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1.
EClinicalMedicine ; 46: 101362, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1757291

ABSTRACT

Background: In moderate-to-severe COVID-19 pneumonia, dexamethasone (DEX) and tocilizumab (TCZ) reduce the occurrence of death and ventilatory support. We investigated the efficacy and safety of DEX+TCZ in an open randomized clinical trial. Methods: From July 24, 2020, through May 18, 2021, patients with moderate-to-severe COVID-19 pneumonia requiring oxygen (>3 L/min) were randomly assigned to receive DEX (10 mg/d 5 days tapering up to 10 days) alone or combined with TCZ (8 mg/kg IV) at day 1, possibly repeated with a fixed dose of 400 mg i.v. at day 3. The primary outcome was time from randomization to mechanical ventilation support or death up to day 14, analysed on an intent-to-treat basis using a Bayesian approach. ClinicalTrials.gov number, NCT04476979. Findings: A total of 453 patients were randomized, 3 withdrew consent, 450 were analysed, of whom 226 and 224 patients were assigned to receive DEX or TCZ+DEX, respectively. At day 14, mechanical ventilation or death occurred in 32/226 (14%) and 27/224 (12%) in the DEX and TCZ+DEX arms, respectively (hazard ratio [HR] 0·85, 90% credible interval [CrI] 0·55 to 1·31). At day 14, the World health Organization (WHO) clinical progression scale (CPS) was significantly improved in the TCZ+DEX arm (OR 0·69, 95% CrI, 0·49 to 0.97). At day 28, the cumulative incidence of oxygen supply independency was 82% in the TCZ+DEX arms and 72% in the DEX arm (HR 1·36, 95% CI 1·11 to 1·67). On day 90, 24 deaths (11%) were observed in the DEX arm and 18 (8%) in the TCZ+DEX arm (HR 0·77, 95% CI 0·42-1·41). Serious adverse events were observed in 25% and 21% in DEX and TCZ+DEX arms, respectively. Interpretation: Mechanical ventilation need and mortality were not improved with TCZ+DEX compared with DEX alone. The safety of both treatments was similar. However, given the wide confidence intervals for the estimate of effect, definitive interpretation cannot be drawn. Funding: Programme Hospitalier de Recherche Clinique [PHRC COVID-19-20-0151, PHRC COVID-19-20-0029], Fondation de l'Assistance Publique - Hôpitaux de Paris (Alliance Tous Unis Contre le Virus) and from Fédération pour la Recherche Médicale" (FRM). Tocilizumab was provided by Roche.

2.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-316533

ABSTRACT

Background: The impact of the variant of concern (VOC) Alpha on the severity of COVID-19 is debated and has to be analyzed in different epidemiological situations. We report our analysis in France.Methods: We conducted an exposed/unexposed cohort study with retrospective data collection, comparing patients infected by VOC Alpha to patients infected by historical lineages. Participants were matched on age (+/- 2.5 years), sex and region of hospitalization. The primary endpoint was the proportion of hospitalized participants with severe COVID-19, defined as a WHO-scale >5 or by the need of a non-rebreather mask, occurring up to day 29 after admission. We used a logistic regression model stratified on each matched pair and accounting for factors known to be associated with the severity of the disease (age, BMI and comorbidities) to compare the 2 groups. Findings: We included 650 pairs of patients hospitalized between Jan 1, 2021, and Feb 28, 2021, in 47 hospitals. Median age was 70 years and 61.3% of participants were male. The proportion of participants with comorbidities was high in both groups (85.0% vs 90%, p=0.004). Infection by VOC Alpha was associated with a higher risk of severe COVID-19 (41.7% vs 38.5% - aOR=1.33 95% CI [1.03-1.72]). The rate of mortality was 24.0% vs 19.0% (aHR 1.21 95% CI [0.93-1.58]).Interpretation: Infection by the VOC Alpha was associated with a higher risk of severe COVID-19 during the third COVID-19 epidemic wave in France.Clinical Trial Registration Details: Registered on ClinicalTrials.gov (NCT04863547). Funding Information: The study was funded by the ANRS Maladies Infectieuses Emergentes.Declaration of Interests: DC reports HIV grants from Janssen (2017-2018, 2019-2020), personal fees from Janssen (2018) and Gilead (2018, 2020) for lectures on HIV outside the submitted work. CC reports personal fees from Janssen (2018), MSD (2019), Gilead (2018-2020), Theratechnologies (2020) and ViiV Healthcare (2018-2020). HC reports personal fees from MSD (2020) and ViiV Healthcare (2020) for lectures on HIV. GMB reports support for attending meetings and personal fees from BMS, MSD, Janssen, Sanofi, Pfizer and Gilead for lectures outside the submitted work. JP reports support for attending meetings and personal fees from Gilead, Pfizer and Eumedica Gilead for lectures. DD reports personal fees from Gilead, ViiV Healthcare and Janssen for participation on an advisory Board. Other authors declare that they have no competing interest.Ethics Approval Statement: The study was approved by the SPILF Ethics Committee.

3.
Infect Dis Now ; 51(6): 556-559, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1230513

ABSTRACT

A broad-based SARS-CoV-2 testing program for all symptomatic healthcare workers (HCWs) was implemented in Tenon hospital, Paris, France. From February 26 to April 22, 2020, 701 symptomatic HCWs were screened, of whom 247 (35.2%) tested positive for SARS-Cov-2. Myalgia, fever, anosmia and ageusia were associated with RT-PCR positivity. Testing of HCWs is an essential step toward control of the epidemic. Further studies could establish clinical algorithms for SARS-CoV-2 diagnosis to compensate for RT-PCR test and chest CT limits or unavailability.


Subject(s)
COVID-19 Testing/methods , COVID-19/diagnosis , Health Personnel , Hospitals , SARS-CoV-2/isolation & purification , Adolescent , Adult , Aged , Ageusia/epidemiology , Anosmia/epidemiology , COVID-19/epidemiology , Female , Fever/epidemiology , France , Humans , Infection Control/methods , Male , Middle Aged , Myalgia/epidemiology , Paris , Primary Health Care , Risk Factors , Young Adult
5.
PLoS One ; 16(1): e0245848, 2021.
Article in English | MEDLINE | ID: covidwho-1052440

ABSTRACT

BACKGROUND: COVID-19 (COronaVIrus Disease 2019) is an infectious respiratory disease caused by the novel SARS-CoV-2 virus. Point of Care (POC) tests have been developed to detect specific antibodies, IgG and IgM, to SARS-CoV-2 virus in human whole blood. They need to be easily usable by the general population in order to alleviate the lockdown that many countries have initiated in response to the growing COVID-19 pandemic. A real-life study has been conducted in order to evaluate the performance of the COVID-PRESTO® POC test and the results were recently published. Even if this test showed very high sensitivity and specificity in a laboratory setting when used by trained professionals, it needs to be further evaluated for practicability when used by the general public in order to be approved by health authorities for in-home use. METHODS: 143 participants were recruited between March 2020 and April 2020 among non-medical populations in central France (nuclear plant workers, individuals attending the Orleans University Hospital vaccination clinic and Orleans University Hospital non-medical staff). Instructions for use, with or without a tutorial video, were made available to the volunteers. Two separate objectives were pursued: evaluation of the capability of participants to obtain an interpretable result, and evaluation of the users' ability to read the results. RESULTS: 88.4% of the test users judged the instructions for use leaflet to be clear and understandable. 99.3% of the users obtained a valid result and, according to the supervisors, 92.7% of the tests were properly performed by the users. Overall, 95% of the users gave positive feedback on the COVID PRESTO® as a potential self-test. Neither age nor education had an influence. CONCLUSION: COVID-PRESTO® was successfully used by an overwhelming majority of participants and its use was judged very satisfactory, therefore showing promising potential as a self-test to be used by the general population. This POC test can become an easy-to-use tool to help detect whether individuals are protected or not, particularly in the context of a second wave or a mass vaccination program.


Subject(s)
COVID-19/diagnosis , SARS-CoV-2/isolation & purification , Adult , Aged , COVID-19/blood , COVID-19/epidemiology , COVID-19/virology , COVID-19 Testing , Communicable Disease Control , Female , France/epidemiology , Hematologic Tests/methods , Humans , Immunoglobulin G/blood , Immunoglobulin G/immunology , Immunoglobulin M/blood , Immunoglobulin M/immunology , Male , Middle Aged , Pandemics/prevention & control , Point-of-Care Testing , Reproducibility of Results , Self-Testing , Sensitivity and Specificity
7.
Thromb Haemost ; 120(12): 1680-1690, 2020 Dec.
Article in English | MEDLINE | ID: covidwho-786732

ABSTRACT

The prospective observational cohort study COMPASS-COVID-19 aimed to develop a risk assessment model for early identification of hospitalized COVID-19 patients at risk for worsening disease. Patients with confirmed COVID-19 (n = 430) hospitalized between March 18 and April 21, 2020 were divided in derivation (n = 310) and validation (n = 120) cohorts. Two groups became evident: (1) good prognosis group (G-group) with patients hospitalized at the conventional COVID-19 ward and (2) Worsening disease group (W-group) with patients admitted to the intensive care unit (ICU) from the emergency departments. The study end point was disease worsening (acute respiratory failure, shock, myocardial dysfunction, bacterial or viral coinfections, and acute kidney injury) requiring ICU admission. All patients were routinely evaluated for full blood count, prothrombin time, fibrinogen, D-dimers, antithrombin (AT), and protein C activity. Data from the first hospitalization day at the conventional ward or the ICU were analyzed. Cardiovascular risk factors and comorbidities were routinely registered. Obesity, hypertension, diabetes and male gender, increased fibrinogen and D-dimers, thrombocytopenia, AT deficiency, lymphopenia, and an International Society on Thrombosis and Haemostasis (ISTH) score for compensated disseminated intravascular coagulation score (cDIC-ISTH) ≥5 were significant risk factors for worsening disease. The COMPASS-COVID-19 score was derived from multivariate analyses and includes obesity, gender, hemoglobin, lymphocyte, and the cDIC-ISTH score (including platelet count, prothrombin time, D-dimers, AT, and protein C levels). The score has a very good discriminating capacity to stratify patients at high and low risk for worsening disease, with an area under the receiver operating characteristic curve value of 0.77, a sensitivity of 81%, and a specificity of 60%. Application of the COMPASS-COVID-19 score at the validation cohort showed 96% sensitivity. The COMPASS-COVID-19 score is an accurate clinical decision-making tool for an easy identification of COVID-19 patients being at high risk for disease worsening.


Subject(s)
COVID-19/epidemiology , SARS-CoV-2/physiology , Adult , Aged , Aged, 80 and over , Cohort Studies , Disease Progression , Female , France/epidemiology , Greece/epidemiology , Hospitalization/statistics & numerical data , Humans , Male , Middle Aged , Predictive Value of Tests , Prospective Studies , Risk Assessment , Young Adult
8.
PLoS One ; 15(9): e0237694, 2020.
Article in English | MEDLINE | ID: covidwho-771808

ABSTRACT

BACKGROUND: The SARS-CoV-2 (Severe Acute Respiratory Syndrome CoronaVirus 2) is responsible for the infectious respiratory disease called COVID-19 (COronaVIrus Disease 2019). In response to the growing COVID-19 pandemic, point-of-care (POC) tests have been developed to detect specific antibodies, IgG and IgM, to SARS-CoV-2 virus in human whole blood. We conducted a prospective observational study to evaluate the performance of two POC tests, COVID-PRESTO® and COVID-DUO®, compared to the gold standard, RT-PCR (real-time reverse transcriptase polymerase chain reaction). METHODS: RT-PCR testing of SARS-Cov-2 was performed from nasopharyngeal swab specimens collected in adult patients visiting the infectious disease department at the hospital (Orléans, France). Capillary whole blood (CWB) samples from the fingertip taken at different time points after onset of the disease were tested with POC tests. The specificity and sensitivity of the rapid test kits compared to test of reference (RT-PCR) were calculated. RESULTS: Among 381 patients with symptoms of COVID-19 who went to the hospital for a diagnostic, 143 patients were RT-PCR negative. Results of test with POC tests were all negative for these patients, indicating a specificity of 100% for both POC tests. In the RT-PCR positive subgroup (n = 238), 133 patients were tested with COVID-PRESTO® and 129 patients were tested with COVID-DUO® (24 patients tested with both). The further the onset of symptoms was from the date of collection, the greater the sensitivity. The sensitivity of COVID-PRESTO® test ranged from 10.00% for patients having experienced their 1st symptoms from 0 to 5 days ago to 100% in patients where symptoms had occurred more than 15 days before the date of tests. For COVID-DUO® test, the sensitivity ranged from 35.71% [0-5 days] to 100% (> 15 days). CONCLUSION: COVID-PRESTO® and DUO® POC tests turned out to be very specific (none false positive) and to be sensitive enough after 15 days from onset of symptom. These easy to use IgG/IgM combined test kits are the first ones allowing a screening with CWB sample, by typing from a finger prick. These rapid tests are particularly interesting for screening in low resource settings.


Subject(s)
Antibodies, Viral/blood , Betacoronavirus/immunology , Clinical Laboratory Techniques/methods , Coronavirus Infections/diagnosis , Immunoassay/methods , Immunoglobulin G/blood , Immunoglobulin M/blood , Pneumonia, Viral/diagnosis , Reagent Kits, Diagnostic , Adult , Aged , Antibody Specificity , Betacoronavirus/genetics , Betacoronavirus/isolation & purification , COVID-19 , COVID-19 Testing , COVID-19 Vaccines , Capillaries , Coronavirus Infections/blood , Fingers/blood supply , Humans , Middle Aged , Nasopharynx/virology , Pandemics , Pneumonia, Viral/blood , Point-of-Care Testing , Prospective Studies , Real-Time Polymerase Chain Reaction , SARS-CoV-2 , Sensitivity and Specificity , Young Adult
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