Clinical and Haematological Phenotypes in Long COVID

NCT04659889 | Completed

• 1 other identifier: LCV
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Long Covid; Covid19

Outcome Measures

Primary Outcomes (1)

• Observation of frequency of abnormal haematological parameters and association with long-Covid clinical phenotypes versus controls.

  6 months

Study Arms (2)

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

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

Diagnostic Test: Blood sampling (venesection)

Interventions

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.

Patients with clinical features of Long Covid; Patients with no symptoms of Long Covid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• HCA International Limited: lead

Study Sites (1)

The Physicians' Clinic

London, W1G 7AE, United Kingdom

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19

Interventions

Blood Specimen Collection; Phlebotomy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Therapeutics

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Physician

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 9, 2020
• Study Start: December 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)