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Jan. 22, 2021, 1:30 a.m. eu

1. Postmenopausal women who have not used HRT (including oral, transdermal, topical, or vaginal preparations) within 1 year prior to study start. Menopause is defined as women who have at least 12 months of spontaneous amenorrhea without another medical cause. OR Men ≥ 18 years of age who are willing to use adequate contraception from Screening until 4 weeks after the last dose of study treatment. 2. Patients with SARS-CoV-2 infection confirmed by a nationally accepted RT-PCR and moderate COVID-19. Patients with a strong clinical suspicion of moderate COVID-19 and a positive point-of-care test for viral infection can also be entered while the result of a nationally accepted RT-PCR assay is awaited, if the RT-PCR assay result is negative, the treatment must be stopped and the patient must be discontinued from the study. The definition of moderate COVID-19 is: i. Positive testing by standard RT-PCR assay. ii. Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness (including fever, cough, anosmia, dysgeusia, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms) or shortness of breath with exertion. iii. Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥20 breaths per minute, heart rate ≥90 beats per minute. iv. No clinical signs indicative of severe or critical illness (i.e. need for ventilation or ICU admission). 3. Hospitalized. 4. Clinical Frailty Score ≤5. 5. World Health Organization (WHO) Ordinal Scale for Clinical Improvement score of 4 or 5. 6. Able to provide IC. 7. Able to comply with the study procedures as defined in the protocol.

1. Postmenopausal women who have not used HRT (including oral, transdermal, topical, or vaginal preparations) within 1 year prior to study start. Menopause is defined as women who have at least 12 months of spontaneous amenorrhea without another medical cause. OR Men ≥ 18 years of age who are willing to use adequate contraception from Screening until 4 weeks after the last dose of study treatment. 2. Patients with SARS-CoV-2 infection confirmed by a nationally accepted RT-PCR and moderate COVID-19. Patients with a strong clinical suspicion of moderate COVID-19 and a positive point-of-care test for viral infection can also be entered while the result of a nationally accepted RT-PCR assay is awaited, if the RT-PCR assay result is negative, the treatment must be stopped and the patient must be discontinued from the study. The definition of moderate COVID-19 is: i. Positive testing by standard RT-PCR assay. ii. Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness (including fever, cough, anosmia, dysgeusia, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms) or shortness of breath with exertion. iii. Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥20 breaths per minute, heart rate ≥90 beats per minute. iv. No clinical signs indicative of severe or critical illness (i.e. need for ventilation or ICU admission). 3. Hospitalized. 4. Clinical Frailty Score ≤5. 5. World Health Organization (WHO) Ordinal Scale for Clinical Improvement score of 4 or 5. 6. Able to provide IC. 7. Able to comply with the study procedures as defined in the protocol.