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1.
J Infect ; 2022 Apr 08.
Article in English | MEDLINE | ID: covidwho-1778315

ABSTRACT

OBJECTIVES: To evaluate the persistence of immunogenicity three months after third dose boosters. METHODS: COV-BOOST is a multicentre, randomised, controlled, phase 2 trial of seven COVID-19 vaccines used as a third booster dose. The analysis was conducted using all randomised participants who were SARS-CoV-2 naïve during the study. RESULTS: Among the 2883 participants randomised, there were 2422 SARS-CoV-2 naïve participants until D84 visit included in the analysis with median age of 70 (IQR: 30-94) years. In the participants who had two initial doses of ChAd, schedules using mRNA vaccines as third dose have the highest anti-spike IgG at D84 (e.g. geometric mean concentration of 8674 ELU/ml (95% CI: 7461-10085) following ChAd/ChAd/BNT). However, in people who had two initial doses of BNT there was no significant difference at D84 in people given ChAd versus BNT (geometric mean ratio (GMR) of 0.95 (95%CI: 0.78, 1.15). Also, people given Ad26.COV2.S (Janssen; hereafter referred to as Ad26) as a third dose had significantly higher anti-spike IgG at D84 than BNT (GMR of 1.20, 95%CI: 1.01,1.43). Responses at D84 between people who received BNT (15 µg) or BNT (30 µg) after ChAd/ChAd or BNT/BNT were similar, with anti-spike IgG GMRs of half-BNT (15 µg) versus BNT (30 µg) ranging between 0.74-0.86. The decay rate of cellular responses were similar between all the vaccine schedules and doses. CONCLUSIONS: 84 days after a third dose of COVID-19 vaccine the decay rates of humoral response were different between vaccines. Adenoviral vector vaccine anti-spike IgG concentration at D84 following BNT/BNT initial doses were higher than for a three dose (BNT/BNT/BNT) schedule. Half dose BNT immune responses were similar to full dose responses. While high antibody tires are desirable in situations of high transmission of new variants of concern, the maintenance of immune responses that confer long-lasting protection against severe disease or death is also of critical importance. Policymakers may also consider adenoviral vector, fractional dose of mRNA, or other non-mRNA vaccines as third doses.

2.
SSRN; 2022.
Preprint in English | SSRN | ID: ppcovidwho-332455

ABSTRACT

Background: Many high-income countries have deployed third “booster” doses of COVID-19 vaccines to populations and some countries have started offering fourth doses. Methods: The COV-BOOST trial is a multicentre, randomised, controlled, phase II trial of seven COVID-19 vaccines as third dose boosters. The current study invited participants who received BNT162b2 (BNT) as third dose in COV-BOOST to be randomised to receive a fourth dose of BNT or mRNA1273 (50 µg, half-m1273). The COV-BOOST trial is a multicentre, randomised, controlled, phase 2 trial of seven COVID-19 vaccines used as a third booster dose. Results: Between 11 and 25 January 2022, 166 participants in the original BNT arm were randomised and received a fourth dose vaccine. The median age was 70.1 (interquartile range: 51.6-77.5) years with 51.8 % (n=86) female participants. The median interval between third and fourth dose was 208.5 (interquartile range: 203.25-214.75) days.Pain and fatigue were the most common local and systemic solicited adverse events for BNT and half-m1273. None of three serious adverse events reported after a fourth dose were related to study vaccine.The fold rises in anti-spike IgG pre- and post-fourth dose were 12.19 (95%CI: 10.37-14.32) and 15.90 (95%CI: 12.92-19.58) in BNT and half-m1273 arms respectively, with fold changes compared to the post third dose-peak of 1.59 (95%CI: 1.41-1.78) and 2.19 (95%CI: 1.90-2.52). T cell responses also boosted. Conclusions: Fourth dose COVID-19 mRNA booster vaccines are well-tolerated and boost cellular and humoral immunity up to, and beyond peak levels achieved following third dose boosters (ISRCTN: 73765130).

3.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-312484

ABSTRACT

Aim: Abnormal laboratory findings have been shown to be associated with severe COVID-19. However, all aspects of this association have not been reviewed systematically. Therefore, the aim of this meta-analysis was to explore crucial laboratory parameters in severe COVID-19 infection. Methods: We performed the literature review of scientific articles indexed in electronic databases. Scientific search engines were used to perform the electronic literature search. After the removal of duplicates and selection of articles of interest, 30 studies were eligible to include. If heterogeneity was high (I2>50%), a random-effects model was applied to combine the data. Otherwise, a fixed-effects model was used. Results: A total of 5586 individuals were assessed (1555 patients with severe COVID-19 infection and 3452 with non-severe infection). Platelets, lymphocytes and serum albumin were significantly lower in severe patients while other biochemical and immunological parameters including prothrombin time, ALT, AST, total bilirubin, LDH, procalcitonin, CRP, IL-6, and IgA were significantly higher in patients with severe infection. Neutrophil and monocyte counts as well as hemoglobin level, D-dimer, hypersensitive troponin I, IL-2R, IgG and IgM levels were different between two groups;however, the difference was not statistically significant (All P-values >0.05). Conclusions: Lymphopenia, elevated liver enzymes, and high levels of inflammatory biomarkers are associated with severe COVID-19 infection.

4.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-312088

ABSTRACT

Background: It remains unclear whether a specific chest CT characteristic is associated with the clinical severity of COVID-19. This meta-analysis was performed to assess the relationship between different chest CT features and severity of clinical presentation in COVID-19. Methods: PubMed, Embase, Scopus, web of science databases (WOS), Cochrane library, and Google scholar were searched up to May 19, 2020 for observational studies that assessed the relationship of different chest CT manifestations and the severity of clinical presentation in COVID-19 infection. Risk of bias assessment was evaluated applying the Newcastle-Ottawa Scale. A random-effects model or fixed-effects model, as appropriately, were used to pool results. Heterogeneity was assessed using Forest plot, Cochran's Q test, and I2. Publication bias was assessed applying Egger’s test. Results: A total of 18 studies involving 3323 patients were included. Bronchial wall thickening (OR 11.64, 95% CI 1.81- 74.66) was more likely to be associated with severe cases of COVID-19 infection, followed by linear opacity (OR 3.27, 95% CI 1.10- 9.70), and GGO (OR 1.37, 95% CI 1.08- 1.73). However, there was no significant association between the presence of consolidation and severity of clinical presentation (OR 2.33, 95% CI 0.85- 6.36). Considering the lesion distribution bilateral lung involvement was more frequently associated with severe clinical presentation (OR 3.44, 95% CI 1.74- 6.79). Conclusions: Our meta-analysis of observational studies suggests some specific chest CT features. The presence of these CT features can help the physicians to early and appropriately approach to the severe and fatal cases of COVID-19.

5.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-319285

ABSTRACT

Background: To inform researchers about the methodology and results of epidemic estimation studies performed for COVID-19 epidemic in Iran, we aimed to perform a rapid review. Methods: We searched for and included published articles, preprint manuscripts and reports that estimated numbers of cumulative or daily deaths or cases of COVID-19 in Iran. We found 131 studies and included 29 of them. Results: The included studies provided outputs for a total of 84 study-model/scenario combinations. Sixteen studies used 3-4 compartmental disease models. At the end of month two of the epidemic (2020-04-19), the lowest (and highest) values of predictions were 1777 (388951) for cumulative deaths, 20588 (2310161) for cumulative cases, and at the end of month four (2020-06-20), were 3590 (1819392) for cumulative deaths, and 144305 (4266964) for cumulative cases. Highest estimates of cumulative deaths (and cases) for latest date available in 2020 were 418834 on 2020-12-19 (and 41475792 on 2020-12-31). Model estimates predict an ominous course of epidemic progress in Iran. Increase in percent population using masks from the current situation to 95% might prevent 26790 additional deaths (95% confidence interval 19925-35208) by the end of year 2020. Conclusions: : Meticulousness and degree of details reported for disease modeling and statistical methods used in the included studies varied widely. Greater heterogeneity was observed regarding the results of predicted outcomes. Consideration of minimum and preferred reporting items in epidemic estimation studies might better inform future revisions of the available models and new models to be developed. Not accounting for under-reporting drives the models’ results misleading.

6.
Lancet ; 398(10318): 2258-2276, 2021 12 18.
Article in English | MEDLINE | ID: covidwho-1550152

ABSTRACT

BACKGROUND: Few data exist on the comparative safety and immunogenicity of different COVID-19 vaccines given as a third (booster) dose. To generate data to optimise selection of booster vaccines, we investigated the reactogenicity and immunogenicity of seven different COVID-19 vaccines as a third dose after two doses of ChAdOx1 nCov-19 (Oxford-AstraZeneca; hereafter referred to as ChAd) or BNT162b2 (Pfizer-BioNtech, hearafter referred to as BNT). METHODS: COV-BOOST is a multicentre, randomised, controlled, phase 2 trial of third dose booster vaccination against COVID-19. Participants were aged older than 30 years, and were at least 70 days post two doses of ChAd or at least 84 days post two doses of BNT primary COVID-19 immunisation course, with no history of laboratory-confirmed SARS-CoV-2 infection. 18 sites were split into three groups (A, B, and C). Within each site group (A, B, or C), participants were randomly assigned to an experimental vaccine or control. Group A received NVX-CoV2373 (Novavax; hereafter referred to as NVX), a half dose of NVX, ChAd, or quadrivalent meningococcal conjugate vaccine (MenACWY)control (1:1:1:1). Group B received BNT, VLA2001 (Valneva; hereafter referred to as VLA), a half dose of VLA, Ad26.COV2.S (Janssen; hereafter referred to as Ad26) or MenACWY (1:1:1:1:1). Group C received mRNA1273 (Moderna; hereafter referred to as m1273), CVnCov (CureVac; hereafter referred to as CVn), a half dose of BNT, or MenACWY (1:1:1:1). Participants and all investigatory staff were blinded to treatment allocation. Coprimary outcomes were safety and reactogenicity and immunogenicity of anti-spike IgG measured by ELISA. The primary analysis for immunogenicity was on a modified intention-to-treat basis; safety and reactogenicity were assessed in the intention-to-treat population. Secondary outcomes included assessment of viral neutralisation and cellular responses. This trial is registered with ISRCTN, number 73765130. FINDINGS: Between June 1 and June 30, 2021, 3498 people were screened. 2878 participants met eligibility criteria and received COVID-19 vaccine or control. The median ages of ChAd/ChAd-primed participants were 53 years (IQR 44-61) in the younger age group and 76 years (73-78) in the older age group. In the BNT/BNT-primed participants, the median ages were 51 years (41-59) in the younger age group and 78 years (75-82) in the older age group. In the ChAd/ChAD-primed group, 676 (46·7%) participants were female and 1380 (95·4%) were White, and in the BNT/BNT-primed group 770 (53·6%) participants were female and 1321 (91·9%) were White. Three vaccines showed overall increased reactogenicity: m1273 after ChAd/ChAd or BNT/BNT; and ChAd and Ad26 after BNT/BNT. For ChAd/ChAd-primed individuals, spike IgG geometric mean ratios (GMRs) between study vaccines and controls ranged from 1·8 (99% CI 1·5-2·3) in the half VLA group to 32·3 (24·8-42·0) in the m1273 group. GMRs for wild-type cellular responses compared with controls ranged from 1·1 (95% CI 0·7-1·6) for ChAd to 3·6 (2·4-5·5) for m1273. For BNT/BNT-primed individuals, spike IgG GMRs ranged from 1·3 (99% CI 1·0-1·5) in the half VLA group to 11·5 (9·4-14·1) in the m1273 group. GMRs for wild-type cellular responses compared with controls ranged from 1·0 (95% CI 0·7-1·6) for half VLA to 4·7 (3·1-7·1) for m1273. The results were similar between those aged 30-69 years and those aged 70 years and older. Fatigue and pain were the most common solicited local and systemic adverse events, experienced more in people aged 30-69 years than those aged 70 years or older. Serious adverse events were uncommon, similar in active vaccine and control groups. In total, there were 24 serious adverse events: five in the control group (two in control group A, three in control group B, and zero in control group C), two in Ad26, five in VLA, one in VLA-half, one in BNT, two in BNT-half, two in ChAd, one in CVn, two in NVX, two in NVX-half, and one in m1273. INTERPRETATION: All study vaccines boosted antibody and neutralising responses after ChAd/ChAd initial course and all except one after BNT/BNT, with no safety concerns. Substantial differences in humoral and cellular responses, and vaccine availability will influence policy choices for booster vaccination. FUNDING: UK Vaccine Taskforce and National Institute for Health Research.


Subject(s)
/administration & dosage , COVID-19/prevention & control , Immunization, Secondary/methods , Immunogenicity, Vaccine , Adult , Aged , Aged, 80 and over , COVID-19/immunology , Female , Humans , Male , Middle Aged , Pandemics , Patient Safety , SARS-CoV-2 , United Kingdom
7.
Cochrane Database Syst Rev ; 6: CD008077, 2021 06 08.
Article in English | MEDLINE | ID: covidwho-1453524

ABSTRACT

BACKGROUND: Heparin is an anticoagulant medication that is usually injected subcutaneously. Subcutaneous administration of heparin may result in complications such as bruising, haematoma, and pain at the injection site. One of the factors that may affect pain, haematoma, and bruising is injection speed. Several studies have been carried out to determine if speed of injection affects the amount of pain and bruising where the injection is given; however, the results of these studies have differed, and study authors have not reached a clear final conclusion. This is the second update of a review first published in 2014. OBJECTIVES: To assess the effects of duration (speed) of subcutaneous heparin injection on pain and bruising at the injection site in people admitted to hospitals or clinics who require treatment with unfractionated heparin (UFH) or low molecular weight heparin (LMWH). We also looked at haematoma at the injection site. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 22 June 2020. We undertook reference checking of included studies to identify additional studies. SELECTION CRITERIA: We searched for randomised controlled trials (RCTs) comparing the effects of different durations of subcutaneous injection of heparin on pain, bruising, and haematoma at the injection site. DATA COLLECTION AND ANALYSIS: For this update, two review authors independently selected studies and extracted data via Covidence software and assessed methodological quality using Cochrane's risk of bias tool. The primary outcomes of interest were pain intensity at injection site and size and incidence of bruising. The secondary outcomes of interest were size and incidence of haematoma at injection site. We calculated the odds ratio (OR), mean difference (MD), or standardised mean difference (SMD) with corresponding 95% confidence intervals (CIs). We assessed the certainty of the evidence using GRADE criteria. MAIN RESULTS: We identified one new study for this update, resulting in a total of five included studies with 503 participants who received subcutaneous injections of LMWH into the abdomen. Given the nature of the intervention, it was not possible to blind participants and caregivers (personnel) in any of the included studies. Two studies described blinding of outcome assessors. Overall, the methodological quality of included studies was moderate. The duration of the fast injection was 10 seconds, and the duration of the slow injection was 30 seconds in all included studies. Four studies reported site pain intensity after each injection at different time points. Two studies assessed site pain intensity immediately after each injection; meta-analysis showed no evidence of a difference in site pain intensity immediately after slow injection when compared to fast injection (MD -1.52, 95% CI -3.56 to 0.53; 140 participants; low-certainty evidence). Meta-analysis of three studies indicated that site pain intensity may be slightly reduced 48 hours after the slow heparin injection compared to fast injection (MD -1.60, 95% CI -2.69 to -0.51; 103 participants; low-certainty evidence). Five studies assessed bruise size at 48 hours, and two studies assessed bruise size at 60 hours. Meta-analysis showed there may be a reduction in bruise size 48 hours (SMD -0.54, 95% CI -1.05 to -0.02; 503 participants; 5 studies; very low-certainty evidence) and 60 hours (SMD -0.49, 95% CI -0.93 to -0.06; 84 participants; 2 studies; low-certainty evidence) after slow injection compared to fast injection. There was no evidence of a difference in bruise size 72 hours after slow injection compared to fast injection (SMD -0.27, 95% CI -0.61 to 0.06; 140 participants; 2 studies; low-certainty evidence). Three studies evaluated incidence of bruising and showed there may be a reduction in bruise incidence 48 hours (OR 0.39, 95% CI 0.26 to 0.60; 444 participants; low-certainty evidence) and 60 hours (OR 0.25, 95% CI 0.10 to 0.65; 84 participants; 2 studies; low-certainty evidence) after slow injection compared to fast injection. We downgraded the certainty of the evidence due to risk of bias concerns, imprecision, and inconsistency. None of the included studies measured size or incidence of haematoma. AUTHORS' CONCLUSIONS: Administering medication safely and enhancing patient comfort are the main aims of clinical nurses. In this review, we identified five RCTs that evaluated the effect of subcutaneous heparin injection duration on pain intensity, bruise size and incidence. We found that pain may be slightly reduced 48 hours after slow injection. Similarly, there may be a reduction in bruise size and incidence after slow injection compared to fast injection 48 and 60 hours postinjection. We downgraded the certainty of the evidence for all outcomes to low or very low due to risk of bias concerns, imprecision, and inconsistency. Accordingly, new trials with a more robust design, more participants, and a focus on different injection speeds will be useful in strengthening the certainty of the available evidence.


Subject(s)
Anticoagulants/administration & dosage , Contusions/prevention & control , Heparin, Low-Molecular-Weight/administration & dosage , Injections, Subcutaneous/methods , Pain, Procedural/prevention & control , Anticoagulants/adverse effects , Bias , Contusions/chemically induced , Contusions/pathology , Hematoma/chemically induced , Hematoma/pathology , Heparin, Low-Molecular-Weight/adverse effects , Humans , Injections, Subcutaneous/adverse effects , Middle Aged , Pain Measurement/methods , Pain, Procedural/etiology , Randomized Controlled Trials as Topic , Time Factors
8.
BMC Public Health ; 21(1): 257, 2021 02 01.
Article in English | MEDLINE | ID: covidwho-1058250

ABSTRACT

BACKGROUND: To inform researchers about the methodology and results of epidemic estimation studies performed for COVID-19 epidemic in Iran, we aimed to perform a rapid review. METHODS: We searched for and included published articles, preprint manuscripts and reports that estimated numbers of cumulative or daily deaths or cases of COVID-19 in Iran. We found 131 studies and included 29 of them. RESULTS: The included studies provided outputs for a total of 84 study-model/scenario combinations. Sixteen studies used 3-4 compartmental disease models. At the end of month two of the epidemic (2020-04-19), the lowest (and highest) values of predictions were 1,777 (388,951) for cumulative deaths, 20,588 (2,310,161) for cumulative cases, and at the end of month four (2020-06-20), were 3,590 (1,819,392) for cumulative deaths, and 144,305 (4,266,964) for cumulative cases. Highest estimates of cumulative deaths (and cases) for latest date available in 2020 were 418,834 on 2020-12-19 (and 41,475,792 on 2020-12-31). Model estimates predict an ominous course of epidemic progress in Iran. Increase in percent population using masks from the current situation to 95% might prevent 26,790 additional deaths (95% confidence interval 19,925-35,208) by the end of year 2020. CONCLUSIONS: Meticulousness and degree of details reported for disease modeling and statistical methods used in the included studies varied widely. Greater heterogeneity was observed regarding the results of predicted outcomes. Consideration of minimum and preferred reporting items in epidemic estimation studies might better inform future revisions of the available models and new models to be developed. Not accounting for under-reporting drives the models' results misleading.


Subject(s)
COVID-19/epidemiology , Epidemics , Humans , Iran/epidemiology
9.
Clin Imaging ; 74: 67-75, 2021 Jun.
Article in English | MEDLINE | ID: covidwho-1009384

ABSTRACT

BACKGROUND: It remains unclear whether a specific chest CT characteristic is associated with the clinical severity of COVID-19. This meta-analysis was performed to assess the relationship between different chest CT features and severity of clinical presentation in COVID-19. METHODS: PubMed, Embase, Scopus, web of science databases (WOS), Cochrane library, and Google scholar were searched up to May 19, 2020 for observational studies that assessed the relationship of different chest CT manifestations and the severity of clinical presentation in COVID-19 infection. Risk of bias assessment was evaluated applying the Newcastle-Ottawa Scale. A random-effects model or fixed-effects model, as appropriately, were used to pool results. Heterogeneity was assessed using Forest plot, Cochran's Q test, and I2. Publication bias was assessed applying Egger's test. RESULTS: A total of 18 studies involving 3323 patients were included. Bronchial wall thickening (OR 11.64, 95% CI 1.81-74.66) was more likely to be associated with severe cases of COVID-19 infection, followed by crazy paving (OR 7.60, 95% CI 3.82-15.14), linear opacity (OR 3.27, 95% CI 1.10-9.70), and GGO (OR 1.37, 95% CI 1.08-1.73). However, there was no significant association between the presence of consolidation and severity of clinical presentation (OR 2.33, 95% CI 0.85-6.36). Considering the lesion distribution bilateral lung involvement was more frequently associated with severe clinical presentation (OR 3.44, 95% CI 1.74-6.79). CONCLUSIONS: Our meta-analysis of observational studies indicates some specific chest CT features are associated with clinical severity of COVID-19.


Subject(s)
COVID-19 , Humans , Lung , SARS-CoV-2 , Thorax , Tomography, X-Ray Computed
10.
Med J Islam Repub Iran ; 34: 52, 2020.
Article in English | MEDLINE | ID: covidwho-771108

ABSTRACT

Background: The worldwide emergence and rapid expansion of COVID-19 emphasizes the need to assess the knowledge gap and to predict the disease-related behaviors and reactions during this epidemic. Methods and design: COVID19 Population Survey of Iran (COPSIR) is a repeated cross sectional survey that will be conducted in 8 waves. In each wave, 515 Iranian adults aged 18 years or older will be randomly selected and interviewed by phone. The study waves will be performed at approximately weekly intervals. The survey tool is adapted from COSMO (COVID-19 Snapshot MOnitoring) study. This study will provide information on trends of knowledge, risk perception, preventive behaviors, psychological problems, essential needs, and public trust among Iranian adults during COVID-19 epidemic. Discussion: The key findings of each wave will be immediately reported to the National Headquarters for Coronavirus Control to set better policies for disease control and prevention. Moreover, if a message is extracted from the results of this study that needs to be communicated to the public, it will be done through the mass media.

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