greater than or equal to 18 yrs? |
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| Gender: Male or Female |
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| Do you have SARS-CoV 2? |
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| Do you have any of these conditions: SARS-CoV 2 or Sars Cov 2? |
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| Do you have any of these conditions: SARS-CoV 2 or Sars Cov 2? |
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| Do you have any of these conditions: Sars Cov 2 or SARS-CoV 2? |
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| Do you have any of these conditions: Sars Cov 2 or SARS-CoV 2? |
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| Do you have any of these conditions: Sars Cov 2 or SARS-CoV 2? |
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| Do you have any of these conditions: SARS-CoV 2 or Sars Cov 2? |
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| Do you have any of these conditions: SARS-CoV 2 or Sars Cov 2? |
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| Do you have any of these conditions: Sars Cov 2 or SARS-CoV 2? |
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| Do you have any of these conditions: SARS-CoV 2 or Sars Cov 2? |
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| Has COVID-19 disease, defined by having one or more of the following new symptoms and signs (within 7 days) |
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| Fevers OR |
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| At least one of the following symptoms: cough, shortness of breath, respiratory rate 20, radiographic evidence of pneumonia OR |
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| Anosmia OR |
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| other clinical symptoms or signs of COVID-19 that are not otherwise explained by comorbidities or co-diagnoses |
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| PCR+ test for SARS-CoV-2 |
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| Has new signs or symptoms of COVID-19 that began 7 days of anticipated first dose of study drug |
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| Persons 18 years old |
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| Is admitted and is anticipated to remain in the hospital for 24 hours |
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| Pregnancy and Contraception: Treatment with EIDD-2801 is contraindicated in |
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| Is willing and able to comply with all study procedures including providing informed consent, collection of virology samples, and any safety tests that are not included as part of standard of care (SOC) |
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| women who are pregnant or nursing and in the male partners of women who are |
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| Is willing and able to take oral medications, and is anticipated to be able to take the full course of 5 days of study agent |
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| pregnant. Extreme care must be taken to avoid pregnancy during the study and |
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| for 50 days after completion of EIDD 2801 dosing in female participants and |
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| for 100 days after completion of EIDD-2801 dosing in female partners of male |
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| participants |
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| Have a negative serum pregnancy test at Screening |
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| \. Female participants of childbearing potential must meet the the following |
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| criteria to be enrolled |
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| Must agree to undergo a follow-up pregnancy test on Study Day 28 |
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| Must agree to use at least 2 forms of contraception during the study and for at least 50 days after dosing of the study drug is complete, as discussed with and approved by the investigator |
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| OR Must have an azoospermic partner (vasectomized or due to a to medical |
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| cause) Note: azoospermic partner is acceptable provided that the partner is |
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| the sole sexual partner of the woman of childbearing potential and the absence |
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| of sperm has been confirmed |
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| Note that female not of childbearing potential is defined as either |
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| i. Surgically sterile: females who are permanently sterile via hysterectomy |
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| bilateral salpingectomy, and/or bilateral oophorectomy by reported medical |
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| history and/or medical records. Surgical sterilization to have occurred a |
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| minimum of 6 weeks, or at the Investigator's discretion, prior to Screening |
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| OR |
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| ii. Postmenopausal: Females at least 60 years of age with amenorrhea for 12 |
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| months (by history) or 45 years of age with amenorrhea for 12 months without |
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| an alternative medical reason with confirmatory follicle stimulating hormone |
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| levels of 40 mIU/mL. The amenorrhea should not be induced by a medical |
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| condition such as anorexia nervosa, hypothyroid disease or polycystic ovarian |
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| disease, or by extreme exercise. It should not be due to concomitant |
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| medications that may have induced the amenorrhea such as oral contraceptives |
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| hormones, gonadotropin releasing hormones, anti-estrogens, or selective |
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| estrogen receptor modulators |
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| \. Male participants must refrain from donating sperm during the study and |
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| for 100 days after dosing of the study drug is complete |
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| \. Male participants with female partners must have either |
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| Surgical sterilization (vasectomy 1 month before screening) OR |
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| Female partner must be of not be of childbearing potential OR |
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| Agree to use 2 forms of contraception during the study and for 100 days after dosing of the study drug is complete, as discussed with and approved by the investigator |
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| Requires more than 6 liters/minute of oxygen to maintain O2 saturation above 95% |
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| Has an illness within the past 30 days that requires mechanical ventilation prior to enrollment |
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| Is anticipated to require ICU admission for mechanical ventilation within 24 hours of enrollment |
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| Is not expected to survive longer than 24 hours |
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| Has a platelet count less than 100,000/L, hemoglobin less than 10 g/dL, or has a disorder of the hematologic system including anemic disorder or other blood dyscrasia, cancer of the hematologic system, history of bone marrow transplant, or other significant hematologic disease |
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| Women who are pregnant or breastfeeding |
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| Has received an experimental vaccine for COVID-19 prior to the first dose of study drug |
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| Is experiencing DAIDS AE grading scale grade 4 baseline medical conditions or laboratory abnormalities |
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| In the opinion of the investigator, has end-organ disease as a result of relevant comorbidities: chronic kidney disease (reduced glomerular filtration rate (GFR) <30 mL/min by the Modification of Diet in Renal Disease (MDRD) study equation prior to COVID-19 symptom onset), decompensated chronic liver disease or cirrhosis, decompensated congestive heart failure, active peripheral vascular disease including active diabetic ulcers, chronic pulmonary disease prior to COVID-19 symptom onset requiring bilevel positive airway pressure (BiPAP) or >2 L/min supplemental oxygen at baseline; if using 2 L/min supplemental oxygen at baseline, consultation with and approval of the sponsor is required prior to enrollment |
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| Has received hydroxychloroquine or chloroquine within 30 days of study enrollment |
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| Has a diagnosis of cancer that is not in remission. Noninvasive cancers, such as basal and squamous cell carcinoma or history of in situ tumors are allowed at the discretion of the investigator after discussion with the sponsor |
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| Is participating in another clinical study that involves pharmacologic intervention or has participated in another study within 30 days of 5 half-lives of the investigational agent (observational study participation is permitted) |
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| Has received an organ transplantation |
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| Has received a bone marrow transplantation |
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| Has been on immunosuppressive medications within one month prior to enrollment |
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| Has any condition that would, in the opinion of the investigator, put the participant at increased risk for participation in a clinical trial |
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| Is currently taking systemic corticosteroids other than replacement doses, or for treatment of COVID-19 |
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| Has known active hepatitis C (HCV RNA positive), active hepatitis B (hepatitis B surface antigen positive), or HIV (ELISA and confirmatory Western blotting). New screening tests not required |
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| Has a Body Mass Index (BMI) >50 kg/m2 |
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| Is currently taking nucleos(t)ide analogues for HIV or Hepatitis B, or for their prevention, within 30 days of study enrollment |
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| Is anticipated to require surgery within 48 hours after hospital admission |
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| Is anticipated to have a nothing per mouth (NPO) order placed within 48 hours after hospital admission that is expected to last for > 24 hours |
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