Therefore, 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…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A) Lung damage assessed by CT scans at approximately t = 3-6 months and t =
12-18 months after SARS-COV2 infection and the association of this damage with
biomarkers and the exposome.
B) Difference in EQ-5D Index Score between intervention and control groups at t
= 12 months after SARS-COV2 infection.
Secondary outcome
- Change in CT scan assessed lung damage between t = 3-6 months and t = 12-18
months.
- The development of symptoms fulfilling the International Consensus Criteria
(ICC) for ME/CSF diagnosis.
- Quality of life measure by EuroQol-5D.
- Fatigue measured by Checklist individual strength (CIS).
- Body height and weight to calculate the body mass index (BMI).
- Body composition by bioelectrical impedance analysis (BIA).
- Dietary intake by a 24h food diary
- Physical activity by accelerometry
- Motivational profiling questionnaire (self-determination theory questionnaire
(SDT))
- Psychosocial functioning questionnaire (HADS)
- (Change in) exhaled breath profile assessed by eNose and GC-MS
- Lung function assessed by spirometry, diffusion capacity, maximal inspiratory
pressure (MIP) and maximal expiratory pressure (MEP)
- (Change in) transcriptome, genome, epigenome, metabolome and microbiome.
Background summary
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.
Study objective
Therefore, 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 CT analyses, multi-omics analysis, exposome
measurements, and an intervention.
Study design
Multi-centre prospective observational study including a nested intervention
study.
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 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).
Study burden and risks
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 CT scans, by performing
extra analyses on biological samples (urine, blood, faeces, nose swab, 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 will be combined with already
scheduled regular care outpatient visits.
Meibergdreef 9
Amsterdam-Zuidoost 1105 AZ
NL
Meibergdreef 9
Amsterdam-Zuidoost 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
for Patients:
-Age: 40-65 years
-Proven ex-COVID-19: Hospitalised: Positive PCR / serology for SARS-CoV2 or
CORADS score 4/5, Non-hospitalised: Positive PCR / serology for SARS-CoV2.
-Able to provide informed consent
-Access to internet (either at home or via relatives/friends).
-Understanding of Dutch language
for healthy volunteers:
- age 18-65
- For the recovered healthy volunteers: proven ex-COVID-19: with a positive PCR
/ serology for SARS-CoV2Able to provide informed consent
- Understanding of Dutch language
Exclusion criteria
-Inability to provide informed consent
-History or suspicion of inability to cooperate adequately
-Participation in any other study involving investigational or marketed
products concomitantly or within four weeks prior to entry into the study or
during the study;
-Investigator*s uncertainty about the willingness or ability of the patient to
comply with the protocol requirements
-Patients with terminal illness;
Design
Recruitment
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL74701.018.20 |
| OMON | NL-OMON28553 |