Clinical Course and Outcomes among COVID-19 Patients at the Hospitel in Bangkok: A Retrospective Study.

A hospitel is a hotel that has been designated as an extension of the healthcare facilities during the COVID-19 pandemic in resource-limited settings. However, the clinical course and outcomes of patients with COVID-19 admitted to this unique type of facility have never been studied. We retrospectively reviewed the medical records of adult patients with COVID-19 who were admitted to a single hospitel in Bangkok, Thailand. Risk factors with respect to chest X-ray progression and clinical progression were analyzed using a logistic regression. A total of 514 patients were recruited, with a mean (standard deviation) age of 35.6 (13.4) years, and 58.6% were women. Patients were admitted after a median (interquartile range) of 3 (2-6) days of illness and were classified with mild (12.3%), moderate (86.6%), and severe (1.1%) conditions. Favipiravir and corticosteroids were prescribed in 26.3% and 14.9% of patients, respectively. Chest X-ray progression was found in 7.6% of patients, and hospital transfer occurred in 2.9%, with no deaths. Favipiravir use (odds ratio (OR) 3.3, 95% confidence interval (CI) 1.4-7.5, p = 0.005), nausea/vomiting after admission (OR 32.3, 95% CI 1.5-700.8, p = 0.03), and higher oxygen saturation on admission (OR 1.99; 95% CI 1.22-3.23, p = 0.005) were factors associated with chest X-ray progression. Additionally, an oxygen requirement on admission was an independent risk factor for hospital transfer (OR 904, 95% CI 113-7242, p < 0.001). In a setting where the hospitel has been proposed as an extension facility for patients with relatively non-severe COVID-19, most patients could achieve a favorable clinical outcome. However, patients who require oxygen supplementation should be closely monitored for disease progression and promptly transferred to a hospital if necessary.

Humoral Immune Response of the Additional Chadox1 NCOV-19 Vaccine Following a Two-Dose Inactivated Whole-Virus SARS-COV-2 Vaccination in Patients on Dialysis

BACKGROUND AND AIMS Patients with end-stage kidney disease (ESKD) are at risk of coronavirus disease 2019 infection and its associated complications. A previous study demonstrated that patients with ESKD on dialysis generated suboptimal humoral immune response (HIR) and lower seroconversion rate after two-dose inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination as compared to healthy individuals. In this study, we examined HIR of the additional dose of ChAdOx1 nCoV-19 vaccine following a standard two-dose inactivated whole-virus SARS-CoV-2 vaccination in patients on dialysis, and compared to those of healthy controls. METHOD We recruited 59 patients with ESKD [31 patients on haemodialysis (HD) and 28 on peritoneal dialysis (PD)) and 16 healthy controls who received two doses of inactivated SARS-CoV-2 vaccine (V2) from Ramathibodi hospital and Banphaeo General Hospital, Bangkok, Thailand, from July 2021 to September 2021. All participants were administered a third dose of the ChAdOx1nCoV-19 vaccine (V3) with a 6-week interval between the V2 to V3. HIR was measured 2 weeks after V2 and V3 using SARS-CoV-2 immunoglobulin G (IgG) assay, which detects antibodies against the S1 receptor-binding domain (RBD) of the SARS-CoV-2 spike protein. Median anti-RBD IgG titer and seroconversion rate, defined as anti-RBD IgG titre ≥ 7.1 BAU/mL, were compared among ESKD patients and to those of healthy controls using the Kruskal–Wallis H test and the chi-squared test, respectively. RESULTS Baseline characteristics of patients on HD, PD and healthy controls are shown in Table 1. Demographic characteristics and baseline laboratory parameters were comparable between the HD and PD groups, except for a lower mean serum albumin level in the PD group (P < .001). None of the healthy controls were immunocompromised or receiving immunosuppressive therapies.Table 1.Clinical characteristics, n (%) HD (n = 31)PD (n = 28)Controls (n = 16)Age, years45 (10)41 (12)41 (9)Male, n (%) 23 (74)17 (61)5 (31)Body mass index, kg/m226 (5)24 (4)27 (6)Charlson Comorbidity Index, median (IQR) 3 (3–5)2.5 (2–4)0Comorbidities, n (%)  Diabetes mellitus HypertensionCardiovascular disease 14 (45)24 (77)7 (23)7 (25)25 (89)2 (7)1 (6)2 (13)0 Causes of ESKD, n (%) Diabetic nephropathy Hypertensive nephropathy Others Unknown6 (19)3 (10)5 (16)14 (45)5 (18)8 (29)8 (29)7 (25)NADialysis vintage, months, median (IQR)33 (17–84)34 (7–57)NATotal Kt/Vurea1.6 (0.3)2.0 (0.4)NALaboratories White blood cells, × 109/L Absolute lymphocyte count, × 109/L Haemoglobin, g/dL Ferritin, ng/mL, median (IQR) Albumin, g/L6.9 (1.9)1.6 (0.5)11 (2)301 (119–441)40 (4)7.3 (2.8)1.5 (0.8)10 (2)367 (156–751)33 (4)*7.7 (2.4)2.2 (0.9)NANANA *P < .05. At 2 weeks after V3, the median anti-RBD IgG titres were significantly increased in all groups compared to those levels after V2 (85[33–412] versus 1566 [861–3083] BAU/mL for patients on HD, 81 [15–144] versus 913 [293–1359] BAU/mL for patients on PD and 250 [92–603] versus 2210 [1531–2782] BAU/mL for healthy controls;P < .001 for all groups). Comparing antibody levels between groups after V3, patients on PD generated significantly lower anti-RBD IgG titer than patients on HD (P = .02) and healthy controls (P < .01) (Figure 1A). The seroconversion rate of the HD and PD groups improved from 94% and 82% after V2 to 100% after V3 in both groups (P = .16 and P = .03, respectively) (Figure 1B). All patients on dialysis who had anti-RBD IgG < 7.1 BAU/mL after V2 (7/59 patients) seroconverted after the additional dose of ChAdOx1 nCoV-19 vaccine. CONCLUSION We suggest that an additional ChAdOx1 nCoV-19 vaccine after a primary two doses inactivated SARS-CoV-2 vaccination could improve seroconversion rate and magnitude of humoral immune response in patients on dialysis. The durability of the immune response to this vaccination regimen requires further study.

An additional dose of viral vector COVID-19 vaccine and mRNA COVID-19 vaccine in kidney transplant recipients: A randomized controlled trial (CVIM 4 study).

Immunogenicity following an additional dose of Coronavirus disease 2019 (COVID-19) vaccine was investigated in an extended primary series among kidney transplant (KT) recipients. Eighty-five KT participants were randomized to receive either an mRNA (M group; n = 43) or viral vector (V group; n = 42) vaccine. Among them, 62% were male, with a median (IQR) age of 50 (43-59) years and post-transplantation duration of 46 (26-82) months. At 2 weeks post-additional dose, there was no difference in the seroconversion rate between the M and V groups (70% vs. 65%, p = .63). A median (IQR) of anti-RBD antibody level was not statistically different between the M group compared with the V group (51.8 [5.1-591] vs. 28.5 [2.9-119.3] BAU/ml, p = .18). Furthermore, the percentage of participants with positive SARS-CoV-2 surrogate virus neutralization test results was not statistically different between groups (20% vs. 15%, p = .40). S1-specific T cell and RBD-specific B cell responses were also comparable between the M and V groups (230 [41-420] vs. 268 [118-510], p = .65 and 2 [0-10] vs. 2 [0-13] spot-forming units/106 peripheral blood mononuclear cells, p = .60). In conclusion, compared with an additional dose of viral vector COVID-19 vaccine, a dose of mRNA COVID-19 vaccine did not elicit significantly different responses in KT recipients, regarding either humoral or cell-mediated immunity. (TCTR20211102003).

Coronavirus Disease 2019 Vaccinations in Patients With Chronic Liver Disease and Liver Transplant Recipients: An Update.

Coronavirus disease 2019 (COVID-19) is a current global pandemic associated with an increased mortality, particularly in patients with comorbidities. Patients with chronic liver disease (CLD) and liver transplant (LT) recipients are at higher risk of morbidity and mortality after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Many liver societies have recommended that these patients should receive COVID-19 vaccinations, although there are limited studies assessing risks and benefits in this population. In addition, two doses of mRNA vaccines may not provide sufficient immune response, and booster dose(s) may be necessary, especially in LT recipients. Notably, variants of concern have recently emerged, and it remains unclear whether currently available vaccines provide adequate and durable protective immunity against these novel variants. This review focuses on the role of COVID-19 vaccinations in CLD and LT recipients.

Durability of Humoral and Cellular Immunity after an Extended Primary Series with Heterologous Inactivated SARS-CoV-2 Prime-Boost and ChAdOx1 nCoV-19 in Dialysis Patients (ICON3).

The durability of a three-dose extended primary series of COVID-9 vaccine in dialysis patients remains unknown. Here, we assessed dynamic changes in SARS-CoV-2-specific humoral and cell-mediated immunity at baseline, 3 months, and 6 months after the extended primary series in 29 hemodialyzed (HD), 28 peritoneal dialyzed (PD) patients, and 14 healthy controls. Participants received two doses of inactivated SARS-CoV-2 vaccine followed by a dose of ChAdOx1 nCoV-19 vaccine. At 6 months, median anti-RBD IgG titers (IQR) significantly declined from baseline in the HD (1741 (1136-3083) BAU/mL vs. 373 (188-607) BAU/mL) and PD (1093 (617-1911) BAU/mL vs. 180 (126-320) BAU/mL) groups, as did the mean percent inhibition of neutralizing antibodies (HD: 96% vs. 81%; PD: 95% vs. 73%) (all p < 0.01). Age and post-vaccination serological response intensity were predictors of early humoral seroprotection loss. In contrast, cell-mediated immunity remained unchanged. In conclusion, humoral immunity declined substantially in dialysis patients, while cell-mediated immunity remained stable 6 months after the extended heterologous primary series of two inactivated SARS-CoV-2/ChAdOx1 nCoV-19 vaccine. A booster dose could be considered in dialysis patients 3 months after this unique regimen, particularly in the elderly or those with a modest initial humoral response.

Immunogenicity of ChAdOx1 nCoV-19 vaccine after a two-dose inactivated SARS-CoV-2 vaccination of dialysis patients and kidney transplant recipients.

Vaccination with inactivated SARS-CoV-2 virus produces suboptimal immune responses among kidney transplant (KT), peritoneal dialyzed (PD), and hemodialyzed (HD) patients. Participants were vaccinated with two-dose inactivated SARS-CoV-2 vaccine (V2) and a third dose of ChAdOx1 nCoV-19 vaccine (V3) at 1-2 months after V2. We enrolled 106 participants: 31 KT, 28 PD, and 31 HD patients and 16 controls. Among KT, PD, and HD groups, median (IQR) of anti-receptor binding domain antibody levels were 1.0 (0.4-26.8), 1092.5 (606.9-1927.2), and 1740.9 (1106-3762.3) BAU/mL, and percent neutralization was 0.9 (0-9.9), 98.8 (95.9-99.5), and 99.4 (98.8-99.7), respectively, at two weeks after V3. Both parameters were significantly increased from V2 across all groups (p < 0.05). Seroconversion and neutralization positivity rates in PD, HD, and control groups were 100% but were impaired in KT patients (39% and 16%, respectively). S1-specific T-cell counts were increased in PD and HD groups (p < 0.05) but not in KT patients. The positive S1-specific T-cell responder rate was > 90% in PD, HD, and control groups, which was higher than that in KT recipients (74%, p < 0.05). The heterologous inactivated virus/ChAdOx1 nCoV-19 vaccination strategy elicited greater immunogenicity among dialysis patients; however, inadequate responses remained among KT recipients (TCTR20210226002).

SARS-CoV-2-specific humoral and cell-mediated immune responses after immunization with inactivated COVID-19 vaccine in kidney transplant recipients (CVIM 1 study).

Immunogenicity following inactivated SARS-CoV-2 vaccination among solid organ transplant recipients has not been assessed. Seventy-five patients (37 kidney transplant [KT] recipients and 38 healthy controls) received two doses, at 4-week intervals, of an inactivated whole-virus SARS-CoV-2 vaccine. SARS-CoV-2-specific humoral (HMI) and cell-mediated immunity (CMI) were measured before, 4 weeks post-first dose, and 2 weeks post-second dose. The median (IQR) age of KT recipients was 50 (42-54) years and 89% were receiving calcineurin inhibitors/mycophenolate/corticosteroid regimens. The median (IQR) time since transplant was 4.5 (2-9.5) years. Among 35 KT patients, the median (IQR) of anti-RBD IgG level measured by CLIA after vaccination was not different from baseline, but was significantly lower than in controls (2.4 [1.1-3.7] vs. 1742.0 [747.7-3783.0] AU/ml, p < .01) as well as percentages of neutralizing antibody inhibition measured by surrogate viral neutralization test (0 [0-0] vs. 71.2 [56.8-92.2]%, p < .01). However, the median (IQR) of SARS-CoV-2 mixed peptides-specific T cell responses measured by ELISpot was significantly increased compared with baseline (30 [4-120] vs. 12 [0-56] T cells/106  PBMCs, p = .02) and not different from the controls. Our findings revealed weak HMI but comparable CMI responses in fully vaccinated KT recipients receiving inactivated SARS-CoV-2 vaccination compared to immunocompetent individuals (Thai Clinical Trials Registry, TCTR20210226002).

Short-Term Immunogenicity Profiles and Predictors for Suboptimal Immune Responses in Patients with End-Stage Kidney Disease Immunized with Inactivated SARS-CoV-2 Vaccine.

INTRODUCTION: Patients with end-stage kidney disease (ESKD) are at risk of severe coronavirus disease and mortality. Immunogenicity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) inactivated whole-virus vaccine in patients with ESKD has never been explored. METHODS: We conducted a prospective cohort study of 60 patients with ESKD and 30 healthy controls. All participants received two doses of an inactivated whole-virus SARS-CoV-2 vaccine (Sinovac Biotech Ltd) 4 weeks apart. SARS-CoV-2-specific humoral and cell-mediated immune responses were investigated and referenced with healthy controls. RESULTS: After two doses, an anti-receptor-binding domain immunoglobulin G of 50 AU/ml or greater was present in 53 of 60 patients (88%) in the ESKD group and all participants (100%) in the control group (P = 0.05). The percentage of patients with ESKD and controls with neutralizing antibodies of 35% threshold or greater was 58% and 88%, respectively (P = 0.01). Furthermore, the proportion of patients with ESKD and S1-specific T cell response was comparable with controls (82% vs. 77%, P = 0.45). Old age, high ferritin level, and low absolute lymphocyte count were independently associated with poor humoral immune responses. CONCLUSIONS: Patients with ESKD could develop similar SARS-CoV-2-specific cell-mediated immune responses compared to healthy controls, although suboptimal humoral immune responses were observed following two doses of SARS-CoV-2 vaccination. Therefore, patients with ESKD and the abovementioned factors are at risk of generating inadequate humoral immune responses, and a vaccine strategy to elicit greater immunogenicity among these relatively immunocompromised patients is warranted. (Thai Clinical Trials Registry, TCTR20210226002).

Clinical characteristics and risk factors for coronavirus disease 2019 (COVID-19) among patients under investigation in Thailand.

To manage coronavirus disease 2019 (COVID-19), a national health authority has implemented a case definition of patients under investigation (PUIs) to guide clinicians' diagnoses. We aimed to determine characteristics among all PUIs and those with and without COVID-19. We retrospectively reviewed clinical characteristics and risk factors for laboratory-confirmed COVID-19 cases among PUIs at a tertiary care center in Bangkok, Thailand, between March 23 and April 7, 2020. Reverse transcription-polymerase chain reaction for SARS-CoV-2 RNA was performed. There were 405 evaluable PUIs; 157 (38.8%) were men, with a mean age ± SD of 36.2 ± 12.6 years. The majority (68.9%) reported no comorbidities. There were 53 (13.1%) confirmed COVID-19 cases. The most common symptoms among those were cough (73.6%), fever (58.5%), sore throat (39.6%), and muscle pain (37.4%). Among these patients, diagnoses were upper respiratory tract infection (69.8%), viral syndrome (15.1%), pneumonia (11.3%), and asymptomatic infection (3.8%). Multivariate analysis identified close contact with an index case (OR, 3.49; 95%CI, 1.49-8.15; P = 0.004), visiting high-risk places (OR, 1.92; 95%CI, 1.03-3.56; P = 0.039), productive cough (OR, 2.03; 95%CI, 1.05-3.92; P = 0.034), and no medical coverage (OR, 3.91; 95%CI, 1.35-11.32; P = 0.012) as independent risk factors for COVID-19 among the PUIs. The majority had favorable outcomes, though one (1.9%) died from severe pneumonia. COVID-19 was identified in 13% of PUIs defined per a national health authority's case definition. History of contact with a COVID-19 patient, visiting a high-risk place, having no medical coverage, and productive cough may identify individuals at risk of COVID-19 in Thailand.

A family cluster of diagnosed coronavirus disease 2019 (COVID-19) kidney transplant recipient in Thailand.

INTRODUCTION: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes an ongoing outbreak of respiratory illness called coronavirus disease 2019 (COVID-19). The clinical course could be ranging from mild to severe illness especially the individuals with an immunocompromised condition such as solid organ transplant recipients. METHOD: We described a family cluster of COVID-19 patients who were admitted during 3rd April 2020 to 30th April 2020. COVID-19 was confirmed by a presence of SARS-CoV-2 ribonucleic acid in the respiratory specimens detected by a qualitative, real-time reverse transcription-polymerase chain reaction. The study focused on the clinical course and management of our cases. RESULTS: A family cluster of four laboratory-confirmed COVID-19 patients, one of those carried an underlying kidney transplant (KT) receiving immunosuppressants. Clinical presentation and severity of our case series are variable depending on each individual immune status. By far, a KT recipient seems to develop more severity despite antiviral therapy, cessation of immunosuppressant, and aggressive intensive care support. CONCLUSION: Our case series plausibly affirmed a person-to-person transmission and potentially severe disease in the transplant population. Clinicians who are encountering with transplant recipients should be aware of possible transmission among family members.