Covid19 Clinical Trial
— DYNAMOCovid-19Official title:
DYNamic Assessment of Multi Organ Level Dysfunction in Patients Recovering From Covid-19
NCT number | NCT05060497 |
Other study ID # | 20050 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 27, 2020 |
Est. completion date | February 24, 2022 |
Verified date | March 2023 |
Source | University of Nottingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In this study the investigators are hoping to the find out what changes occur within the body of people recovering from Covid-19 at 5-7 months and 11-13 months following discharge from hospital, compared to healthy controls, and whether these changes can help explain why some patients may experience fatigue. Measurements will be taken using state-of-the-art MRI imaging at rest and also during low intensity exercise, to mimic everyday activity. In doing so it is expected that this will inform ways to adapt exercise rehabilitation programmes, making them better suited for Covid-19 survivors.
Status | Completed |
Enrollment | 31 |
Est. completion date | February 24, 2022 |
Est. primary completion date | February 24, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Covid patients - - Adults aged 18 years and over, - Severe, laboratory confirmed Covid-19 infection that required hospital admission, - 5-7 months post discharge from local hospital Trusts. Controls - - No active or previous Covid infection, ie no previous positive Covid PCR test and absence of active symptoms - Matched for age, gender, BMI and ethnicity. Exclusion Criteria: - Absolute contraindications for MR scan - Pre-Covid diagnosed chronic respiratory, renal, cardiovascular or cerebrovascular disease or diabetes - BMI<20kg/m2 - Pregnancy - Those requiring oxygen therapy or non-invasive ventilation - Those on anticoagulation will be included but will not have a muscle biopsy - Active arthritis - Overt muscle damage, e.g. plasma creatine kinase > 300 - Any other conditions in addition to the above that the investigators consider may affect study measurements or safety |
Country | Name | City | State |
---|---|---|---|
United Kingdom | NIHR Nottingham BRC Respiratory Theme, University of Nottingham and NUH Trust | Nottingham | Nottinghamshire |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham |
United Kingdom,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Resting state brain structural measures - white matter and grey matter volumes | Use of MRI sequences to assess grey matter and white matter volume in patients with severe Covid-19 at 5-7 months and 11-13 months of discharge from hospital as well as non-Covid, age, gender, BMI and ethnicity matched volunteers. | 5-7 months post hospital discharge for patients | |
Primary | Resting state brain structural measures - white matter microstructure | Use of MRI sequences to assess white matter tract distribution in patients with severe Covid-19 at 5-7 months and 11-13 months of discharge from hospital as well as non-Covid, age, gender, BMI and ethnicity matched volunteers. | 5-7 months post hospital discharge for patients | |
Primary | Resting state cardiac structural integrity - cardiac output | Use of MRI sequences to assess cardiac output at rest in patients with severe Covid-19 at 5-7 months and 11-13 months of discharge from hospital as well as non-Covid, age, gender, BMI and ethnicity matched volunteers. | 5-7 months post hospital discharge for patients | |
Primary | Resting state cardiac structural integrity - cardiac fibrosis | Use of MRI sequences to look for the degree of fibrosis at rest in patients with severe Covid-19 at 5-7 months and 11-13 months of discharge from hospital as well as non-Covid, age, gender, BMI and ethnicity matched volunteers. | 5-7 months post hospital discharge for patients | |
Primary | Resting state whole-body fat and muscle volumes | Use of MRI sequence (mDixon) to assess whole-body fat and muscle content in patients with severe Covid-19 at 5-7 months and 11-13 months of discharge from hospital as well as non-Covid, age, gender, BMI and ethnicity matched volunteers. | 5-7 months post hospital discharge for patients | |
Primary | Resting state myocellular fat content | Use of MR spectroscopy sequence to assess intramyocellular and extramyocellular lipid content in patients with severe Covid-19 at 5-7 months and 11-13 months of discharge from hospital as well as non-Covid, age, gender, BMI and ethnicity matched volunteers. | 5-7 months post hospital discharge for patients | |
Primary | Dynamic changes in cerebral haemodynamics during low level supine in-bore exercise - cerebral blood flow | MRI sequences will be carried out at rest, during steady-state low level in-bore supine exercise and recovery to assess changes in cerebral blood flow in patients with severe Covid-19 at 5-7 months and 11-13 months of discharge from hospital as well as non-Covid, age, gender, BMI and ethnicity matched volunteers. | 5-7 months post hospital discharge for patients | |
Primary | Dynamic changes in cerebral haemodynamics during low level supine in-bore exercise - cerebral perfusion | MRI sequences will be carried out at rest, during steady-state low level in-bore supine exercise and recovery to assess changes in cerebral perfusion in patients with severe Covid-19 at 5-7 months and 11-13 months of discharge from hospital as well as non-Covid, age, gender, BMI and ethnicity matched volunteers. | 5-7 months post hospital discharge for patients | |
Primary | Dynamic changes in cerebral haemodynamics during low level supine in-bore exercise - cerebral oxygen extraction | MRI sequences will be carried out at rest, during steady-state low level in-bore supine exercise and recovery to assess changes in cerebral oxygen extraction in patients with severe Covid-19 at 5-7 months and 11-13 months of discharge from hospital as well as non-Covid, age, gender, BMI and ethnicity matched volunteers. | 5-7 months post hospital discharge for patients | |
Primary | Dynamic changes in cerebral haemodynamics during low level supine in-bore exercise - cardiac output | MRI sequences will be carried out at rest, during steady-state low level in-bore supine exercise and recovery to assess changes in cardiac output in patients with severe Covid-19 at 5-7 months and 11-13 months of discharge from hospital as well as non-Covid, age, gender, BMI and ethnicity matched volunteers. | 5-7 months post hospital discharge for patients | |
Primary | Recovery kinetics of skeletal muscle phosphocreatine | Recovery kinetics of phosphocreatine (Pcr) in the gastrocnemius will be measured following its depletion using MR spectroscopy to assess skeletal muscle quality in patients with severe Covid-19 at 5-7 months and 11-13 months of discharge from hospital as well as non-Covid, age, gender, BMI and ethnicity matched volunteers. | 5-7 months post hospital discharge for patients | |
Primary | Muscle mRNA | Muscle mRNA expression will be determined in skeletal muscle samples obtained from a micro biopsy of the vastus laterals in patients with severe Covid-19 at 5-7 months and 11-13 months of discharge from hospital as well as non-Covid, age, gender, BMI and ethnicity matched volunteers. | 5-7 months post hospital discharge for patients | |
Primary | Whole body glucose disposal - glucose and insulin concentrations | Oral glucose tolerance test will be used to measure glucose and insulin concentration for whole body glucose disposal in patients with severe Covid-19 at 5-7 months and 11-13 months of discharge from hospital as well as non-Covid, age, gender, BMI and ethnicity matched volunteers. | 5-7 months post hospital discharge for patients | |
Primary | Whole body glucose disposal - resting energy expenditure | Indirect calorimetry will be used to measure resting energy expenditure for whole body glucose disposal in patients with severe Covid-19 at 5-7 months and 11-13 months of discharge from hospital as well as non-Covid, age, gender, BMI and ethnicity matched volunteers. | 5-7 months post hospital discharge for patients | |
Primary | Motor unit size | Intramuscular electromyography will be used to measure motor unit size in the vastus lateralis in patients with severe Covid-19 at 5-7 months and 11-13 months of discharge from hospital as well as non-Covid, age, gender, BMI and ethnicity matched volunteers. | 5-7 months post hospital discharge for patients | |
Secondary | Clinical and demographic data | age, ethnicity, covid related hospital stay (for patients), covid related interventions (for patients), comorbidities, medications list | 5-7 months post hospital discharge for patients | |
Secondary | muscle strength and function | quadriceps maximum voluntary contraction using cybex dynamometer | 5-7 months post hospital discharge for patients | |
Secondary | hand grip strength | hand grip strength using a hand grip dynamometer will be measured | 5-7 months post hospital discharge for patients | |
Secondary | Short Physical performance battery test (SPPB) | SPPB will be used to assess gait speed, balance and ability to sit up from a chair. Scores within the domains will add up to 4 with 0 being the minimum score | 5-7 months post hospital discharge for patients | |
Secondary | Physical activity | Measuring step count using Sensewear activity arm band | 5-7 months post hospital discharge for patients | |
Secondary | questionnaires for quality of life and symptoms | Fatigue severity score - min score 7 max score 63 | 5-7 months post hospital discharge for patients | |
Secondary | questionnaires for quality of life and symptoms | Quality of life as judged by SF-36 - min score 0 max score 100 | 5-7 months post hospital discharge for patients | |
Secondary | questionnaires for quality of life and symptoms | Dyspnoea-12 - min score 0 max score 36 | 5-7 months post hospital discharge for patients | |
Secondary | questionnaires for quality of life and symptoms | Nottingham activities of daily living - min score 0 max score 22 | 5-7 months post hospital discharge for patients | |
Secondary | questionnaires for quality of life and symptoms | Mental health assessed by personal health questionnaire - min score 0 max score 27 | 5-7 months post hospital discharge for patients | |
Secondary | questionnaires for quality of life and symptoms | MoCA cognition level - min score 0 max score 30 | 5-7 months post hospital discharge for patients | |
Secondary | questionnaires for quality of life and symptoms | Frailty as judged by Rockwood CFS - min score 1 max score 9 | 5-7 months post hospital discharge for patients | |
Secondary | blood biomarkers for cardiac function | concentration of troponin | 5-7 months post hospital discharge for patients | |
Secondary | blood biomarkers for cardiac function | concentration of brain natriuretic peptide | 5-7 months post hospital discharge for patients | |
Secondary | blood biomarkers for renal function | calculated glomerular filtration rate | 5-7 months post hospital discharge for patients | |
Secondary | blood biomarkers for liver function | concentration of alanine transaminase | 5-7 months post hospital discharge for patients | |
Secondary | blood biomarkers for skeletal muscle function | concentration of creatine kinase | 5-7 months post hospital discharge for patients | |
Secondary | blood biomarkers for inflammation | concentration of cytokines such as TNF alpha, IL-6 and C-reactive peptide | 5-7 months post hospital discharge for patients | |
Secondary | blood biomarkers for diabetes | Measurement of HbA1c | 5-7 months post hospital discharge for patients |
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