Precision Medicine for more Oxygen - COVID-19 extension

Rationale:
According to the World Health Organization, lung diseases are among the deadliest diseases worldwide and lead to extremely debilitating symptoms and loss of quality of life and productivity. The recent outbreak of COVID-19 introduces many questions, one of them being the long-term effects of the disease. It is now suggested that COVID-19 survivors might be at higher risk for developing long-term reversible or perhaps irreversible lung damage.

Objective:
The Precision Medicine for more Oxygen (P4O2) program aims to identify treatable traits and innovative personalized therapeutic strategies to both prevent progression of early stage lung damage and to reverse established lung damage by stimulating repair in order to reduce burden of disease and to increase quality of life. This is the COVID extension of the original P4O2 project. The aim is to understand which patients will develop chronic lung disease following infection with SARS-COV2 and to find phenotypes. Therefore, there will be state of the art chest CT analyses, multi-omics analysis, exposome measurements, and a personalized intervention.

Study design:
Multi-centre prospective observational study including a nested intervention study.

Study population:
100 positive or highly suspected ex-COVID-19 patients, 40-65 years old. Patients will be recruited from post-COVID-19 outpatient clinics.

Intervention:
The efficacy of a personalized counselling intervention will be investigated in a nested study. Half of the patients will receive a personalized counselling intervention based on dietary quality and physical activity, which will consist of individual, group and educational sessions. Furthermore, this group will voluntary be provided with additional tailored nutritional support. The other half of the group will serve as control group and will not receive personalized counselling or nutritional support. However, this group might participate in the educational sessions (voluntary).

Main study parameters/endpoints:
A) Lung damage assessed by chest CT scans at approximately t = 3 months and t = 12 months after SARS-COV2 infection and the association of this damage with clinical parameters, biomarkers, and the exposome.
B) Difference in EQ-5D Index Score between intervention and control groups at t = 12 months after SARS-COV2 infection.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Patients will benefit from participation since they receive additional attention for their situation. This study adds to the general clinical follow-up by performing additional analyses on the chest CT scans, by performing extra analyses on biological samples (urine, blood, faeces, nosebrush, breath), and by performing analyses of their exposure to environmental factors that might influence their recovery. They also use a Garmin watch to track physical activity, which might directly help them to improve their lifestyle. All patients will be invited to participate in the educational sessions (also the control group), in which they will receive suggestions to improve their general health. Risk and inconveniences are limited to the time investment associated with the measurements. The measurements will therefore be performed at the same day of the 2 out-patient clinical visits and will approximately take 90 minutes per visit. The measurements include various non-invasive measurements, as well as minor invasive blood sampling (48 ml) and nose brush, as well as an additional CT scan for part of the group. Study visits will be combined with already scheduled regular care outpatient visits.

A. Pulmonary and extra-pulmonary damage assessed by imaging techniques at t = 3 months and t = 12 months after SARS-COV2 infection can be associated with clinical parameters, biomarkers, and the exposome.
B. Personalized counselling intervention on quality of dietary intake and level of physical activity can improve general health and decrease complaints and signs of disease after SARS-COV2 infection (both pulmonary and extrapulmonary).

Visit 1: 3 months post discharge after COVID-19 hospitalisation
Visit 2: 9 months after visit 1.

The efficacy of a personalized counselling intervention will be investigated in a nested study. Half of the patients will receive a personalized counselling intervention based on dietary quality and physical activity, which will consist of individual, group and educational sessions. Furthermore, this group will voluntary be provided with additional tailored nutritional support. The other half of the group will serve as control group and will not receive personalized counselling or nutritional support. However, this group might participate in the educational sessions (voluntary).