Composition of the coordinating centre and trial steering committee

The trial management committee is composed of co-investigators, trial manager, a site manager, and trial monitor and chaired by the chief investigator. It provides oversight of day-to-day management of the trial and prepares reports for the trial steering committee and data safety monitoring committee.

The steering committee comprises site investigators, external experts, a patient representative with lived experience due to persistent symptoms after COVID-19 infection and is chaired by the chief investigator. The committee will be responsible for reviewing trial progress periodically in terms of recruitment, retention, safety reporting, and approving any protocol amendments. At the time of writing this manuscript, the committee had met twice.

Composition of the data monitoring committee, its role and reporting structure

A four-member independent data safety monitoring committee (DSMC) includes a statistician not involved in random sequence generation to develop the blinded interim reports that will help DSMC to assess trial progress, medication compliance, safety of trial participants, and data quality. Unblinded reports will be presented if only required by the DSMC. Details of the DSMC roles and responsibilities, meeting format, and reporting structure are elaborated in the DSMC charter (supplementary). Recommendations to amend the protocol or change the conduct of the trial made by the DMSC will be considered by the steering committee. The steering committee has exclusives rights for deciding whether to continue, hold, or stop the trial based on the DMSC recommendations.

Adverse event reporting and harms

At therapeutic doses of colchicine, apart from (mild and transient) gastrointestinal disturbances, no concerning major adverse effects have been reported in literature. A predefined list of adverse symptoms (e.g. diarrhoea, nausea, vomiting, abdominal pain, sore throat) will be asked at every visit. Any other adverse effects reported by the participants will be recorded in the CRFs. Participants will be counselled to contact the site research coordinator immediately in case of any adverse symptoms.

All serious adverse events will be treated at the recruiting hospital, documented in trial-specific forms, and reported to the trial sponsor within 24 h of occurrence or knowledge of the event. The site principal investigator and research staff will document the time of onset, duration, resolution, and actions taken as well as an assessment of the intensity and relationship of the event with the study treatment. This complete report will be submitted to the local ethics committee and to the sponsor for a complete investigation of causality within 14 days.

Frequency and plans for auditing trial conduct

No external or internal audit is planned for this trial except for routine trial monitoring. The PROMs, hospital records, and all original signed informed consent forms made available by the clinical investigator will serve as a source for data verification by the trial monitor at the trial coordinating centre during remote or on-site trial monitoring. The query management system to raise, respond, and close the query with changes to the responses will be recorded with an audit trail.

Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees)

Any protocol amendments made during the study will be approved by the ethics committee before the implementation and updated in the trial registry.

There was one protocol amendment related to inclusion criteria. When the trial was initiated, those who were more than 100 days (3 months) after COVID-19 infection were excluded even if they had persistent symptoms. The amended inclusion criteria removed the upper limit of days since COVID-19 infection and were approved by the trial steering committee. The modified protocol was approved by the ethics committee of the sponsor and all participating centres.

Dissemination plans

The trial results will be published in a peer-reviewed biomedical journal irrespective of the direction of the result as per the Consolidated Standards of Reporting Trials (CONSORT) statement. All members of the protocol writing group and the site investigators will be co-authors in the manuscript. Any other researcher meeting the ICMJE authorship criteria will also be granted co-authorship. Site-specific data or sub-study results or any other exploratory analyses will not be analysed until the publication of the main result. The steering committee will approve the manuscripts from this trial before the decision to publish. The funding agency will be acknowledged, but they will have no influence on the data analyses, interpretation of trial results, writing of the manuscript, or the decision to publish. The study results will be shared with the trial participants via a newsletter.