Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05652634 |
| Other study ID # |
KLI 1100-B |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 9, 2023 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Medical University of Graz |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The disease caused by the pathogen SARS-CoV-2 is known as coronavirus disease with the
acronym COVID-19. The acute phase of this condition typically lasts one to two weeks and
usually results in a full recovery. However, in about 10-30% of those affected, the symptoms
persist for more than four weeks after the onset of the disease. In this case, there is an
ongoing COVID-19 illness known as long COVID. Long COVID can persist for many months and
cause significant distress and limitations to those affected due to the long-term health
consequences.
The causes of long COVID are still unclear and, accordingly, therapeutic measures are still
insufficiently developed. It is assumed that long COVID can in principle affect anyone. Age,
gender, obesity and the number of symptoms during an acute COVID-19 illness are discussed as
risk factors for long COVID. Another potential risk factor for developing long COVID could be
chronic stress, which has been shown to put a strain on the immune system. It is known from
infections with other coronaviruses and other viral respiratory diseases that chronic stress
can lead to prolonged illness and limited recovery. The aim of this study is to
systematically examine chronic stress, as it existed before infection with the coronavirus,
as a possible risk factor for long COVID.
For this purpose, 600 people who have been proven to be infected with SARS-CoV-2 and have
developed symptoms of COVID-19 will be included in this study.
Description:
Wider research context / theoretical framework: The pathophysiology leading to symptom
persistence after acute COVID-19, defining long COVID, is widely unknown. Chronic stress may
be a risk factor for long COVID as it can impair immune regulation and induce exaggerated
inflammatory responses. It is known to negatively influence upper respiratory infections and
was found to be associated with long-term symptoms following other coronavirus infections
(SARS). In addition, chronic stress is an established risk factor for unspecific functional
symptoms and mental health impairment. Data on these issues are scanty, however much-needed
for developing proper interventions.
Hypotheses/research questions/objectives: The primary aim of the study is to analyze the
influence of chronic stress on symptom persistence in COVID-19. The study team hypothesizes
that elevated levels of pre-existing self-reported chronic stress measured at the beginning
of infection predict a higher proportion of patients with symptom persistence at one month
after testing positive for SARS-CoV-2 infection (primary outcome). Secondary aims are to
investigate the influence of chronic stress on medium- to long-term mental health outcome. In
addition, the researchers longitudinally investigate chronic stress, stress-related
biomarkers and allostatic load in patients with symptom persistence as compared to recovered
patients.
Approach/methods: This is a longitudinal prospective observational study designed according
to STROBE guidelines in persons newly tested positive for SARS-CoV-2 infection by qPCR with
symptoms of acute COVID-19. Monitoring of COVID-19-related symptoms and symptom persistence
is conducted online, by phone and in outpatient clinic visits. Pre-existing chronic stress is
investigated by questionnaires on perceived stress and negative life events and by analysis
of hair cortisol concentrations prior to infection. Collection of blood allows measurement of
SARS-CoV-2 antibodies, stress-related biomarkers and the calculation of allostatic load.
Baseline and longitudinal data collection encompasses comorbidities, regular medication,
screening for anxiety, depression, acute stress symptoms, and cognitive function.
Level of originality/innovation: This is the first study prospectively investigating chronic
stress as a risk factor for long COVID and associated mental health impairment by a
multimodal approach. In addition, the researchers probe for stress-related biomarkers
associated with symptom persistence and also investigate the impact of protective factors,
such as resilience, psychosomatic competence and social support, on symptom persistence. Two
novel bio-psycho-social assessment tools contribute to the results of this study. Results of
this project will lead to innovative preventive and treatment interventions targeting symptom
persistence and mental health sequelae after acute COVID-19.
Primary researchers: Christian Fazekas (PI), Nandu Goswami, Barbara Hanfstingl, Voyko Kavcic.
