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1.
JCI Insight ; 7(7)2022 Apr 08.
Article in English | MEDLINE | ID: covidwho-1702851

ABSTRACT

Duration of protection from SARS-CoV-2 infection in people living with HIV (PWH) following vaccination is unclear. In a substudy of the phase II/III the COV002 trial (NCT04400838), 54 HIV+ male participants on antiretroviral therapy (undetectable viral loads, CD4+ T cells > 350 cells/µL) received 2 doses of ChAdOx1 nCoV-19 (AZD1222) 4-6 weeks apart and were followed for 6 months. Responses to vaccination were determined by serology (IgG ELISA and Meso Scale Discovery [MSD]), neutralization, ACE-2 inhibition, IFN-γ ELISpot, activation-induced marker (AIM) assay and T cell proliferation. We show that, 6 months after vaccination, the majority of measurable immune responses were greater than prevaccination baseline but with evidence of a decline in both humoral and cell-mediated immunity. There was, however, no significant difference compared with a cohort of HIV-uninfected individuals vaccinated with the same regimen. Responses to the variants of concern were detectable, although they were lower than WT. Preexisting cross-reactive T cell responses to SARS-CoV-2 spike were associated with greater postvaccine immunity and correlated with prior exposure to beta coronaviruses. These data support the ongoing policy to vaccinate PWH against SARS-CoV-2, and they underpin the need for long-term monitoring of responses after vaccination.


Subject(s)
COVID-19 , HIV Infections , COVID-19/prevention & control , HIV Infections/drug therapy , Humans , Male , SARS-CoV-2 , Vaccination
2.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-310655

ABSTRACT

Background: The ChAdOx1 nCoV-19 (AZD1222) vaccine is immunogenic and protects against COVID-19. However, data on vaccine immunogenicity are needed for the 40 million people living with HIV (PWH), who may have less functional immunity and more associated co-morbidities than the general population. Methods: Between the 5th and 24th November 2020, 54 adults with HIV, aged 18-55 years, were enrolled into a single arm open label vaccination study within the protocol of the larger phase 2/3 COV002 trial. A prime-boost regimen of ChAdOx1 nCoV-19, with two doses (5 × 1010 vp) was given 4-6 weeks apart. All participants were on antiretroviral therapy (ART) with undetectable plasma HIV viral loads and CD4+ T cell counts >350 cells/µl at enrolment. Data were captured on adverse events. Humoral responses were measured by anti-spike IgG ELISA and antibody-mediated live virus neutralisation. Cell-mediated immune responses were measured by ex-vivo interferon-γ enzyme-linked immunospot assay (ELISpot) and T cell proliferation. All outcomes were compared with a HIV uninfected group from the main COV002 study.Findings: 54 participants with HIV (median age 42.5 years (IQR 37.2-49.8)) received two doses of ChAdOx1 nCoV-19. Median CD4+ T cell count at enrolment was 694 cells/µl (IQR 562-864). Results are reported for 56 days of follow-up. Local and systemic reactions occurring during the first 7 days after prime vaccination included pain at the injection site (49%), fatigue (47%), headache (47%), malaise (34%), chills (23%), and muscle or (36%) joint pain (9%), the frequencies of which were similar to the HIV-negative participants. There were no serious adverse events. Anti-spike IgG responses by ELISA peaked at Day 42 (median 1440 ELISA units, IQR 704-2728) and were sustained out to Day 56. There was no correlation with CD4+ T cell count or age and the magnitude of the anti-spike IgG response at Day 56 (P>0.05 for both). ELISpot and T cell proliferative responses peaked between Day 14 and 28 after prime and were sustained through to Day 56. When compared to participants without HIV there was no statistical difference in magnitude or persistence of SARS-CoV-2 spike-specific humoral or cellular responses (P>0.05 for all analyses).Interpretation: In this study of PWH, vaccination with ChAdOx1 nCoV-19 was well tolerated and there was no difference in humoral and cell-mediated immune responses compared to an adult cohort without HIV who received the same vaccination regime. Trial Registration: Trial Registration number is NCT04400838. Funding: UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midlands NIHR Clinical Research Network, and AstraZeneca. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.Declaration of Interest: Oxford University has entered into a partnership with AstraZeneca for further development of ChAdOx1 nCoV-19 (AZD1222). AstraZeneca reviewed the data from the study and the final manuscript before 474 submission, but the authors retained editorial control. SCG is cofounder of Vaccitech (a collaborator in the early development of this vaccine candidate) and named as an inventor on a patent covering use of ChAdOx1-vectored vaccines (PCT/GB2012/000467) and a patent application covering this SARS-CoV-2 vaccine. TL is named as an inventor on a patent application covering this SARS-CoV-2 vaccine and was consultant to Vaccitech. PMF is a consultant to Vaccitech. AJP is Chair of the UK Department of Health and Social Care’s JCVI, but does not participate in policy advice on coronavirus vaccines, and is a member of the WHO Strategic Advisory Group of Experts (SAGE). AVSH is a cofounder of and consultant to Vaccitech and is named as an inventor on a patent covering design and use of ChAdOx1-vectored vaccines (PCT/GB2012/0004 7).Ethical Approval: Written informed consent was obtained from all participants, and the trial was done in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. This study was approved in the UK by the Medicines and Healthcare products Regulatory Agency (reference 21584/0424/001-0001) and the South Central Berkshire Research Ethics Committee (reference 20/SC/0145). Vaccine use was authorised by Genetically Modified Organisms Safety Committees at each participating site.

3.
Journal of Traditional Chinese Medical Sciences ; 2022.
Article in English | ScienceDirect | ID: covidwho-1611895

ABSTRACT

Traditional Chinese medicine has widely been used internationally in the treatment of coronavirus disease 2019 (COVID-19) since January 2020. There has been great interest in initiating clinical studies testing different Chinese medicine therapies for COVID-19, but the majority of registered studies have yet to move forward due to a lack of COVID-19 patients in mainland China. The aim of this article was to systematically review the current clinical research evidence on Chinese medicine for treating COVID-19 from international and domestic bibliographic databases to reflect on the advances in this field.

4.
Lancet HIV ; 8(8): e474-e485, 2021 08.
Article in English | MEDLINE | ID: covidwho-1275800

ABSTRACT

BACKGROUND: Data on vaccine immunogenicity against SARS-CoV-2 are needed for the 40 million people globally living with HIV who might have less functional immunity and more associated comorbidities than the general population. We aimed to explore safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine in people with HIV. METHODS: In this single-arm open-label vaccination substudy within the protocol of the larger phase 2/3 trial COV002, adults aged 18-55 years with HIV were enrolled at two HIV clinics in London, UK. Eligible participants were required to be on antiretroviral therapy (ART), with undetectable plasma HIV viral loads (<50 copies per mL), and CD4 counts of more than 350 cells per µL. A prime-boost regimen of ChAdOx1 nCoV-19, with two doses was given 4-6 weeks apart. The primary outcomes for this substudy were safety and reactogenicity of the vaccine, as determined by serious adverse events and solicited local and systemic reactions. Humoral responses were measured by anti-spike IgG ELISA and antibody-mediated live virus neutralisation. Cell-mediated immune responses were measured by ex-vivo IFN-γ enzyme-linked immunospot assay (ELISpot) and T-cell proliferation. All outcomes were compared with an HIV-uninfected group from the main COV002 study within the same age group and dosing strategy and are reported until day 56 after prime vaccination. Outcomes were analysed in all participants who received both doses and with available samples. The COV002 study is registered with ClinicalTrials.gov, NCT04400838, and is ongoing. FINDINGS: Between Nov 5 and Nov 24, 2020, 54 participants with HIV (all male, median age 42·5 years [IQR 37·2-49·8]) were enrolled and received two doses of ChAdOx1 nCoV-19. Median CD4 count at enrolment was 694·0 cells per µL (IQR 573·5-859·5). No serious adverse events occurred. Local and systemic reactions occurring during the first 7 days after prime vaccination included pain at the injection site (26 [49%] of 53 participants with available data), fatigue (25 [47%]), headache (25 [47%]), malaise (18 [34%]), chills (12 [23%]), muscle ache (19 [36%]), joint pain (five [9%]), and nausea (four [8%]), the frequencies of which were similar to the HIV-negative participants. Anti-spike IgG responses by ELISA peaked at day 42 (median 1440 ELISA units [EUs; IQR 704-2728]; n=50) and were sustained until day 56 (median 941 EUs [531-1445]; n=49). We found no correlation between the magnitude of the anti-spike IgG response at day 56 and CD4 cell count (p=0·93) or age (p=0·48). ELISpot and T-cell proliferative responses peaked at day 14 and 28 after prime dose and were sustained to day 56. Compared with participants without HIV, we found no difference in magnitude or persistence of SARS-CoV-2 spike-specific humoral or cellular responses (p>0·05 for all analyses). INTERPRETATION: In this study of people with HIV, ChAdOx1 nCoV-19 was safe and immunogenic, supporting vaccination for those well controlled on ART. FUNDING: UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca.


Subject(s)
Antibodies, Viral/blood , COVID-19 Vaccines/immunology , COVID-19/prevention & control , HIV Infections/immunology , SARS-CoV-2/immunology , Adult , CD4 Lymphocyte Count , COVID-19 Vaccines/adverse effects , HIV Infections/drug therapy , Humans , Male , Middle Aged , Vaccination
5.
Front Psychol ; 12: 645460, 2021.
Article in English | MEDLINE | ID: covidwho-1268290

ABSTRACT

Objectives: The corona virus disease-2019 (COVID-19) pandemic spread globally, and we aimed to investigate the psychosocial impact on healthcare workers (HWs) in China during the pandemic. Methods: In this systematic review and meta-analysis, we searched seven electronic databases for cross-sectional studies on psychosocial impact on HWs in relation to COVID-19 from January 1, 2020 to October 7, 2020. We included primary studies involving Chinese HWs during the pandemic, and data were extracted from the published articles. Our primary outcome was prevalence of anxiety, depression, and stress disorders. We pooled prevalence value with their 95% confidence interval using random effect models and assessed study quality on the basis of an 11-item checklist recommended by the Agency for Healthcare Research and Quality. The study protocol was registered in PROSPERO (CRD42020195843). Results: We identified 25 articles comprising a total of 30,841 completed questionnaires and 22 studies for meta-analysis. The prevalence of anxiety, depression, and stress disorders was 34.4% (29.5-39.4%), 31.1% (24.5-37.7%), and 29.1% (24.3-33.8%) for HWs. The pooled prevalence of anxiety disorders for HWs from late January to early February was 46.4% (42.9-49.9%), significantly higher than those in mid-term February (28.0%, 23.9-32.1%) and after late February (27.6%, 16.0-39.2%). The pooled prevalence of depression disorders for HWs from late January to early February was 46.5% (38.8-54.2%), significantly higher than those in mid-term February (27.1%, 19.8-34.5%) and after late February (32.9%, 16.2-49.5%). HWs working in Hubei Province had a higher prevalence of anxiety (37.9 vs. 30.8%) and a lower prevalence of depression (27.5 vs. 34.7%) than those working in other regions. Nurses had a higher prevalence of anxiety (44.1 vs. 29.0%) and depression (34.1 vs. 29.2%) than other HWs. Conclusions: About one-third of HWs in China suffered anxiety, depression, and stress at the early epidemic of COVID-19. HWs in Hubei Province, especially nurses, had a higher prevalence of psychological disorders. During the pandemic, a negative psychological state may persist in a proportion of Chinese HWs, fluctuating with the control of the pandemic. The long-term impact should continue to be observed. Attention should be paid to HWs for their psychological impact due to the pandemic. Systematic Review Registration: The study protocol was registered with PROSPERO (CRD42020195843).

6.
Complement Ther Med ; 60: 102744, 2021 Aug.
Article in English | MEDLINE | ID: covidwho-1252645

ABSTRACT

INTRODUCTION: Chinese patent medicine (CPM) is an indispensable part of traditional Chinese medicine. Coronavirus Disease 2019 (COVID-19) manifests is an acute respiratory infectious disease. This systematic review aimed to evaluate the therapeutic effects and safety of oral CPM for COVID-19. METHODS: We included randomized controlled trials (RCTs) that tested oral CPM for the treatment of COVID-19 identified from publications in CNKI, Wanfang, VIP, Web of Science, SinoMed, PubMed, Embase, BioRxiv, MedRxiv and arXiv before November 2nd, 2020. The risk of bias for each trial was assessed using the Cochrane Risk of Bias Tool 2.0. RevMan 5.4 software was used for data analyses. The certainty of the evidence was assessed using the online GRADEpro tool. RESULTS: Seven RCTs including 1079 participants were identified. The overall bias was assessed as "-high risk of bias" for all included trials. Oral CPM investigated were: Lianhua Qingwen capsule/granules (LHQW), Jinhua Qinggan granules (JHQG), Huoxiang Zhengqi dripping pills (HXZQ), Toujie Quwen granules (TJQW) and Lianhua Qingke granules (LHQK). Compared with conventional western therapy alone for people with COVID-19: regarding the main outcomes, the results showed that oral CPM combined with conventional western therapy improved cure rate (RR = 1.20, 95 % CI 1.04-1.38, involving LHQW and TJQW), reduced aggravation rate (RR = 0.50, 95 % CI 0.29 - 0.85, involving LHQW, JHQG, LHQK and TJQW); with regard to additional outcomes, the results showed that add-on oral CPM shortened the duration of fever, cough and fatigue, improved the recovery rate of cough and fatigue, and increased the improvement and recovery rate of chest CT manifestations. There were some differences in therapeutic effects among various CPMs for the same COVID-19 outcome. The use of TJQW and LHQG appeared not to increase the risk of adverse events, but JHQG may cause mild diarrhea. CONCLUSION: Low-certainty or very low-certainty evidence demonstrated that oral CPM may have add-on potential therapeutic effects for patients with non-serious COVID-19. These findings need to be further confirmed by well-designed clinical trials with adequate sample sizes.


Subject(s)
COVID-19/therapy , Drugs, Chinese Herbal/therapeutic use , Medicine, Chinese Traditional , Nonprescription Drugs/administration & dosage , Randomized Controlled Trials as Topic , SARS-CoV-2 , Administration, Oral , Bias , Humans
7.
Front Pharmacol ; 11: 583450, 2020.
Article in English | MEDLINE | ID: covidwho-1133942

ABSTRACT

Objective: To present the evidence of the therapeutic effects and safety of Chinese herbal medicine (CHM) used with or without conventional western therapy for COVID-19. Methods: Clinical studies on the therapeutic effects and safety of CHM for COVID-19 were included. We summarized the general characteristics of included studies, evaluated methodological quality of randomized controlled trials (RCTs) using the Cochrane risk of bias tool, analyzed the use of CHM, used Revman 5.4 software to present the risk ratio (RR) or mean difference (MD) and their 95% confidence interval (CI) to estimate the therapeutic effects and safety of CHM. Results: A total of 58 clinical studies were identified including RCTs (17.24%, 10), non-randomized controlled trials (1.72%, 1), retrospective studies with a control group (18.97%, 11), case-series (20.69%, 12) and case-reports (41.38%, 24). No RCTs of high methodological quality were identified. The most frequently tested oral Chinese patent medicine, Chinese herbal medicine injection or prescribed herbal decoction were: Lianhua Qingwen granule/capsule, Xuebijing injection and Maxing Shigan Tang. In terms of aggravation rate, pooled analyses showed that there were statistical differences between the intervention group and the comparator group (RR 0.42, 95% CI 0.21 to 0.82, six RCTs; RR 0.38, 95% CI 0.23 to 0.64, five retrospective studies with a control group), that is, CHM plus conventional western therapy appeared better than conventional western therapy alone in reducing aggravation rate. In addition, compared with conventional western therapy, CHM plus conventional western therapy had potential advantages in increasing the recovery rate and shortening the duration of fever, cough and fatigue, improving the negative conversion rate of nucleic acid test, and increasing the improvement rate of chest CT manifestations and shortening the time from receiving the treatment to the beginning of chest CT manifestations improvement. For adverse events, pooled data showed that there were no statistical differences between the CHM and the control groups. Conclusion: Current low certainty evidence suggests that there maybe a tendency that CHM plus conventional western therapy is superior to conventional western therapy alone. The use of CHM did not increase the risk of adverse events.

8.
Eur J Integr Med ; 40: 101229, 2020 Dec.
Article in English | MEDLINE | ID: covidwho-885275

ABSTRACT

INTRODUCTION: Tai Chi (TC), a gentle exercise, incorporates meditative movement and respiratory control. The high risk of cross infection for people with cystic fibrosis (CF) requires close management in healthcare settings, limiting group activities such as TC. A mixed-methods randomized controlled feasibility study compared teaching TC over the internet with in-person, face to face TC tuition provided to CF patients. This article explores qualitative data from patients and TC instructors on their attitudes, acceptability and engagement with the two modes of TC delivery. METHODS: Qualitative data from CF patients (>6 years) were collected using Skype interviews/focus groups and written feedback. TC instructors provided weekly written feedback, and took part in interviews/ focus groups at the end of the study. Patient and instructor interviews explored their experiences and engagement with TC online delivery and ability to practice. RESULTS: Irrespective of the type of TC delivery, all CF participants interviewed (n = 28) practiced between lessons and most wanted to continue TC. Teenagers were more likely to miss TC appointments. Internet delivery was well received by both patients and TC instructors. Two patients reported difficulties with screen size/camera and one with internet connectivity. CONCLUSION: Both face-to-face and internet delivery of TC lessons were equally well received and perceived as beneficial. In the current COVID-19 pandemic, CF patients self-isolating could find this intervention provides important support, therefore the programme was made available on YouTube in April 2020 and linked to the websites of the CF charities funding the research.

9.
Eur J Integr Med ; 36: 101136, 2020 Jun.
Article in English | MEDLINE | ID: covidwho-621838

ABSTRACT

Increasingly we are reaching a situation where current antimicrobial medicines are no longer effective for common infections, and antimicrobial resistance (AMR) is now a global public health crisis. The reliance on antimicrobials such as antibiotics has become a major issue for both medicine and agriculture, particularly given the slow development of new medicines and pharmaceutical industry investment. The UK government has been working with other international bodies in the search for solutions to the many challenges AMR poses. Herbal medicines may provide a useful modality in the fight against AMR and can work solely or in tandem with current antimicrobial approaches. Recommendations for herbal medicine use during the COVID-19 viral pandemic have featured in Chinese national guidelines and policies, but UK strategies have no such guidance on herbal treatment for any infectious disease. More research is urgently needed to explore the biological plausibility and safety of herbal medicines to manage AMR. AMR is universal, affecting anyone and everyone, at any age and in any country. Investigating how such approaches can be integrated into western medicine will be important to elucidate.

10.
Chin J Integr Med ; 26(4): 243-250, 2020 Apr.
Article in English | MEDLINE | ID: covidwho-1125

ABSTRACT

OBJECTIVE: Since December 2019, an outbreak of corona virus disease 2019 (COVID-19) occurred in Wuhan, and rapidly spread to almost all parts of China. This was followed by prevention programs recommending Chinese medicine (CM) for the prevention. In order to provide evidence for CM recommendations, we reviewed ancient classics and human studies. METHODS: Historical records on prevention and treatment of infections in CM classics, clinical evidence of CM on the prevention of severe acute respiratory syndrome (SARS) and H1N1 influenza, and CM prevention programs issued by health authorities in China since the COVID-19 outbreak were retrieved from different databases and websites till 12 February, 2020. Research evidence included data from clinical trials, cohort or other population studies using CM for preventing contagious respiratory virus diseases. RESULTS: The use of CM to prevent epidemics of infectious diseases was traced back to ancient Chinese practice cited in Huangdi's Internal Classic (Huang Di Nei Jing) where preventive effects were recorded. There were 3 studies using CM for prevention of SARS and 4 studies for H1N1 influenza. None of the participants who took CM contracted SARS in the 3 studies. The infection rate of H1N1 influenza in the CM group was significantly lower than the non-CM group (relative risk 0.36, 95% confidence interval 0.24-0.52; n=4). For prevention of COVID-19, 23 provinces in China issued CM programs. The main principles of CM use were to tonify qi to protect from external pathogens, disperse wind and discharge heat, and resolve dampness. The most frequently used herbs included Radix astragali (Huangqi), Radix glycyrrhizae (Gancao), Radix saposhnikoviae (Fangfeng), Rhizoma Atractylodis Macrocephalae (Baizhu), Lonicerae Japonicae Flos (Jinyinhua), and Fructus forsythia (Lianqiao). CONCLUSIONS: Based on historical records and human evidence of SARS and H1N1 influenza prevention, Chinese herbal formula could be an alternative approach for prevention of COVID-19 in high-risk population. Prospective, rigorous population studies are warranted to confirm the potential preventive effect of CM.


Subject(s)
Betacoronavirus , Coronavirus Infections/therapy , Drugs, Chinese Herbal/therapeutic use , Epidemics , Medicine, Chinese Traditional , Pneumonia, Viral/therapy , Astragalus propinquus , COVID-19 , Clinical Trials as Topic , Coronavirus Infections/drug therapy , Epidemics/history , Epidemics/prevention & control , History, Ancient , Humans , Infection Control/history , Infection Control/methods , Influenza A Virus, H1N1 Subtype , Influenza, Human/therapy , Medicine, Chinese Traditional/history , Medicine, Chinese Traditional/methods , Pandemics , Qi , SARS-CoV-2 , Severe Acute Respiratory Syndrome/therapy
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