METHODS AND COMPOSITIONS FOR TREATING LONG COVID-19
The invention provides methods of treating long COVID in a patient in need thereof, comprising administering to said patient a composition comprising a therapeutically effective amount of at least one human milk oligosaccharides, wherein such treatment reduces or improves at least one sign or symptom of long COVID.
1 . A method for the treatment of long COVID in a patient in need thereof, the method comprising administering to said patient a composition comprising a therapeutically effective amount of at least one human milk oligosaccharide, wherein such treatment reduces or improves at least one sign or symptom of long COVID.
2 . The method of claim 1 , wherein the at least one human milk oligosaccharide is selected from the group consisting of lacto-N-tetraose (LNT), lacto-N-neotetraose (LNnT), lacto-N-hexaose (LNH), lacto-N-neohexaose (LNnH), 2′fucosyllactose (2′FL), 3′fucosyllacose (3′FL), lacto-difucotetraose (LDFT), lacto-N-fucopentaose II/III (LNFP I/III), lactose-N-fucopentaose I (LNFP I), lacto-N-difuco-hexaose I (LNDFH I), lacto-N-difuco-hexaose II (LNDFH II), difucosyl-para-lacto-N-neohexaose (DFpLNnH), difucosyllacto-N-hexaose c (DFLNH c), 3′sialyllactose (3′SL), 6′sialyllactose (6′SL), LS-tetrasaccharide a (LSTa), LS-tetrasaccharide b (LST b), LS-tetrasaccharide c (LST c), 3′-sialyl-N-acetyllactosamine (3′SLN), 6′-sialyl-N-acetyllactosamine (6′SLN), or disialyllacto-N-tetraose (DSLNT).
3 . The method of claim 2 , wherein the one or more human milk oligosaccharide selected from 2′FL, 3′FL, 3′SL, 6′SL, LNT, or LNnT.
4 . The method of claim 1 , wherein the composition comprising one or more human milk oligosaccharides contains a mixture of two, three, four or five human milk oligosaccharides.
5 . (canceled)
6 . The method of claim 1 , wherein the composition comprises a mixture of one neutral core and one neutral fucosylated human milk oligosaccharide, or comprises a mixture of one neutral and one acidic human milk oligosaccharide.
7 . (canceled)
8 . The method of claim 2 , wherein the one or more human milk oligosaccharides is selected from 2′FL, 3′SL or 6′SL.
9 . (canceled)
10 . The method of claim 1 , wherein the composition is not a mammalian milk and is not derived from mammalian milk.
11 . (canceled)
12 . The method of claim 1 , wherein the composition comprises 10% or more, 20% or more, 30% or more, 40% or more, or 50% or more by mass one or more human milk oligosaccharides.
13 . The method of claim 1 , wherein the at least one symptom is selected from the group consisting of brain fog or other neurological signs and symptom; depression, anxiety, or other neuropsychiatric symptom; fatigue; muscle weakness; dyspnea, cough, or other respiratory symptom; insomnia or sleep disturbance; headache; paresthesias; dysautonomia; olfactory or gustatory dysfunction; hair loss or other dermatologic symptom; palpitations/tachycardia, chest pain, or other cardiac symptom; arthralgia/joint pain; rhinitis; Sicca/Sjogren syndrome; fever; and gastroenterological symptom; or a combination of any of thereof.
14 . The method of claim 13 , wherein the treatment reduces fatigue as measured by visual analogue scale, Samn-Perelli seven point fatigue scale, Karolinska Sleepiness Scale, or Psychomotor Vigilance Task; and/or reduces muscle weakness as measured by a test selected from the group consisting of lower handgrip muscle strength, short physical performance battery (SPPB) score, Timed Up and Go test (TUGT), walking speed (WS), and/or grip strength (GS).
15 . The method of claim 13 , wherein the treatment reduces brain fog as measured by the cognitive battery score.
16 . The method of claim 13 , wherein the treatment reduces a neurological sign or symptom, wherein the neurological sign or symptom is memory impairment as measured by a test selected from Short Test of Mental Status, the Montreal Cognitive Assessment (MoCA) or the Mini-Mental State Examination (MMSE), or by an assessment of symptoms by a physician.
17 . The method of claim 13 , wherein the treatment improves insomnia and/or sleep disturbance as measured by the Karolinska Sleep Scale (KSS) or the Sleepiness Symptoms Questionnaire (SSQ).
18 . The method of claim 13 , wherein the treatment reduces dyspnea as measured by a clinical scale selected from the group consisting of the Medical Research Council (MRC) scale, the Baseline Dyspnea Index (BDI), and Transitional Dyspnea Index (TDI), or a combination thereof.
19 . The method of claim 13 , wherein the treatment reduces depression and/or anxiety and/or other neuropsychiatric symptoms, reduces or improves headache, disautonomias, and/or paresthesias, or improves olfactory dysfunction or gustatory dysfunction.
20 . (canceled)
21 . (canceled)
22 . The method of claim 13 , wherein the method reduces hair loss or other dermatologic symptoms, palpitations, or joint pain/arthralgia.
23 . (canceled)
24 . (canceled)
25 . (canceled)
26 . The method of claim 1 , wherein the method improves gut microbiome dysbiosis.
27 . (canceled)
28 . (canceled)
29 . (canceled)
30 . (canceled)
31 . The method of claim 1 , wherein said long COVID patient had mild, moderate or severe acute COVID infection during the acute phase of infection.
32 . The method of claim 31 , wherein the patient had mild or moderate COVID-19.
33 . The method of claim 32 , wherein the patient had COVID-19 not requiring hospitalization.
34 . The method of claim 1 , wherein the patient is 55 years old or less.
35 . (canceled)
36 . The method of claim 1 , wherein the patient is 55 years or older.
37 . (canceled)
38 . (canceled)
39 . The method of claim 1 , wherein the patient is female.
40 . The method of claim 1 , wherein the patient is male.
41 . The method of claim 1 , wherein the patient has a body mass index (BMI) greater than or equal to 30.
42 . The method of claim 1 , wherein the patient experienced at least five symptoms during the first week of infection.
43 . The method of claim 1 , wherein said long COVID patient was prescribed antibiotics during the acute phase of infection.
44 . The method of claim 1 , wherein the patient has been vaccinated against SARS-CoV-2.
45 . The method of claim 1 , wherein the patient has not been vaccinated against SARS-CoV-2.
46 . (canceled)
47 . (canceled)
48 . The method of claim 1 , wherein the reduction and/or improvement of at least one sign or symptom of long COVID is assessed by a method comprising use of the Work Productivity and Activity Impairment (WPAI) Questionnaire.