HElping Alleviate the Longer-term consequences of COVID-19 (HEAL-COVID): a national platform trial

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

The University of Cambridge (UoC), Cambridge University Hospitals NHS Foundation Trust (CUH) and the University of Liverpool (UoL) require access to NHS England data for the purpose of the following research project: HElping Alleviate the Longer-term consequences of COVID-19 (HEAL-COVID): a national platform trial The following is a summary of the aims of the research project provided by UoC CUH and UoL: [1 paragraph unchanged] This is a clinical trial platform which will have at most one [34 words unchanged] is expected that 877 participants will be randomised to each treatment arm. Therefore Therefore, the estimate for total cohort size, once recruited is around 3,500 at most. The aims of the study are to determine the safety and effectiveness [33 words unchanged] clinical trial that uses the data minimisation principle as required by GDPR. All the data requested maps to an outcome specified with the clinical trial protocol, and the list of outcomes is as follows: All the data requested maps to an outcome specified with the clinical trial protocol, and the list of outcomes is as follows: [8 paragraphs unchanged] UoL will provide the HEAL-COVID participant’s NHS Number, Date of Birth and corresponding randomisation number (Pseudo Study ID) to NHS England for linking purposes. Randomisation date and end of study participation date will also be provided for each participant, as the protocol requires 12 months follow-up for each participant from randomisation. End of study participation date will either be the date when the 12 month follow up point was reached or the date the participant withdrew from the study. All hospitals across the UK will be eligible to recruit participants. The following NHS England Data will be accessed: > Hospital Episode Statistics: - Admitted Patient Care (APC) - Critical Care (CC) - Outpatients (OP) > Emergency Care Data Set (ECDS) > Civil Registration Mortality > Medicines dispensed in Primary Care (NHSBSA data) [1 paragraph unchanged] University of Cambridge and Cambridge University Hospitals NHS Foundation Trust are joint sponsors and are legally responsible for the trial. Along with UoL they are joint data controllers in this agreement. UoL will have access to patient identifiers - NHS Numbers, Date of Birth and randomisation number (pseudo Study ID). Bangor University are processors of the health economics data. The data sent to Bangor University will be record-level pseudonymised NHS England data. UoL will provide record-level pseudonymised NHS England data securely to Bangor University to enable them to conduct Health Economics analysis. The data will not contain NHS/CHI Number or any other identifiers and only the randomisation number (Pseudo Study IDs) will be used. Aparito are a data processor of the patient completed questionnaires only, but they will not access the data requested from NHS England and so for the purposes of this agreement are not considered a Data Processor. The level of the Data will be: Co-applicants of the grant application to the National Institute for Health Research (NIHR) are involved as part of the wider study. However, they are not considered Data Controllers for this agreement as they have no role in determining the means by which the personal data are being processed under this agreement. They will not have access to record-level NHS England data and so for the purposes of this agreement are not considered Data Processors. The funder will have a role in monitoring study progress but for the purposes of this agreement are not considered a Data Processor or Data Controller, nor will they have any influence on the outcomes nor suppress any of the findings of the research. None of the additional funders listed in the protocol have any commercial interests in relation to the treatments being proposed for this trial. > Identifiable This clinical trial is a stand-alone trial and should there be any plans for future linkage of this data to other datasets then this application will come back via NHS England's Data Access Request process for amendment. Although all Data items requested under this DSA are pseudonymised, UoL also hold the cohort identifiers, therefore, although no attempt will be made, the technical ability to re-identify participants exists. The Data Controllers rely on GDPR Article 6(1)(e) of the General Data Protection Regulation (GDPR) to process personal data where processing is necessary for a task carried out in the public interest. In this instance the public interest task is research. It is in the public interest to conduct this clinical trial funded by the National Institute for Health Research (NIHR) programme which aims to find treatment to reduce mortality and morbidity following acute COVID-19. This routine data is necessary to identify morbidity and mortality during the follow up period. Both Controllers also rely on Article 9(2)(j) of the GDPR to process special category data (in this case health data) where processing is necessary for scientific research purposes. Data minimisation process is being followed and only data that is required specifically for the purposes of this study has been requested, to protect the rights of the data subjects. The Data will be minimised as follows: The data are required for research purposes in the public interest- meeting the conditions in the DPA 2018 Schedule 1 Part 1 (4) - which GDPR Recital 52(2) determines is an appropriate derogation from the prohibition on processing special categories of personal data. The ways in which the processing of data will be of benefit to the public – thereby demonstrating that the processing is in the public interest – are described in section ‘5d. ii. Expected Measurable Benefits to Health and/or Social Care Including Target Date’. > Limited to a study cohort identified by UoL – all hospitals across the UK will be eligible to recruit participants. - In accordance with GDPR Article 89(1) processing is subject to appropriate safeguards. These include: > Limited to data between 2020/21 to latest available. Randomisation date and end of study participation date will also be provided for each participant. For each individual patient, data will only be provided from their date of randomisation and until 12 months follow-up for each participant from randomisation. End of study participation date will either be the date when the 12 month follow up point was reached or the date the participant withdrew from the study. i. The data recipient’s technical and organisational measures to safeguard the data have been assessed and meet NHS England's acceptance criteria (see sections 2 and 5b of this application for further details); UoL is a joint controller, and UoC and CUH joint controllers and research sponsors, as the organisations jointly responsible for ensuring that the Data will only be processed for the purpose described above. ii. The requested data has been assessed as proportionate to the aim pursued (see section 5a of this application for further details); The lawful basis for processing personal data under the UK GDPR is: iii. Controls, data retention and processing activities have been assessed to ensure respect to the essence of the right to data protection; Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller; iv. Measures to protect the rights and freedoms of data subjects have been assessed including transparency (fair processing) publishing subject’s rights. The lawful basis for processing special category data under the UK GDPR is: Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. It is in the public interest to conduct this clinical trial which aims to find treatment to reduce mortality and morbidity following acute COVID-19. This routine data is necessary to identify morbidity and mortality during the follow up period. The funding is provided by National Institute for Health Research (NIHR). The funding is specifically for the project described. The funder will have no ability to suppress or otherwise limit the publication of findings. Bangor University is a processor acting under the instructions of UoL. Bangor University’s role is limited to conducting economic analysis. Co-applicants of the grant application to the National Institute for Health Research (NIHR) are involved as part of the wider study. However, they are not Data Controllers for this agreement as they have no role in determining the means by which the personal data are being processed under this agreement. They will not have access to record-level NHS England data and so for the purposes of this agreement are not considered Data Processors. The funder will have a role in monitoring study progress but for the purposes of this agreement are not considered a Data Processor or Data Controller, nor will they have any influence on the outcomes nor suppress any of the findings of the research. None of the additional funders listed in the protocol have any commercial interests in relation to the treatments being proposed for this trial. Aparito are a data processor of the patient completed questionnaires only, but they will not access the data requested from NHS England and so for the purposes of this agreement are not considered a Data Processor. Data will be accessed by: > Substantive employees of Bangor University, UoL, UoC and CUH.

Processing activities

UoL will securely provide transfer data to NHS England with a file containing a list England. The data will consist of identifiers: identifying details NHS Number, Date of Birth and randomisation numbers (Pseudo Study IDs) a unique person ID) for the cohort to be linked with NHS England data. Randomisation date and end of patients recruited into HEAL-COVID. Date of randomisation for each participant will also be provided to indicate the start date from which data will be collected for a participant. End study participation date will also be provided so that data is not requested after for each participant, as the protocol requires 12 months of follow-up. Additionally if a follow-up for each participant withdraws from routine data collection, data will only be collected up to the date of withdrawal. randomisation. NHS England will then create extracts of the requested data, removing any identifiers from the data sets except for the randomisation number (Pseudo Study IDs). This will then be securely transmitted to UoL via NHS England's Secure File Transfer Service (SEFT). Thus, there is a flow of identifiable data into NHS England but the flow out of NHS England will be pseudonymised, with the identifying data removed and replaced with the corresponding randomisation number (Pseudo Study IDs). NHS England will provide the relevant records from the HES, ECDS, deaths and NHSBSA datasets to UoL. The Data will contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient This process will be done on a monthly basis for linkage to Civil Registrations of Deaths, Medicines Dispensed in Primary Care and Hospital Episode Statistics Admitted Patient Care data. On an annual basis the cohort will be linked to the Hospital Episode Statistics datasets (Admitted Patient Care, Outpatients, Critical Care and Emergency Care Data Set) and Medicines Dispensed in Primary Care. UoL will securely transfer the Data to Bangor University, UoC and CUH. Data from NHS England will be stored at UoL’s ‘on premise’ secure managed network drive and accessible only to approved members of UOL holding a contract of employment with UoL. Multiple secure University storage locations are used as the servers are mirrored in case there is an issue in one of the buildings (Business Continuity). Only approved members of the study team holding an contract of employment with UoL will have access to the patient identifiers. Bangor University, as a data processor, will not have access to patient identifiers. The Data will be stored on servers at UoL, Bangor University, UoC and CUH. UOL will provide record-level pseudonymised NHS England data securely to Bangor University to enable them to conduct Health Economics analysis. The data will not contain identifiers and only the randomisation number (Pseudo Study IDs) will be used. Bangor University will not attempt to re-identify any study participants. Files holding the record-level pseudonymised data will be held securely by Bangor University in server folders with access restricted to approved Bangor University study data analysts holding a contract of employment with Bangor University. The Data will be accessed by authorised personnel via remote access. Statistical data analysis will be carried out via UOL and Bangor University owned devices connected to either the UOL and Bangor University network either directly in person or remotely, using an appropriate statistical package. To remotely access the devices requires a secure 2-factor authenticator (VPN) and users are then able to securely access the secure server on the respective University’s IT framework. All data analysis will be conducted within the confines of the respective University’s secure server, and will not be downloaded to remote devices for storage or processing. The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract. HES and ECDS DISCLOSURE CONTROL / SMALL NUMBER SUPPRESSION For remote access: In order to protect patient confidentiality, when presenting results calculated from HES record level data, outputs will contain only aggregate level data with small numbers suppressed in line with HES Analysis Guide. When publishing HES data, data processors must make sure that: - Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA; · National-level figures only may be presented unrounded, without small number suppression - Access controls granting users the minimum level of access required are in place; · cell values from 1 to 7 (inclusive) are suppressed at a sub-national level to prevent possible identification of individuals from small counts within the table. - Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data; · Zeros (0) do not need to be suppressed. - Multifactor authentication (MFA) is required for remote access; · All other counts will be rounded to the nearest 5. - Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access; Data will not be made available to any third parties other than those specified except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide. - All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy. The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose). Remote processing will be from secure locations within England/Wales. The data will not leave England/Wales at any time. Access to confidential patient identifiable data is restricted to employees of UoL. Employees of Bangor University, UoC and CUH are permitted to access pseudonymised data only. All personnel accessing the Data have been appropriately trained in data protection and confidentiality. The Data will not be linked with any other data. There will be no requirement and no attempt to reidentify individuals when using the Data. Analysts from the Bangor University, UoL, UoC and CUH will analyse the Data for the purposes described above.

Expected output

[1 paragraph unchanged] Only aggregated summaries of data with small number suppressed in line with the HES analysis guide will be contained in the outputs. No patient level information will be published or onwardly shared. The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived. HEAL-COVID is a Clinical Trial of Investigational Medicinal Products (CTIMPS) and as such there is a requirement to report within 12 months of the end of the trial (February 2024). trial. Outputs are due to be published at the end of the trial [31 words unchanged] arm, however this is expected to be between March 2022 and February 2024. 2026. Outputs are approved following NIHR review.

Expected measurable benefits

[2 paragraphs unchanged] Expected benefits within the project timescales (March 2021 to February 2024) 2026) include: [8 paragraphs unchanged]

Benefits reported

Not stated in the previous version; added here.

Analysis is ongoing and all results will be published within the next year. It is not possible to provide measurable benefits at this time prior to publication.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

[11 paragraphs unchanged] UoL will provide the HEAL-COVID participant’s NHS Number, Date of Birth and corresponding randomisation number (Pseudo Study ID) to NHS Digital England for linking purposes. Randomisation date and end of study participation date will [45 words unchanged] study. All hospitals across the UK will be eligible to recruit participants. [1 paragraph unchanged] University of Cambridge and Cambridge University Hospitals NHS Foundation Trust are joint [46 words unchanged] data. The data sent to Bangor University will be record-level pseudonymised NHS Digital England data. UoL will provide record-level pseudonymised NHS England data securely to Bangor University to enable them to conduct Health Economics analysis. The data will not contain NHS/CHI Number or any other identifiers and only the randomisation number (Pseudo Study IDs) will be used. Aparito are a data processor of the patient completed questionnaires only, but they will not access the data requested from NHS Digital England and so for the purposes of this agreement are not considered a Data Processor. Co-applicants of the grant application to the National Institute for Health Research [35 words unchanged] processed under this agreement. They will not have access to record-level NHS Digital England data and so for the purposes of this agreement are not considered [57 words unchanged] commercial interests in relation to the treatments being proposed for this trial. This clinical trial is a stand-alone trial and should there be any [6 words unchanged] data to other datasets then this application will come back via NHS Digital’s England's Data Access Request process for amendment. [3 paragraphs unchanged] i. The data recipient’s technical and organisational measures to safeguard the data have been assessed and meet NHS Digital’s England's acceptance criteria (see sections 2 and 5b of this application for further details); [3 paragraphs unchanged]

Processing activities

UoL will securely provide NHS Digital England with a file containing a list of identifiers: NHS Number, Date of [62 words unchanged] collection, data will only be collected up to the date of withdrawal. NHS Digital England will then create extracts of the requested data, removing any identifiers from [9 words unchanged] Study IDs). This will then be securely transmitted to UoL via NHS Digital's England's Secure File Transfer Service (SEFT). Thus, there is a flow of identifiable data into NHS Digital England but the flow out of NHS Digital England will be pseudonymised, with the identifying data removed and replaced with the corresponding randomisation number (Pseudo Study IDs). [1 paragraph unchanged] Data from NHS Digital England will be stored at UoL’s ‘on premise’ secure managed network drive and [61 words unchanged] University, as a data processor, will not have access to patient identifiers. UOL will provide record-level pseudonymised NHS Digital England data securely to Bangor University to enable them to conduct Health Economics [50 words unchanged] University study data analysts holding a contract of employment with Bangor University. [8 paragraphs unchanged]

Unchanged: Expected output, Expected measurable benefits.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Datasets: − Secondary Uses Service Payment By Results Episodes

Objective for processing

[1 paragraph unchanged] The legal basis for the processing and storage of personal data is that it is a task in the public interest Article 6 (1) (e). It is in the public interest to conduct this clinical trial funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme which aims to find treatment to reduce mortality and morbidity following acute COVID-19. This routine data is necessary to identify morbidity and mortality during the follow up period. The data will be analysed to produce statistical summaries (Article 9(2)(j)). The research has received appropriate Health Research Authority approval throughout the UK. [4 paragraphs unchanged] Secondary outcomes include include: [5 paragraphs unchanged] University of Liverpool (UoL) UoL will provide the HEAL-COVID participant’s NHS number, date Number, Date of birth Birth and corresponding randomisation number (Study (Pseudo Study ID) to NHS Digital for linking purposes. Randomisation date and End end of study participation date will also be provided for each participant, as [38 words unchanged] study. All hospitals across the UK will be eligible to recruit participants. [1 paragraph unchanged] University of Cambridge and Cambridge University Hospitals NHS Foundation Trust are joint sponsors and are legally responsible for the trial. Along with University of Liverpool (UoL) UoL they are joint data controllers. controllers in this agreement. UoL will have access to patient identifiers - NHS numbers, DOB Numbers, Date of Birth and randomisation number. number (pseudo Study ID). Bangor University are processors of the health economics data. The data sent to Bangor University will be pseudonymised. record-level pseudonymised NHS Digital data. Aparito are a data processor of the patient completed questionnaires only, but they will not process access the data requested from NHS Digital. Digital and so for the purposes of this agreement are not considered a Data Processor. Co-applicants of the grant application to the NIHR HTA National Institute for Health Research (NIHR) are involved as part of the wider study. However, they are not data processors or data controllers. Their role is to provide advice on the trial design and conduct of the trial and considered Data Controllers for this agreement as they have no role in determining the means by which the personal data are being processed under this agreement. They will not view have access to record-level NHS Digital data and so for the disaggregated data. purposes of this agreement are not considered Data Processors. The funder will have a role in monitoring study progress but will for the purposes of this agreement are not be considered a data processor Data Processor or data controller, Data Controller, nor will they have any influence on the outcomes nor suppress any [17 words unchanged] commercial interests in relation to the treatments being proposed for this trial. This clinical trial is a stand-alone trial and should there be any [7 words unchanged] to other datasets then this application will come back via NHS Digital’s DARS / DigiTrials Data Access Request process for amendment. The Data Controllers rely on GDPR Article 6(1)(e) of the General Data Protection Regulation (GDPR) to process personal data where processing is necessary for a task carried out in the public interest. In this instance the public interest task is research. It is in the public interest to conduct this clinical trial funded by the National Institute for Health Research (NIHR) programme which aims to find treatment to reduce mortality and morbidity following acute COVID-19. This routine data is necessary to identify morbidity and mortality during the follow up period. Both Controllers also rely on Article 9(2)(j) of the GDPR to process special category data (in this case health data) where processing is necessary for scientific research purposes. Data minimisation process is being followed and only data that is required specifically for the purposes of this study has been requested, to protect the rights of the data subjects. The data are required for research purposes in the public interest- meeting the conditions in the DPA 2018 Schedule 1 Part 1 (4) - which GDPR Recital 52(2) determines is an appropriate derogation from the prohibition on processing special categories of personal data. The ways in which the processing of data will be of benefit to the public – thereby demonstrating that the processing is in the public interest – are described in section ‘5d. ii. Expected Measurable Benefits to Health and/or Social Care Including Target Date’. - In accordance with GDPR Article 89(1) processing is subject to appropriate safeguards. These include: i. The data recipient’s technical and organisational measures to safeguard the data have been assessed and meet NHS Digital’s acceptance criteria (see sections 2 and 5b of this application for further details); ii. The requested data has been assessed as proportionate to the aim pursued (see section 5a of this application for further details); iii. Controls, data retention and processing activities have been assessed to ensure respect to the essence of the right to data protection; iv. Measures to protect the rights and freedoms of data subjects have been assessed including transparency (fair processing) publishing subject’s rights.

Processing activities

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by "Personnel" (as defined within the Data Sharing Framework Contract i.e. employees, agents and contractors of the Data Recipient who may have access to that data). UoL will securely provide NHS Digital with a file containing a list of identifiers: NHS Number, Date of Birth and randomisation numbers (Pseudo Study IDs) of patients recruited into HEAL-COVID. Date of randomisation for each participant will also be provided to indicate the start date from which data will be collected for a participant. End date will also be provided so that data is not requested after the 12 months of follow-up. Additionally if a participant withdraws from routine data collection, data will only be collected up to the date of withdrawal. UoL will securely provide NHS Digital with a file containing a list of NHS numbers, dates of birth and randomisation numbers (Study IDs) of patients recruited into HEAL-COVID. Date of randomisation for each participant will also be provided to indicate the start date from which data will be collected for a participant. End date will also be provided so that data is not requested after the 12 months of follow-up. Additionally if a participant withdraws from routine data collection, data will only be collected up to the date of withdrawal. NHS Digital will then create extracts of the requested data, removing any identifiers from the data sets except for the randomisation number (Pseudo Study IDs). This will then be securely transmitted to UoL via NHS Digital's Secure File Transfer Service (SEFT). Thus, there is a flow of identifiable data into NHS Digital but the flow out of NHS Digital will be pseudonymised, with the identifying data removed and replaced with the corresponding randomisation number (Pseudo Study IDs). NHS Digital will then create an extract of the requested data, removing any identifiers from the datasets except for the randomisation number. This will then be securely transmitted to UoL. Thus, there is a flow of identifiable data into NHS Digital but the flow out of NHS Digital will be pseudonymised, with the identifying data removed and replaced with the corresponding randomisation number. This process will be done on a monthly basis for linkage to Civil Registrations of Deaths, Medicines Dispensed in Primary Care and Hospital Episode Statistics Admitted Patient Care data. On an annual basis the cohort will be linked to the Hospital Episode Statistics datasets (Admitted Patient Care, Outpatients, Critical Care and Emergency Care Data Set) and Medicines Dispensed in Primary Care. This process will be done on a monthly basis for linkage to Civil Registrations of Deaths, Medicines Dispensed in Primary Care and SUS data. On an annual basis the cohort will be linked to the Hospital Episode Statistics datasets. Data from NHS Digital will be stored at UoL’s ‘on premise’ secure managed network drive and accessible only to approved members of UOL holding a contract of employment with UoL. Multiple secure University storage locations are used as the servers are mirrored in case there is an issue in one of the buildings (Business Continuity). Only approved members of the study team holding an contract of employment with UoL will have access to the patient identifiers. Bangor University, as a data processor, will not have access to patient identifiers. Data from NHS digital will be stored at UoL’s ‘on premise’ secure managed network drive and accessible only to those individuals permitted to access the data. Multiple storage locations are used as the servers are mirrored in case there is an issue in one of the buildings. Only approved members of UOL will have access to the NHS identifiers, Bangor University, as a data processor, will not have access to these identifiers. UOL will provide record-level pseudonymised NHS Digital data securely to Bangor University to enable them to conduct Health Economics analysis. The data will not contain identifiers and only the randomisation number (Pseudo Study IDs) will be used. Bangor University will not attempt to re-identify any study participants. Files holding the record-level pseudonymised data will be held securely by Bangor University in server folders with access restricted to approved Bangor University study data analysts holding a contract of employment with Bangor University. UOL will provide the relevant data securely to Bangor University to enable them to conduct Health Economics analysis. The data will not contain NHS number and only the randomisation number will be used. Bangor University will not be able re-identify any participants. Files holding pseudonymised data will be held securely by Bangor University in folders with access restricted to approved Bangor University analysts. Statistical data analysis will be carried out via UOL and Bangor University owned devices connected to either the UOL and Bangor University network either directly in person or remotely, using an appropriate statistical package. To remotely access the devices requires a secure 2-factor authenticator (VPN) and users are then able to securely access the secure server on the respective University’s IT framework. All data analysis will be conducted within the confines of the respective University’s secure server, and will not be downloaded to remote devices for storage or processing. HES and ECDS DISCLOSURE CONTROL / SMALL NUMBER SUPPRESSION In order to protect patient confidentiality, when presenting results calculated from HES record level data, outputs will contain only aggregate level data with small numbers suppressed in line with HES Analysis Guide. When publishing HES data, data processors must make sure that: · National-level figures only may be presented unrounded, without small number suppression · cell values from 1 to 7 (inclusive) are suppressed at a sub-national level to prevent possible identification of individuals from small counts within the table. · Zeros (0) do not need to be suppressed. · All other counts will be rounded to the nearest 5. Data will not be made available to any third parties other than those specified except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide.

Expected output

The aim of the trial is to change the standard of care [9 words unchanged] and do not alter longer-term clinical outcomes. The outputs of the study will aim to be be disseminated to both patient and public audiences, as well as healthcare [42 words unchanged] of our work are effectively shared with people who experience Long COVID. Only aggregated summaries of data with small number suppressed in line with the HES analysis guide will be contained in the outputs. No patient level information will be provided. published or onwardly shared. HEAL-COVID is a CTIMP Clinical Trial of Investigational Medicinal Products (CTIMPS) and as such there is a requirement to report within 12 months of the end of the trial (February 2024). Outputs will are due to be published at the end of the trial and throughout as each [23 words unchanged] available for each treatment arm, however this is expected to be between January March 2022 and February 2024. Outputs are approved following NIHR HTA review.

Expected measurable benefits

COVID-19 is a new disease for which the natural history remains uncertain. [118 words unchanged] the post-acute phase. This trial is considering licensed treatments and the beneficiaries will are hoped to be the NHS and patients. [10 paragraphs unchanged]

Benefits reported

Stated in the previous version and removed here.

Yielded Benefits is not a requirement for new applications.