1. is not expected to survive more than 24 hours; 2. is on extracorporeal membrane oxygenation (ecmo) at the screening visit; 3. has an underlying clinical condition where, in the opinion of the investigator, it would be extremely unlikely that the patient would come off ventilation (eg, motor neuron disease, duchenne muscular dystrophy, or rapidly progressive pulmonary fibrosis); 4. has a known history of idiopathic pulmonary fibrosis or interstitial lung disease as defined by the american thoracic society 2018 guidelines; 5. has known active tuberculosis (tb), a history of incompletely treated tb, and/or suspected or known extrapulmonary tb; 6. has child pugh class b or c active liver disease or an alanine aminotransferase or aspartate aminotransferase level \> 4 x the upper limit of normal at the screening visit; 7. has moderate to severe renal insufficiency, defined as an estimated glomerular filtration rate (egfr) ≤ 30 ml/min/1.73 m2, at the screening visit or requires hemodialysis; 8. has a malignant tumor (excluding a malignant tumor cured with no recurrence in the past 5 years, completely resected basal cell and squamous cell carcinoma of skin, and/or completely resected carcinoma in situ of any type); 9. has an uncontrolled systemic or local autoimmune or inflammatory disease besides covid 19; 10. has evidence of an active concurrent non covid 19 pneumonia (requiring additional antimicrobial treatment) caused by a known or suspected bacterial pathogen, respiratory syncytial virus (rsv), influenza virus, sars cov 1, middle east respiratory syndrome cov, aspergillus, mucormycosis causing fungi, or other pulmonary pathogen(s); note: a viral respiratory panel will be administered at the screening visit to determine eligibility. at a minimum, the panel will evaluate for rsv, influenza a, and influenza b. 11. has received any other investigational therapeutic products within 4 weeks or 5 half-lives, whichever is longer, prior to randomization; 12. has a known history of human immunodeficiency virus (hiv), hepatitis b, or hepatitis c infection; 13. has a known serious allergic reaction or hypersensitivity to any components of fp-025; 14. is pregnant or breastfeeding; 15. has a history of drug or alcohol abuse within the past 2 years; 16. is currently on another systemic immunomodulatory therapy that is not considered standard of care treatment for covid 19 (eg, calcineurin inhibitor, hydroxychloroquine, anti cytokine therapy, or janus kinase inhibitor); or note: corticosteroids, including dexamethasone, in doses used for standard of care treatment for covid 19 are allowed. note: corticosteroids that are being used for other indications are also allowed as long as the daily prednisone (or other corticosteroid equivalent) dose is ≤ 10 mg. inhaled corticosteroids and nasal corticosteroids are also acceptable. note: as therapies for covid-19 are rapidly evolving, other medications that may be considered standard of care can be considered with prior approval from the sponsor or medical monitor. 17. has any other condition that, in the opinion of the investigator, could interfere with (or for which the treatment might interfere with) the conduct of the study or interpretation of the study results or that would place the patient at undue risk by participating in the study.

1. is not expected to survive more than 24 hours; 2. is on extracorporeal membrane oxygenation (ecmo) at the screening visit; 3. has an underlying clinical condition where, in the opinion of the investigator, it would be extremely unlikely that the patient would come off ventilation (eg, motor neuron disease, duchenne muscular dystrophy, or rapidly progressive pulmonary fibrosis); 4. has a known history of idiopathic pulmonary fibrosis or interstitial lung disease as defined by the american thoracic society 2018 guidelines; 5. has known active tuberculosis (tb), a history of incompletely treated tb, and/or suspected or known extrapulmonary tb; 6. has child pugh class b or c active liver disease or an alanine aminotransferase or aspartate aminotransferase level \> 4 x the upper limit of normal at the screening visit; 7. has moderate to severe renal insufficiency, defined as an estimated glomerular filtration rate (egfr) ≤ 30 ml/min/1.73 m2, at the screening visit or requires hemodialysis; 8. has a malignant tumor (excluding a malignant tumor cured with no recurrence in the past 5 years, completely resected basal cell and squamous cell carcinoma of skin, and/or completely resected carcinoma in situ of any type); 9. has an uncontrolled systemic or local autoimmune or inflammatory disease besides covid 19; 10. has evidence of an active concurrent non covid 19 pneumonia (requiring additional antimicrobial treatment) caused by a known or suspected bacterial pathogen, respiratory syncytial virus (rsv), influenza virus, sars cov 1, middle east respiratory syndrome cov, aspergillus, mucormycosis causing fungi, or other pulmonary pathogen(s); note: a viral respiratory panel will be administered at the screening visit to determine eligibility. at a minimum, the panel will evaluate for rsv, influenza a, and influenza b. 11. has received any other investigational therapeutic products within 4 weeks or 5 half-lives, whichever is longer, prior to randomization; 12. has a known history of human immunodeficiency virus (hiv), hepatitis b, or hepatitis c infection; 13. has a known serious allergic reaction or hypersensitivity to any components of fp-025; 14. is pregnant or breastfeeding; 15. has a history of drug or alcohol abuse within the past 2 years; 16. is currently on another systemic immunomodulatory therapy that is not considered standard of care treatment for covid 19 (eg, calcineurin inhibitor, hydroxychloroquine, anti cytokine therapy, or janus kinase inhibitor); or note: corticosteroids, including dexamethasone, in doses used for standard of care treatment for covid 19 are allowed. note: corticosteroids that are being used for other indications are also allowed as long as the daily prednisone (or other corticosteroid equivalent) dose is ≤ 10 mg. inhaled corticosteroids and nasal corticosteroids are also acceptable. note: as therapies for covid-19 are rapidly evolving, other medications that may be considered standard of care can be considered with prior approval from the sponsor or medical monitor. 17. has any other condition that, in the opinion of the investigator, could interfere with (or for which the treatment might interfere with) the conduct of the study or interpretation of the study results or that would place the patient at undue risk by participating in the study.

is not expected to survive more than 24 hours; is on extracorporeal membrane oxygenation (ecmo) at the screening visit; has an underlying clinical condition where, in the opinion of the investigator, it would be extremely unlikely that the patient would come off ventilation (eg, motor neuron disease, duchenne muscular dystrophy, or rapidly progressive pulmonary fibrosis); has a known history of idiopathic pulmonary fibrosis or interstitial lung disease as defined by the american thoracic society 2018 guidelines; has known active tuberculosis (tb), a history of incompletely treated tb, and/or suspected or known extrapulmonary tb; has child pugh class b or c active liver disease or an alanine aminotransferase or aspartate aminotransferase level > 4 x the upper limit of normal at the screening visit; has moderate to severe renal insufficiency, defined as an estimated glomerular filtration rate (egfr) ≤ 30 ml/min/1.73 m2, at the screening visit or requires hemodialysis; has a malignant tumor (excluding a malignant tumor cured with no recurrence in the past 5 years, completely resected basal cell and squamous cell carcinoma of skin, and/or completely resected carcinoma in situ of any type); has an uncontrolled systemic or local autoimmune or inflammatory disease besides covid 19; has evidence of an active concurrent non covid 19 pneumonia (requiring additional antimicrobial treatment) caused by a known or suspected bacterial pathogen, respiratory syncytial virus (rsv), influenza virus, sars cov 1, middle east respiratory syndrome cov, aspergillus, mucormycosis causing fungi, or other pulmonary pathogen(s); note: a viral respiratory panel will be administered at the screening visit to determine eligibility. at a minimum, the panel will evaluate for rsv, influenza a, and influenza b. has received any other investigational therapeutic products within 4 weeks or 5 half-lives, whichever is longer, prior to randomization; has a known history of human immunodeficiency virus (hiv), hepatitis b, or hepatitis c infection; has a known serious allergic reaction or hypersensitivity to any components of fp-025; is pregnant or breastfeeding; has a history of drug or alcohol abuse within the past 2 years; is currently on another systemic immunomodulatory therapy that is not considered standard of care treatment for covid 19 (eg, calcineurin inhibitor, hydroxychloroquine, anti cytokine therapy, or janus kinase inhibitor); or note: corticosteroids, including dexamethasone, in doses used for standard of care treatment for covid 19 are allowed. note: corticosteroids that are being used for other indications are also allowed as long as the daily prednisone (or other corticosteroid equivalent) dose is ≤ 10 mg. inhaled corticosteroids and nasal corticosteroids are also acceptable. note: as therapies for covid-19 are rapidly evolving, other medications that may be considered standard of care can be considered with prior approval from the sponsor or medical monitor. has any other condition that, in the opinion of the investigator, could interfere with (or for which the treatment might interfere with) the conduct of the study or interpretation of the study results or that would place the patient at undue risk by participating in the study.

is not expected to survive more than 24 hours; is on extracorporeal membrane oxygenation (ecmo) at the screening visit; has an underlying clinical condition where, in the opinion of the investigator, it would be extremely unlikely that the patient would come off ventilation (eg, motor neuron disease, duchenne muscular dystrophy, or rapidly progressive pulmonary fibrosis); has a known history of idiopathic pulmonary fibrosis or interstitial lung disease as defined by the american thoracic society 2018 guidelines; has known active tuberculosis (tb), a history of incompletely treated tb, and/or suspected or known extrapulmonary tb; has child pugh class b or c active liver disease or an alanine aminotransferase or aspartate aminotransferase level > 4 x the upper limit of normal at the screening visit; has moderate to severe renal insufficiency, defined as an estimated glomerular filtration rate (egfr) ≤ 30 ml/min/1.73 m2, at the screening visit or requires hemodialysis; has a malignant tumor (excluding a malignant tumor cured with no recurrence in the past 5 years, completely resected basal cell and squamous cell carcinoma of skin, and/or completely resected carcinoma in situ of any type); has an uncontrolled systemic or local autoimmune or inflammatory disease besides covid 19; has evidence of an active concurrent non covid 19 pneumonia (requiring additional antimicrobial treatment) caused by a known or suspected bacterial pathogen, respiratory syncytial virus (rsv), influenza virus, sars cov 1, middle east respiratory syndrome cov, aspergillus, mucormycosis causing fungi, or other pulmonary pathogen(s); note: a viral respiratory panel will be administered at the screening visit to determine eligibility. at a minimum, the panel will evaluate for rsv, influenza a, and influenza b. has received any other investigational therapeutic products within 4 weeks or 5 half-lives, whichever is longer, prior to randomization; has a known history of human immunodeficiency virus (hiv), hepatitis b, or hepatitis c infection; has a known serious allergic reaction or hypersensitivity to any components of fp-025; is pregnant or breastfeeding; has a history of drug or alcohol abuse within the past 2 years; is currently on another systemic immunomodulatory therapy that is not considered standard of care treatment for covid 19 (eg, calcineurin inhibitor, hydroxychloroquine, anti cytokine therapy, or janus kinase inhibitor); or note: corticosteroids, including dexamethasone, in doses used for standard of care treatment for covid 19 are allowed. note: corticosteroids that are being used for other indications are also allowed as long as the daily prednisone (or other corticosteroid equivalent) dose is ≤ 10 mg. inhaled corticosteroids and nasal corticosteroids are also acceptable. note: as therapies for covid-19 are rapidly evolving, other medications that may be considered standard of care can be considered with prior approval from the sponsor or medical monitor. has any other condition that, in the opinion of the investigator, could interfere with (or for which the treatment might interfere with) the conduct of the study or interpretation of the study results or that would place the patient at undue risk by participating in the study.

1. is not expected to survive more than 24 hours; 2. is on extracorporeal membrane oxygenation (ecmo) at the screening visit; 3. has an underlying clinical condition where, in the opinion of the investigator, it would be extremely unlikely that the patient would come off ventilation (eg, motor neuron disease, duchenne muscular dystrophy, or rapidly progressive pulmonary fibrosis); 4. has a known history of idiopathic pulmonary fibrosis or interstitial lung disease as defined by the american thoracic society 2018 guidelines; 5. has known active tuberculosis (tb), a history of incompletely treated tb, and/or suspected or known extrapulmonary tb; 6. has child pugh class b or c active liver disease or an alanine aminotransferase or aspartate aminotransferase level > 4 x the upper limit of normal at the screening visit; 7. has moderate to severe renal insufficiency, defined as an estimated glomerular filtration rate (egfr) ≤ 30 ml/min/1.73 m2, at the screening visit or requires hemodialysis; 8. has a malignant tumor (excluding a malignant tumor cured with no recurrence in the past 5 years, completely resected basal cell and squamous cell carcinoma of skin, and/or completely resected carcinoma in situ of any type); 9. has an uncontrolled systemic or local autoimmune or inflammatory disease besides covid 19; 10. has evidence of an active concurrent non covid 19 pneumonia (requiring additional antimicrobial treatment) caused by a known or suspected bacterial pathogen, respiratory syncytial virus (rsv), influenza virus, sars cov 1, middle east respiratory syndrome cov, aspergillus, mucormycosis causing fungi, or other pulmonary pathogen(s); note: a viral respiratory panel will be administered at the screening visit to determine eligibility. at a minimum, the panel will evaluate for rsv, influenza a, and influenza b. 11. has received any other investigational therapeutic products within 4 weeks or 5 half-lives, whichever is longer, prior to randomization; 12. has a known history of human immunodeficiency virus (hiv), hepatitis b, or hepatitis c infection; 13. has a known serious allergic reaction or hypersensitivity to any components of fp-025; 14. is pregnant or breastfeeding; 15. has a history of drug or alcohol abuse within the past 2 years; 16. is currently on another systemic immunomodulatory therapy that is not considered standard of care treatment for covid 19 (eg, calcineurin inhibitor, hydroxychloroquine, anti cytokine therapy, or janus kinase inhibitor); or note: corticosteroids, including dexamethasone, in doses used for standard of care treatment for covid 19 are allowed. note: corticosteroids that are being used for other indications are also allowed as long as the daily prednisone (or other corticosteroid equivalent) dose is ≤ 10 mg. inhaled corticosteroids and nasal corticosteroids are also acceptable. note: as therapies for covid-19 are rapidly evolving, other medications that may be considered standard of care can be considered with prior approval from the sponsor or medical monitor. 17. has any other condition that, in the opinion of the investigator, could interfere with (or for which the treatment might interfere with) the conduct of the study or interpretation of the study results or that would place the patient at undue risk by participating in the study.

1. is not expected to survive more than 24 hours; 2. is on extracorporeal membrane oxygenation (ecmo) at the screening visit; 3. has an underlying clinical condition where, in the opinion of the investigator, it would be extremely unlikely that the patient would come off ventilation (eg, motor neuron disease, duchenne muscular dystrophy, or rapidly progressive pulmonary fibrosis); 4. has a known history of idiopathic pulmonary fibrosis or interstitial lung disease as defined by the american thoracic society 2018 guidelines; 5. has known active tuberculosis (tb), a history of incompletely treated tb, and/or suspected or known extrapulmonary tb; 6. has child pugh class b or c active liver disease or an alanine aminotransferase or aspartate aminotransferase level > 4 x the upper limit of normal at the screening visit; 7. has moderate to severe renal insufficiency, defined as an estimated glomerular filtration rate (egfr) ≤ 30 ml/min/1.73 m2, at the screening visit or requires hemodialysis; 8. has a malignant tumor (excluding a malignant tumor cured with no recurrence in the past 5 years, completely resected basal cell and squamous cell carcinoma of skin, and/or completely resected carcinoma in situ of any type); 9. has an uncontrolled systemic or local autoimmune or inflammatory disease besides covid 19; 10. has evidence of an active concurrent non covid 19 pneumonia (requiring additional antimicrobial treatment) caused by a known or suspected bacterial pathogen, respiratory syncytial virus (rsv), influenza virus, sars cov 1, middle east respiratory syndrome cov, aspergillus, mucormycosis causing fungi, or other pulmonary pathogen(s); note: a viral respiratory panel will be administered at the screening visit to determine eligibility. at a minimum, the panel will evaluate for rsv, influenza a, and influenza b. 11. has received any other investigational therapeutic products within 4 weeks or 5 half-lives, whichever is longer, prior to randomization; 12. has a known history of human immunodeficiency virus (hiv), hepatitis b, or hepatitis c infection; 13. has a known serious allergic reaction or hypersensitivity to any components of fp-025; 14. is pregnant or breastfeeding; 15. has a history of drug or alcohol abuse within the past 2 years; 16. is currently on another systemic immunomodulatory therapy that is not considered standard of care treatment for covid 19 (eg, calcineurin inhibitor, hydroxychloroquine, anti cytokine therapy, or janus kinase inhibitor); or note: corticosteroids, including dexamethasone, in doses used for standard of care treatment for covid 19 are allowed. note: corticosteroids that are being used for other indications are also allowed as long as the daily prednisone (or other corticosteroid equivalent) dose is ≤ 10 mg. inhaled corticosteroids and nasal corticosteroids are also acceptable. note: as therapies for covid-19 are rapidly evolving, other medications that may be considered standard of care can be considered with prior approval from the sponsor or medical monitor. 17. has any other condition that, in the opinion of the investigator, could interfere with (or for which the treatment might interfere with) the conduct of the study or interpretation of the study results or that would place the patient at undue risk by participating in the study.