Therapies for Long COVID

Not Applicable

Completed

• Conditions: COVID-19 (SARS-CoV-2 infection); Infections and Infestations

• Registration Number: ISRCTN15674970
• Lead Sponsor: niversity of Birmingham

Brief Summary

2022 Interim results article in https://pubmed.ncbi.nlm.nih.gov/35879616/ Symptoms and risk factors for long COVID (added 01/08/2022) 2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35473737/ (added 01/08/2022)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-24
• Study Completion: 2023-03-01
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 3040

Inclusion Criteria

Non-hospitalised individuals aged 18 years and older with a positive RT-PCR test for SARS-CoV-2 in CPRD Aurum (minimum 2000 participants)

Propensity score-matched individuals without a diagnosis of COVID-19 (suspected or confirmed) in CPRD Aurum and without a positive SARS CoV-2 RT-PCR result and without a record of hospital admission within 28 days of the index date (minimum 500 participants)

Exclusion Criteria

Aged under 18 years or hospitalised for COVID-19:
1. Individuals without a positive SARS CoV-2 RT-PCR test result in CPRD Aurum
2. Individuals with a hospital admission within 28 days of a positive SARS CoV-2 RT-PCR result in CPRD Aurum
3. Individuals aged under 18 years
4. Individuals unable/unwilling to provide informed consent
5. Individuals unable/unwilling to undertake the protocol activities
6. Individuals deemed appropriate for exclusion by their GP (e.g., on a palliative care register)

Matched controls - Group 1 (minimum of 500 participants):
1. Individuals with a diagnosis of COVID-19 in CPRD Aurum or positive SARS CoV-2 RT-PCR result in SGSS or GP record
2. Individuals coded in their primary care record as having suspected COVID-19
3. Individuals aged under 18 years
4. Individuals unable or unwilling to provide informed consent
5. Individuals unable or unwilling to undertake the protocol activities
6. Individuals deemed appropriate for exclusion by their GP (e.g., on a palliative care register)

Matched controls - Group 2 (50 participants):
1. Participants unable/unwilling to provide informed consent
2. Participants unable/unwilling to undertake the protocol activities
3. Participants deemed appropriate for exclusion by their GP (e.g., on palliative care register)

Bio-sampling and wearables (BioWear) cohort (200 Long COVID participants, 50 participants from Control Group 1 and 50 participants from Control Group 2):
1. Participants who have not previously consented to be contacted for bio-sampling/use of wearables
2. Participants unable/unwilling to provide informed consent
3. Participants unable/unwilling to undertake the protocol activities

Co-production workshops:
1. Individuals unable/unwilling to provide informed consent
2. Individuals unable/unwilling to attend a co-production workshop

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptoms measured using the Symptom Burden Questionnaire for Long COVID TM at baseline and monthly for 12 months

Secondary Outcome Measures

Name	Time	Method
1. Fatigue measured using The Functional Assessment of Chronic Illness Therapy – Fatigue Scale (FACIT-Fatigue) at baseline and monthly for 12 months<br>2. Breathlessness measured using the modified MRC Dyspnoea Scale at baseline and monthly for 12 months<br>3. Recovery from COVID-19 measured using the COVID-19 core outcome measure for recovery at baseline and monthly for 12 months<br>4. Mood and mental health measured using PHQ-2, GAD-2 and PCL-2 at baseline and monthly for 12 months<br>5. Quality of life measured using EQ-5D at baseline and monthly for 12 months<br>6. Mortality assessed using linked Office for National Statistics mortality records at 12 months<br>7. Hospital admissions assessed using linked Hospital Episode Statistics Admitted Patient Care data at 12 months