2020/21 publications

Between 1 April 2020 and 31 March 2021, the following articles were published which relate to studies that have been supported by the NIHR Sheffield Clinical Research Facility (CRF).

Characterisation of 22445 patients attending UK emergency departments with suspected COVID-19 infection: Observational cohort study (STH16228: PRIEST)

Derivation and validation of a clinical severity score for acutely ill adults with suspected COVID-19: The PRIEST observational cohort study (STH16228: PRIEST)

Post-exertion oxygen saturation as a prognostic factor for adverse outcome in patients attending the emergency department with suspected COVID-19: a substudy of the PRIEST observational cohort study (STH16228: PRIEST)

Accuracy of PE rule-out strategies in pregnancy: secondary analysis of the DiPEP study prospective cohort (STH17334: DiPEP)

Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial (STH18085: HALT-IT)

Controlled observational study and economic evaluation of the effect of city-centre night-time alcohol intoxication management services on the emergency care system compared with usual care (STH19210: EDARA)

Evaluating alcohol intoxication management services: the EDARA mixed-methods study (STH19210: EDARA)

Diagnostic accuracy of the magnetocardiograph for patients with suspected acute coronary syndrome (STH19368: MCG Study)

Preoperative intravenous iron to treat anaemia before major abdominal surgery (PREVENTT): a randomised, double-blind, controlled trial (STH17221: PREVENTT)

Intravascular Ultrasound Pulmonary Artery Denervation to Treat Pulmonary Arterial Hypertension (TROPHY1): Multicenter, Early Feasibility Study (STH18907: TROPHY)

Novel loss of function mutation in NOTCH1 in a family with bicuspid aortic valve, ventricular septal defect, thoracic aortic aneurysm, and aortic valve stenosis (STH19626: BRAVE)

Prolonged enoxaparin therapy compared with standard-of-care antithrombotic therapy in opiate-treated patients undergoing primary percutaneous coronary intervention (STH19902: PENNYWISE)

Whole-genome sequencing of a sporadic primary immunodeficiency cohort (STH18558: Whole-genome sequencing of a sporadic primary immunodeficiency cohort)

Development and validation of the ISARIC 4C Deterioration model for adults hospitalised with COVID-19: a prospective cohort study (STH18220: ISARIC)

Features of 20133 UK patients in hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: prospective observational cohort study (STH18220: ISARIC)

Outcome of Hospitalization for COVID-19 in Patients with Interstitial Lung Disease (STH18220: ISARIC)

Genetic mechanisms of critical illness in COVID-19 (STH21104: GenOMICC)

Effect of Hydrocortisone on Mortality and Organ Support in Patients With Severe COVID-19 - The REMAP-CAP COVID-19 Corticosteroid Domain Randomized Clinical Trial (STH21369: REMAP-CAP)

Implementation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 (REMAP-COVID) trial in a US health system—lessons learned and recommendations (STH21369: REMAP-CAP)

Interleukin-6 Receptor Antagonists in Critically Ill Patients with Covid-19 (STH21369: REMAP-CAP)

Corticotroph tumor progression during long-term therapy with osilodrostat in a patient with persistent Cushing’s disease (STH18457: LINC 3)

Efficacy and safety of osilodrostat in patients with Cushing's disease (LINC 3): a multicentre phase III study with a double-blind, randomised withdrawal phase (STH18457: LINC 3)

Modified-Release Hydrocortisone in Congenital Adrenal Hyperplasia (STH18946: DIUR005)

Pharmacodynamic studies of nasal tetracosactide with salivary glucocorticoids for a noninvasive Short Synacthen Test (STH19270: NeSST2)

Turoctocog alfa pegol provides effective management for major and minor surgical procedures in patients across all age groups with severe haemophilia A: Full data set from the pathfinder 3 and 5 phase III trials (STH16366: Pathfinder 3)

Long-term safety and efficacy of N8-GP in previously treated adults and adolescents with hemophilia A: Final results from pathfinder2 (STH16367: Pathfinder 2)

Open-Label, phase 2 study of blinatumomab as second salvage therapy in adults with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (STH19577: Blinatumomab in Aggressive B-Cell Non Hodgkin Lymphoma)

Azithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (STH21355: RECOVERY)

Dexamethasone in Hospitalized Patients with Covid-19 (STH21355: RECOVERY)

Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19 (STH21355: RECOVERY)

Lopinavir–ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (STH21355: RECOVERY)

RECOVERY trial: the UK covid-19 study resetting expectations for clinical trials (STH21355: RECOVERY)

Clinical Experience with Use of Remdesivir in the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2: a Case Series (STH21358: GILEAD SEVERE)

Patients With Uncomplicated Coronavirus Disease 2019 (COVID-19) Have Long-Term Persistent Symptoms and Functional Impairment Similar to Patients with Severe COVID-19: A Cautionary Tale During a Global Pandemic (STH21358: GILEAD SEVERE)

Remdesivir for Severe Coronavirus Disease 2019 (COVID19) Versus a Cohort Receiving Standard of Care (STH21358: GILEAD SEVERE)

Remdesivir for 5 or 10 Days in Patients with Severe Covid-19 (STH21358: GILEAD SEVERE)

Antibody evasion by the P.1 strain of SARS-CoV-2 (STH21413: COV002)

Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 variant of concern 202012/01 (B.1.1.7): an exploratory analysis of a randomised controlled trial (STH21413: COV002)

Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B.1.351 Variant (STH21413: COV002)

Evidence of escape of SARS-CoV-2 variant B.1.351 from natural and vaccine-induced sera (STH21413: COV002)

Phase 1/2 trial of SARS-CoV-2 vaccine ChAdOx1 nCoV-19 with a booster dose induces multifunctional antibody responses (STH21413: COV002)

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK (STH21413: COV002)

Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial (STH21413: COV002)

Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial (STH21413: COV002)

Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomised trials (STH21413: COV002)

T cell and antibody responses induced by a single dose of ChAdOx1 nCoV-19 (AZD1222) vaccine in a phase 1/2 clinical trial (STH21413: COV002)

Repeatability and sensitivity to change of noninvasive end points in PAH: the RESPIRE study (STH18285: REPEATABILITY)

Effect of denosumab on osteolytic lesion activity after total hip arthroplasty: a single-centre, randomised, double-blind, placebo-controlled, proof of concept trial (STH15714: Denosumab in THA)

Femoral neck strain prediction during level walking using a combined musculoskeletal and finite element model approach (STH19009: MultiSim Developing models of the human musculoskeletal system)

Fit for purpose? A cross-sectional study to evaluate the acceptability and usability of HeadUp, a novel neck support collar for neurological neck weakness (STH15573: Head Up)

Deficits in Mitochondrial Spare Respiratory Capacity Contribute to the Neuropsychological Changes of Alzheimer’s Disease (STH17001: Improving detection and prevention of cognitive decline in ageing)

Obesity and Brain Vulnerability in Normal and Abnormal Aging: A Multimodal MRI Study (STH17001: Improving detection and prevention of cognitive decline in ageing)

Amiloride, fluoxetine or riluzole to reduce brain volume loss in secondary progressive multiple sclerosis: the MS-SMART four-arm RCT (STH17249: MS-SMART)

Psychological and demographic characteristics of 368 patients with dissociative seizures: data from the CODES cohort (STH18295: CODES)

A Multifactorial Model of Multiple Sclerosis Gait and Its Changes Across Different Disability Levels (STH18829: MS SMART - ADD ON)

Wearable sensors can reliably quantify gait alterations associated with disability in people with progressive multiple sclerosis in a clinical setting (STH18829: MS SMART - ADD ON)

Phase 1–2 Trial of Antisense Oligonucleotide Tofersen for SOD1 ALS (STH19145: SOD1)

Value of systematic genetic screening of patients with amyotrophic lateral sclerosis (STH19219: AMBRoSIA)

Caregiver Delivered Sensory Electrical Stimulation for Post Stroke Upper Limb Spasticity: A Single Blind Crossover Randomized Feasibility Study (STH19263: MUSTS)

Ofatumumab versus Teriflunomide in Multiple Sclerosis (STH19613: Asclepios)

Value of cervical electrical impedance spectroscopy to predict spontaneous preterm delivery in asymptomatic women: the ECCLIPPx prospective cohort study (STH16102: ECCLIPPX-spectroscopy of the cervix)

Is short-term-variation of fetal-heart-rate a better predictor of fetal acidaemia in labour? A feasibility study (STH19362: STV Monica Study)

Characteristics and outcomes of pregnant women admitted to hospital with confirmed SARS-CoV-2 infection in UK: national population based cohort study (STH21366: UKOSS PIP)

Altered Macrophage Polarization Induces Experimental Pulmonary Hypertension and Is Observed in Patients With Pulmonary Arterial Hypertension (STH15222: STH-ObS)

Long-term study of oral treprostinil to treat pulmonary arterial hypertension: dosing, tolerability, and pharmacokinetics (STH15554: freedom-C, STH15578: freedom-C)

Whole-Blood RNA Profiles Associated with Pulmonary Arterial Hypertension and Clinical Outcome (STH17049: UK-HIPAH)

Bayesian Inference Associates Rare KDR Variants With Specific Phenotypes in Pulmonary Arterial Hypertension (STH17067: BRIDGE & STH17049: UK-HIPAH)

Expression Quantitative Trait Locus Mapping in Pulmonary Arterial Hypertension (STH17067: BRIDGE & STH17049: UK-HIPAH)

Results from the REPAIR Study Final Analysis: Effects of Macitentan on Right Ventricular (RV) Remodelling in Pulmonary Arterial Hypertension (PAH) (STH18766: REPAIR)

Direct healthcare resource utilisation, health-related quality of life, and work productivity in patients with moderate rheumatoid arthritis: an observational study (STH20702: RAUNMET)

Outcomes in rheumatoid arthritis patients treated with abatacept: a UK multi-centre observational study (STH20867: Observational chart review study of patients with rheumatoid arthritis treated with abatacept.)

Safety and immunogenicity of novel 5T4 viral vectored vaccination regimens in early stage prostate cancer: a phase I clinical trial (STH18657: Vaccination in prostate caNCEr - VANCE01)

Radical Cystectomy Against Intravesical BCG for High-Risk High-Grade Nonmuscle Invasive Bladder Cancer: Results From the Randomized Controlled BRAVO-Feasibility Study (STH19168: BRAVO study 2: RCT)