Mechanisms Underlying Long-term Fatigue and Exercise Intolerance Following COVID-19

NCT04914754 | Completed

• 1 other identifier: 137711
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The MEXICO study is an observational study that aims to identify underlying mechanisms contributing to exercise intolerance in the presence of persistent COVID-19 symptoms (Long COVID).

Conditions

COVID-19

Keywords

Long COVID; Exercise intolerance; Quality of Life; Coronavirus

Outcome Measures

Primary Outcomes (5)

• Pulmonary function (spirometry)

  Pulmonary function (ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) (FEV1/FVC)), measured using spirometry, is a co-primary outcome. Compare pulmonary function between long COVID patients with and without severe exercise impairment.

  Baseline

• Cardiac function (echocardiography)

  Cardiac function (ejection fraction), measured by echocardiography, is a co-primary outcome. Characterise and compare cardiac function between long COVID patients with and without severe exercise impairment.

  Baseline

• Microvascular function (microvascular reactivity)

  Microvascular reactivity, measured by near-infrared Spectroscopy (NIRS), is a co-primary outcome. Characterise and compare microvascular function between long COVID patients with and without severe exercise impairment.

  Baseline

• Macrovascular function (central BP)

  Central blood pressure, measured by pulse wave analysis, is a co-primary outcome. Characterise and compare macrovascular function between long COVID patients with and without severe exercise impairment.

  Baseline

• Skeletal muscle oxidative capacity

  Skeletal muscle oxidative capacity (assessed as the rate of oxygen consumption recovery post-exercise), measured using NIRS, is a co-primary outcome. Characterise and compare skeletal muscle oxidative capacity between long COVID patients with and without severe exercise impairment.

  Baseline

Secondary Outcomes (1)

• Change in cardiorespiratory fitness (VO2max)

  Baseline and 9 months

Study Arms (3)

Long COVID with mild exercise impairment

Patients with prior serological or clinical diagnosis of CoV-2 infection and a referred to the UCLH Long-COVID clinic for persistent fatigue or exercise intolerance.

Healthy Control

Healthy sex-matched and age-matched to within 5 years of Long Covid participants were recruited from UCL staff and students.

Long COVID with severe exercise impairment

Patients with prior serological or clinical diagnosis of CoV-2 infection and a referred to the UCLH Long-COVID clinic for persistent fatigue or exercise intolerance and an abnormal walk test criteria included: peripheral oxygen desaturation, \<85% predicted walk distance, a lactate rise\> 1.0 from baseline or a Borg score \> 5 for breathlessness or fatigue at end of test.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population (n=51) are either patients with symptoms of Long COVID who have been referred for clinical investigation (with or without severe exercise impairment) or healthy controls.

You may qualify if:

• Serological or clinical diagnosis of CoV-2 infection
• Ability to provide written informed consent.

You may not qualify if:

• \< 18 years old.
• Considered a vulnerable adult
• Participant unwilling to consent
• Terminal illness or severe comorbidities affecting attendance or study investigations
• Pregnancy
• If the participant is not willing to give their consent for a clinical advisor to contact them if necessary
• Inability or presence of a contra-indication for exercise testing
• Chronic oral corticosteroid use (e.g. any maintenance dose of oral steroid, 4 or more course of oral steroid in previous 12 months, but not including prescription of dexamethasone during the acute episode of COVID-19, as long as that has been discontinued).

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London

London, WC1E6HX, United Kingdom

Location

Related Publications (3)

• Jones S, Tillin T, Williams S, Eastwood SV, Hughes AD, Chaturvedi N. Type 2 diabetes does not account for ethnic differences in exercise capacity or skeletal muscle function in older adults. Diabetologia. 2020 Mar;63(3):624-635. doi: 10.1007/s00125-019-05055-w. Epub 2019 Dec 9.

  PMID: 31820039 BACKGROUND

• Jones PW, Beeh KM, Chapman KR, Decramer M, Mahler DA, Wedzicha JA. Minimal clinically important differences in pharmacological trials. Am J Respir Crit Care Med. 2014 Feb 1;189(3):250-5. doi: 10.1164/rccm.201310-1863PP.

  PMID: 24383418 BACKGROUND

• Casaburi R. Factors determining constant work rate exercise tolerance in COPD and their role in dictating the minimal clinically important difference in response to interventions. COPD. 2005 Mar;2(1):131-6. doi: 10.1081/copd-200050576.

  PMID: 17136973 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, plasma and serum.

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Professor Hughes

  UCL, University College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: June 7, 2021
• Study Start: May 7, 2021
• Primary Completion: June 20, 2022
• Study Completion: January 17, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Locations

GB (1)