Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000524897
Ethics application status
Approved
Date submitted
28/04/2021
Date registered
4/05/2021
Date last updated
4/08/2022
Date data sharing statement initially provided
4/05/2021
Date results information initially provided
4/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Long-term health impacts of COVID-19 on confirmed cases: Long-COVID Study
Scientific title
The long-term impacts of COVID-19 on confirmed cases in Wellington, New Zealand: An observational, cross-sectional study
Secondary ID [1] 304078 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long COVID-19 321740 0
Condition category
Condition code
Infection 319480 319480 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will be adults aged 18 and over with a laboratory diagnosis of COVID-19 notified to Regional Public Health in the preceding 12-18 months.
Participants will undertake 8 online questionnaires sent via email about physical and mental health (approx 20-25 minutes). They will also be requested to provide a blood sample at their local blood collection centre. Optional consent will be sought to store a single blood sample for future unspecified use for up to 24 months after study completion. Several blood samples will be taken for the main study which will be analysed and destroyed. If the participants consents to taking part in the optional study, an extra single blood sample will be taken for storage for future unspecified use.
The questionnaires and blood samples will be done once at at a single timepoint between 12-18 months post onset of acute COVID-19 infection.
Intervention code [1] 320409 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327356 0
To determine Percentage of participants with better current overall health than before getting COVID-19 using study specific questionnaire (Appendix 2 in protocol)
Timepoint [1] 327356 0
Timepoint between 12-18 months post onset of acute COVID-19 infection
Primary outcome [2] 327357 0
To determine Percentage of participants with same current overall health as before getting COVID-19 using study specific questionnaire (Appendix 2 in protocol)
Timepoint [2] 327357 0
Timepoint between 12-18 months post onset of acute COVID-19 infection
Primary outcome [3] 327358 0
To determine Percentage of participants with worse current overall health than before getting COVID-19 using study specific questionnaire (Appendix 2 in protocol)
Timepoint [3] 327358 0
Timepoint between 12-18 months post onset of acute COVID-19 infection
Secondary outcome [1] 394713 0
To determine prevalence of anaemia in confirmed cases after a minimum of 12 months post- infection using blood sample
Timepoint [1] 394713 0
Hemoglobin level at a timepoint between 12-18 months post onset of acute COVID-19 infection
Secondary outcome [2] 394714 0
To determine prevalence of lymphopaenia in confirmed cases after a minimum of 12 months post- infection using blood sample
Timepoint [2] 394714 0
Lymphocyte count at a timepoint between 12-18 months post onset of acute COVID-19 infection
Secondary outcome [3] 394715 0
To determine prevalence of renal impairment in confirmed cases after a minimum of 12 months post- infection using blood sample
Timepoint [3] 394715 0
Renal function tests (Serum Sodium, Potassium, Creatinine level, eGFr (glomerular filtration rate) and Serum Albumin level) at a timepoint between 12-18 months post onset of acute COVID-19 infection
Secondary outcome [4] 394716 0
To determine prevalence of new-onset diabetes in confirmed cases after a minimum of 12 months post- infection using blood sample
Timepoint [4] 394716 0
Glycated haemoglobin (HbA1c) level at a timepoint between 12-18 months post onset of acute COVID-19 infection
Secondary outcome [5] 394717 0
To determine prevalence of thyroid dysfunction in confirmed cases after a minimum of 12 months post- infection using blood sample
Timepoint [5] 394717 0
Thyroid function tests (Free T3, T4, TSH) at a timepoint between 12-18 months post onset of acute COVID-19 infection
Secondary outcome [6] 394718 0
To determine prevalence of liver dysfunction in confirmed cases after a minimum of 12 months post- infection using blood sample
Timepoint [6] 394718 0
Liver function test (AST, ALT, GGT, Bilirubin) at a timepoint between 12-18 months post onset of acute COVID-19 infection
Secondary outcome [7] 394719 0
To determine COVID-19 antibody status after a minimum of 12 months post- infection using blood sample
Timepoint [7] 394719 0
COVID-19 antibodies (IgG, IgM, total antibodies) at a timepoint between 12-18 months post onset of acute COVID-19 infection
Secondary outcome [8] 394720 0
To determine Proportion of participants with issues with mobility
Timepoint [8] 394720 0
EQ-5D-5L score at a timepoint between 12-18 months post onset of acute COVID-19 infection
Secondary outcome [9] 394721 0
To determine Proportion of participants with issues with self-care
Timepoint [9] 394721 0
EQ-5D-5L score at a timepoint between 12-18 months post onset of acute COVID-19 infection
Secondary outcome [10] 394722 0
To determine Proportion of participants with issues with conducting usual activities
Timepoint [10] 394722 0
EQ-5D-5L score at a timepoint between 12-18 months post onset of acute COVID-19 infection
Secondary outcome [11] 394723 0
To determine Proportion of participants with issues with pain/discomfort
Timepoint [11] 394723 0
EQ-5D-5L score at a timepoint between 12-18 months post onset of acute COVID-19 infection
Secondary outcome [12] 394724 0
To determine self-reported health state in confirmed cases after a minimum of 12 months post- infection
Timepoint [12] 394724 0
Mean score on Visual Analogue Scale at a timepoint between 12-18 months post onset of acute COVID-19 infection
Secondary outcome [13] 394725 0
To determine Proportion of participants with breathlessness above Grade 1
Timepoint [13] 394725 0
MRC Dyspnoea Scale Score at a timepoint between 12-18 months post onset of acute COVID-19 infection
Secondary outcome [14] 394726 0
To determine Proportion of participants with breathlessness at each of Grade 2-5.
Timepoint [14] 394726 0
MRC Dyspnoea Scale Score at a timepoint between 12-18 months post onset of acute COVID-19 infection
Secondary outcome [15] 394727 0
To determine the presence of fatigue in confirmed cases after a minimum of 12 months post- infection
Timepoint [15] 394727 0
Mean total score of Fatigue Severity Scale at a timepoint between 12-18 months post onset of acute COVID-19 infection
Secondary outcome [16] 394728 0
To determine Proportion of participants with no signs of anxiety
Timepoint [16] 394728 0
Generalised Anxiety Disorder-7 (GAD7) at a timepoint between 12-18 months post onset of acute COVID-19 infection
Secondary outcome [17] 394729 0
To determine Proportion of participants with symptoms of mild, moderate and severe anxiety (composite outcome)
Timepoint [17] 394729 0
Generalised Anxiety Disorder-7 (GAD7) at a timepoint between 12-18 months post onset of acute COVID-19 infection
Secondary outcome [18] 394730 0
To determine Proportion of participants with poor sleep quality
Timepoint [18] 394730 0
Pittsburgh Sleep Quality Index (PSQI) at a timepoint between 12-18 months post onset of acute COVID-19 infection
Secondary outcome [19] 394731 0
To determine Proportion of participants with at least one ongoing symptom using WHO symptom questionnaire
Timepoint [19] 394731 0
Timepoint between 12-18 months post onset of acute COVID-19 infection
Secondary outcome [20] 394732 0
Proportion of participants with two or more ongoing symptoms using WHO symptom questionnaire
Timepoint [20] 394732 0
Timepoint between 12-18 months post onset of acute COVID-19 infection
Secondary outcome [21] 394733 0
To determine Proportion of participant with each ongoing symptom using WHO symptom questionnaire
Timepoint [21] 394733 0
Timepoint between 12-18 months post onset of acute COVID-19 infection

Eligibility
Key inclusion criteria

1. Aged 18 years and above
2. Laboratory PCR confirmed SARS-CoV2 infection
3. Between 12 months and 17 months since the first onset of COVID-19 symptoms
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have had symptoms of an acute infection in the past two weeks
2. Have been asked to self-isolate, quarantine or stay at home by Public Health officials
3. Have any other condition which, at the investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or the study results.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data description principles are that categorical data will be described by counts and proportions; survival data will be described by Kaplan-Meier survival curves and estimates of 25th, median, and 75th percentiles of survival; count data will be described by rates and total counts in relation to observation time; ordinal data will be described by cross-tabulation and summaries as described for continuous data; and continuous data by mean and standard deviation (SD), median and 25th and 75th percentiles as the inter-quartile range (IQR), and minimum (min) to maximum (max) as the range.
There is no planned sample size. We aim to recruit all consenting adults diagnosed with COVID-19 in the Greater Wellington Region during the first wave.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2021
Actual
18/08/2021
Date of last participant enrolment
Anticipated
1/08/2021
Actual
7/03/2022
Date of last data collection
Anticipated
1/09/2021
Actual
2/05/2022
Sample size
Target
96
Accrual to date
Final
44
Recruitment outside Australia
Country [1] 23628 0
New Zealand
State/province [1] 23628 0
Wellington

Funding & Sponsors
Funding source category [1] 308461 0
Other
Name [1] 308461 0
Medical Research Institute of New Zealand
Country [1] 308461 0
New Zealand
Primary sponsor type
Other
Name
Medical Research Institute of New Zealand
Address
L7 CSB, Wellington Hospital,
Newtown, Wellington,
New Zealand, 6012
Country
New Zealand
Secondary sponsor category [1] 309301 0
None
Name [1] 309301 0
Address [1] 309301 0
Country [1] 309301 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308417 0
New Zealand Health and Disbability Ethics Committee
Ethics committee address [1] 308417 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 308417 0
New Zealand
Date submitted for ethics approval [1] 308417 0
28/04/2021
Approval date [1] 308417 0
25/05/2021
Ethics approval number [1] 308417 0
21/STH/111

Summary
Brief summary
Long-term sequelae of COVID-19 are unknown but there is increasing evidence that some people who have recovered from COVID-19 report lasting effects of the infection or have had the usual symptoms for far longer than would be expected, namely ‘Long COVID’. Our aim is to get a better understanding of how COVID-19 impacts both physical and mental health in the long run. This will be done via blood tests and questionnaires to identify any abnormalities. Potential participants are eligible if they have had a laboratory confirmed diagnosis of COVID-19, 12 – 17 months ago, are over 18 years old and have been under the care of Regional Public Health during the initial illness. Once informed consent is obtained, participants will complete 8 questionnaires online and provide a blood sample at their local blood collection centre. Additional informed consent will be sought if a participant agrees to provide a blood sample to be stored for future unspecified research. All informed consent processes will be done remotely. The entire study will be done remotely, except for blood sampling which will be done at a local collection centre. Once a participant has completed the questionnaire and given a blood sample, an investigator will be in touch with them with the results via telephone. The investigator will also send out a link via email to the Participant Satisfaction Survey at the end of the phone call. This will be a descriptive analysis of the feasibility of conducting a study remotely, purely for internal use at MRINZ.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110642 0
Dr Nethmi Kearns
Address 110642 0
Medical Research Institute of New Zealand
L7 CSB, Wellington Hospital,
Newtown, Wellington,
New Zealand, 6012
Country 110642 0
New Zealand
Phone 110642 0
+64 4805 0147
Fax 110642 0
Email 110642 0
[email protected]
Contact person for public queries
Name 110643 0
Dr Nethmi Kearns
Address 110643 0
Medical Research Institute of New Zealand
L7 CSB, Wellington Hospital,
Newtown, Wellington,
New Zealand, 6012
Country 110643 0
New Zealand
Phone 110643 0
+644805 0147
Fax 110643 0
Email 110643 0
[email protected]
Contact person for scientific queries
Name 110644 0
Dr Nethmi Kearns
Address 110644 0
Medical Research Institute of New Zealand
L7 CSB, Wellington Hospital,
Newtown, Wellington,
New Zealand, 6012
Country 110644 0
New Zealand
Phone 110644 0
+644805 0147
Fax 110644 0
Email 110644 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be available for sharing due to the small number of participants and risk of identifying participants even with de-identified data. Results of analyses can be requested.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11519Study protocol  [email protected] 381896-(Uploaded-28-04-2021-12-52-43)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.