- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04710836
NoRCoRP Assessment Clinic (NoRCoRP)
The Nottingham Recovery From COVID-19 Research Platform Assessment Clinic
Aperçu de l'étude
Statut
Les conditions
Description détaillée
The severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2 / COVID-19) pandemic, has affected over 13 million people, and caused significant worldwide mortality and morbidity. Frequent long-term respiratory complications include persistent breathlessness and fatigue, with potential for ongoing organising pneumonia and new pulmonary fibrosis as well as thromboembolic disease. Additional features seen in at least some patients post hospital include impaired musculoskeletal function, impaired renal function, neurological impairment, cardiac dysfunction and significant psychiatric morbidity.
The majority of patients with COVID-19 were not admitted to hospital, and the longer-term consequences of infection with SARS-CoV-2 in this much larger patient group are unknown. Whilst many patients had relatively mild disease and made a good recovery, a significant number have been left with symptoms similar to those who were admitted to hospital.
In setting up a post COVID-19 respiratory review clinic, we expect to generate new findings, support studies that have already been submitted for funding, to provide a focus for further grant funding, and to provide an infrastructure to support new clinical trials. We also expect the insights gained from research using this platform to be of value for service planning in the region and beyond. We will prioritise patients who were not admitted to hospital but who have been left with significant morbidity by establishing this new General Practitioner (GP) referral research clinic.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Charlotte Bolton
- Numéro de téléphone: 54844 01159 691169
- E-mail: charlotte.bolton@nottingham.ac.uk
Sauvegarde des contacts de l'étude
- Nom: Alex Jenkins
- E-mail: alex.jenkins@nottingham.ac.uk
Lieux d'étude
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Nottingham, Royaume-Uni, NG5 1PB
- Recrutement
- Nottingham City Hospital
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Contact:
- Charlotte Bolton
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Adults (≥18 years) referred into the post COVID-19 respiratory outpatient clinic from primary care, following a swab, imaging or strong clinical diagnosis of COVID-19
- Adults discharged from hospital with a clinical diagnosis of COVID-19 (who are not included in the PHOSP-COVID study)
Exclusion Criteria:
- Children (<18 years) referred into the post COVID-19 respiratory outpatient clinic. This clinic is only open to adults and referrals for children will not be accepted
- Adults discharged from hospital with a clinical diagnosis of COVID-19 and have been included in the PHOSP-COVID study
- Patients unable to provide informed consent by themselves
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Number of participants with symptoms at presentation to the research clinic
Délai: September 2020 - August 2024
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Patient reported symptoms
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September 2020 - August 2024
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Short Physical Performance Battery
Délai: September 2020 - August 2024
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Assessment of functional capacity
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September 2020 - August 2024
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Quadricep muscle strength
Délai: September 2020 - August 2024
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Assessment of functional capacity using a handheld dynamometer
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September 2020 - August 2024
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Chalder's Fatigue Score
Délai: September 2020 - August 2024
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Assessment of fatigue using the Chalder 11-item fatigue questionnaire
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September 2020 - August 2024
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Number of participants with rehabilitation needs at presentation to clinic
Délai: September 2020 - August 2024
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Rehabilitation needs based on clinical assessment by a multidisciplinary team (musculoskeletal, cognitive and cardiopulmonary)
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September 2020 - August 2024
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EQ-5D-5L
Délai: September 2020 - August 2024
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Assessment of generic health status using the EQ-5D-5L questionnaire
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September 2020 - August 2024
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Montreal Cognitive Assessment
Délai: September 2020 - August 2024
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Assessment of cognitive state using the MoCA questionnaire
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September 2020 - August 2024
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Anxiety and Depression
Délai: September 2020 - August 2024
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Derived by completion of the Hospital Anxiety and Depression Scale (HADS) questionnaire
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September 2020 - August 2024
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Pittsburgh Sleep Quality Index
Délai: September 2020 - August 2024
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Assessment of sleep quality using the PSQI questionnaire
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September 2020 - August 2024
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Healthcare service needs following COVID-19 diagnosis
Délai: September 2020 - August 2032
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Monitoring of NHS records for incidence of re-presentation to primary or secondary care related to COVID-19 complications and survival.
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September 2020 - August 2032
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Biological markers of recovery from COVID-19
Délai: September 2020 - August 2032
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Assessment of blood taken for clinical purposes (where available) including renal function, liver function, full blood count, HbA1C, Brain natriuretic peptide, vitamin D, thyroid function, C-reactive protein (CRP), Creatine kinase for markers of COVID-19 recovery.
Batched inflammatory and metabolic markers as well as whole blood DNA will also be assessed from stored samples.
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September 2020 - August 2032
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Fried Frailty Index
Délai: September 2020 - August 2024
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Frailty assessment covering: shrinking, exhaustion, physical activity, slowness and weakness domains.
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September 2020 - August 2024
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Body composition
Délai: September 2020 - August 2024
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Body composition derived from bioelectrical impedance analysis to determine: body mass index, fat free mass index, fat free mass (kg), fat mass (kg).
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September 2020 - August 2024
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Charlotte Bolton, University of Nottingham & Nottingham University Hospitals NHS Trust
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 20RM056
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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