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1.
J Am Soc Nephrol ; 32(11): 2958-2969, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1526711

ABSTRACT

BACKGROUND: The long-term outcome of COVID-19-associated collapsing glomerulopathy is unknown. METHODS: We retrospectively identified 76 native kidney biopsies from patients with history of COVID-19 between March 2020 and April 2021. Presenting and outcome data were obtained for all 23 patients with collapsing glomerulopathy and for seven patients with noncollapsing podocytopathies. We performed APOL1 genotyping by Sanger sequencing, immunostaining for spike and nucleocapsid proteins, and in situ hybridization for SARS-CoV-2. RESULTS: The 23 patients with COVID-19-associated collapsing glomerulopathy were median age 57 years (range, 35-72), included 16 men, and were predominantly (91%) Black. Severity of COVID-19 was mild or moderate in most (77%) patients. All but one patient presented with AKI, 17 had nephrotic-range proteinuria, and six had nephrotic syndrome. Fourteen (61%) patients required dialysis at presentation. Among 17 patients genotyped, 16 (94%) were high-risk APOL1. Among 22 (96%) patients with median follow-up at 155 days (range, 30-412), 11 (50%) received treatment for COVID-19, and eight (36%) received glucocorticoid therapy for podocytopathy. At follow-up, 19 (86%) patients were alive, and 15 (68%) were dialysis free, including seven of 14 who initially required dialysis. The dialysis-free patients included 64% (seven of 11) of those treated for COVID-19 and 75% (six of eight) of those treated with glucocorticoids for podocytopathy. Overall, 36% achieved partial remission of proteinuria, 32% had no remission, and 32% reached combined end points of ESKD or death. Viral infection of the kidney was not detected. CONCLUSIONS: Half of 14 patients with COVID-19-associated collapsing glomerulopathy requiring dialysis achieved dialysis independence, but the long-term prognosis of residual proteinuric CKD remains guarded, indicating a need for more effective therapy.


Subject(s)
COVID-19/complications , Kidney Glomerulus/pathology , Podocytes/pathology , Renal Insufficiency/pathology , Renal Insufficiency/virology , Adult , Aged , COVID-19/pathology , COVID-19/therapy , Female , Humans , Male , Middle Aged , Recovery of Function , Renal Dialysis , Renal Insufficiency/therapy , Retrospective Studies , Treatment Outcome
2.
BMC Musculoskelet Disord ; 22(1): 953, 2021 Nov 15.
Article in English | MEDLINE | ID: covidwho-1526624

ABSTRACT

BACKGROUND: Hand osteoarthritis is a common and disabling problem without effective therapies. Accumulating evidence suggests the role of local inflammation in causing pain and structural progression in hand osteoarthritis, and hand osteoarthritis with synovitis is a commonly encountered clinical phenotype. Methotrexate is a well-established, low-cost, and effective treatment for inflammatory arthritis with a well-described safety profile. The aim of this multicentre, randomised, double-blind, placebo-controlled trial is to determine whether methotrexate reduces pain over 6 months in patients with hand osteoarthritis and synovitis. METHODS: Ninety-six participants with hand osteoarthritis and synovitis will be recruited through the Osteoarthritis Clinical Trial Network (Melbourne, Hobart, Adelaide, and Perth), and randomly allocated in a 1:1 ratio to receive either methotrexate 20 mg or identical placebo once weekly for 6 months. The primary outcome is pain reduction (assessed by 100 mm visual analogue scale) at 6 months. The secondary outcomes include changes in physical function and quality of life assessed using Functional Index for Hand Osteoarthritis, Australian Canadian Osteoarthritis Hand Index, Health Assessment Questionnaire, Michigan Hand Outcomes Questionnaire, Short-Form-36, tender and swollen joint count, and grip strength, and structural progression assessed using progression of synovitis and bone marrow lesions from magnetic resonance imaging and radiographic progression at 6 months. Adverse events will be recorded. The primary analysis will be by intention to treat, including all participants in their randomised groups. DISCUSSION: This study will provide high-quality evidence to address whether methotrexate has an effect on reducing pain over 6 months in patients with hand osteoarthritis and synovitis, with major clinical and public health importance. While a positive trial will inform international clinical practice guidelines for the management of hand osteoarthritis, a negative trial would be highly topical and change current trends in clinical practice. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12617000877381. Registered 15 June 2017, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373124.


Subject(s)
Osteoarthritis , Synovitis , Australia , Canada , Double-Blind Method , Humans , Methotrexate/therapeutic use , Multicenter Studies as Topic , Osteoarthritis/diagnostic imaging , Osteoarthritis/drug therapy , Quality of Life , Randomized Controlled Trials as Topic , Synovitis/diagnostic imaging , Synovitis/drug therapy , Treatment Outcome
3.
Ann Vasc Surg ; 76: 285-288, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1525691

ABSTRACT

The arterial revascularization procedure is still a challenging issue in Covid-19 associated limb ischemia. Herein we aimed to present a case of a 64 year-old woman with acute ischemic signs in upper extremity who was diagnosed as a probable Covid-19 case incidentally after admission. Although late admission and failed recurrent embolectomies lead to an eventful course, intra-arterial thrombolysis seemed to present a benefitable treatment option for our patient.


Subject(s)
COVID-19/complications , Ischemia/etiology , Upper Extremity/blood supply , Acute Disease , Amputation , COVID-19/diagnosis , Embolectomy , Female , Humans , Ischemia/diagnostic imaging , Ischemia/physiopathology , Ischemia/therapy , Middle Aged , Regional Blood Flow , Thrombolytic Therapy , Time-to-Treatment , Treatment Outcome
4.
J Korean Med Sci ; 36(44): e309, 2021 Nov 15.
Article in English | MEDLINE | ID: covidwho-1526761

ABSTRACT

BACKGROUND: We assessed maternal and neonatal outcomes of critically ill pregnant and puerperal patients in the clinical course of coronavirus disease 2019 (COVID-19). METHODS: Records of pregnant and puerperal women with polymerase chain reaction positive COVID-19 virus who were admitted to our intensive care unit (ICU) from March 2020 to August 2021 were investigated. Demographic, clinical and laboratory data, pharmacotherapy, and neonatal outcomes were analyzed. These outcomes were compared between patients that were discharged from ICU and patients who died in ICU. RESULTS: Nineteen women were included in this study. Additional oxygen was required in all cases (100%). Eight patients (42%) were intubated and mechanically ventilated. All patients that were mechanically ventilated have died. Increased levels of C-reactive protein (CRP) was seen in all patients (100%). D-dimer values increased in 15 patients (78.9%); interleukin-6 (IL-6) increased in 16 cases (84.2%). Sixteen patients used antiviral drugs. Eleven patients were discharged from the ICU and eight patients have died due to complications of COVID-19 showing an ICU mortality rate of 42.1%. Mean number of hospitalized days in ICU was significantly lower in patients that were discharged (P = 0.037). Seventeen patients underwent cesarean-section (C/S) (89.4%). Mean birth week was significantly lower in patients who died in ICU (P = 0.024). Eleven preterm (57.8%) and eight term deliveries (42.1%) occurred. CONCLUSION: High mortality rate was detected among critically ill pregnant/parturient patients followed in the ICU. Main predictors of mortality were the need of invasive mechanical ventilation and higher number of days hospitalized in ICU. Rate of C/S operations and preterm delivery were high. Pleasingly, the rate of neonatal death was low and no neonatal COVID-19 occurred.


Subject(s)
COVID-19/mortality , Pregnancy Complications, Infectious/mortality , Puerperal Disorders/mortality , SARS-CoV-2 , Adult , Antiviral Agents/therapeutic use , COVID-19/blood , COVID-19/diagnostic imaging , COVID-19/therapy , Cesarean Section , Combined Modality Therapy , Critical Illness/mortality , Delivery, Obstetric/statistics & numerical data , Female , Hospital Mortality , Humans , Infant, Newborn , Intensive Care Units/statistics & numerical data , Length of Stay/statistics & numerical data , Lung/diagnostic imaging , Oxygen Inhalation Therapy , Pregnancy , Pregnancy Outcome , Respiration, Artificial , Retrospective Studies , Treatment Outcome , Young Adult
5.
Artif Organs ; 45(12): 1466-1476, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1526347

ABSTRACT

BACKGROUND: Coronavirus disease-19 (COVID-19) ranges from asymptomatic infection to severe cases requiring admission to the intensive care unit. Together with supportive therapies (ventilation in particular), the suppression of the pro-inflammatory state has been a hypothesized target. Pharmacological therapies with corticosteroids and interleukin-6 (IL-6) receptor antagonists have reduced mortality. The use of extracorporeal cytokine removal, also known as hemoperfusion (HP), could be a promising non-pharmacological approach to decrease the pro-inflammatory state in COVID-19. METHODS: We conducted a systematic review of PubMed and EMBASE databases in order to summarize the evidence regarding HP therapy in COVID-19. We included original studies and case series enrolling at least five patients. RESULTS: We included 11 articles and describe the characteristics of the populations studied from both clinical and biological perspectives. The methodological quality of the included studies was generally low. Only two studies had a control group, one of which included 101 patients in total. The remaining studies had a range between 10 and 50 patients included. There was large variability in the HP techniques implemented and in clinical and biological outcomes reported. Most studies described decreasing levels of IL-6 after HP treatment. CONCLUSION: Our review does not support strong conclusions regarding the role of HP in COVID-19. Considering the very low level of clinical evidence detected, starting HP therapies in COVID-19 patients does not seem supported outside of clinical trials. Prospective randomized data are needed.


Subject(s)
COVID-19/therapy , Cytokines/blood , Hemoperfusion , Inflammation Mediators/blood , Adult , Aged , Biomarkers/blood , COVID-19/blood , COVID-19/mortality , COVID-19/physiopathology , Female , Hemoperfusion/adverse effects , Hemoperfusion/mortality , Humans , Male , Middle Aged , Risk Factors , Treatment Outcome
6.
Artif Organs ; 45(12): 1522-1532, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1526346

ABSTRACT

Disturbed oxygenation is foremost the leading clinical presentation in COVID-19 patients. However, a small proportion also develop carbon dioxide removal problems. The Advanced Organ Support (ADVOS) therapy (ADVITOS GmbH, Munich, Germany) uses a less invasive approach by combining extracorporeal CO2 -removal and multiple organ support for the liver and the kidneys in a single hemodialysis device. The aim of our study is to evaluate the ADVOS system as treatment option in-COVID-19 patients with multi-organ failure and carbon dioxide removal problems. COVID-19 patients suffering from severe respiratory insufficiency, receiving at least two treatments with the ADVOS multi system (ADVITOS GmbH, Munich, Germany), were eligible for study inclusion. Briefly, these included patients with acute kidney injury (AKI) according to KDIGO guidelines, and moderate or severe ARDS according to the Berlin definition, who were on invasive mechanical ventilation for more than 72 hours. In total, nine COVID-19 patients (137 ADVOS treatment sessions with a median of 10 treatments per patient) with moderate to severe ARDS and carbon dioxide removal problems were analyzed. During the ADVOS treatments, a rapid correction of acid-base balance and a continuous CO2 removal could be observed. We observed a median continuous CO2 removal of 49.2 mL/min (IQR: 26.9-72.3 mL/min) with some treatments achieving up to 160 mL/min. The CO2 removal significantly correlated with blood flow (Pearson 0.421; P < .001), PaCO2 (0.341, P < .001) and HCO 3 - levels (0.568, P < .001) at the start of the treatment. The continuous treatment led to a significant reduction in PaCO2 from baseline to the last ADVOS treatment. In conclusion, it was feasible to remove CO2 using the ADVOS system in our cohort of COVID-19 patients with acute respiratory distress syndrome and multiorgan failure. This efficient removal of CO2 was achieved at blood flows up to 300 mL/min using a conventional hemodialysis catheter and without a membrane lung or a gas phase.


Subject(s)
COVID-19/therapy , Carbon Dioxide/blood , Extracorporeal Circulation/instrumentation , Lung/physiopathology , Multiple Organ Failure/therapy , Renal Dialysis/instrumentation , Respiration, Artificial , Aged , COVID-19/blood , COVID-19/diagnosis , COVID-19/physiopathology , Critical Illness , Extracorporeal Circulation/adverse effects , Female , Humans , Male , Middle Aged , Multiple Organ Failure/blood , Multiple Organ Failure/diagnosis , Multiple Organ Failure/physiopathology , Renal Dialysis/adverse effects , Respiration, Artificial/adverse effects , Time Factors , Treatment Outcome
7.
Blood Coagul Fibrinolysis ; 32(8): 544-549, 2021 Dec 01.
Article in English | MEDLINE | ID: covidwho-1526211

ABSTRACT

Standard biomarkers have been widely used for COVID-19 diagnosis and prognosis. We hypothesize that thrombogenicity metrics measured by thromboelastography will provide better diagnostic and prognostic utility versus standard biomarkers in COVID-19 positive patients. In this observational prospective study, we included 119 hospitalized COVID-19 positive patients and 15 COVID-19 negative patients. On admission, we measured standard biomarkers and thrombogenicity using a novel thromboelastography assay (TEG-6s). In-hospital all-cause death and thrombotic occurrences (thromboembolism, myocardial infarction and stroke) were recorded. Most COVID-19 patients were African--Americans (68%). COVID-19 patients versus COVID-19 negative patients had higher platelet-fibrin clot strength (P-FCS), fibrin clot strength (FCS) and functional fibrinogen level (FLEV) (P ≤ 0.003 for all). The presence of high TEG-6 s metrics better discriminated COVID-19 positive from negative patients. COVID-19 positive patients with sequential organ failure assessment (SOFA) score at least 3 had higher P-FCS, FCS and FLEV than patients with scores less than 3 (P ≤ 0.001 for all comparisons). By multivariate analysis, the in-hospital composite endpoint occurrence of death and thrombotic events was independently associated with SOFA score more than 3 [odds ratio (OR) = 2.9, P = 0.03], diabetes (OR = 3.3, P = 0.02) and FCS > 40 mm (OR = 3.4, P = 0.02). This largest observational study suggested the early diagnostic and prognostic utility of thromboelastography to identify COVID-19 and should be considered hypothesis generating. Our results also support the recent FDA guidance regarding the importance of measurement of whole blood viscoelastic properties in COVID-19 patients. Our findings are consistent with the observation of higher hospitalization rates and poorer outcomes for African--Americans with COVID-19.


Subject(s)
COVID-19/blood , SARS-CoV-2 , Thrombophilia/diagnosis , Adult , African Americans/statistics & numerical data , Aged , Aged, 80 and over , Biomarkers , COVID-19/complications , COVID-19/epidemiology , COVID-19 Testing , Cardiovascular Diseases/epidemiology , Comorbidity , Diabetes Mellitus/epidemiology , Early Diagnosis , European Continental Ancestry Group/statistics & numerical data , Female , Fibrin/analysis , Fibrin Clot Lysis Time , Fibrinogen/analysis , Hospitalization , Humans , Hyperlipidemias/epidemiology , L-Lactate Dehydrogenase/blood , Male , Middle Aged , Obesity/epidemiology , Organ Dysfunction Scores , Prognosis , Prospective Studies , Thrombelastography , Thrombophilia/blood , Thrombophilia/drug therapy , Thrombophilia/etiology , Treatment Outcome
8.
Chest ; 160(1): 175-186, 2021 07.
Article in English | MEDLINE | ID: covidwho-1525725

ABSTRACT

BACKGROUND: SARS-CoV-2 aerosolization during noninvasive positive-pressure ventilation may endanger health care professionals. Various circuit setups have been described to reduce virus aerosolization. However, these setups may alter ventilator performance. RESEARCH QUESTION: What are the consequences of the various suggested circuit setups on ventilator efficacy during CPAP and noninvasive ventilation (NIV)? STUDY DESIGN AND METHODS: Eight circuit setups were evaluated on a bench test model that consisted of a three-dimensional printed head and an artificial lung. Setups included a dual-limb circuit with an oronasal mask, a dual-limb circuit with a helmet interface, a single-limb circuit with a passive exhalation valve, three single-limb circuits with custom-made additional leaks, and two single-limb circuits with active exhalation valves. All setups were evaluated during NIV and CPAP. The following variables were recorded: the inspiratory flow preceding triggering of the ventilator, the inspiratory effort required to trigger the ventilator, the triggering delay, the maximal inspiratory pressure delivered by the ventilator, the tidal volume generated to the artificial lung, the total work of breathing, and the pressure-time product needed to trigger the ventilator. RESULTS: With NIV, the type of circuit setup had a significant impact on inspiratory flow preceding triggering of the ventilator (P < .0001), the inspiratory effort required to trigger the ventilator (P < .0001), the triggering delay (P < .0001), the maximal inspiratory pressure (P < .0001), the tidal volume (P = .0008), the work of breathing (P < .0001), and the pressure-time product needed to trigger the ventilator (P < .0001). Similar differences and consequences were seen with CPAP as well as with the addition of bacterial filters. Best performance was achieved with a dual-limb circuit with an oronasal mask. Worst performance was achieved with a dual-limb circuit with a helmet interface. INTERPRETATION: Ventilator performance is significantly impacted by the circuit setup. A dual-limb circuit with oronasal mask should be used preferentially.


Subject(s)
COVID-19 , Continuous Positive Airway Pressure , Disease Transmission, Infectious/prevention & control , Noninvasive Ventilation , Air Filters , Benchmarking/methods , COVID-19/therapy , COVID-19/transmission , Continuous Positive Airway Pressure/adverse effects , Continuous Positive Airway Pressure/instrumentation , Continuous Positive Airway Pressure/methods , Critical Pathways/standards , Critical Pathways/trends , Humans , Infectious Disease Transmission, Patient-to-Professional/prevention & control , Noninvasive Ventilation/adverse effects , Noninvasive Ventilation/instrumentation , Noninvasive Ventilation/methods , Research Design , Respiratory Function Tests/methods , SARS-CoV-2 , Treatment Outcome , Ventilators, Mechanical
10.
Ann Vasc Surg ; 76: 289-292, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1525692

ABSTRACT

To describe the case of a young female patient, affected by Systemic Lupus Erythematous, hospitalized for severe SARS-CoV-2 infection pneumonia and presenting a treatment-resistant acute upper limb ischemia. Two days after hospital admission, the patient suffered sudden right upper limb pain associated with mild functional impairment. At physical examination, radial and ulnar pulses were absent, and no flow signal was detected at duplex ultrasound scan. Therefore, an acute limb ischemia diagnoses was posed. Despite several surgical and endovascular revascularization attempts, the patient underwent an above the elbow amputation in 10th postoperative day from first surgical embolectomy, and she died for respiratory failure 25 days after hospitalization. Our case of acute upper limb ischemia seems to confirm that clinical manifestation and fate of thrombotic disorder in COVID-19 patients could be precipitated by concomitant autoimmune diseases.


Subject(s)
COVID-19/complications , Ischemia/etiology , Lupus Erythematosus, Systemic/complications , Upper Extremity/blood supply , Acute Disease , Amputation , COVID-19/diagnosis , COVID-19/therapy , Disease Progression , Embolectomy , Endovascular Procedures , Fatal Outcome , Female , Humans , Ischemia/diagnostic imaging , Ischemia/physiopathology , Ischemia/therapy , Lupus Erythematosus, Systemic/diagnosis , Middle Aged , Treatment Outcome
12.
BMJ Case Rep ; 14(11)2021 Nov 17.
Article in English | MEDLINE | ID: covidwho-1522936

ABSTRACT

After radical nephrectomy, clear cell renal cell carcinoma (ccRCC) recurs locally in <3% of patients. Recurrences typically occur 1-2 years postoperatively and grow at 5-20 mm per year. In contrast, this patient's recurrence was unexpectedly large and swift. A 71-year-old woman was initially found on workup for recurrent urinary tract infections to have a 12 cm left renal tumour. After negative staging scans, she progressed to left open radical nephrectomy. Histology revealed a stage T2b 12 cm ccRCCwith sarcomatoid differentiation, International Society of Urological Pathology (ISUP) grade 4, with clear margins. Only 3 months later, the patient developed left-sided abdominal pain, and CT scans revealed a 15 cm left retroperitoneal local recurrence, as well as widespread peritoneal tumours. In discussion with her treating team, the patient and her family elected not to undergo biopsy or systemic therapy. The patient was palliated and passed away 8 days after re-presentation.


Subject(s)
Carcinoma, Renal Cell , Kidney Neoplasms , Aged , Carcinoma, Renal Cell/diagnostic imaging , Carcinoma, Renal Cell/surgery , Female , Humans , Kidney Neoplasms/diagnostic imaging , Kidney Neoplasms/surgery , Neoplasm Recurrence, Local/surgery , Nephrectomy , Treatment Outcome
13.
J Behav Addict ; 10(2): 361-370, 2021 Jul 06.
Article in English | MEDLINE | ID: covidwho-1518390

ABSTRACT

Background: Several behaviors, besides consumption of psychoactive substances, produce short-term reward that may lead to persistent aberrant behavior despite adverse consequences. Growing evidence suggests that these behaviors warrant consideration as nonsubstance or "behavioral" addictions, such as pathological gambling, internet gaming disorder and internet addiction. Case presentation: Here, we report two cases of behavioral addictions (BA), compulsive sexual behavior disorder for online porn use and internet gaming disorder. A 57-years-old male referred a loss of control over his online pornography use, started 15 years before, while a 21-years-old male university student reported an excessive online gaming activity undermining his academic productivity and social life. Both patients underwent a high-frequency repetitive transcranial magnetic stimulation (rTMS) protocol over the left dorsolateral prefrontal cortex (l-DLPFC) in a multidisciplinary therapeutic setting. A decrease of addictive symptoms and an improvement of executive control were observed in both cases. Discussion: Starting from these clinical observations, we provide a systematic review of the literature suggesting that BAs share similar neurobiological mechanisms to those underlying substance use disorders (SUD). Moreover, we discuss whether neurocircuit-based interventions, such as rTMS, might represent a potential effective treatment for BAs.


Subject(s)
Behavior, Addictive/psychology , Behavior, Addictive/therapy , Erotica/psychology , Internet Addiction Disorder/psychology , Internet Addiction Disorder/therapy , Prefrontal Cortex/physiology , Transcranial Magnetic Stimulation , Humans , Male , Middle Aged , Treatment Outcome , Young Adult
14.
Trials ; 22(1): 796, 2021 Nov 12.
Article in English | MEDLINE | ID: covidwho-1518288

ABSTRACT

BACKGROUND: The advised standard treatment for bacterial brain abscess following surgery is 6 to 8 weeks of intravenous (IV) antibiotic treatment, but an early switch to oral antibiotic treatment has been suggested to be equally effective. METHODS: This investigator-initiated, international, multi-center, parallel group, open-label, randomized (1:1 allocation) controlled trial will examine if oral treatment after 2 weeks of IV antibiotic therapy is non-inferior to standard 6-8 weeks of IV antibiotics for bacterial brain abscess in adults (≥ 18 years of age). The study will be conducted at hospitals across Denmark, the Netherlands, France, Australia, and Sweden. Exclusion criteria are severe immunocompromise or impaired gastro-intestinal absorption, pregnancy, device-related brain abscesses, and brain abscess caused by nocardia, tuberculosis, or Pseudomonas spp. The primary objective is a composite endpoint at 6 months after randomization consisting of all-cause mortality, intraventricular rupture of brain abscess, unplanned re-aspiration or excision of brain abscess, relapse, or recurrence. The primary endpoint will be adjudicated by an independent blinded endpoint committee. Secondary outcomes include extended Glasgow Outcome Scale scores and all-cause mortality at end of treatment as well as 3, 6, and 12 months since randomization, completion of assigned treatment, IV catheter associated complications, durations of admission and antibiotic treatment, severe adverse events, quality of life scores, and cognitive evaluations. The planned sample size is 450 patients for a one-sided alpha of 0.025 and a power of 90% to exclude a difference in favor of standard treatment of more than 10%. Date of initiation of first study center was November 3, 2020, with active recruitment for 3 years and follow-up for 1 year of all patients. DISCUSSION: The results of this study may guide future recommendations for treatment of bacterial brain abscess. If early transition to oral antibiotics proves non-inferior to standard IV treatment, this will provide considerable health and costs benefits. TRIAL REGISTRATION: ClinicalTrials.gov NCT04140903, first registered 28.10.2019. EudraCT number: 2019-002845-39, first registered 03.07.2019.


Subject(s)
Brain Abscess , COVID-19 , Adult , Anti-Bacterial Agents/adverse effects , Brain Abscess/diagnosis , Brain Abscess/drug therapy , Humans , Quality of Life , Treatment Outcome
15.
Trials ; 22(1): 808, 2021 Nov 15.
Article in English | MEDLINE | ID: covidwho-1518287

ABSTRACT

BACKGROUND: Pre-exposure prophylaxis (PrEP) is a promising strategy to break COVID-19 transmission. Although hydroxychloroquine was evaluated for treatment and post-exposure prophylaxis, it is not evaluated for COVID-19 PrEP yet. The aim of this study was to evaluate the efficacy and safety of PrEP with hydroxychloroquine against placebo in healthcare workers at high risk of SARS-CoV-2 infection during an epidemic period. METHODS: We conducted a double-blind placebo-controlled randomized clinical trial in three hospitals in Barcelona, Spain. From 350 adult healthcare workers screened, we included 269 participants with no active or past SARS-CoV-2 infection (determined by a negative nasopharyngeal SARS-CoV-2 PCR and a negative serology against SARS-CoV-2). Participants allocated in the intervention arm (PrEP) received 400 mg of hydroxychloroquine daily for the first four consecutive days and subsequently, 400 mg weekly during the study period. Participants in the control group followed the same treatment schedule with placebo tablets. RESULTS: 52.8% (142/269) of participants were in the hydroxychloroquine arm and 47.2% (127/269) in the placebo arm. Given the national epidemic incidence decay, only one participant in each group was diagnosed with COVID-19. The trial was stopped due to futility and our study design was deemed underpowered to evaluate any benefit regarding PrEP efficacy. Both groups showed a similar proportion of participants experiencing at least one adverse event (AE) (p=0.548). No serious AEs were reported. Almost all AEs (96.4%, 106/110) were mild. Only mild gastrointestinal symptoms were significantly higher in the hydroxychloroquine arm compared to the placebo arm (27.4% (39/142) vs 15.7% (20/127), p=0.041). CONCLUSIONS: Although the efficacy of PrEP with hydroxychloroquine for preventing COVID-19 could not be evaluated, our study showed that PrEP with hydroxychloroquine at low doses is safe. TRIAL REGISTRATION: ClinicalTrials.gov NCT04331834 . Registered on April 2, 2020.


Subject(s)
COVID-19 , Pre-Exposure Prophylaxis , Adult , COVID-19/drug therapy , Double-Blind Method , Humans , Hydroxychloroquine/adverse effects , SARS-CoV-2 , Treatment Outcome
16.
J Med Internet Res ; 23(11): e29201, 2021 11 12.
Article in English | MEDLINE | ID: covidwho-1515510

ABSTRACT

BACKGROUND: People with serious mental illness (SMI) have significant unmet mental health needs. Development and testing of digital interventions that can alleviate the suffering of people with SMI is a public health priority. OBJECTIVE: The aim of this study is to conduct a fully remote randomized waitlist-controlled trial of CORE, a smartphone intervention that comprises daily exercises designed to promote reassessment of dysfunctional beliefs in multiple domains. METHODS: Individuals were recruited via the web using Google and Facebook advertisements. Enrolled participants were randomized into either active intervention or waitlist control groups. Participants completed the Beck Depression Inventory-Second Edition (BDI-II), Generalized Anxiety Disorder-7 (GAD-7), Hamilton Program for Schizophrenia Voices, Green Paranoid Thought Scale, Recovery Assessment Scale (RAS), Rosenberg Self-Esteem Scale (RSES), Friendship Scale, and Sheehan Disability Scale (SDS) at baseline (T1), 30-day (T2), and 60-day (T3) assessment points. Participants in the active group used CORE from T1 to T2, and participants in the waitlist group used CORE from T2 to T3. Both groups completed usability and accessibility measures after they concluded their intervention periods. RESULTS: Overall, 315 individuals from 45 states participated in this study. The sample comprised individuals with self-reported bipolar disorder (111/315, 35.2%), major depressive disorder (136/315, 43.2%), and schizophrenia or schizoaffective disorder (68/315, 21.6%) who displayed moderate to severe symptoms and disability levels at baseline. Participants rated CORE as highly usable and acceptable. Intent-to-treat analyses showed significant treatment×time interactions for the BDI-II (F1,313=13.38; P<.001), GAD-7 (F1,313=5.87; P=.01), RAS (F1,313=23.42; P<.001), RSES (F1,313=19.28; P<.001), and SDS (F1,313=10.73; P=.001). Large effects were observed for the BDI-II (d=0.58), RAS (d=0.61), and RSES (d=0.64); a moderate effect size was observed for the SDS (d=0.44), and a small effect size was observed for the GAD-7 (d=0.20). Similar changes in outcome measures were later observed in the waitlist control group participants following crossover after they received CORE (T2 to T3). Approximately 41.5% (64/154) of participants in the active group and 60.2% (97/161) of participants in the waitlist group were retained at T2, and 33.1% (51/154) of participants in the active group and 40.3% (65/161) of participants in the waitlist group were retained at T3. CONCLUSIONS: We successfully recruited, screened, randomized, treated, and assessed a geographically dispersed sample of participants with SMI entirely via the web, demonstrating that fully remote clinical trials are feasible in this population; however, study retention remains challenging. CORE showed promise as a usable, acceptable, and effective tool for reducing the severity of psychiatric symptoms and disability while improving recovery and self-esteem. Rapid adoption and real-world dissemination of evidence-based mobile health interventions such as CORE are needed if we are to shorten the science-to-service gap and address the significant unmet mental health needs of people with SMI during the COVID-19 pandemic and beyond. TRIAL REGISTRATION: ClinicalTrials.gov NCT04068467; https://clinicaltrials.gov/ct2/show/NCT04068467.


Subject(s)
COVID-19 , Depressive Disorder, Major , Mental Disorders , Humans , Mental Disorders/therapy , Pandemics , SARS-CoV-2 , Smartphone , Treatment Outcome
17.
Qual Life Res ; 30(8): 2123-2135, 2021 Aug.
Article in English | MEDLINE | ID: covidwho-1509285

ABSTRACT

BACKGROUND: Veno-venous extracorporeal membrane oxygenation (VV-ECMO) has been used successfully for the past decade in adult patients with acute respiratory distress syndrome (ARDS) refractory to conventional ventilatory support. However, knowledge of the health-related quality of life (HRQoL) in VV-ECMO patients is still limited. Thus, this study aimed to provide a comprehensive overview of the HRQoL following VV-ECMO support in ARDS patients. METHODS: A systematic search was performed on PubMed and Web of Science databases from January 1st, 2009 to October 19th, 2020. Studies reporting on HRQoL following VV-ECMO for ARDS in adults were included. Two authors independently selected studies, extracted data, and assessed methodological quality. RESULTS: Eight studies were eligible for inclusion, consisting of seven observational studies and one randomized controlled trial (total N = 441). All eight studies had a quantitative design and reported 265 VV-ECMO survivors to have a reduced HRQoL compared to a generally healthy population. Follow-up time varied between six months to three years. Additionally, only four studies (total N = 335) compared the HRQoL of VV-ECMO (N = 159) to conventionally treated survivors (N = 176), with one study showing a significantly better HRQoL in VV-ECMO survivors, while three studies were stating comparable HRQoL across groups. Notably, most survivors in these studies appeared to experience varying degrees of anxiety, depression, and post-traumatic stress disorder (PTSD). CONCLUSIONS: ARDS survivors supported by VV-ECMO have a decline in HRQoL and suffered from physical and psychological impairments. This HRQoL reduction is comparable or even better to the HRQoL in conventionally treated ARDS survivors.


Subject(s)
Extracorporeal Membrane Oxygenation/psychology , Quality of Life/psychology , Respiratory Distress Syndrome/therapy , Adult , Cross-Sectional Studies , Extracorporeal Membrane Oxygenation/methods , Health Status , Humans , Respiratory Distress Syndrome/psychology , Survivors , Treatment Outcome
19.
BMC Psychiatry ; 21(1): 560, 2021 11 11.
Article in English | MEDLINE | ID: covidwho-1511735

ABSTRACT

BACKGROUND: In addition to having a negative impact on the physical and emotional health of the population, the global Covid-19 pandemic has necessitated psychotherapists moving their practice to online environments. This service evaluation examines the efficacy of Eye Movement Desensitization and Reprocessing (EMDR) Therapy delivered via the internet. METHODS: A real-world service evaluation was conducted from a self-selecting group of EMDR therapists that subscribe to either a JISCMail discussion list or either the UK or All Ireland National EMDR Associations. Author designed questionnaires were used to gather information on the efficacy of EMDR delivered online as well as client and therapist characteristics. RESULTS: Thirty-three therapists provided efficacy data on a total of 93 patients. Statistically significant and clinically meaningful reductions were found in all four-psychometrics used both in adult and children and young people populations. Client outcome was not related to therapist experience. CONCLUSIONS: EMDR delivered via the internet can be an effective treatment for clients experiencing mental health issues.


Subject(s)
COVID-19 , Eye Movement Desensitization Reprocessing , Stress Disorders, Post-Traumatic , Adolescent , Adult , Child , Eye Movements , Humans , Pandemics , SARS-CoV-2 , Treatment Outcome
20.
BMC Pregnancy Childbirth ; 21(1): 760, 2021 Nov 10.
Article in English | MEDLINE | ID: covidwho-1511731

ABSTRACT

BACKGROUND: Infection with SARS-CoV-2 during pregnancy can lead to a severe condition in the patient, which is challenging for obstetricians and anaesthesiologists. Upon severe COVID-19 and a lack of improvement after multidrug therapy and mechanical ventilation, extracorporeal membrane oxygenation (ECMO) is introduced as the last option. Such treatment is critical in women with very preterm pregnancy when each additional day of the intrauterine stay is vital for the survival of the newborn. CASE PRESENTATION: We report a case of a 38-year-old woman at 27 weeks of gestation treated with multidrug therapy and ECMO. The woman was admitted to the intensive care unit (ICU) with increasing fever, cough and dyspnoea. The course of the pregnancy was uncomplicated. She was otherwise healthy. At admission, she presented with severe dyspnoea, with oxygen saturation (SpO2) of 95% on passive oxygenation, heart rate of 145/min, and blood pressure of 145/90. After confirmation of SARS-CoV-2 infection, she received steroids, remdesivir and convalescent plasma therapy. The foetus was in good condition. No signs of an intrauterine infection were visible. Due to tachypnea of 40/min and SpO2 of 90%, the woman was intubated and mechanically ventilated. Due to circulatory failure, the prothrombotic activity of the coagulation system, further saturation worsening, and poor control of sedation, she was qualified for veno-venous ECMO. An elective caesarean section was performed at 29 weeks on ECMO treatment in the ICU. A preterm female newborn was delivered with an Apgar score of 7 and a birth weight of 1440 g. The newborn had no laboratory or clinical evidence of COVID-19. The placenta showed the following pathological changes: large subchorionic haematoma, maternal vascular malperfusion, marginal cord insertion, and chorangioma. CONCLUSIONS: This case presents the successful use of ECMO in a pregnant woman with acute respiratory distress syndrome in the course of severe COVID-19. Further research is required to explain the aetiology of placental disorders (e.g., maternal vascular malperfusion lesions or thrombotic influence of COVID-19). ECMO treatment in pregnant women remains challenging; thus, it should be used with caution. Long-term assessment may help to evaluate the safety of the ECMO procedure in pregnant women.


Subject(s)
COVID-19/therapy , Extracorporeal Membrane Oxygenation/methods , Placenta/pathology , Pregnancy Complications, Infectious/therapy , Adult , COVID-19/diagnosis , Cesarean Section , Female , Humans , Placenta/virology , Pregnancy , Pregnancy Complications, Infectious/diagnosis , Pregnancy Trimester, Second , Treatment Outcome
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