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1.
BJGP Open ; 2022 May 17.
Article in English | MEDLINE | ID: covidwho-1855866

ABSTRACT

BACKGROUND: Among the manifestations of COVID-19 are taste and smell disorders (TSDs). AIM: To evaluate the sensitivity and specificity of TSDs and other associated symptoms to estimate predictive values for determining SARS-CoV-2 infection. DESIGN & SETTING: A retrospective observational study of healthcare professionals in Catalonia, Spain. METHOD: A study of the sensitivity and specificity of TSDs has been carried out using the polymerase chain reaction (PCR) test for the diagnosis of SARS-CoV-2 as the gold standard value. Logistic regressions adjusted for age and sex were performed to identify additional symptoms that might be associated with COVID-19. RESULTS: The results are based on 226 healthcare workers with clinical symptoms suggestive of COVID-19, 116 with positive PCR and 110 with negative PCR. TSDs had an odds ratio (OR) of 12.4 (95% confidence interval [CI] = 6.3 to 26.2), sensitivity 60.3% and specificity 89.1%. In the logistic regression model, the association of TSD, fever or low-grade fever, shivering, dyspnoea, arthralgia, and myalgia obtained an area under the curve (AUC) of 85.7% (95% CI = 80.7 % to 90.7 %), sensitivity 82.8 %, specificity 80.0%, and positive predictive values 81.4% and negative 81.5%. CONCLUSION: TSDs are a strong predictor of COVID-19. The association of TSD, fever, low-grade fever or shivering, dyspnoea, arthralgia, and myalgia correctly predicts 85.7% of the results of the COVID-19 test.

2.
Nat Commun ; 13(1): 2583, 2022 05 11.
Article in English | MEDLINE | ID: covidwho-1839524

ABSTRACT

Data on convalescent plasma (CP) treatment in COVID-19 outpatients are scarce. We aimed to assess whether CP administered during the first week of symptoms reduced the disease progression or risk of hospitalization of outpatients. Two multicenter, double-blind randomized trials (NCT04621123, NCT04589949) were merged with data pooling starting when <20% of recruitment target was achieved. A Bayesian-adaptive individual patient data meta-analysis was implemented. Outpatients aged ≥50 years and symptomatic for ≤7days were included. The intervention consisted of 200-300mL of CP with a predefined minimum level of antibodies. Primary endpoints were a 5-point disease severity scale and a composite of hospitalization or death by 28 days. Amongst the 797 patients included, 390 received CP and 392 placebo; they had a median age of 58 years, 1 comorbidity, 5 days symptoms and 93% had negative IgG antibody-test. Seventy-four patients were hospitalized, 6 required mechanical ventilation and 3 died. The odds ratio (OR) of CP for improved disease severity scale was 0.936 (credible interval (CI) 0.667-1.311); OR for hospitalization or death was 0.919 (CI 0.592-1.416). CP effect on hospital admission or death was largest in patients with ≤5 days of symptoms (OR 0.658, 95%CI 0.394-1.085). CP did not decrease the time to full symptom resolution. TRIAL REGISTRATION: Clinicaltrials.gov NCT04621123 and NCT04589949. REGISTRATION: NCT04621123 and NCT04589949 on https://www. CLINICALTRIALS: gov.


Subject(s)
COVID-19 , Bayes Theorem , COVID-19/therapy , Humans , Immunization, Passive , Middle Aged , Multicenter Studies as Topic , Outpatients , Randomized Controlled Trials as Topic , SARS-CoV-2 , Treatment Outcome
3.
Vaccines (Basel) ; 10(4)2022 Apr 12.
Article in English | MEDLINE | ID: covidwho-1786106

ABSTRACT

Our purpose was to identify the reasons why members of the population, aged 18-60 years, are vaccinated against COVID-19 at the mass vaccination point in Bages, Spain. This is 1 of 42 provisional spaces outside of health centres which have been set up in Catalonia in the context of the COVID-19 pandemic, and where people from all over Catalonia could go to be vaccinated by appointment. METHODOLOGY: We performed a cross-sectional study of users attending mass vaccination points in Bages during the months of July, August, and September 2021. RESULTS: A total of 1361 questionnaires were statistically analysed. The most common reasons for vaccination were fear of infecting family (49.52%) and fear of self-infection (39.45%), followed by socialising (31.00%) and travel (30.56%). However, by applying a logistic regression model to each reason for vaccination, it was possible to estimate the associations regarding age, sex, marital status, educational level, production sector, mass vaccination point, previous COVID-19 infection, and COVID-19 infection of a family member. RELEVANCE: The data generated will inform decisions and formulations of appropriate campaigns that will promote vaccination in specific population groups.

4.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-309589

ABSTRACT

We assessed the duration and baseline determinants of antibody responses to SARS-CoV-2 spike antigens and the occurrence of reinfections in a prospective cohort of 173 Spanish primary health care worker patients followed up initially for nine months and subsequently up to 12.5 months after COVID-19 symptoms onset. Seropositivity to SARS-CoV-2 spike and receptor binding domain antigens up to 149-270 days was 92.49% (90.17% IgG, 76.3% IgA, 60.69% IgM). In a subset of 64 health care workers who had not yet been vaccinated by April 2021, seropositivity was 96.88% (95.31% IgG, 82.81% IgA) up to 322-379 days post symptoms onset. There were four suspected reinfections detected by passive case detection, two among seronegative individuals (five and seven months after the first episode), and one low antibody responder. Antibody levels significantly correlated with fever, hospitalization, anosmia/hypogeusia, allergies, smoking and occupation. Stable sustainment of IgG responses raises hope for long-lasting COVID-19 vaccine immunity.

5.
Lancet Respir Med ; 10(3): 278-288, 2022 03.
Article in English | MEDLINE | ID: covidwho-1671366

ABSTRACT

BACKGROUND: Convalescent plasma has been proposed as an early treatment to interrupt the progression of early COVID-19 to severe disease, but there is little definitive evidence. We aimed to assess whether early treatment with convalescent plasma reduces the risk of hospitalisation and reduces SARS-CoV-2 viral load among outpatients with COVID-19. METHODS: We did a multicentre, double-blind, randomised, placebo-controlled trial in four health-care centres in Catalonia, Spain. Adult outpatients aged 50 years or older with the onset of mild COVID-19 symptoms 7 days or less before randomisation were eligible for enrolment. Participants were randomly assigned (1:1) to receive one intravenous infusion of either 250-300 mL of ABO-compatible high anti-SARS-CoV-2 IgG titres (EUROIMMUN ratio ≥6) methylene blue-treated convalescent plasma (experimental group) or 250 mL of sterile 0·9% saline solution (control). Randomisation was done with the use of a central web-based system with concealment of the trial group assignment and no stratification. To preserve masking, we used opaque tubular bags that covered the investigational product and the infusion catheter. The coprimary endpoints were the incidence of hospitalisation within 28 days from baseline and the mean change in viral load (in log10 copies per mL) in nasopharyngeal swabs from baseline to day 7. The trial was stopped early following a data safety monitoring board recommendation because more than 85% of the target population had received a COVID-19 vaccine. Primary efficacy analyses were done in the intention-to-treat population, safety was assessed in all patients who received the investigational product. This study is registered with ClinicalTrials.gov, NCT04621123. FINDINGS: Between Nov 10, 2020, and July 28, 2021, we assessed 909 patients with confirmed COVID-19 for inclusion in the trial, 376 of whom were eligible and were randomly assigned to treatment (convalescent plasma n=188 [serum antibody-negative n=160]; placebo n=188 [serum antibody-negative n=166]). Median age was 56 years (IQR 52-62) and the mean symptom duration was 4·4 days (SD 1·4) before random assignment. In the intention-to-treat population, hospitalisation within 28 days from baseline occurred in 22 (12%) participants who received convalescent plasma versus 21 (11%) who received placebo (relative risk 1·05 [95% CI 0·78 to 1·41]). The mean change in viral load from baseline to day 7 was -2·41 log10 copies per mL (SD 1·32) with convalescent plasma and -2·32 log10 copies per mL (1·43) with placebo (crude difference -0·10 log10 copies per mL [95% CI -0·35 to 0·15]). One participant with mild COVID-19 developed a thromboembolic event 7 days after convalescent plasma infusion, which was reported as a serious adverse event possibly related to COVID-19 or to the experimental intervention. INTERPRETATION: Methylene blue-treated convalescent plasma did not prevent progression from mild to severe illness and did not reduce viral load in outpatients with COVID-19. Therefore, formal recommendations to support the use of convalescent plasma in outpatients with COVID-19 cannot be concluded. FUNDING: Grifols, Crowdfunding campaign YoMeCorono.


Subject(s)
COVID-19 , Methylene Blue , Adult , COVID-19/therapy , COVID-19 Vaccines , Double-Blind Method , Humans , Immunization, Passive , Middle Aged , Outpatients , SARS-CoV-2 , Treatment Outcome
6.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-293378

ABSTRACT

Background: Convalescent plasma (CP) for hospitalized patients with COVID-19 has not demonstrated clear benefits. However, data on outpatients with early symptoms are scarce. We aimed to assess whether treatment with CP administered during the first 7 days of symptoms reduced the disease progression or risk of hospitalization of outpatients. Methods: Two double-blind randomized trials ( NCT04621123 , NCT04589949 ) were merged with data pooling starting when <20% of their predefined sample size had been recruited. A Bayesian adaptive individual patient data meta-analysis was implemented. Analyses were done with Bayesian proportional odds and logistic models, where odds ratios (OR)<1.0 indicate a favorable outcome for CP. Fourteen study sites across the Netherlands and Catalonia in Spain participated in the trial. The two studies included outpatients aged ≥50 years and diagnosed with COVID-19 and symptomatic for ≤7days. The intervention consisted of one unit (200-300mL) of CP with a predefined minimum level of antibodies. The two primary endpoints were (a) a 5-point disease severity scale (fully recovered by day 7 or not, hospital or ICU admission and death) and (b) a composite of hospitalization or death. Results: Of 797 patients included, 390 received CP and 392 placebo. At baseline, they had a median age of 58 years, 1 comorbidity, symptoms for 5 days and 93% tested negative for SARS-CoV-2 S-protein IgG antibodies. Seventy-four patients were hospitalized, 6 required mechanical ventilation and 3 died. The OR of CP for an improved disease severity scale was 0.936 (credible interval (CI) 0.667-1.311). The OR for hospitalization or death was 0.919 (CI 0.592-1.416). The effect of CP on hospital admission or death was largest in patients with ≤5 days of symptoms (OR 0.658, 95% CI 0.394-1.085). CP did not decrease the time to full symptom resolution (p=0.62). Conclusion: Treatment with CP of outpatients in the first 7 days of symptoms did not improve the outcome of COVID-19. The possible beneficial effect in patients with ≤5 days of symptoms requires further study.   Registration: NCT04621123 and NCT04589949 on https://www.clinicaltrials.gov

7.
Transl Res ; 240: 26-32, 2022 02.
Article in English | MEDLINE | ID: covidwho-1492708

ABSTRACT

Antibodies to the nucleocapsid (N) antigen are suggested to be used to monitor infections after COVID-19 vaccination, as first generation subunit vaccines are based on the spike (S) protein. We used multiplex immunoassays to simultaneously measure antibody responses to different fragments of the SARS-CoV-2 S and N antigens for evaluating the immunogenicity of the mRNA-1273 (Spykevax) and the BNT162b2 (Comirnaty) vaccines in 445 health care workers. We report a >4-fold increase post-vaccination of IgG levels to the full length (N FL) and C-terminus of N (N CT) in 5.2% and 18.0% of individuals, respectively, and of IgA in 3.6% (N FL) and 9.0% (N CT) of them. The increase in IgG levels and avidity was more pronounced after Spykevax than Comirnaty vaccination (36.2% vs 13.1% for N CT, and 10.6% vs 3.7% for N FL). Data suggest the induction of cross-reactive antibodies against the N CT region after administering these S-based vaccines, and this should be taken into account when using N seropositivity to detect breakthroughs.


Subject(s)
Antibodies, Viral/immunology , COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Nucleocapsid/immunology , SARS-CoV-2/metabolism , Spike Glycoprotein, Coronavirus/immunology , COVID-19/virology , Humans , Immunoglobulin A/blood , Immunoglobulin G/blood , Longitudinal Studies
8.
J Med Internet Res ; 23(9): e29622, 2021 09 14.
Article in English | MEDLINE | ID: covidwho-1406795

ABSTRACT

BACKGROUND: The COVID-19 pandemic has turned the care model of health systems around the world upside down, causing the abrupt cancellation of face-to-face visits and redirection of the model toward telemedicine. Digital transformation boosts information systems-the more robust they are, the easier it is to monitor the health care system in a highly complex state and allow for more agile and reliable analysis. OBJECTIVE: The purpose of this study was to analyze diagnoses from primary care visits and distinguish between those that had higher and lower variations, relative to the 2019 and 2020 periods (roughly before and during COVID-19), to identify clinical profiles that may have been most impaired from the least-used diagnostic codes for visits during the pandemic. METHODS: We used a database from the Primary Care Services Information Technologies Information System of Catalonia. We analyzed the register of visits (n=2,824,185) and their International Classification of Diseases (ICD-10) diagnostic codes (n=3,921,974; mean 1.38 per visit), as approximations of the reasons for consultations, at 3 different grouping levels. The data were represented by a term frequency matrix and analyzed recursively in different partitions aggregated according to date. RESULTS: The increase in non-face-to-face visits (+267%) did not counterbalance the decrease in face-to-face visits (-47%), with an overall reduction in the total number of visits of 1.36%, despite the notable increase in nursing visits (10.54%). The largest increases in 2020 were visits with diagnoses related to COVID-19 (ICD-10 codes Z20-Z29: 2.540%), along with codes related to economic and housing problems (ICD-10 codes Z55-Z65: 44.40%). Visits with most of the other diagnostic codes decreased in 2020 relative to those in 2019. The largest reductions were chronic pathologies such as arterial hypertension (ICD-10 codes I10-I16: -32.73%) or diabetes (ICD-10 codes E08-E13: -21.13%), but also obesity (E65-E68: -48.58%) and bodily injuries (ICD-10 code T14: -33.70%). Visits with mental health-related diagnostic codes decreased, but the decrease was less than the average decrease. There was a decrease in consultations-for children, adolescents, and adults-for respiratory infections (ICD-10 codes J00-J06: -40.96%). The results show large year-on-year variations (in absolute terms, an average of 12%), which is representative of the strong shock to the health system. CONCLUSIONS: The disruption in the primary care model in Catalonia has led to an explosive increase in the number of non-face-to-face visits. There has been a reduction in the number of visits for diagnoses related to chronic pathologies, respiratory infections, obesity, and bodily injuries. Instead, visits for diagnoses related to socioeconomic and housing problems have increased, which emphasizes the importance of social determinants of health in the context of this pandemic. Big data analytics with routine care data yield findings that are consistent with those derived from intuition in everyday clinical practice and can help inform decision making by health planners in order to use the next few years to focus on the least-treated diseases during the COVID-19 pandemic.


Subject(s)
COVID-19 , Pandemics , Adolescent , Adult , Child , Data Analysis , Humans , Primary Health Care , SARS-CoV-2 , Spain/epidemiology
9.
J Med Internet Res ; 23(9): e29622, 2021 09 14.
Article in English | MEDLINE | ID: covidwho-1328052

ABSTRACT

BACKGROUND: The COVID-19 pandemic has turned the care model of health systems around the world upside down, causing the abrupt cancellation of face-to-face visits and redirection of the model toward telemedicine. Digital transformation boosts information systems-the more robust they are, the easier it is to monitor the health care system in a highly complex state and allow for more agile and reliable analysis. OBJECTIVE: The purpose of this study was to analyze diagnoses from primary care visits and distinguish between those that had higher and lower variations, relative to the 2019 and 2020 periods (roughly before and during COVID-19), to identify clinical profiles that may have been most impaired from the least-used diagnostic codes for visits during the pandemic. METHODS: We used a database from the Primary Care Services Information Technologies Information System of Catalonia. We analyzed the register of visits (n=2,824,185) and their International Classification of Diseases (ICD-10) diagnostic codes (n=3,921,974; mean 1.38 per visit), as approximations of the reasons for consultations, at 3 different grouping levels. The data were represented by a term frequency matrix and analyzed recursively in different partitions aggregated according to date. RESULTS: The increase in non-face-to-face visits (+267%) did not counterbalance the decrease in face-to-face visits (-47%), with an overall reduction in the total number of visits of 1.36%, despite the notable increase in nursing visits (10.54%). The largest increases in 2020 were visits with diagnoses related to COVID-19 (ICD-10 codes Z20-Z29: 2.540%), along with codes related to economic and housing problems (ICD-10 codes Z55-Z65: 44.40%). Visits with most of the other diagnostic codes decreased in 2020 relative to those in 2019. The largest reductions were chronic pathologies such as arterial hypertension (ICD-10 codes I10-I16: -32.73%) or diabetes (ICD-10 codes E08-E13: -21.13%), but also obesity (E65-E68: -48.58%) and bodily injuries (ICD-10 code T14: -33.70%). Visits with mental health-related diagnostic codes decreased, but the decrease was less than the average decrease. There was a decrease in consultations-for children, adolescents, and adults-for respiratory infections (ICD-10 codes J00-J06: -40.96%). The results show large year-on-year variations (in absolute terms, an average of 12%), which is representative of the strong shock to the health system. CONCLUSIONS: The disruption in the primary care model in Catalonia has led to an explosive increase in the number of non-face-to-face visits. There has been a reduction in the number of visits for diagnoses related to chronic pathologies, respiratory infections, obesity, and bodily injuries. Instead, visits for diagnoses related to socioeconomic and housing problems have increased, which emphasizes the importance of social determinants of health in the context of this pandemic. Big data analytics with routine care data yield findings that are consistent with those derived from intuition in everyday clinical practice and can help inform decision making by health planners in order to use the next few years to focus on the least-treated diseases during the COVID-19 pandemic.


Subject(s)
COVID-19 , Pandemics , Adolescent , Adult , Child , Data Analysis , Humans , Primary Health Care , SARS-CoV-2 , Spain/epidemiology
10.
BMC Med ; 19(1): 155, 2021 06 28.
Article in English | MEDLINE | ID: covidwho-1286823

ABSTRACT

We assessed the duration and baseline determinants of antibody responses to SARS-CoV-2 spike antigens and the occurrence of reinfections in a prospective cohort of 173 Spanish primary health care worker patients followed initially for 9 months and subsequently up to 12.5 months after COVID-19 symptoms onset. Seropositivity to SARS-CoV-2 spike and receptor-binding domain antigens up to 149-270 days was 92.49% (90.17% IgG, 76.3% IgA, 60.69% IgM). In a subset of 64 health care workers who had not yet been vaccinated by April 2021, seropositivity was 96.88% (95.31% IgG, 82.81% IgA) up to 322-379 days post symptoms onset. Four suspected reinfections were detected by passive case detection, two among seronegative individuals (5 and 7 months after the first episode), and one low antibody responder. Antibody levels significantly correlated with fever, hospitalization, anosmia/hypogeusia, allergies, smoking, and occupation. Stable sustainment of IgG responses raises hope for long-lasting COVID-19 vaccine immunity.


Subject(s)
COVID-19/epidemiology , Health Personnel/statistics & numerical data , Adult , Antibodies, Viral/blood , COVID-19/blood , COVID-19/virology , COVID-19 Vaccines/administration & dosage , Cohort Studies , Cross-Sectional Studies , Female , Humans , Middle Aged , Prospective Studies , Reinfection/blood , Reinfection/epidemiology , Reinfection/virology , SARS-CoV-2/isolation & purification , Seroepidemiologic Studies , Spain/epidemiology
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