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1.
EClinicalMedicine ; 45: 101323, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1734347

ABSTRACT

Background: Production of affordable coronavirus disease 2019 (COVID-19) vaccines in low- and middle-income countries is needed. NDV-HXP-S is an inactivated egg-based recombinant Newcastle disease virus vaccine expressing the spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It's being developed by public sector manufacturers in Thailand, Vietnam, and Brazil; herein are initial results from Thailand. Methods: This phase 1 stage of a randomised, dose-escalation, observer-blind, placebo-controlled, phase 1/2 trial was conducted at the Vaccine Trial Centre, Mahidol University (Bangkok). Healthy males and non-pregnant females, aged 18-59 years and negative for SARS-CoV-2 antibodies, were eligible. Participants were randomised to receive one of six treatments by intramuscular injection twice, 28 days apart: 1 µg, 1 µg+CpG1018 (a toll-like receptor 9 agonist), 3 µg, 3 µg+CpG1018, 10 µg, or placebo. Participants and personnel assessing outcomes were masked to treatment. The primary outcomes were solicited and spontaneously reported adverse events (AEs) during 7 and 28 days after each vaccination, respectively. Secondary outcomes were immunogenicity measures (anti-S IgG and pseudotyped virus neutralisation). An interim analysis assessed safety at day 57 in treatment-exposed individuals and immunogenicity through day 43 per protocol. ClinicalTrials.gov (NCT04764422). Findings: Between March 20 and April 23, 2021, 377 individuals were screened and 210 were enroled (35 per group); all received dose one; five missed dose two. The most common solicited AEs among vaccinees, all predominantly mild, were injection site pain (<63%), fatigue (<35%), headache (<32%), and myalgia (<32%). The proportion reporting a vaccine-related AE ranged from 5·7% to 17·1% among vaccine groups and was 2·9% in controls; there was no vaccine-related serious adverse event. The 10 µg formulation's immunogenicity ranked best, followed by 3 µg+CpG1018, 3 µg, 1 µg+CpG1018, and 1 µg formulations. On day 43, the geometric mean concentrations of 50% neutralising antibody ranged from 122·23 international units per mL (IU/mL; 1 µg, 95% confidence interval (CI) 86·40-172·91) to 474·35 IU/mL (10 µg, 95% CI 320·90-701·19), with 93·9% to 100% of vaccine groups attaining a ≥ 4-fold increase over baseline. Interpretation: NDV-HXP-S had an acceptable safety profile and potent immunogenicity. The 3 µg and 3 µg+CpG1018 formulations advanced to phase 2. Funding: National Vaccine Institute (Thailand), National Research Council (Thailand), Bill & Melinda Gates Foundation, National Institutes of Health (USA).

2.
Infect Dis Ther ; 11(1): 231-248, 2022 Feb.
Article in English | MEDLINE | ID: covidwho-1682185

ABSTRACT

INTRODUCTION: Many immunomodulators have been studied in clinical trials for the treatment of coronavirus disease 2019 (COVID-19). However, data identifying the most effective and safest treatment are lacking. We conducted a systematic review and network meta-analysis to rank immunomodulators in the treatment of COVID-19 according to their efficacy and safety. METHODS: Published and peer-reviewed randomized controlled trials assessing the efficacy of immunomodulators in hospitalized patients with COVID-19 were searched up to June 30, 2021. Direct and network meta-analyses were applied to assess the outcomes. The probability of efficacy and safety was estimated, and the drugs were awarded a numerical ranking. RESULTS: Twenty-six studies were eligible. Compared with standard of care, dexamethasone and tocilizumab had significantly lower mortality rates with pooled risk ratios (RRs) of 0.91 (95% confidence interval [CI] 0.84-0.99) and 0.88 (95% CI 0.82-0.96), respectively. Meanwhile, the most effective corticosteroid, interleukin-6 antagonist, and Janus kinase (JAK) inhibitor were hydrocortisone, sarilumab, and ruxolitinib, respectively. However, when superimposed infection was considered, ruxolitinib was the best treatment followed by baricitinib. Moreover, methylprednisolone had the worst combined efficacy and safety among the examined treatments. CONCLUSIONS: Overall, immunomodulators were more effective than standard of care. Important differences exist among immunomodulators regarding both efficacy and safety in favor of ruxolitinib and baricitinib. Further well-conducted randomized controlled trials should focus on JAK inhibitors. Methylprednisolone use should be discouraged because of its poor efficacy and high risk of superimposed infection. TRIAL REGISTRATION: PROSPERO registration identifier CRD 42021257421.

3.
Trop Dis Travel Med Vaccines ; 7(1): 29, 2021 Nov 15.
Article in English | MEDLINE | ID: covidwho-1518302

ABSTRACT

BACKGROUND: International travel is among the leading impactful factors of COVID-19 transmission; thus, adequate knowledge, good attitude and good preventive practices toward COVID-19 for international travelers are particularly essential for successful pandemic control. METHODS: A cross-sectional, questionnaire-based study was conducted to determine knowledge, attitude and practices (KAP) of international travelers (both Thai and non-Thai) and expatriates in Thailand. The data were collected at the Thai Travel Clinic, Bangkok, Thailand and via online platforms during May to October 2020. The independent T-test, Chi-square test and multiple regression analysis (MRA) were applied to determine factors influencing the KAP. RESULTS: Of 399 travelers, 46.6% were male, 72.1% had a Bachelor's degree or higher, and the mean age was 35.6 ± 9.6 years. Due to unexpected travel restrictions and lock down, 77.9% of participants were Thai and the respective major purpose of travel was business/work. Travel cancellation/postponement was reported at 73.9%. While sufficient knowledge (≥ 60% correct answers) was reported in 77.9% of participants, a low percentage of correct answers was found in the questions regarding disease transmission. The travelers reported a neutral attitude and an overall moderate concern regarding the COVID-19 situation. Adequate preventive practices were determined by the average practice score 3.54 ± 0.38 (0 = never and 4 = always). The MRA revealed that the factors influencing good practices were travelers who: i) enrolled from outside the hospital (online platform); ii) received pretravel advice at hospital; iii) were female; iv) participated before the declaration of the end of the outbreak; v) were aged 40-49 years, and vi) visited friends and relatives. CONCLUSIONS: The majority of travelers in this study had sufficient knowledge, a neutral attitude and adequate preventive practices toward COVID-19. The factors influencing good practices included pretravel advice, sex, age and the point in the timeline of the outbreak. In order to better control the COVID-19 pandemic situation, pretravel counselling and advice should be promoted as a means to improve knowledge, particularly in disease transmission, increase awareness and emphasize appropriate preventive measures toward COVID-19 among international travelers. Furthermore, preventive practices should be bolstered at all times regardless of the outbreak situation.

4.
Infect Dis Ther ; 11(1): 231-248, 2022 Feb.
Article in English | MEDLINE | ID: covidwho-1509378

ABSTRACT

INTRODUCTION: Many immunomodulators have been studied in clinical trials for the treatment of coronavirus disease 2019 (COVID-19). However, data identifying the most effective and safest treatment are lacking. We conducted a systematic review and network meta-analysis to rank immunomodulators in the treatment of COVID-19 according to their efficacy and safety. METHODS: Published and peer-reviewed randomized controlled trials assessing the efficacy of immunomodulators in hospitalized patients with COVID-19 were searched up to June 30, 2021. Direct and network meta-analyses were applied to assess the outcomes. The probability of efficacy and safety was estimated, and the drugs were awarded a numerical ranking. RESULTS: Twenty-six studies were eligible. Compared with standard of care, dexamethasone and tocilizumab had significantly lower mortality rates with pooled risk ratios (RRs) of 0.91 (95% confidence interval [CI] 0.84-0.99) and 0.88 (95% CI 0.82-0.96), respectively. Meanwhile, the most effective corticosteroid, interleukin-6 antagonist, and Janus kinase (JAK) inhibitor were hydrocortisone, sarilumab, and ruxolitinib, respectively. However, when superimposed infection was considered, ruxolitinib was the best treatment followed by baricitinib. Moreover, methylprednisolone had the worst combined efficacy and safety among the examined treatments. CONCLUSIONS: Overall, immunomodulators were more effective than standard of care. Important differences exist among immunomodulators regarding both efficacy and safety in favor of ruxolitinib and baricitinib. Further well-conducted randomized controlled trials should focus on JAK inhibitors. Methylprednisolone use should be discouraged because of its poor efficacy and high risk of superimposed infection. TRIAL REGISTRATION: PROSPERO registration identifier CRD 42021257421.

5.
JGH Open ; 5(11): 1257-1265, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1487483

ABSTRACT

Coronavirus disease 2019 (COVID-19) is an important health problem that has a serious adverse impact on the global economy and healthcare systems. The virus is not only involved in the respiratory system, but also causes other systemic effects as well as several gastrointestinal and liver issues. Evidence has shown direct viral invasion into the gastrointestinal tissue and supporting vascular network, causing various manifestations such as diarrhea, nausea, gastrointestinal bleeding, and abnormal liver function tests. The degree of gastrointestinal injury, especially in terms of liver involvement, is correlated with disease severity. There is no specific treatment for gastrointestinal involvement, and the symptoms can be managed with supportive therapy. Moreover, increased liver decompensation and mortality can be found in COVID-19-infected patients with coexisting liver disease. As the virus can be identified in gastrointestinal contents, endoscopic procedures during the pandemic should be carefully selected and proper protection strategies should be encouraged to prevent viral transmission.

6.
PLoS One ; 16(8): e0255796, 2021.
Article in English | MEDLINE | ID: covidwho-1350170

ABSTRACT

Serological assays to detect antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) might contribute to confirming the suspected coronavirus disease 2019 (COVID-19) in patients not detected with molecular assays. Human antibodies that target the host angiotensin-converting enzyme 2-binding domain of the viral spike protein are a target for serodiagnosis and therapeutics. This study aimed to characterize the classes and subclasses of antibody responses to a recombinant receptor-binding protein (RBD) of SARS-CoV-2 in COVID-19 patients and investigated the reactivity of these antibodies in patients with other tropical infections and healthy individuals in Thailand. ELISAs for IgM, IgA, IgG and IgG subclasses based on RBD antigen were developed and tested with time series of 27 serum samples from 15 patients with COVID-19 and 60 samples from pre-COVID-19 outbreaks including acute dengue fever, murine typhus, influenza, leptospirosis and healthy individuals. Both RBD-specific IgA and IgG were detected in only 21% of the COVID-19 patients in the acute phase. The median IgA and IgG levels were significantly higher in the convalescent serum sample compared to the acute serum sample (P < 0.05). We observed the highest correlation between levels of IgG and IgA (rho = 0. 92). IgG1 and IgG3 were the major IgG subclasses detected in SARS-CoV-2 infection. Only acute IgG3 level was negatively associated with viral detection based on RT-PCR of ORF1ab gene (rho = -0.57). The median IgA and IgG levels in convalescence sera of COVID-19 patients were significantly higher than healthy individuals and convalescent sera of other febrile infectious patients. The analyses of antibody classes and subclasses provide insights into human immune responses against SARS-CoV-2 during natural infection and interpretation of antibody assays.


Subject(s)
Antibodies, Viral/blood , Antibody Formation , COVID-19/pathology , Immunoglobulin Isotypes/blood , Spike Glycoprotein, Coronavirus/immunology , Adult , Aged , COVID-19/blood , COVID-19/virology , Female , Humans , Immunoglobulin A/blood , Immunoglobulin G/blood , Immunoglobulin M/blood , Longitudinal Studies , Male , Middle Aged , Protein Domains/immunology , Recombinant Proteins/biosynthesis , Recombinant Proteins/immunology , SARS-CoV-2/isolation & purification , SARS-CoV-2/metabolism , Spike Glycoprotein, Coronavirus/chemistry , Spike Glycoprotein, Coronavirus/genetics , Spike Glycoprotein, Coronavirus/metabolism , Thailand , Young Adult
7.
Am J Trop Med Hyg ; 104(2): 487-489, 2020 Dec 15.
Article in English | MEDLINE | ID: covidwho-1175672

ABSTRACT

We report a 50-year-old Thai woman with recent travel to Denmark who presented with acute high-grade fever, vomiting, and myalgia for 1 day. Initial laboratory results revealed leukopenia, elevated aspartate transaminase, and elevated alanine transaminase. Chest radiograph showed no pulmonary infiltration. Reverse transcriptase-PCR (RT-PCR) of the nasopharyngeal swab detected SARS-CoV-2, and RT-PCR of the blood detected dengue virus serotype 2. COVID-19 with dengue fever co-infection was diagnosed. Her symptoms were improved with supportive treatment. Integration of clinical manifestations, history of exposure, laboratory profiles, and dynamic of disease progression assisted the physicians in precise diagnosis. Co-circulating and nonspecific presentations of dengue infection and COVID-19 challenge the healthcare system in tropical countries. To solve this threat, multi-sector strategies are required, including public health policy, development of accurate point-of-care testing, and proper prevention for both diseases.


Subject(s)
COVID-19/diagnosis , Coinfection/diagnosis , Coinfection/virology , Dengue/diagnosis , Travel , Dengue Virus/classification , Dengue Virus/genetics , Dengue Virus/isolation & purification , Female , Humans , Middle Aged , SARS-CoV-2/genetics , SARS-CoV-2/isolation & purification , Serogroup , Thailand
8.
Trop Doct ; 51(2): 212-215, 2021 Apr.
Article in English | MEDLINE | ID: covidwho-992235

ABSTRACT

Our cross-sectional study estimated the prevalence and clinical relevance of hypokalaemia among confirmed COVID-19 cases admitted in three hospitals in Bangkok during the early outbreak in Thailand. Of 36 patients, nine were in the hypokalaemia group (25%) and 27 in the normokalaemia group (75%). All cases were asymptomatic, and 94.4% had mild hypokalaemia. Hypokalaemia was found significantly earlier in the course of COVID-19 without evidence of significant extrarenal potassium loss. Body temperature and mean serum sodium in the hypokalaemia group tended to be higher than the normokalaemia group. Hypokalaemia and potentially higher serum sodium among COVID-19 patients were the remarkable findings. This issue warrants for further investigation.


Subject(s)
COVID-19/blood , Hypokalemia/epidemiology , Adult , COVID-19/epidemiology , COVID-19/therapy , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Prevalence , Thailand/epidemiology
9.
Am J Trop Med Hyg ; 103(1): 83-85, 2020 07.
Article in English | MEDLINE | ID: covidwho-829378

ABSTRACT

We report a young Thai man from the Thai-Myanmar border suffering from 2 days of fever and myalgia without respiratory tract signs or symptoms. He reported no history of travel through an area with confirmed COVID-19 cases or contact with sick persons. After excluding malaria and dengue, which are common causative agents of acute undifferentiated febrile illness (AUFI) in Thailand, chest radiography was performed according to the patient triage protocol of our institute for AUFI during the COVID-19 outbreak. Chest radiography revealed findings compatible with pneumonia. Nasopharyngeal, throat, and sputum samples tested positive for SARS-CoV-2 by real-time reverse transcriptase-PCR. The preadmission diagnosis of COVID-19 in this patient enabled appropriate management and isolation to prevent nosocomial transmission. Fever and nonspecific symptoms and laboratory results in early COVID-19 may be difficult to distinguish from tropical infectious diseases, especially when respiratory signs and symptoms are absent. This fact necessitates vigilant awareness in clinical investigation, management, and infection control, especially in tropical resource-limited settings.


Subject(s)
Coronavirus Infections/diagnosis , Fever/virology , Pneumonia, Viral/diagnosis , Adult , Betacoronavirus , COVID-19 , Humans , Male , Myalgia/virology , Pandemics , Radiography, Thoracic , SARS-CoV-2
10.
Am J Trop Med Hyg ; 103(3): 1204-1206, 2020 Sep.
Article in English | MEDLINE | ID: covidwho-646641

ABSTRACT

The quality and type of specimen collection affect the sensitivity of real-time reverse transcriptase-PCR (rRT-PCR) for the diagnosis of SARS-CoV-2. In this report, the course over time of rRT-PCR for SARS-CoV-2 in 26 clinical specimens collected from the upper (nasopharyngeal and throat swabs) and lower (sputum) respiratory tracts of COVID-19 cases with pneumonia was investigated along with the clinical course. The preliminary results revealed that higher SARS-CoV-2 RNA concentration and longer time for detection make self-collected sputum a preferable specimen for the diagnosis and follow-up of COVID-19 pneumonia. Self-collection of sputum can minimize the risk of unnecessary exposure to healthcare workers, preserve the shortage of personal protective equipment, and limit viral transmission to the environment.


Subject(s)
Betacoronavirus , Coronavirus Infections/diagnosis , Pneumonia, Viral/diagnosis , Real-Time Polymerase Chain Reaction/methods , Specimen Handling/methods , Adult , Aged , COVID-19 , COVID-19 Testing , Clinical Laboratory Techniques , Humans , Male , Middle Aged , Nasopharynx/virology , Pandemics , RNA, Viral/analysis , SARS-CoV-2 , Sputum/virology
11.
Am J Trop Med Hyg ; 102(5): 940-942, 2020 05.
Article in English | MEDLINE | ID: covidwho-614664

ABSTRACT

This case report underlines the appearance of a "walking pneumonia" in a novel coronavirus disease (COVID-19) patient, with evidence of progressive lung involvement on chest imaging studies. The patient traveled from Wuhan, Hubei, China, to Thailand in January 2020. One of her family members was diagnosed with COVID-19. She presented to the hospital because of her concern, but she was without fever or any respiratory symptoms. Three days earlier, her nasopharyngeal and throat swabs revealed a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test by real-time reverse transcriptase polymerase chain reaction (RT-PCR). Her initial chest radiography was abnormal, and her first sputum SARS-CoV-2 test yielded inconclusive results. A subsequent sputum test was positive for SARS-CoV-2. Diagnosis in this patient was facilitated by chest imaging and repeat viral testing. Thus, chest imaging studies might enhance capabilities for early diagnosis of COVID-19 pneumonia.


Subject(s)
Betacoronavirus , Clinical Laboratory Techniques , Coronavirus Infections , Lung/diagnostic imaging , Pandemics , Pneumonia, Viral , COVID-19 , COVID-19 Testing , COVID-19 Vaccines , Coronavirus Infections/diagnosis , Coronavirus Infections/physiopathology , Female , Humans , Middle Aged , Pneumonia, Viral/diagnosis , Pneumonia, Viral/physiopathology , Radiography , SARS-CoV-2
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