Investigating the long-term effects of COVID-19 on multiple organs
Assessing the Effects of Coronavirus Disease (COVID-19) on Multiple Organ Systems and Impact on Quality of Life, Functional Capacity and Mental Health
This study is trying to see how COVID-19 affects different organs in people who have recovered from the virus and how these effects impact their quality of life over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 750 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Oxford Academic / other |
| Locations | 1 site (Oxford) |
| Trial ID | NCT04510025 on ClinicalTrials.gov |
What this trial studies
The C-MORE study is a prospective observational study that aims to characterize the prevalence of multi-organ injury among COVID-19 survivors after hospital discharge. It will utilize advanced magnetic resonance imaging (MRI) technology to assess the lungs, heart, brain, liver, and kidneys of 616 patients at 3, 6, and 12 months following the onset of COVID-19 symptoms. Additionally, the study will evaluate the impact of these injuries on quality of life, exercise tolerance, and mental health. By examining the relationship between persistent multi-organ damage and various factors, the study seeks to provide a comprehensive understanding of the long-term consequences of COVID-19.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have had a moderate to severe COVID-19 infection confirmed by RT-PCR.
Not a fit: Patients with contraindications to MRI or significant diseases that could affect their ability to participate may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management and rehabilitation strategies for COVID-19 survivors experiencing multi-organ complications.
How similar studies have performed: Other studies have indicated the potential for multi-organ effects in COVID-19 patients, but this specific approach using longitudinal MRI assessments is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the study. * Male or Female, aged 18 years or above. * Diagnosis of COVID-19 infection confirmed by detection of viral nucleic acid on reverse-transcription Polymerase Chain Reaction (RT-PCR). * Infection should be of moderate to severe intensity (i.e, patients with clinical signs of pneumonia such as respiratory rate \> 30 breaths/min; or severe respiratory distress; or SpO2 \< 90% (on room air) and admission for \>48 hours. * Controls: Participants with no serological evidence of previous infection, or active/previous symptoms suggestive of COVID-19, and who may or may not have comorbidities. Exclusion Criteria: * Contraindication to MRI e.g. pregnancy, pacemaker, ferromagnetic implant, shrapnel injury, severe claustrophobia, inability to lie flat. * Any other significant disease or disorder which, in the opinion of the investigator, might influence the participant's ability to participate in the study. * Any signs of active COVID-19 infection on day of visit. * Significantly impaired renal function (eGFR\<30 ml/min)
Where this trial is running
Oxford
- University of Oxford — Oxford, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Betty Raman, MBBS, DPhil, FRACP
- Email: betty.raman@cardiov.ox.ac.uk
- Phone: 01865234580
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.