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Feb. 25, 2022, noon oms

Inclusion Criteria-Part A: <br/ > 1. Positive result of a molecular RT-qPCR diagnostic test or SARS-CoV-2 RNA result from a clinical specimen deemed clinically associated with the current episode of illness, warranting hospital admission as per investigatorâ??s judgement, or previously hospitalized (central and/or local laboratory COVID-19 test results are accepted from any biological material source) <br/ > 2. Hospitalization for COVID -19 respiratory disease and treated with supplemental oxygen (including MV, ECMO or any other means of oxygen administration) in hospital for at least 1 day <br/ > 3. Written, electronic, or oral informed consent from the patient or Legally Authorized Representative prior to any study procedures in a manner approved by an IRB or Ethics Committee <br/ > 4. Male or female, aged â?¥18 to â?¤80 years of age, inclusively at the time of informed consent <br/ > 5. Able to perform and willing to comply with all study procedures and requirements <br/ > 6. Able to bear weight and ambulate a minimum of 10 m distance (use of inhaled oxygen permitted) <br/ > 7. Randomization day is dependent on type of qualifying respiratory support and date of initial confirmed COVID-19 diagnosis as described in Table 1 <br/ > 8. COVID-19 pneumonia findings on imaging (chest X-ray or CT Scan) with a minimum of two lung lobes involvement <br/ > 9. Shortness of breath â?¥ grade 3 on mBDS dyspnea scale <br/ > 10. Laboratory parameters (CBC, biochemistry) deemed by the investigator as acceptable and/or not clinically significant to enroll the patient <br/ > 11. Women of childbearing potential (WOCBP) must be non-pregnant and non-lactating, and must be abstinent from heterosexual intercourse for 90 days following last dose of study medication or agree to use one of the acceptable, highly effective double contraception: <br/ > a. oral, intravaginal, or transdermal combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation <br/ > b. oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation <br/ > c. intrauterine device (IUD) <br/ > 12. Male patients must be surgically sterile ( > 30 days since vasectomy with no viable sperm), abstinent, or if engaged in sexual relations with a WOCBP, the participant and his partner must be surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, <br/ > bilateral oophorectomy) or using an acceptable, highly effective contraceptive method from screening until study completion, including the follow-up period and an additional 90 days after the last dose of study medication <br/ > 13. Males will not donate sperm for at least 90 days after the last dose of study medication <br/ > 14. Partners of male patients and female patients will report pregnancy occurring within 90 days from cessation of study medication <br/ > 15. Patients can be on other medication (on and off label), apart from the ones specifically outlined in the Exclusion Criteria to treat COVID-19 respiratory disease that the investigator deems clinically relevant in combination with the study drug <br/ > 16. Patients can concomitantly receive any standard of care as per investigatorsâ?? clinical decision, standard of care may encompass any approved medication, on or off label apart from the ones specifically outlined in the exclusion criteria. Concomitant medication may be other medication(s) apart

Inclusion Criteria-Part A: <br/ > 1. Positive result of a molecular RT-qPCR diagnostic test or SARS-CoV-2 RNA result from a clinical specimen deemed clinically associated with the current episode of illness, warranting hospital admission as per investigatorâ??s judgement, or previously hospitalized (central and/or local laboratory COVID-19 test results are accepted from any biological material source) <br/ > 2. Hospitalization for COVID -19 respiratory disease and treated with supplemental oxygen (including MV, ECMO or any other means of oxygen administration) in hospital for at least 1 day <br/ > 3. Written, electronic, or oral informed consent from the patient or Legally Authorized Representative prior to any study procedures in a manner approved by an IRB or Ethics Committee <br/ > 4. Male or female, aged â?¥18 to â?¤80 years of age, inclusively at the time of informed consent <br/ > 5. Able to perform and willing to comply with all study procedures and requirements <br/ > 6. Able to bear weight and ambulate a minimum of 10 m distance (use of inhaled oxygen permitted) <br/ > 7. Randomization day is dependent on type of qualifying respiratory support and date of initial confirmed COVID-19 diagnosis as described in Table 1 <br/ > 8. COVID-19 pneumonia findings on imaging (chest X-ray or CT Scan) with a minimum of two lung lobes involvement <br/ > 9. Shortness of breath â?¥ grade 3 on mBDS dyspnea scale <br/ > 10. Laboratory parameters (CBC, biochemistry) deemed by the investigator as acceptable and/or not clinically significant to enroll the patient <br/ > 11. Women of childbearing potential (WOCBP) must be non-pregnant and non-lactating, and must be abstinent from heterosexual intercourse for 90 days following last dose of study medication or agree to use one of the acceptable, highly effective double contraception: <br/ > a. oral, intravaginal, or transdermal combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation <br/ > b. oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation <br/ > c. intrauterine device (IUD) <br/ > 12. Male patients must be surgically sterile ( > 30 days since vasectomy with no viable sperm), abstinent, or if engaged in sexual relations with a WOCBP, the participant and his partner must be surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, <br/ > bilateral oophorectomy) or using an acceptable, highly effective contraceptive method from screening until study completion, including the follow-up period and an additional 90 days after the last dose of study medication <br/ > 13. Males will not donate sperm for at least 90 days after the last dose of study medication <br/ > 14. Partners of male patients and female patients will report pregnancy occurring within 90 days from cessation of study medication <br/ > 15. Patients can be on other medication (on and off label), apart from the ones specifically outlined in the Exclusion Criteria to treat COVID-19 respiratory disease that the investigator deems clinically relevant in combination with the study drug <br/ > 16. Patients can concomitantly receive any standard of care as per investigatorsâ?? clinical decision, standard of care may encompass any approved medication, on or off label apart from the ones specifically outlined in the exclusion criteria. Concomitant medication may be other medication(s) apart