Created at Source Raw Value Validated value
Feb. 25, 2022, noon oms

Patients will not be eligible for study participation if they meet any of the exclusion criteria. <br/ > <br/ > 1. Patient has severe COVID-19 infection as per ICMR guideline <br/ > (Respiratory rate >30/min, breathlessness or SpO2 < 90% on <br/ > room air). Patients with WHO ordinal scale for clinical <br/ > improvement severity scores 6 or 7 at baseline will be excluded. <br/ > 2. Patient is currently receiving extracorporeal membrane <br/ > oxygenation (ECMO), nitric oxide therapy, or high-frequency <br/ > oscillatory ventilation <br/ > 3. Patient is unlikely to survive for > 24 hours from randomization, in the opinion of the investigator <br/ > 4. Patient has a history of chronic oxygen use or any pre-existing respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization <br/ > 5. Patient has a history of venous thromboembolism (VTE), DVT, or pulmonary embolus <br/ > 6. Patient has a malignancy of any type <br/ > 7. Patient has breast cancer or a history of breast cancer and now cancer free for < 5 years <br/ > 8. Patient has suspected active uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19) <br/ > 9. Patients with any of following laboratory results out of the ranges detailed below at screening should be discussed depending on their medication: <br/ > Absolute neutrophil count less than or equal to 1.0 Ã? 109/L <br/ > Platelets < 50 Ã? 109/L <br/ > Alanine aminotransferase or aspartate aminotransferase > 5 Ã? upper limit of normal <br/ > 10. Patient is sharing a ventilator, or co-ventilating, with any other patient. <br/ > 11. Patient has had treatment with immunomodulators or <br/ > immunosuppressant drugs, including but not limited to antiinterleukin (IL)-6, IL-6R, IL-1RA, IL-1 Beta within 7 days prior to randomization <br/ > 12. Patient has history of long-term use of antirejection or <br/ > immunomodulatory drugs <br/ > 13. Patient is pregnant or lactating <br/ > 14. Patient has severe chronic kidney disease greater than or equal to Stage 4 or requiring dialysis <br/ > 15. Patient has a known hypersensitivity to progesterone or DEX <br/ > 16. Patient is taking systemic corticosteroids for an indication other than COVID-19 <br/ > 17. Patient has known or active human immunodeficiency virus <br/ > (HIV)/ acquired immune deficiency syndrome (AIDS) infection <br/ > 18. Patient has known or active tuberculosis (TB) infection or evidence of latent TB <br/ > 19. Patient has known or active hepatitis B or hepatitis C <br/ > 20. History or presence of conditions that may place the patient at increased risk as determined by the investigator. <br/ > 21. Has taken other investigational drugs or participated in any <br/ > clinical study within 30 days or 5 half-lives (if known) of the <br/ > investigational drugâ??s PK, PD, or biological activity (if known), <br/ > whichever is longer, prior to first dose of study drug in this study or is currently participating in another clinical study. <br/ >

Patients will not be eligible for study participation if they meet any of the exclusion criteria. <br/ > <br/ > 1. Patient has severe COVID-19 infection as per ICMR guideline <br/ > (Respiratory rate >30/min, breathlessness or SpO2 < 90% on <br/ > room air). Patients with WHO ordinal scale for clinical <br/ > improvement severity scores 6 or 7 at baseline will be excluded. <br/ > 2. Patient is currently receiving extracorporeal membrane <br/ > oxygenation (ECMO), nitric oxide therapy, or high-frequency <br/ > oscillatory ventilation <br/ > 3. Patient is unlikely to survive for > 24 hours from randomization, in the opinion of the investigator <br/ > 4. Patient has a history of chronic oxygen use or any pre-existing respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization <br/ > 5. Patient has a history of venous thromboembolism (VTE), DVT, or pulmonary embolus <br/ > 6. Patient has a malignancy of any type <br/ > 7. Patient has breast cancer or a history of breast cancer and now cancer free for < 5 years <br/ > 8. Patient has suspected active uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19) <br/ > 9. Patients with any of following laboratory results out of the ranges detailed below at screening should be discussed depending on their medication: <br/ > Absolute neutrophil count less than or equal to 1.0 Ã? 109/L <br/ > Platelets < 50 Ã? 109/L <br/ > Alanine aminotransferase or aspartate aminotransferase > 5 Ã? upper limit of normal <br/ > 10. Patient is sharing a ventilator, or co-ventilating, with any other patient. <br/ > 11. Patient has had treatment with immunomodulators or <br/ > immunosuppressant drugs, including but not limited to antiinterleukin (IL)-6, IL-6R, IL-1RA, IL-1 Beta within 7 days prior to randomization <br/ > 12. Patient has history of long-term use of antirejection or <br/ > immunomodulatory drugs <br/ > 13. Patient is pregnant or lactating <br/ > 14. Patient has severe chronic kidney disease greater than or equal to Stage 4 or requiring dialysis <br/ > 15. Patient has a known hypersensitivity to progesterone or DEX <br/ > 16. Patient is taking systemic corticosteroids for an indication other than COVID-19 <br/ > 17. Patient has known or active human immunodeficiency virus <br/ > (HIV)/ acquired immune deficiency syndrome (AIDS) infection <br/ > 18. Patient has known or active tuberculosis (TB) infection or evidence of latent TB <br/ > 19. Patient has known or active hepatitis B or hepatitis C <br/ > 20. History or presence of conditions that may place the patient at increased risk as determined by the investigator. <br/ > 21. Has taken other investigational drugs or participated in any <br/ > clinical study within 30 days or 5 half-lives (if known) of the <br/ > investigational drugâ??s PK, PD, or biological activity (if known), <br/ > whichever is longer, prior to first dose of study drug in this study or is currently participating in another clinical study. <br/ >