Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04659889 |
| Other study ID # |
LCV |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2020 |
| Est. completion date |
June 1, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
HCA International Limited |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Analysis of the relationship between clinical characteristics and haematological parameters
in long COVID.
The novel coronavirus (Covid19) pandemic declared by the World Health Organisation in March
2020 has had an enormous huge impact upon health, health systems and society. Early research
has focused on the acute illness caused by the virus. It is now clear that significant
numbers of patients infected with Covid19 continue to suffer with multiple, often severe,
unexplained symptoms for months after initial infection, so-called long-Covid.
Long-Covid symptoms are typically multi-system in their presentation comprising
constitutional changes (e.g. fever and fatigue), neuropsychiatric disturbance (e.g. anxiety,
insomnia and brain fog), neurosensory symptoms (e.g. headaches and pins and needles),
cardiorespiratory effects (e.g. breathlessness and chest pain), gastrointestinal dysfunction
(e.g. diarrhoea and food intolerances) and dermatological changes (e.g. rashes and vascular
changes).
The objectives of this observational, cross-sectional, case-control study are to describe
long-Covid clinical phenotypes and to explore whether clinical symptom presentations
correlate with haematological and other inflammatory blood abnormalities that might shed
insight into underlying pathogenic mechanisms.
The study will require the participation of long-Covid patients, seen in an outpatient
setting at The Physicians' Clinic, and will correlate clinical symptom phenotypes with
laboratory parameters we believe might be relevant to long-Covid. Recruitment of asymptomatic
patients, who have recovered from Covid19 infection, will provide a control patient group.
Eligible patients will be sent a patient information sheet, describing the study objectives
and protocol, inviting them to participate in the study and seeking consent for their
participation, which will require analysis of their [anonymised] clinical and laboratory
data. Clinical information will be retrieved from patient case records and patients will be
asked to complete a symptom questionnaire. All patients will require one blood sample to be
taken which will typically form part of their clinical care. Recruitment will occur over a 6
month period.
Description:
There are estimated to be tens of thousands of long-Covid patients in the UK, and the number
is set to grow as the pandemic continues. Little is known about the cause of long-Covid
clinical syndromes and there are no evidence-based treatments available to patients. There is
therefore an urgent need to undertake research into long-Covid.
Long-Covid referral to our general medical outpatient clinics has been growing, as these
patients typically present with multiple symptoms that require a holistic approach to patient
care. Patients are often distressed and disabled by their symptoms, exacerbated by the lack
of any detailed understanding about their condition, and the absence of specific treatment
strategies. Anecdotal reports of ongoing inflammation in long-Covid, not typically measurable
in routine blood tests, have prompted interest in exploring the nature of this inflammation
further. In addition, some long-Covid patients have reported clinical improvement following
empiric treatment with anti-inflammatory medications including anti-histamines and
corticosteroids. These clinical observations, and the enthusiasm expressed by the long-Covid
patient community for further research to be conducted, have been the key drivers for this
study. Patients attending our clinics have all without exception expressed their interest in
participating in this work.
This small sample size study sets out to explore whether there are identifiable abnormalities
in the blood cells of long-Covid patients that might correlate with patients' clinical
presentations which may in turn trigger further avenues of investigation.
The study participants are all patients with a history of Covid19 infection and who either
have ongoing symptoms or who have fully recovered. The clinical information is available in
case records as part clinical care and patients' blood samples are sent for analysis as part
of ongoing clinical care. Patients are informed about their blood test results as part of
ongoing clinic care. All patients are provided with information about the study and asked to
consent to their anonymised clinical and laboratory data being used as part of this
observational study. We also seek consent to save serum for additional blood analysis
depending on the results of the initial study. No genetic investigations will be conducted.
This study does not involve any treatment intervention, and there is no risk of harm to
patients. The use of person-identifiable information will be restricted to an absolute
minimum, and all data will be anonymised for purposes of our study analysis. The members of
the research team all work within one organisation adhering to GDPR standards, and all email
communication remains within that organisation and is password-protected. No conflicts of
interest have been identified. We have undertaken to share individual results with
participating patients by the end of the study.
