Created at Source Raw Value Validated value
June 25, 2024, noon usa

1. exhibiting signs of moderate or severe pulmonary disease (such as chronic obstructive pulmonary disease (copd), asthma, or pulmonary fibrosis) 2. ongoing requirement of oxygen therapy 3. pulse oxygen saturation (spo2) of \<94% on room air at the time of screening 4. history of splenectomy 5. liver cirrhosis or patient showing signs of clinical jaundice at the time of screening 6. chronic kidney disease stage 4 or requiring dialysis at the time of screening 7. new york heart association (nyha) class iii or iv congestive heart failure (chf) 8. exhibiting signs of uncontrolled hypo-or hyper- thyroidism at the time of screening 9. uncontrolled rheumatologic disorders at the time of screening 10. history of organ transplantation or are candidates for organ transplantation at the time of screening 11. history of chronic fatigue syndrome prior to covid-19 infection 12. history of fibromyalgia prior to covid-19 infection 13. history of major psychiatric disorder including bipolar disorders, schizophrenia, schizoaffective disorder, major depression. patients with major depression can be enrolled if patient has had no episode within the past year or is considered in remission or controlled by treatment. 14. any malignancy within the past 5 years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases. 15. any other clinically significant serious systemic diseases which would interfere with study conduct or study results interpretation per the investigator. 16. treatment with immunosuppressive or immunomodulatory medications within 5 half-lives prior to screening. patients on replacement therapy for adrenal insufficiency will be allowed. patients on stable (\> 3 months) low dose corticosteroid ≤ 5 mg prednisone will be allowed. 17. history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (pro 140) are not eligible 18. ongoing use of ccr5 antagonist 19. inability to provide informed consent or to comply with test requirements 20. consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment 21. pregnancy or breast feeding 22. participating in another study for an investigational treatment

1. exhibiting signs of moderate or severe pulmonary disease (such as chronic obstructive pulmonary disease (copd), asthma, or pulmonary fibrosis) 2. ongoing requirement of oxygen therapy 3. pulse oxygen saturation (spo2) of \<94% on room air at the time of screening 4. history of splenectomy 5. liver cirrhosis or patient showing signs of clinical jaundice at the time of screening 6. chronic kidney disease stage 4 or requiring dialysis at the time of screening 7. new york heart association (nyha) class iii or iv congestive heart failure (chf) 8. exhibiting signs of uncontrolled hypo-or hyper- thyroidism at the time of screening 9. uncontrolled rheumatologic disorders at the time of screening 10. history of organ transplantation or are candidates for organ transplantation at the time of screening 11. history of chronic fatigue syndrome prior to covid-19 infection 12. history of fibromyalgia prior to covid-19 infection 13. history of major psychiatric disorder including bipolar disorders, schizophrenia, schizoaffective disorder, major depression. patients with major depression can be enrolled if patient has had no episode within the past year or is considered in remission or controlled by treatment. 14. any malignancy within the past 5 years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases. 15. any other clinically significant serious systemic diseases which would interfere with study conduct or study results interpretation per the investigator. 16. treatment with immunosuppressive or immunomodulatory medications within 5 half-lives prior to screening. patients on replacement therapy for adrenal insufficiency will be allowed. patients on stable (\> 3 months) low dose corticosteroid ≤ 5 mg prednisone will be allowed. 17. history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (pro 140) are not eligible 18. ongoing use of ccr5 antagonist 19. inability to provide informed consent or to comply with test requirements 20. consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment 21. pregnancy or breast feeding 22. participating in another study for an investigational treatment

April 13, 2024, 8 a.m. usa

exhibiting signs of moderate or severe pulmonary disease (such as chronic obstructive pulmonary disease (copd), asthma, or pulmonary fibrosis) ongoing requirement of oxygen therapy pulse oxygen saturation (spo2) of <94% on room air at the time of screening history of splenectomy liver cirrhosis or patient showing signs of clinical jaundice at the time of screening chronic kidney disease stage 4 or requiring dialysis at the time of screening new york heart association (nyha) class iii or iv congestive heart failure (chf) exhibiting signs of uncontrolled hypo-or hyper- thyroidism at the time of screening uncontrolled rheumatologic disorders at the time of screening history of organ transplantation or are candidates for organ transplantation at the time of screening history of chronic fatigue syndrome prior to covid-19 infection history of fibromyalgia prior to covid-19 infection history of major psychiatric disorder including bipolar disorders, schizophrenia, schizoaffective disorder, major depression. patients with major depression can be enrolled if patient has had no episode within the past year or is considered in remission or controlled by treatment. any malignancy within the past 5 years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases. any other clinically significant serious systemic diseases which would interfere with study conduct or study results interpretation per the investigator. treatment with immunosuppressive or immunomodulatory medications within 5 half-lives prior to screening. patients on replacement therapy for adrenal insufficiency will be allowed. patients on stable (> 3 months) low dose corticosteroid ≤ 5 mg prednisone will be allowed. history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (pro 140) are not eligible ongoing use of ccr5 antagonist inability to provide informed consent or to comply with test requirements consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment pregnancy or breast feeding participating in another study for an investigational treatment

exhibiting signs of moderate or severe pulmonary disease (such as chronic obstructive pulmonary disease (copd), asthma, or pulmonary fibrosis) ongoing requirement of oxygen therapy pulse oxygen saturation (spo2) of <94% on room air at the time of screening history of splenectomy liver cirrhosis or patient showing signs of clinical jaundice at the time of screening chronic kidney disease stage 4 or requiring dialysis at the time of screening new york heart association (nyha) class iii or iv congestive heart failure (chf) exhibiting signs of uncontrolled hypo-or hyper- thyroidism at the time of screening uncontrolled rheumatologic disorders at the time of screening history of organ transplantation or are candidates for organ transplantation at the time of screening history of chronic fatigue syndrome prior to covid-19 infection history of fibromyalgia prior to covid-19 infection history of major psychiatric disorder including bipolar disorders, schizophrenia, schizoaffective disorder, major depression. patients with major depression can be enrolled if patient has had no episode within the past year or is considered in remission or controlled by treatment. any malignancy within the past 5 years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases. any other clinically significant serious systemic diseases which would interfere with study conduct or study results interpretation per the investigator. treatment with immunosuppressive or immunomodulatory medications within 5 half-lives prior to screening. patients on replacement therapy for adrenal insufficiency will be allowed. patients on stable (> 3 months) low dose corticosteroid ≤ 5 mg prednisone will be allowed. history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (pro 140) are not eligible ongoing use of ccr5 antagonist inability to provide informed consent or to comply with test requirements consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment pregnancy or breast feeding participating in another study for an investigational treatment

Nov. 16, 2021, 6:30 p.m. usa

exhibiting signs of moderate or severe pulmonary disease (such as copd, asthma, or pulmonary fibrosis) ongoing requirement of oxygen therapy pulse oxygen saturation (spo2) of <94% on room air at the time of screening history of splenectomy liver cirrhosis or patient showing signs of clinical jaundice at the time of screening chronic kidney disease stage 4 or requiring dialysis at the time of screening nyha class iii or iv congestive heart failure (chf) exhibiting signs of uncontrolled hypo-or hyper- thyroidism at the time of screening uncontrolled rheumatologic disorders at the time of screening history of organ transplantation or are candidates for organ transplantation at the time of screening history of chronic fatigue syndrome prior to covid-19 infection history of fibromyalgia prior to covid-19 infection history of major psychiatric disorder including bipolar disorders, schizophrenia, schizoaffective disorder, major depression. patients with major depression can be enrolled if patient has had no episode within the past year or is considered in remission or controlled by treatment. any malignancy within the past 5 years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases. any other clinically significant serious systemic diseases which would interfere with study conduct or study results interpretation per the investigator. treatment with immunosuppressive or immunomodulatory medications within 5 half-lives prior to screening. patients on replacement therapy for adrenal insufficiency will be allowed. patients on stable (> 3 months) low dose corticosteroid ≤ 5 mg prednisone will be allowed. history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (pro 140) are not eligible ongoing use of ccr5 antagonist inability to provide informed consent or to comply with test requirements consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment pregnancy or breast feeding participating in another study for an investigational treatment

exhibiting signs of moderate or severe pulmonary disease (such as copd, asthma, or pulmonary fibrosis) ongoing requirement of oxygen therapy pulse oxygen saturation (spo2) of <94% on room air at the time of screening history of splenectomy liver cirrhosis or patient showing signs of clinical jaundice at the time of screening chronic kidney disease stage 4 or requiring dialysis at the time of screening nyha class iii or iv congestive heart failure (chf) exhibiting signs of uncontrolled hypo-or hyper- thyroidism at the time of screening uncontrolled rheumatologic disorders at the time of screening history of organ transplantation or are candidates for organ transplantation at the time of screening history of chronic fatigue syndrome prior to covid-19 infection history of fibromyalgia prior to covid-19 infection history of major psychiatric disorder including bipolar disorders, schizophrenia, schizoaffective disorder, major depression. patients with major depression can be enrolled if patient has had no episode within the past year or is considered in remission or controlled by treatment. any malignancy within the past 5 years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases. any other clinically significant serious systemic diseases which would interfere with study conduct or study results interpretation per the investigator. treatment with immunosuppressive or immunomodulatory medications within 5 half-lives prior to screening. patients on replacement therapy for adrenal insufficiency will be allowed. patients on stable (> 3 months) low dose corticosteroid ≤ 5 mg prednisone will be allowed. history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (pro 140) are not eligible ongoing use of ccr5 antagonist inability to provide informed consent or to comply with test requirements consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment pregnancy or breast feeding participating in another study for an investigational treatment

March 7, 2021, 12:31 a.m. usa

1. exhibiting signs of moderate or severe pulmonary disease (such as copd, asthma, or pulmonary fibrosis) 2. ongoing requirement of oxygen therapy 3. pulse oxygen saturation (spo2) of <94% on room air at the time of screening 4. history of splenectomy 5. liver cirrhosis or patient showing signs of clinical jaundice at the time of screening 6. chronic kidney disease stage 4 or requiring dialysis at the time of screening 7. nyha class iii or iv congestive heart failure (chf) 8. exhibiting signs of uncontrolled hypo-or hyper- thyroidism at the time of screening 9. uncontrolled rheumatologic disorders at the time of screening 10. history of organ transplantation or are candidates for organ transplantation at the time of screening 11. history of chronic fatigue syndrome prior to covid-19 infection 12. history of fibromyalgia prior to covid-19 infection 13. history of major psychiatric disorder including bipolar disorders, schizophrenia, schizoaffective disorder, major depression. patients with major depression can be enrolled if patient has had no episode within the past year or is considered in remission or controlled by treatment. 14. any malignancy within the past 5 years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases. 15. any other clinically significant serious systemic diseases which would interfere with study conduct or study results interpretation per the investigator. 16. treatment with immunosuppressive or immunomodulatory medications within 5 half-lives prior to screening. patients on replacement therapy for adrenal insufficiency will be allowed. patients on stable (> 3 months) low dose corticosteroid ≤ 5 mg prednisone will be allowed. 17. history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (pro 140) are not eligible 18. ongoing use of ccr5 antagonist 19. inability to provide informed consent or to comply with test requirements 20. consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment 21. pregnancy or breast feeding 22. participating in another study for an investigational treatment

1. exhibiting signs of moderate or severe pulmonary disease (such as copd, asthma, or pulmonary fibrosis) 2. ongoing requirement of oxygen therapy 3. pulse oxygen saturation (spo2) of <94% on room air at the time of screening 4. history of splenectomy 5. liver cirrhosis or patient showing signs of clinical jaundice at the time of screening 6. chronic kidney disease stage 4 or requiring dialysis at the time of screening 7. nyha class iii or iv congestive heart failure (chf) 8. exhibiting signs of uncontrolled hypo-or hyper- thyroidism at the time of screening 9. uncontrolled rheumatologic disorders at the time of screening 10. history of organ transplantation or are candidates for organ transplantation at the time of screening 11. history of chronic fatigue syndrome prior to covid-19 infection 12. history of fibromyalgia prior to covid-19 infection 13. history of major psychiatric disorder including bipolar disorders, schizophrenia, schizoaffective disorder, major depression. patients with major depression can be enrolled if patient has had no episode within the past year or is considered in remission or controlled by treatment. 14. any malignancy within the past 5 years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases. 15. any other clinically significant serious systemic diseases which would interfere with study conduct or study results interpretation per the investigator. 16. treatment with immunosuppressive or immunomodulatory medications within 5 half-lives prior to screening. patients on replacement therapy for adrenal insufficiency will be allowed. patients on stable (> 3 months) low dose corticosteroid ≤ 5 mg prednisone will be allowed. 17. history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (pro 140) are not eligible 18. ongoing use of ccr5 antagonist 19. inability to provide informed consent or to comply with test requirements 20. consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment 21. pregnancy or breast feeding 22. participating in another study for an investigational treatment

Jan. 6, 2021, 12:31 a.m. usa

1. subjects showing signs of severe pneumonia, acute respiratory distress syndrome (ards) or respiratory failure necessitating mechanical ventilation during the course of their covid-19 illness; 2. history of moderate or severe chronic respiratory disease (such as copd or asthma) and requirement for long-term oxygen therapy; 3. patient with pulse oxygen saturation (spo2) of <94% on room air at the time of screening 4. history of pulmonary embolus or deep venous thrombosis within the past year 5. history of splenectomy 6. history of chronic liver disease or patient showing signs of clinical jaundice at the time of screening 7. history of severe chronic kidney disease or requiring dialysis at the time of screening 8. patient with nyha class iii or iv congestive heart failure (chf) 9. patient with uncontrolled rheumatologic disorders at the time of screening 10. patients with a history of organ transplantation or are candidates for organ transplantation at the time of screening 11. patients with underlying chronic viral or bacterium illnesses including hepatitis of any kind, hiv, epstein-barr virus (ebv), chronic lyme disease 12. no history of chronic fatigue syndrome prior to covid-19 infection 13. no history of fibromyalgia prior to covid-19 infection 14. patients with malignant tumor, or other serious systemic diseases 15. treatment with any of the following: 1. hydroxychloroquine, oral or parenteral corticosteroids, immunosuppressants, or immunomodulating agents within 7 days prior to the screening visit 2. albuterol as nebulizer for the off-label treatment of covid-19 within 7 days prior to the screening visit 16. subjects who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (pro 140) are not eligible 17. inability to provide informed consent or to comply with test requirements 18. consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment 19. pregnancy or breast feeding 20. subject participating in another study with for an investigational treatment for covid-19

1. subjects showing signs of severe pneumonia, acute respiratory distress syndrome (ards) or respiratory failure necessitating mechanical ventilation during the course of their covid-19 illness; 2. history of moderate or severe chronic respiratory disease (such as copd or asthma) and requirement for long-term oxygen therapy; 3. patient with pulse oxygen saturation (spo2) of <94% on room air at the time of screening 4. history of pulmonary embolus or deep venous thrombosis within the past year 5. history of splenectomy 6. history of chronic liver disease or patient showing signs of clinical jaundice at the time of screening 7. history of severe chronic kidney disease or requiring dialysis at the time of screening 8. patient with nyha class iii or iv congestive heart failure (chf) 9. patient with uncontrolled rheumatologic disorders at the time of screening 10. patients with a history of organ transplantation or are candidates for organ transplantation at the time of screening 11. patients with underlying chronic viral or bacterium illnesses including hepatitis of any kind, hiv, epstein-barr virus (ebv), chronic lyme disease 12. no history of chronic fatigue syndrome prior to covid-19 infection 13. no history of fibromyalgia prior to covid-19 infection 14. patients with malignant tumor, or other serious systemic diseases 15. treatment with any of the following: 1. hydroxychloroquine, oral or parenteral corticosteroids, immunosuppressants, or immunomodulating agents within 7 days prior to the screening visit 2. albuterol as nebulizer for the off-label treatment of covid-19 within 7 days prior to the screening visit 16. subjects who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (pro 140) are not eligible 17. inability to provide informed consent or to comply with test requirements 18. consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment 19. pregnancy or breast feeding 20. subject participating in another study with for an investigational treatment for covid-19

Dec. 24, 2020, 12:31 a.m. usa

1. subjects showing signs of severe pneumonia, acute respiratory distress syndrome (ards) or respiratory failure necessitating mechanical ventilation during the course of their covid-19 illness; 2. history of moderate or severe chronic respiratory disease (such as codp or asthma) and requirement for long-term oxygen therapy; 3. patient with pulse oxygen saturation (spo2) of <94% on room air at the time of screening 4. history of pulmonary embolus or deep venous thrombosis within the past year 5. history of splenectomy 6. history of chronic liver disease or patient showing signs of clinical jaundice at the time of screening 7. history of severe chronic kidney disease or requiring dialysis at the time of screening 8. patient with nyha class iii or iv congestive heart failure (chf) 9. patient with uncontrolled rheumatologic disorders at the time of screening 10. patients with a history of organ transplantation or are candidates for organ transplantation at the time of screening 11. patients with underlying chronic viral or bacterium illnesses including hepatitis of any kind, hiv, epstein-barr virus (ebv), chronic lyme disease 12. no history of chronic fatigue syndrome prior to covid-19 infection 13. no history of fibromyalgia prior to covid-19 infection 14. patients with malignant tumor, or other serious systemic diseases 15. treatment with any of the following: 1. hydroxychloroquine, oral or parenteral corticosteroids, immunosuppressants, or immunomodulating agents within 7 days prior to the screening visit 2. albuterol as nebulizer for the off-label treatment of covid-19 within 7 days prior to the screening visit 16. subjects who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (pro 140) are not eligible 17. inability to provide informed consent or to comply with test requirements 18. consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment 19. pregnancy or breast feeding 20. subject participating in another study with for an investigational treatment for covid-19

1. subjects showing signs of severe pneumonia, acute respiratory distress syndrome (ards) or respiratory failure necessitating mechanical ventilation during the course of their covid-19 illness; 2. history of moderate or severe chronic respiratory disease (such as codp or asthma) and requirement for long-term oxygen therapy; 3. patient with pulse oxygen saturation (spo2) of <94% on room air at the time of screening 4. history of pulmonary embolus or deep venous thrombosis within the past year 5. history of splenectomy 6. history of chronic liver disease or patient showing signs of clinical jaundice at the time of screening 7. history of severe chronic kidney disease or requiring dialysis at the time of screening 8. patient with nyha class iii or iv congestive heart failure (chf) 9. patient with uncontrolled rheumatologic disorders at the time of screening 10. patients with a history of organ transplantation or are candidates for organ transplantation at the time of screening 11. patients with underlying chronic viral or bacterium illnesses including hepatitis of any kind, hiv, epstein-barr virus (ebv), chronic lyme disease 12. no history of chronic fatigue syndrome prior to covid-19 infection 13. no history of fibromyalgia prior to covid-19 infection 14. patients with malignant tumor, or other serious systemic diseases 15. treatment with any of the following: 1. hydroxychloroquine, oral or parenteral corticosteroids, immunosuppressants, or immunomodulating agents within 7 days prior to the screening visit 2. albuterol as nebulizer for the off-label treatment of covid-19 within 7 days prior to the screening visit 16. subjects who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (pro 140) are not eligible 17. inability to provide informed consent or to comply with test requirements 18. consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment 19. pregnancy or breast feeding 20. subject participating in another study with for an investigational treatment for covid-19