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1.
Infection ; 2022 Mar 07.
Article in English | MEDLINE | ID: covidwho-1729429

ABSTRACT

PURPOSE: Pregnant and postpartum women are at increased risk of developing severe COVID-19. Monoclonal antibodies (mAbs) are now widely used in high-income countries to treat mild to moderate COVID-19 outpatients at risk for developing severe disease. Very few data are available on the use of mAbs in special populations, including pregnant and postpartum women. Here we present our early experience with mAbs in these two populations. METHODS: Electronic records of pregnant and postpartum women treated with mAbs at Careggi University Hospital, Florence, were retrieved. Relevant data were extracted (age, presence of risk factors for COVID-19, oxygen support, mAb type, gestational age, and pregnancy status). When available, outcomes at 28 days after administration were also included. RESULTS: From March 1st to September 30th 2021, eight pregnant and two postpartum women have been treated with mAbs at our center. The median age was 31 years (IQR 30-33.5, range 29-38), median gestational age was 24 weeks. Seven patients had additional risk factors. According to the Italian disposition, all patients received casirivimab/imdevimab, with five receiving a 2.4 mg dose and five receiving a 8 g dose. Eight patients improved. One developed myocarditis, considered a COVID-19 complication. Another required a transient increase of low flow oxygen support before improving and being discharged. At a 28 days follow-up, all patients were clinically recovered. We did not observe mAbs related adverse events. CONCLUSION: Although preliminary data should be interpreted with caution, it is remarkable how mAbs were well tolerated by pregnant women with COVID-19. Further data on mAbs in this special population should be collected but the use of mAbs in pregnant and postpartum patients should be considered. Even thus oral antivirals are becoming available, they are not recommended in pregnant and postpartum women. This population may specifically benefit from treatment with last generation mAbs.

2.
JAMA Netw Open ; 4(11): e2136246, 2021 11 01.
Article in English | MEDLINE | ID: covidwho-1540039

ABSTRACT

Importance: Convalescent plasma (CP) has been generally unsuccessful in preventing worsening of respiratory failure or death in hospitalized patients with COVID-19 pneumonia. Objective: To evaluate the efficacy of CP plus standard therapy (ST) vs ST alone in preventing worsening respiratory failure or death in patients with COVID-19 pneumonia. Design, Setting, and Participants: This prospective, open-label, randomized clinical trial enrolled (1:1 ratio) hospitalized patients with COVID-19 pneumonia to receive CP plus ST or ST alone between July 15 and December 8, 2020, at 27 clinical sites in Italy. Hospitalized adults with COVID-19 pneumonia and a partial pressure of oxygen-to-fraction of inspired oxygen (Pao2/Fio2) ratio between 350 and 200 mm Hg were eligible. Interventions: Patients in the experimental group received intravenous high-titer CP (≥1:160, by microneutralization test) plus ST. The volume of infused CP was 200 mL given from 1 to a maximum of 3 infusions. Patients in the control group received ST, represented by remdesivir, glucocorticoids, and low-molecular weight heparin, according to the Agenzia Italiana del Farmaco recommendations. Main Outcomes and Measures: The primary outcome was a composite of worsening respiratory failure (Pao2/Fio2 ratio <150 mm Hg) or death within 30 days from randomization. Results: Of the 487 randomized patients (241 to CP plus ST; 246 to ST alone), 312 (64.1%) were men; the median (IQR) age was 64 (54.0-74.0) years. The modified intention-to-treat population included 473 patients. The primary end point occurred in 59 of 231 patients (25.5%) treated with CP and ST and in 67 of 239 patients (28.0%) who received ST (odds ratio, 0.88; 95% CI, 0.59-1.33; P = .54). Adverse events occurred more frequently in the CP group (12 of 241 [5.0%]) compared with the control group (4 of 246 [1.6%]; P = .04). Conclusions and Relevance: In patients with moderate to severe COVID-19 pneumonia, high-titer anti-SARS-CoV-2 CP did not reduce the progression to severe respiratory failure or death within 30 days. Trial Registration: ClinicalTrials.gov Identifier: NCT04716556.


Subject(s)
COVID-19/therapy , Hospital Mortality , Hospitalization , Immunization, Passive , Plasma , Respiratory Insufficiency , Aged , COVID-19/complications , COVID-19/mortality , Disease Progression , Female , Humans , Italy , Male , Middle Aged , Prospective Studies , SARS-CoV-2 , Severity of Illness Index , Standard of Care
3.
Eur J Immunol ; 52(2): 352-355, 2022 02.
Article in English | MEDLINE | ID: covidwho-1530141

ABSTRACT

A late presenter AIDS patient with severe T cell depletion presented non-severe COVID-19 symptoms, with prolonged viral shedding. Our case report supports the hypothesis that an effective T cell response may be dispensable for the control of COVID-19 progression to severe forms, while it may be necessary for SARS-CoV-2 clearance.


Subject(s)
Acquired Immunodeficiency Syndrome/immunology , CD4-Positive T-Lymphocytes/immunology , CD8-Positive T-Lymphocytes/immunology , COVID-19/immunology , SARS-CoV-2/immunology , Acquired Immunodeficiency Syndrome/blood , Adult , CD4 Lymphocyte Count , CD4-Positive T-Lymphocytes/metabolism , CD8-Positive T-Lymphocytes/metabolism , COVID-19/blood , Female , Humans , SARS-CoV-2/metabolism
5.
Int J Infect Dis ; 108: 231-236, 2021 Jul.
Article in English | MEDLINE | ID: covidwho-1202384

ABSTRACT

OBJECTIVE: Evaluate the real-world accuracy of Myxovirus resistance protein A (MxA) detected by the rapid, point-of-care FebriDx test during the second-wave pandemic in Italy in patients with acute respiratory infection (ARI) and a clinical suspicion of COVID-19. DESIGN AND METHODS: Prospective, observational, diagnostic accuracy study whereby hospitalized patients with ARI were consecutively enrolled in a single tertiary care center in Italy from August 1, 2020 to January 31, 2021. RESULTS: COVID-19 was diagnosed in 136/200 (68.0%) patients and Non-COVID-19 was diagnosed in 64/200 (32.0%) patients. COVID-19 patients were younger and had a lower Charlson comorbidity index compared to Non-COVID-19 patients (p < 0.001). Concordance between FebriDx, MxA and rt-PCR for SARS-CoV-2 (gold standard) was good (k 0.93, 95% CI 0.87-0.99). Overall sensitivity and specificity were 97.8% [95% CI 93.7-99.5] and 95.3% [95% CI 86.9%-99.0%], respectively. FebriDx demonstrated a negative predictive value of 95.3% (95% CI 86.9-99.0) for an observed disease prevalence of 68%. CONCLUSIONS: FebriDx MxA showed high diagnostic accuracy to identify COVID-19 and could be considered as a real-time triage tool to streamline the management of suspected COVID-19 patients. FebriDx also detected bacterial etiology in Non-COVID-19 patients suggesting good performance to distinguish bacterial from viral respiratory infection.


Subject(s)
COVID-19 , SARS-CoV-2 , COVID-19 Testing , Humans , Italy/epidemiology , Point-of-Care Testing , Prospective Studies , Sensitivity and Specificity
6.
Open Forum Infect Dis ; 8(3): ofab049, 2021 Mar.
Article in English | MEDLINE | ID: covidwho-1069296

ABSTRACT

We evaluated 100 postacute coronavirus disease 2019 (COVID-19) patients a median (interquartile range) of 60 (48-67) days after discharge from the Careggi University Hospital, Italy. Eighty-four (84%) had at least 1 persistent symptom, irrespective of COVID-19 severity. A considerable number of hospital readmissions (10%) and/or infectious diseases (14%) during the postdischarge period were reported.

7.
Euro Surveill ; 25(17)2020 04.
Article in English | MEDLINE | ID: covidwho-142724

ABSTRACT

We analysed the first 84 coronavirus disease (COVID-19) patients hospitalised in an infectious and tropical disease unit in Florence, Italy, over 30 days after the start of the COVID-19 outbreak in Italy. A 12% reduction in the rate of intensive care unit transfer was observed after the implementation of intensity care measures in the regular ward such as increasing the nurse/patient ratio, presence of critical care physicians and using high flow nasal cannulae oxygenation.


Subject(s)
Coronavirus Infections/mortality , Coronavirus Infections/therapy , Coronavirus , Intensive Care Units/organization & administration , Pandemics , Pneumonia, Viral/mortality , Pneumonia, Viral/therapy , Age Distribution , Aged , Betacoronavirus , COVID-19 , Cannula , Cohort Studies , Comorbidity , Contact Tracing , Coronavirus Infections/diagnosis , Critical Care , Disease Outbreaks , Female , Humans , Italy/epidemiology , Male , Middle Aged , Patient Transfer , Pneumonia, Viral/diagnosis , Respiratory Care Units , SARS-CoV-2 , Sex Distribution , Treatment Outcome
8.
Transpl Infect Dis ; 22(4): e13286, 2020 Aug.
Article in English | MEDLINE | ID: covidwho-47858

ABSTRACT

During the novel coronavirus pandemic, organ transplant recipients represent a frail susceptible category due to long-term immunosuppressive therapy. For this reason, clinical manifestations may differ from general population and different treatment approaches may be needed. We present the case of a 36-year-old kidney-transplanted woman affected by Senior-Loken syndrome diagnosed with COVID-19 pneumonia after a contact with her positive mother. Initial symptoms were fatigue, dry cough, and coryza; she never had fever nor oxygen supplementation. Hydroxychloroquine and lopinavir/ritonavir were started, and the antiviral drug was replaced with darunavir/cobicistat after 2 days for diarrhea. Immunosuppressant levels were closely monitored, and we observed very high tacrolimus trough levels despite initial dose reduction. The patient was left with steroid therapy alone. The peculiarity of clinical presentation and the management difficulties represent the flagship of our case report. We stress the need for guidelines in transplant recipients with COVID-19 infection with particular regard to the management of therapy.


Subject(s)
Antiviral Agents/adverse effects , Coronavirus Infections/drug therapy , Cytochrome P-450 CYP3A Inhibitors/adverse effects , Graft Rejection/prevention & control , Immunosuppressive Agents/adverse effects , Kidney Transplantation , Lopinavir/adverse effects , Pneumonia, Viral/drug therapy , Ritonavir/adverse effects , Tacrolimus/adverse effects , Adult , Antiviral Agents/therapeutic use , Betacoronavirus , C-Reactive Protein/immunology , COVID-19 , Ciliopathies/complications , Cobicistat/therapeutic use , Common Cold/etiology , Common Cold/physiopathology , Coronavirus Infections/complications , Coronavirus Infections/immunology , Coronavirus Infections/physiopathology , Cough/etiology , Cough/physiopathology , Darunavir/therapeutic use , Deprescriptions , Drug Combinations , Drug Interactions , Enzyme Inhibitors/therapeutic use , Fatigue/etiology , Fatigue/physiopathology , Female , Glucocorticoids/therapeutic use , Humans , Hydroxychloroquine/therapeutic use , Immunocompromised Host/immunology , Interleukin-10/immunology , Interleukin-1beta/immunology , Interleukin-6/immunology , Interleukin-8/immunology , Kidney Diseases, Cystic/complications , Kidney Failure, Chronic/etiology , Kidney Failure, Chronic/surgery , Leber Congenital Amaurosis/complications , Methylprednisolone/therapeutic use , Optic Atrophies, Hereditary/complications , Pandemics , Pneumonia, Viral/complications , Pneumonia, Viral/immunology , Pneumonia, Viral/physiopathology , SARS-CoV-2 , Severity of Illness Index
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