Methods for treating or preventing SARS-CoV-2 infections and COVID-19 with anti-SARS-CoV-2 spike glycoprotein antibodies

A method for preventing a SARS-CoV-2 infection or COVID-19 in a subject, the method comprising administering a prophylactic composition to the subject, wherein the prophylactic composition comprises at least one antigen-binding molecule that binds a surface protein of SARS-CoV-2, wherein the at least one antigen-binding molecule is an anti-SARS-CoV-2 spike glycoprotein antibody or antigen-binding fragment thereof comprising three heavy chain complementarity determining regions (HCDRs) and three light chain complementarity determining regions (LCDRs), HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3, contained within a heavy chain variable region (HCVR) and light chain variable region (LCVR) amino acid sequence pair comprising the amino acid sequences selected from the group consisting of SEQ ID NOs:

• 2 and 10, SEQ ID NOs:
• 22 and 30, and SEQ ID NOs:
• 42 and 50.

A method for improving one or more clinical parameters of a SARS-CoV-2 infection, the method comprising administering a therapeutic composition to a subject with a SARS-CoV-2 infection, wherein the therapeutic composition comprises a first anti-SARS-CoV-2 spike glycoprotein antibody or antigen-binding fragment thereof comprising three heavy chain complementarity determining regions (HCDRs) and three light chain complementarity determining regions (LCDRs) contained within a heavy chain variable region (HCVR) and light chain variable region (LCVR) amino acid sequence pair comprising the amino acid sequences of SEQ ID NOs:

• 2 and 10N/10n, and a second anti-SARS-CoV-2 spike glycoprotein antibody or antigen-binding fragment thereof comprising three HCDRs and three LCDRs contained within an HCVR and an LCVR amino acid sequence pair comprising the amino acid sequences of SEQ ID NOs:
• 22 and 30, wherein a time to alleviate at least one clinical parameter of a SARS-CoV-2 infection in a population of seronegative subjects administered said therapeutic composition is shorter than that of a comparable population of seronegative subjects administered a placebo.

A method for improving one or more clinical parameters of a SARS-CoV-2 infection, the method comprising administering a therapeutic composition to a subject with a SARS-CoV-2 infection, wherein the therapeutic composition comprises a first anti-SARS-CoV-2 spike glycoprotein antibody or antigen-binding fragment thereof comprising three heavy chain complementarity determining regions (HCDRs) and three light chain complementarity determining regions (LCDRs) contained within a heavy chain variable region (HCVR) and light chain variable region (LCVR) amino acid sequence pair comprising the amino acid sequences of SEQ ID NOs:

• 2 and 10, and a second anti-SARS-CoV-2 spike glycoprotein antibody or antigen-binding fragment thereof comprising three HCDRs and three LCDRs contained within an HCVR and an LCVR amino acid sequence pair comprising the amino acid sequences of SEQ ID NOs:
• 22 and 30, wherein a time to alleviate at least one clinical parameter of a SARS-CoV-2 infection in a population of seronegative subjects administered said therapeutic composition is shorter than that of a comparable population of seropositive subjects.

A method for improving one or more clinical parameters of a SARS-CoV-2 infection, the method comprising administering a therapeutic composition to a subject with a SARS-CoV-2 infection, wherein the therapeutic composition comprises a first anti-SARS-CoV-2 spike glycoprotein antibody or antigen-binding fragment thereof comprising three heavy chain complementarity determining regions (HCDRs) and three light chain complementarity determining regions (LCDRs) contained within a heavy chain variable region (HCVR) and light chain variable region (LCVR) amino acid sequence pair comprising the amino acid sequences of SEQ ID NOs:

• 2 and 10, and a second anti-SARS-CoV-2 spike glycoprotein antibody or antigen-binding fragment thereof comprising three HCDRs and three LCDRs contained within an HCVR and an LCVR amino acid sequence pair comprising the amino acid sequences of SEQ ID NOs:
• 22 and 30, wherein said therapeutic composition reduces viral load through 7 days post-administration (Day 7) in a population of subjects as compared to the day of administration (Day 0).

A method for improving one or more clinical parameters of a SARS-CoV-2 infection, the method comprising administering a therapeutic composition to a subject with a SARS-CoV-2 infection, wherein the therapeutic composition comprises a first anti-SARS-CoV-2 spike glycoprotein antibody or antigen-binding fragment thereof comprising three heavy chain complementarity determining regions (HCDRs) and three light chain complementarity determining regions (LCDRs) contained within a heavy chain variable region (HCVR) and light chain variable region (LCVR) amino acid sequence pair comprising the amino acid sequences of SEQ ID NOs:

• 2 and 10, and a second anti-SARS-CoV-2 spike glycoprotein antibody or antigen-binding fragment thereof comprising three HCDRs and three LCDRs contained within an HCVR and an LCVR amino acid sequence pair comprising the amino acid sequences of SEQ ID NOs:
• 22 and 30, wherein said therapeutic composition reduces viral load in a population of subjects.

A method for improving one or more clinical parameters of a SARS-CoV-2 infection, the method comprising administering a therapeutic composition to a subject with a SARS-CoV-2 infection, wherein the therapeutic composition comprises a first anti-SARS-CoV-2 spike glycoprotein antibody or antigen-binding fragment thereof comprising three heavy chain complementarity determining regions (HCDRs) and three light chain complementarity determining regions (LCDRs) contained within a heavy chain variable region (HCVR) and light chain variable region (LCVR) amino acid sequence pair comprising the amino acid sequences of SEQ ID NOs:

• 2 and 10, and a second anti-SARS-CoV-2 spike glycoprotein antibody or antigen-binding fragment thereof comprising three HCDRs and three LCDRs contained within an HCVR and an LCVR amino acid sequence pair comprising the amino acid sequences of SEQ ID NOs:
• 22 and 30, wherein said therapeutic composition reduces time to symptom alleviation by a median of 4 days in a population of subjects treated with 0.6 g of the first anti-SARS-CoV-2 spike glycoprotein antibody and 0.6 g of the second anti-SARS-CoV-2 spike glycoprotein antibody or 1.2 g of the first anti-SARS-CoV-2 spike glycoprotein antibody and 1.2 g of the second anti-SARS-CoV-2 spike glycoprotein antibody, as compared to a comparable population of subjects treated with a placebo.