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3.
Lancet ; 396(10249): 467-478, 2020 08 15.
Article in English | MEDLINE | ID: covidwho-981752

ABSTRACT

BACKGROUND: The pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) might be curtailed by vaccination. We assessed the safety, reactogenicity, and immunogenicity of a viral vectored coronavirus vaccine that expresses the spike protein of SARS-CoV-2. METHODS: We did a phase 1/2, single-blind, randomised controlled trial in five trial sites in the UK of a chimpanzee adenovirus-vectored vaccine (ChAdOx1 nCoV-19) expressing the SARS-CoV-2 spike protein compared with a meningococcal conjugate vaccine (MenACWY) as control. Healthy adults aged 18-55 years with no history of laboratory confirmed SARS-CoV-2 infection or of COVID-19-like symptoms were randomly assigned (1:1) to receive ChAdOx1 nCoV-19 at a dose of 5 × 1010 viral particles or MenACWY as a single intramuscular injection. A protocol amendment in two of the five sites allowed prophylactic paracetamol to be administered before vaccination. Ten participants assigned to a non-randomised, unblinded ChAdOx1 nCoV-19 prime-boost group received a two-dose schedule, with the booster vaccine administered 28 days after the first dose. Humoral responses at baseline and following vaccination were assessed using a standardised total IgG ELISA against trimeric SARS-CoV-2 spike protein, a muliplexed immunoassay, three live SARS-CoV-2 neutralisation assays (a 50% plaque reduction neutralisation assay [PRNT50]; a microneutralisation assay [MNA50, MNA80, and MNA90]; and Marburg VN), and a pseudovirus neutralisation assay. Cellular responses were assessed using an ex-vivo interferon-γ enzyme-linked immunospot assay. The co-primary outcomes are to assess efficacy, as measured by cases of symptomatic virologically confirmed COVID-19, and safety, as measured by the occurrence of serious adverse events. Analyses were done by group allocation in participants who received the vaccine. Safety was assessed over 28 days after vaccination. Here, we report the preliminary findings on safety, reactogenicity, and cellular and humoral immune responses. The study is ongoing, and was registered at ISRCTN, 15281137, and ClinicalTrials.gov, NCT04324606. FINDINGS: Between April 23 and May 21, 2020, 1077 participants were enrolled and assigned to receive either ChAdOx1 nCoV-19 (n=543) or MenACWY (n=534), ten of whom were enrolled in the non-randomised ChAdOx1 nCoV-19 prime-boost group. Local and systemic reactions were more common in the ChAdOx1 nCoV-19 group and many were reduced by use of prophylactic paracetamol, including pain, feeling feverish, chills, muscle ache, headache, and malaise (all p<0·05). There were no serious adverse events related to ChAdOx1 nCoV-19. In the ChAdOx1 nCoV-19 group, spike-specific T-cell responses peaked on day 14 (median 856 spot-forming cells per million peripheral blood mononuclear cells, IQR 493-1802; n=43). Anti-spike IgG responses rose by day 28 (median 157 ELISA units [EU], 96-317; n=127), and were boosted following a second dose (639 EU, 360-792; n=10). Neutralising antibody responses against SARS-CoV-2 were detected in 32 (91%) of 35 participants after a single dose when measured in MNA80 and in 35 (100%) participants when measured in PRNT50. After a booster dose, all participants had neutralising activity (nine of nine in MNA80 at day 42 and ten of ten in Marburg VN on day 56). Neutralising antibody responses correlated strongly with antibody levels measured by ELISA (R2=0·67 by Marburg VN; p<0·001). INTERPRETATION: ChAdOx1 nCoV-19 showed an acceptable safety profile, and homologous boosting increased antibody responses. These results, together with the induction of both humoral and cellular immune responses, support large-scale evaluation of this candidate vaccine in an ongoing phase 3 programme. FUNDING: UK Research and Innovation, Coalition for Epidemic Preparedness Innovations, National Institute for Health Research (NIHR), NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and the German Center for Infection Research (DZIF), Partner site Gießen-Marburg-Langen.


Subject(s)
Betacoronavirus/immunology , Coronavirus Infections/prevention & control , Immunogenicity, Vaccine , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Viral Vaccines/adverse effects , Viral Vaccines/immunology , Acetaminophen/therapeutic use , Adenoviruses, Simian/genetics , Adult , Analgesics, Non-Narcotic/therapeutic use , Antibodies, Neutralizing/blood , Antibodies, Viral/blood , COVID-19 , COVID-19 Vaccines , Coronavirus Infections/drug therapy , Coronavirus Infections/immunology , Female , Genetic Vectors/administration & dosage , Humans , Immunization, Secondary , Immunoglobulin G/blood , Male , Pneumonia, Viral/drug therapy , SARS-CoV-2 , Single-Blind Method , Spike Glycoprotein, Coronavirus/immunology , T-Lymphocytes/immunology , United Kingdom , Viral Vaccines/administration & dosage
4.
Agri ; 33(3): 203-204, 2021 Jul.
Article in English | MEDLINE | ID: covidwho-925954

ABSTRACT

Pain is a common but often ignored symptom in COVID-19 patients. Early and adequate treatment with detailed pain assessment in these patients may reduce the risk of pain chronicization, and mood dysregulation. To provide analgesia, paracetamol can be listed as the first option in these patients, and then NSAIDs can also be reliably used for pain management in patients with COVID-19 if there are no absolute contraindications such as kidney failure or gastric bleeding. Codeine is also a good alternative for patients with anxiety who do not respond to simple pain-relievers.


Subject(s)
Analgesics, Non-Narcotic/therapeutic use , COVID-19/complications , Pain/etiology , SARS-CoV-2 , Acetaminophen/administration & dosage , Acetaminophen/therapeutic use , Administration, Oral , Analgesics, Non-Narcotic/administration & dosage , Analgesics, Opioid/adverse effects , Analgesics, Opioid/therapeutic use , Humans , Pain/drug therapy
5.
Ann Pharm Fr ; 79(3): 275-285, 2021 May.
Article in English | MEDLINE | ID: covidwho-885411

ABSTRACT

OBJECTIVE: Self-medication practices are widely practiced globally as major form of self-care for pain management. Unfortunately, with COVID-19 pandemic, prescription only drugs are now increasingly being self-prescribed. Present study was therefore, conducted to generate data on self-medication practice with analgesics using non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen, and the antibiotics among nursing students of University College Farasan Campus. MATERIALS AND METHODS: A cross-sectional descriptive study was conducted among 177 study participants (20±3 years) between December 2019 to February 2020 using questionnaire. Data analyses were done using origin software (6.1, Illinois, USA). Significance was considered at P<0.05. Study was conducted in Department of Nursing, University College Farasan Province, a premier educational institute of Farasan Island affiliated to Jazan university, KSA. RESULTS: Self-medication practices were high among nursing students (n=154 participants, 87%). Acetaminophen was highest used drug for analgesic purposes without prescriptions (n=101 participants, 57%). Among NSAIDs, Ibuprofen was most preferred for various analgesic purposes (n=35 participants, 20%) followed by diclofenac (n=9 participants, 5%) and meloxicam (n=5 participants, 3%). Azithromycine was the only antibiotic used by participants (n=4 participant, 2%). Most common causes of self-medication were headache (45%), menstrual pain (23%) and fever (14%). Main reason for self-medications was lack of time to consult doctor (68%). Furthermore, self-medication was significantly associated with study year (P<0.003). CONCLUSION: Results give rise to concern for general well-being of future nursing workforce. There is need to implement educational actions and awareness programmes to limit self-medication practices among educated youth of this beautiful Island.


Subject(s)
Acetaminophen/therapeutic use , Analgesics, Non-Narcotic/therapeutic use , Anti-Bacterial Agents/therapeutic use , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Self Medication , Students, Nursing/statistics & numerical data , Adolescent , COVID-19 , Cross-Sectional Studies , Female , Humans , Male , Pandemics , Prescription Drugs , Saudi Arabia , Surveys and Questionnaires , Universities , Young Adult
8.
Clin Pharmacol Ther ; 108(4): 719-729, 2020 10.
Article in English | MEDLINE | ID: covidwho-327352

ABSTRACT

The pandemic spread of the new coronavirus disease 2019 (COVID-19) infection in China first, and all over the world at present, has become a global health emergency due to the rapidly increasing number of affected patients. Currently, a clear relationship between COVID-19 infection incidence and/or complications due to chronic or occasional treatments for other pathologies is still not clear, albeit the COVID-19 pandemic may condition the treatment strategy of complex disorders, such as osteoarthritis (OA). Importantly, OA is the most common age-related joint disease, affecting more than 80% of people older than the age of 55, an age burden also shared with the highest severity in COVID-19 patients. OA patients often show a large array of concomitant pathologies, such as diabetes, inflammation, and cardiovascular diseases that are again shared with COVID-19 patients and may therefore increase complications. Moreover, different OA treatments, such as NSAIDs, paracetamol, corticosteroids, opioids, or other molecules have a wide array of iatrogenic effects, potentially increasing COVID-19 secondary infection incidence or complications. In this review we critically analyze the evidence on either negative or positive effects of drugs commonly used to manage OA in this particular scenario. This would provide orthopedic surgeons in particular, and physicians, pharmacologists, and clinicians in general, a comprehensive description about the safety of the current pharmacological approaches and a decision-making tool to treat their OA patients as the coronavirus pandemic continues.


Subject(s)
Betacoronavirus , Coronavirus Infections/drug therapy , Disease Management , Osteoarthritis/drug therapy , Pandemics/prevention & control , Pneumonia, Viral/drug therapy , Analgesics, Non-Narcotic/therapeutic use , Analgesics, Opioid/therapeutic use , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , COVID-19 , Coronavirus Infections/epidemiology , Humans , Immunosuppressive Agents/therapeutic use , Osteoarthritis/epidemiology , Pneumonia, Viral/epidemiology , SARS-CoV-2
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