COVID-19 (SARS-CoV-2 infection) Infections and Infestations
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 99 years old 2. Evidence of SARS-CoV-2 infection confirmed by PCR or serology 3 months (+/- 6 weeks) earlier 3. Clinical indication for a chest CT scan as per clinician judgment 4. Participants who have been identified and consented for the main PHOS-PCOVID study are also eligible to join this study 5. Allow inclusion of patients who are receiving up to 10 mg of prednisolone a day
Exclusion criteria
Exclusion criteria: 1. Life-limiting illness within 12 months 2. Significant pre-existing lung disease prior to March 2020, which in the investigator’s judgement could make the chest CT scans difficult to interpret
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Lung function decline =10% OR worsening extent of ILD on CT scan using image analysis or MDT discussion at 3 and 12 months (+/- 3 months) after acute infection 2. Resolution of ILD: any of the following: =10% relative improvement in FVC, DLco, or reduction of radiological extent at 12 months (+/- 3 months) post SARS-CoV-2 3. Persistence of ILD in those not meeting the definition of progression or resolution at 12 months (+/- 3 months) post SARS-CoV-2 4. Persistence of ILAs measured using Computerised Tomography at 12 months (+/- 3 months) post SARS-CoV-2 5. Markers of severity of acute infection (e.g. CRP) measured using initial clinical assessment at 12 months (+/- 3 months) post SARS-CoV-2 6. Medical therapy used for acute infection measured using clinical records at 12 months (+/- 3 months) post SARS-CoV-2 7. Breathlessness measured using the Medical Research Council dyspnoea scale, Dyspnoea 12 at 3 months, 6 months (+/- 6 weeks) and 12 months (+/- 3 months) post SARS-CoV-2 infection 8. Fatigue measured using FACIT-F at 3 months, 6 months (+/- 6 weeks) and 12 months (+/- 3 months) post SARS-CoV-2 infection 9. Cognition measured using the Montreal Cognition Assessment (MOCA) at 3 months, 6 months (+/- 6 weeks) and 12 months (+/- 3 months) post SARS-CoV-2 infection 10. Quality of life measured using Short Form-36 (SF-36), EQ5D-5L at 3 months, 6 months (+/- 6 weeks) and 12 months (+/- 3 months) post SARS-CoV-2 infection 11. Impact of COVID19 on aerobic capacity and endurance measured using the incremental shuttle walk test or cardiopulmonary exercise test, if clinically indicated, at 3 months, 6 months (+/- 6 weeks) and 12 months (+/- 3 months) post SARS-CoV-2 infection Exploratory: 1. Exploratory circulating biomarkers measured using whole blood RNA sequencing (including peripheral blood mononuclear cells) and analysis of epigenetic modifications and proteomics at 3 months, 6 months (+/- 6 weeks) and 12 months (+/- 3 months) post SARS-CoV-2 infection 2. Se | — |
Primary
| Measure | Time frame |
|---|---|
| Multi-disciplinary team (MDT) confirmed diagnosis of ILD at 12 months (+/- 3 months) after acute infection | — |
Countries
United Kingdom