The primary aim of this study is to determine types and prevalence of residual pulmonary damage after hospital admission for acute COVID-19. In particular, we aim at determining the prevalence of clinically *silent* pulmonary perfusion abnormalities…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Pulmonary vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of the study is to determine types and prevalence of
residual pulmonary damage after hospital admission for acute COVID-19 at 3 and
12 months follow-up.
Secondary outcome
1. To determine clinical and imaging parameters in the acute phase of COVID-19
that may predict lung damage (including pulmonary perfusion abnormalities) at 3
and 12 month follow-up
2. To determine which types of damage remain after 1 year
3. To correlate the amount and type of pulmonary damage with the clinical
parameters 3 and 12 month follow-up
4. To determine the value of d-dimer levels and YEARS criteria at 3 months for
prediction of pulmonary perfusion abnormalities
Background summary
The rapid spread of the novel *severe acute respiratory syndrome coronavirus
2* (SARS-CoV-2), has led to an ongoing pandemic of coronavirus disease 2019
(COVID-19). In the Netherlands, patients were mainly admitted to hospitals
because of moderate to severe symptoms of the disease, usually due to
substantial pulmonary involvement. The first wave of acute COVID-19 has passed
but patients who were admitted to hospitals, and especially those admitted to
an intensive care unit, may show a prolonged period of convalescence with
mounting evidence of potentially permanent lung damage (**). Such damage has
been reported to be scarring and fibrosis, but sequelae of pulmonary thrombotic
or thromboembolic events may also be present. Little is known about the
prevalence and extent of such long-term lung damage in formerly hospitalized
patients with known lung involvement during their acute phase. There is also a
need for understanding factors that contribute to chronic damage and identify
targets for prevention or treatment of long-term debilitating disease.
Study objective
The primary aim of this study is to determine types and prevalence of residual
pulmonary damage after hospital admission for acute COVID-19. In particular, we
aim at determining the prevalence of clinically *silent* pulmonary perfusion
abnormalities and establish the connection between current complaints and lung
damage as well as the relation between clinical factors during hospitalization
and residual lung damage. The ultimate goal is to find predictors, modifiable
by treatment during or after the hospital stay, that effect long-term outcome
positively. With this study we aim at better understanding of the chronic phase
of the disease and of how adverse outcomes might be prevented.
Study design
Prospective cohort study of patients suffering of COVID-19.
Study burden and risks
The patient will not benefit directly from participation to the study unless a
treatable abnormality is diagnosed. We expect benefits at a group level for new
patients should potential interventions emerge as a result of this study. CT
angiography holds a very low risk of allergic events due iodinated contrast.
The radiation exposure is such that EU dose reference levels for chest CT
(indicated in the vast majority of this group) are met.
Nijmeegsebaan 31
Groesbeek 6561 KE
NL
Nijmeegsebaan 31
Groesbeek 6561 KE
NL
Listed location countries
Age
Inclusion criteria
1. Patients eligible for post-COVID-19 care program
2. Written informed consent from patient or legal representative
3. CT during admission with CO-RADS ><= 3 or Laboratory confirmed (PRC of
serologic) diagnosis of COVID-19
Exclusion criteria
1. Age <18 years
2. Pregnancy
3. Subjects with a history of allergy or intolerance to iodinated intravenous
contrast media
4. Subjects with pre-existent severe renal impairment (creatinine clearance
less than 30 mL/min/1.73m^2)
5. Subjects using therapeutic anticoagulation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74223.091.20 |