Long CovidNCT04659889
Clinical and Haematological Phenotypes in Long COVID
An observational study of Long Covid and Covid19, run by HCA International Limited at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long Covid, Covid19
- What is being tested?
- Blood sampling (venesection)
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2020to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The first group will be patients post documented SARS-CoV-2 infection displaying symptoms of long Covid and the second group will be patients who are asymptomatic post documented SARS-CoV-2 infection
Who may be able to join
- Patients post documented SARS-CoV-2 infection displaying symptoms of long Covid
- Asymptomatic post documented SARS-CoV-2 infection
- All patients will be aged 18 or over
Who cannot join
- Patients below the age of 18
- Patients who have not previously had COVID-19
- Any adult deemed to trigger consideration of being a Vulnerable Adult.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Relationship Between Clinical and Haematological Phenotypes in Long COVID
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.
Read more
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.
Read the detailed 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.
- Conditions
- Long Covid, Covid19
- Being tested
- Blood sampling (venesection)
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling (venesection)Diagnostic test
All study participants will have a single blood test to analyse the following parameters:
(i) Serum biochemistry, CRP, Thyroid function and liver enzymes (ii) FBC, d-Dimer, ESR, Blood film (iii) SARS-CoV2 antibody status and serum save (iv) Peripheral blood immunophenotyping.
| Study group | Role | What they receive |
|---|---|---|
| Patients with clinical features of Long Covid | Patients who have had COVID-19 (PCR proven and/or clinical features of COVID-19) who are currently displaying symptoms of long Covid Receives: Diagnostic Test: Blood sampling (venesection) | |
| Patients with no symptoms of Long Covid | Patients who have had COVID-19 (PCR proven and/or clinical features of COVID-19) who are not displaying symptoms of long Covid Receives: Diagnostic Test: Blood sampling (venesection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observation of frequency of abnormal haematological parameters and association with long-Covid clinical phenotypes versus controls.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start1 Dec 2020
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long CovidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- HCA International Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Paul Glynne, HCA International Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659889
- Sponsor's protocol ID
- LCV
- Status last verified
- Aug 2021
- First submitted
- 7 Dec 2020
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Relationship Between Clinical and Haematological Phenotypes in Long COVID
- ClinicalTrials.gov ID
- NCT04659889
- Acronym / sponsor ID
- LCV
- Conditions
- Long Covid, Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- HCA International LimitedUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with clinical features of Long Covid | – | Diagnostic Test: Blood sampling (venesection)Patients who have had COVID-19 (PCR proven and/or clinical features of COVID-19) who are currently displaying symptoms of long Covid |
| Patients with no symptoms of Long Covid | – | Diagnostic Test: Blood sampling (venesection)Patients who have had COVID-19 (PCR proven and/or clinical features of COVID-19) who are not displaying symptoms of long Covid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The first group will be patients post documented SARS-CoV-2 infection displaying symptoms of long Covid and the second group will be patients who are asymptomatic post documented SARS-CoV-2 infection
Key inclusion criteria (3 listed)
- Patients post documented SARS-CoV-2 infection displaying symptoms of long Covid
- Asymptomatic post documented SARS-CoV-2 infection
- All patients will be aged 18 or over
Key exclusion criteria (3 listed)
- Patients below the age of 18
- Patients who have not previously had COVID-19
- Any adult deemed to trigger consideration of being a Vulnerable Adult.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling (venesection)All study participants will have a single blood test to analyse the following parameters: (i) Serum biochemistry, CRP, Thyroid function and liver enzymes (ii) FBC, d-Dimer, ESR, Blood film (iii) SARS-CoV2 antibody status and serum save (iv) Peripheral blood immunophenotyping. | Diagnostic test | Patients with clinical features of Long Covid, Patients with no symptoms of Long Covid |
Primary outcome
Observation of frequency of abnormal haematological parameters and association with long-Covid clinical phenotypes versus controls.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long Covid and Covid19, run by HCA International Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observation of frequency of abnormal haematological parameters and association with long-Covid clinical phenotypes versus controls. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.