# US 2025/0093335 A1 · Method for evaluating severity risk of coronavirus infectious disease, and kit for evaluating severity risk of coronavirus infection disease

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- Number: US 2025/0093335 A1
- Document ID: US20250093335A1
- Status: Published application
- Kind: A1
- Application number: 18/291,704
- Filed: 2022-03-08
- Published: 2025-03-20
- Earliest claimed: 2021-07-29
- Assignees: Tohoku University
- Applicants: Tohoku University
- Inventors: Tsutomu TAMADA
- Web page: https://patentgrep.com/patent/US20250093335A1

## CPC

- G01N 33/5091: {for testing the pathological state of an organism}
- C07K 14/165: Coronaviridae, e.g. avian infectious bronchitis virus
- C07K 16/24: against cytokines, lymphokines or interferons
- C12Q 1/02: involving viable microorganisms
- G01N 33/50: Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing (measuring or testing processes involving enzymes or microorganisms, compositions or test papers therefor; processes for forming such compositions, condition responsive control in microbiological or enzymological processes C12Q)
- G01N 33/505: {involving T-cells}
- G01N 33/53: Immunoassay; Biospecific binding assay; Materials therefor
- G01N 33/569: for microorganisms, e.g. protozoa, bacteria, viruses
- G01N 33/56983: {Viruses}
- G01N 33/68: involving proteins, peptides or amino acids {(involving lipoproteins G01N33/92)}
- G01N 2333/165: Coronaviridae, e.g. avian infectious bronchitis virus
- G01N 2800/50: Determining the risk of developing a disease
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES

## Abstract

Provided is a method for evaluating a severity risk of a coronavirus infectious disease. The method includes: (a) a step of bringing a subject-derived T cell into contact with a protein or fragment thereof derived from another kind of coronavirus which is a different kind of coronavirus from a causal virus of the coronavirus infectious disease; and (b) a step of evaluating a severity risk of the coronavirus infectious disease based on responsiveness of the T cell to the protein or fragment thereof. Also provided is a kit for evaluating a severity risk of a coronavirus infectious disease including a protein or fragment thereof derived from another kind of coronavirus which is a different kind of coronavirus from the causal virus of the coronavirus infectious disease.

## Claims

### Claim at position 1

-13. (canceled)

### Claim 14

A method for evaluating a severity risk of a coronavirus infectious disease, the method comprising:
(a) a step of bringing a subject-derived T cell into contact with a protein or fragment thereof derived from another kind of coronavirus which is a different kind of coronavirus from a causal virus of the coronavirus infectious disease; and
(b) a step of evaluating a severity risk of the coronavirus infectious disease based on responsiveness of the T cell to the protein or fragment thereof.

### Claim 15 (depends on 14)

The method for evaluating a severity risk of a coronavirus infectious disease according to claim 14, wherein
the protein or fragment thereof is derived from a first of another kind of coronavirus utilizing a different molecule as a receptor from a molecule utilized as a receptor by the causal virus, and
the step (b) is a step of evaluating that the severity risk of the coronavirus infectious disease is high in a case where the responsiveness of the T cell to the protein or fragment thereof is low.

### Claim 16 (depends on 14)

The method for evaluating a severity risk of a coronavirus infectious disease according to claim 14, wherein
the protein or fragment thereof is derived from a second of another kind of coronavirus utilizing as a receptor the same molecule as the molecule utilized as a receptor by the causal virus, and
the step (b) is a step of evaluating that the severity risk of the coronavirus infectious disease is high in a case where the responsiveness of the T cell to the protein or fragment thereof is high.

### Claim 17 (depends on 14)

The method for evaluating a severity risk of a coronavirus infectious disease according to claim 14, wherein the step (a) comprises:
(a1) a step of bringing the T cell into contact with a protein or fragment thereof derived from a first of another kind of coronavirus utilizing a different molecule as a receptor from a molecule utilized as a receptor by the causal virus; and
(a2) a step of bringing the T cell into contact with a protein or fragment thereof derived from a second of another kind of coronavirus utilizing as a receptor the same molecule as the molecule utilized as a receptor by the causal virus, and
the step (b) comprises:
(b1) a step of measuring a first responsiveness of the T cell to the protein or fragment thereof derived from the first of another kind of coronavirus;
(b2) a step of measuring a second responsiveness of the T cell to the protein or fragment thereof derived from the second of another kind of coronavirus; and
(b3) a step of evaluating a severity risk of the coronavirus infectious disease based on a ratio value of the second responsiveness to the first responsiveness (second responsiveness/first responsiveness).

### Claim 18 (depends on 14)

The method for evaluating a severity risk of a coronavirus infectious disease according to claim 14, wherein the coronavirus from which the causal virus and the protein or fragment thereof are derived are of the genus Betacoronavirus or the genus Alphacoronavirus.

### Claim 19 (depends on 14)

The method for evaluating a severity risk of a coronavirus infectious disease according to claim 14, wherein the causal virus is SARS-CoV-2.

### Claim 20

A kit for evaluating a severity risk of a coronavirus infectious disease, the kit comprising
a protein or fragment thereof derived from another kind of coronavirus which is a different kind of coronavirus from a causal virus of the coronavirus infectious disease.

### Claim 21 (depends on 20)

The kit for evaluating a severity risk of a coronavirus infectious disease according to claim 20, the kit further comprising a specific binding substance for a cytokine secreted by a T cell in response to antigen stimulation.

### Claim 22 (depends on 21)

The kit for evaluating a severity risk of a coronavirus infectious disease according to claim 21, the kit comprising: the specific binding substance bound to a solid-phase carrier; and the specific binding substance labeled with a labeling substance.

### Claim 23 (depends on 20)

The kit for evaluating a severity risk of a coronavirus infectious disease according to claim 20, wherein the cytokine is at least one selected from the group consisting of interferon γ, interleukin 2, and tumor-necrosis factor alpha.

### Claim 24 (depends on 20)

The kit for evaluating a severity risk of a coronavirus infectious disease according to claim 20, wherein the protein or fragment thereof comprises:
a protein or fragment thereof derived from a first of another kind of coronavirus utilizing a different molecule as a receptor from a molecule utilized as a receptor by the causal virus; and
a protein or fragment thereof derived from a second of another kind of coronavirus utilizing as a receptor the same molecule as the molecule utilized as a receptor by the causal virus.

### Claim 25 (depends on 20)

The kit for evaluating a severity risk of a coronavirus infectious disease according to claim 20, wherein the causal virus and the coronavirus from which the protein or fragment thereof is derived are of the genus Betacoronavirus or the genus Alphacoronavirus.

### Claim 26 (depends on 20)

The kit for evaluating a severity risk of a coronavirus infectious disease according to claim 20, wherein the causal virus is SARS-CoV-2.
