1. age \< 18 years. 2. subject has a body mass index \>35 kg/m2 or glycosylated hemoglobin (hgb a1c) ≥ 9% at screening. 3. currently requires (or in opinion of investigator is likely to require within 48 hours of enrollment) mechanical ventilation or extracorporeal membrane oxygen saturation (ecmo). 4. prior history (or considered to be at risk) of acute liver disease or chronic unstable liver disease (child-pugh b or c) or alanine transaminase (alt) or aspartate transaminase (ast) \> 5 × uln at screening. 5. prior history of chronic obstructive pulmonary disease requiring supplemental oxygen, or active/incompletely treated tuberculosis. 6. concomitant uncontrolled systemic bacterial or fungal infection or concomitant viral infection other than covid-19 (e.g., influenza, respiratory syncytial virus). 7. any underlying condition or therapy associated with immunosuppression. 8. serious concomitant illness which in the opinion of the investigator precludes the subject from enrolling in the trial. 9. history of untreated syphilis, hepatitis b, or untreated hepatitis c virus. 10. uncontrolled human immunodeficiency virus. 11. acute kidney injury stage 3 or higher or chronic kidney disease stage 4 or higher. 12. known hypersensitivity to foralumab or excipients. 13. females of child-bearing potential, who are pregnant, breast-feeding, intend to become pregnant or are not using highly effective contraceptive methods. females who are postmenopausal (defined as at least 12 months of amenorrhea) are not considered to be of child-bearing potential. highly effective contraceptive methods are defined as: 1. having a male partner who is sterile (vasectomized or orchiectomized) prior to the female subject's entry into the trial and is the sole sexual partner for that female subject 2. surgically sterile (hysterectomy or bilateral oophorectomy); bilateral tubal ligation with surgery at least 6 weeks before study initiation 3. use of intra-uterine devices in place for at least 3 months 4. stable hormonal contraception for at least 3 months before study initiation and through study completion 5. barrier method (condom or diaphragm) with spermicide for at least 14 days before study initiation through study completion 6. true abstinence: when this is in line with the preferred and usual lifestyle of the subject (period abstinence \[eg, calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception) 14. active participation in any other clinical trial or receipt of an experimental treatment within the preceding 30 days. 15. receipt of covid-19 convalescent plasma, or covid-19 mabs, within 3 months of enrollment. 16. receipt of any anti-il-6 mab or similar anti-inflammatory medications (e.g, janus kinase inhibitors) within 3 months of enrollment. 17. prior receipt of any covid-19 vaccine. 18. receipt of any treatment for covid-19 (off-label, compassionate use, or investigational use) except per local soc within 30 days prior to screening. 19. history of opioid or cocaine (including crack cocaine) use. 20. use of any nasally administered medications within 1 week of enrollment. 21. in the opinion of the investigator, the subject is unable to comply with the requirements to participate in the study.

1. age \< 18 years. 2. subject has a body mass index \>35 kg/m2 or glycosylated hemoglobin (hgb a1c) ≥ 9% at screening. 3. currently requires (or in opinion of investigator is likely to require within 48 hours of enrollment) mechanical ventilation or extracorporeal membrane oxygen saturation (ecmo). 4. prior history (or considered to be at risk) of acute liver disease or chronic unstable liver disease (child-pugh b or c) or alanine transaminase (alt) or aspartate transaminase (ast) \> 5 × uln at screening. 5. prior history of chronic obstructive pulmonary disease requiring supplemental oxygen, or active/incompletely treated tuberculosis. 6. concomitant uncontrolled systemic bacterial or fungal infection or concomitant viral infection other than covid-19 (e.g., influenza, respiratory syncytial virus). 7. any underlying condition or therapy associated with immunosuppression. 8. serious concomitant illness which in the opinion of the investigator precludes the subject from enrolling in the trial. 9. history of untreated syphilis, hepatitis b, or untreated hepatitis c virus. 10. uncontrolled human immunodeficiency virus. 11. acute kidney injury stage 3 or higher or chronic kidney disease stage 4 or higher. 12. known hypersensitivity to foralumab or excipients. 13. females of child-bearing potential, who are pregnant, breast-feeding, intend to become pregnant or are not using highly effective contraceptive methods. females who are postmenopausal (defined as at least 12 months of amenorrhea) are not considered to be of child-bearing potential. highly effective contraceptive methods are defined as: 1. having a male partner who is sterile (vasectomized or orchiectomized) prior to the female subject's entry into the trial and is the sole sexual partner for that female subject 2. surgically sterile (hysterectomy or bilateral oophorectomy); bilateral tubal ligation with surgery at least 6 weeks before study initiation 3. use of intra-uterine devices in place for at least 3 months 4. stable hormonal contraception for at least 3 months before study initiation and through study completion 5. barrier method (condom or diaphragm) with spermicide for at least 14 days before study initiation through study completion 6. true abstinence: when this is in line with the preferred and usual lifestyle of the subject (period abstinence \[eg, calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception) 14. active participation in any other clinical trial or receipt of an experimental treatment within the preceding 30 days. 15. receipt of covid-19 convalescent plasma, or covid-19 mabs, within 3 months of enrollment. 16. receipt of any anti-il-6 mab or similar anti-inflammatory medications (e.g, janus kinase inhibitors) within 3 months of enrollment. 17. prior receipt of any covid-19 vaccine. 18. receipt of any treatment for covid-19 (off-label, compassionate use, or investigational use) except per local soc within 30 days prior to screening. 19. history of opioid or cocaine (including crack cocaine) use. 20. use of any nasally administered medications within 1 week of enrollment. 21. in the opinion of the investigator, the subject is unable to comply with the requirements to participate in the study.

age < 18 years. subject has a body mass index >35 kg/m2 or glycosylated hemoglobin (hgb a1c) ≥ 9% at screening. currently requires (or in opinion of investigator is likely to require within 48 hours of enrollment) mechanical ventilation or extracorporeal membrane oxygen saturation (ecmo). prior history (or considered to be at risk) of acute liver disease or chronic unstable liver disease (child-pugh b or c) or alanine transaminase (alt) or aspartate transaminase (ast) > 5 × uln at screening. prior history of chronic obstructive pulmonary disease requiring supplemental oxygen, or active/incompletely treated tuberculosis. concomitant uncontrolled systemic bacterial or fungal infection or concomitant viral infection other than covid-19 (e.g., influenza, respiratory syncytial virus). any underlying condition or therapy associated with immunosuppression. serious concomitant illness which in the opinion of the investigator precludes the subject from enrolling in the trial. history of untreated syphilis, hepatitis b, or untreated hepatitis c virus. uncontrolled human immunodeficiency virus. acute kidney injury stage 3 or higher or chronic kidney disease stage 4 or higher. known hypersensitivity to foralumab or excipients. females of child-bearing potential, who are pregnant, breast-feeding, intend to become pregnant or are not using highly effective contraceptive methods. females who are postmenopausal (defined as at least 12 months of amenorrhea) are not considered to be of child-bearing potential. highly effective contraceptive methods are defined as: having a male partner who is sterile (vasectomized or orchiectomized) prior to the female subject's entry into the trial and is the sole sexual partner for that female subject surgically sterile (hysterectomy or bilateral oophorectomy); bilateral tubal ligation with surgery at least 6 weeks before study initiation use of intra-uterine devices in place for at least 3 months stable hormonal contraception for at least 3 months before study initiation and through study completion barrier method (condom or diaphragm) with spermicide for at least 14 days before study initiation through study completion true abstinence: when this is in line with the preferred and usual lifestyle of the subject (period abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception) active participation in any other clinical trial or receipt of an experimental treatment within the preceding 30 days. receipt of covid-19 convalescent plasma, or covid-19 mabs, within 3 months of enrollment. receipt of any anti-il-6 mab or similar anti-inflammatory medications (e.g, janus kinase inhibitors) within 3 months of enrollment. prior receipt of any covid-19 vaccine. receipt of any treatment for covid-19 (off-label, compassionate use, or investigational use) except per local soc within 30 days prior to screening. history of opioid or cocaine (including crack cocaine) use. use of any nasally administered medications within 1 week of enrollment. in the opinion of the investigator, the subject is unable to comply with the requirements to participate in the study.

age < 18 years. subject has a body mass index >35 kg/m2 or glycosylated hemoglobin (hgb a1c) ≥ 9% at screening. currently requires (or in opinion of investigator is likely to require within 48 hours of enrollment) mechanical ventilation or extracorporeal membrane oxygen saturation (ecmo). prior history (or considered to be at risk) of acute liver disease or chronic unstable liver disease (child-pugh b or c) or alanine transaminase (alt) or aspartate transaminase (ast) > 5 × uln at screening. prior history of chronic obstructive pulmonary disease requiring supplemental oxygen, or active/incompletely treated tuberculosis. concomitant uncontrolled systemic bacterial or fungal infection or concomitant viral infection other than covid-19 (e.g., influenza, respiratory syncytial virus). any underlying condition or therapy associated with immunosuppression. serious concomitant illness which in the opinion of the investigator precludes the subject from enrolling in the trial. history of untreated syphilis, hepatitis b, or untreated hepatitis c virus. uncontrolled human immunodeficiency virus. acute kidney injury stage 3 or higher or chronic kidney disease stage 4 or higher. known hypersensitivity to foralumab or excipients. females of child-bearing potential, who are pregnant, breast-feeding, intend to become pregnant or are not using highly effective contraceptive methods. females who are postmenopausal (defined as at least 12 months of amenorrhea) are not considered to be of child-bearing potential. highly effective contraceptive methods are defined as: having a male partner who is sterile (vasectomized or orchiectomized) prior to the female subject's entry into the trial and is the sole sexual partner for that female subject surgically sterile (hysterectomy or bilateral oophorectomy); bilateral tubal ligation with surgery at least 6 weeks before study initiation use of intra-uterine devices in place for at least 3 months stable hormonal contraception for at least 3 months before study initiation and through study completion barrier method (condom or diaphragm) with spermicide for at least 14 days before study initiation through study completion true abstinence: when this is in line with the preferred and usual lifestyle of the subject (period abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception) active participation in any other clinical trial or receipt of an experimental treatment within the preceding 30 days. receipt of covid-19 convalescent plasma, or covid-19 mabs, within 3 months of enrollment. receipt of any anti-il-6 mab or similar anti-inflammatory medications (e.g, janus kinase inhibitors) within 3 months of enrollment. prior receipt of any covid-19 vaccine. receipt of any treatment for covid-19 (off-label, compassionate use, or investigational use) except per local soc within 30 days prior to screening. history of opioid or cocaine (including crack cocaine) use. use of any nasally administered medications within 1 week of enrollment. in the opinion of the investigator, the subject is unable to comply with the requirements to participate in the study.

1. age < 18 years. 2. subject has a body mass index >35 kg/m2 or glycosylated hemoglobin (hgb a1c) ≥ 9% at screening. 3. currently requires (or in opinion of investigator is likely to require within 48 hours of enrollment) mechanical ventilation or extracorporeal membrane oxygen saturation (ecmo). 4. prior history (or considered to be at risk) of acute liver disease or chronic unstable liver disease (child-pugh b or c) or alanine transaminase (alt) or aspartate transaminase (ast) > 5 × uln at screening. 5. prior history of chronic obstructive pulmonary disease requiring supplemental oxygen, or active/incompletely treated tuberculosis. 6. concomitant uncontrolled systemic bacterial or fungal infection or concomitant viral infection other than covid-19 (e.g., influenza, respiratory syncytial virus). 7. any underlying condition or therapy associated with immunosuppression. 8. serious concomitant illness which in the opinion of the investigator precludes the subject from enrolling in the trial. 9. history of untreated syphilis, hepatitis b, or untreated hepatitis c virus. 10. uncontrolled human immunodeficiency virus. 11. acute kidney injury stage 3 or higher or chronic kidney disease stage 4 or higher. 12. known hypersensitivity to foralumab or excipients. 13. females of child-bearing potential, who are pregnant, breast-feeding, intend to become pregnant or are not using highly effective contraceptive methods. females who are postmenopausal (defined as at least 12 months of amenorrhea) are not considered to be of child-bearing potential. highly effective contraceptive methods are defined as: 1. having a male partner who is sterile (vasectomized or orchiectomized) prior to the female subject's entry into the trial and is the sole sexual partner for that female subject 2. surgically sterile (hysterectomy or bilateral oophorectomy); bilateral tubal ligation with surgery at least 6 weeks before study initiation 3. use of intra-uterine devices in place for at least 3 months 4. stable hormonal contraception for at least 3 months before study initiation and through study completion 5. barrier method (condom or diaphragm) with spermicide for at least 14 days before study initiation through study completion 6. true abstinence: when this is in line with the preferred and usual lifestyle of the subject (period abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception) 14. active participation in any other clinical trial or receipt of an experimental treatment within the preceding 30 days. 15. receipt of covid-19 convalescent plasma, or covid-19 mabs, within 3 months of enrollment. 16. receipt of any anti-il-6 mab or similar anti-inflammatory medications (e.g, janus kinase inhibitors) within 3 months of enrollment. 17. prior receipt of any covid-19 vaccine. 18. receipt of any treatment for covid-19 (off-label, compassionate use, or investigational use) except per local soc within 30 days prior to screening. 19. history of opioid or cocaine (including crack cocaine) use. 20. use of any nasally administered medications within 1 week of enrollment. 21. in the opinion of the investigator, the subject is unable to comply with the requirements to participate in the study.

1. age < 18 years. 2. subject has a body mass index >35 kg/m2 or glycosylated hemoglobin (hgb a1c) ≥ 9% at screening. 3. currently requires (or in opinion of investigator is likely to require within 48 hours of enrollment) mechanical ventilation or extracorporeal membrane oxygen saturation (ecmo). 4. prior history (or considered to be at risk) of acute liver disease or chronic unstable liver disease (child-pugh b or c) or alanine transaminase (alt) or aspartate transaminase (ast) > 5 × uln at screening. 5. prior history of chronic obstructive pulmonary disease requiring supplemental oxygen, or active/incompletely treated tuberculosis. 6. concomitant uncontrolled systemic bacterial or fungal infection or concomitant viral infection other than covid-19 (e.g., influenza, respiratory syncytial virus). 7. any underlying condition or therapy associated with immunosuppression. 8. serious concomitant illness which in the opinion of the investigator precludes the subject from enrolling in the trial. 9. history of untreated syphilis, hepatitis b, or untreated hepatitis c virus. 10. uncontrolled human immunodeficiency virus. 11. acute kidney injury stage 3 or higher or chronic kidney disease stage 4 or higher. 12. known hypersensitivity to foralumab or excipients. 13. females of child-bearing potential, who are pregnant, breast-feeding, intend to become pregnant or are not using highly effective contraceptive methods. females who are postmenopausal (defined as at least 12 months of amenorrhea) are not considered to be of child-bearing potential. highly effective contraceptive methods are defined as: 1. having a male partner who is sterile (vasectomized or orchiectomized) prior to the female subject's entry into the trial and is the sole sexual partner for that female subject 2. surgically sterile (hysterectomy or bilateral oophorectomy); bilateral tubal ligation with surgery at least 6 weeks before study initiation 3. use of intra-uterine devices in place for at least 3 months 4. stable hormonal contraception for at least 3 months before study initiation and through study completion 5. barrier method (condom or diaphragm) with spermicide for at least 14 days before study initiation through study completion 6. true abstinence: when this is in line with the preferred and usual lifestyle of the subject (period abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception) 14. active participation in any other clinical trial or receipt of an experimental treatment within the preceding 30 days. 15. receipt of covid-19 convalescent plasma, or covid-19 mabs, within 3 months of enrollment. 16. receipt of any anti-il-6 mab or similar anti-inflammatory medications (e.g, janus kinase inhibitors) within 3 months of enrollment. 17. prior receipt of any covid-19 vaccine. 18. receipt of any treatment for covid-19 (off-label, compassionate use, or investigational use) except per local soc within 30 days prior to screening. 19. history of opioid or cocaine (including crack cocaine) use. 20. use of any nasally administered medications within 1 week of enrollment. 21. in the opinion of the investigator, the subject is unable to comply with the requirements to participate in the study.