Colchicine for Long COVID
Background
COVID-19 caused by the SARS-CoV-2 virus is a highly transmissible disease that has affected millions worldwide. The majority of COVID-19 survivors have recovered, but many have reported lingering health issues or symptoms that suddenly appear even after months of the initial infection. The World Health Organization (WHO) recently provided a case definition for this post-COVID condition termed "Long COVID" or "post-acute COVID syndrome". Long COVID has been labelled as 'the next public health disaster' due to its significant health, economic, and societal burden. The debilitating symptoms of Long COVID are wide-ranging, multisystemic, and pre-dominantly fluctuating or relapsing.
Despite a rapidly increasing population of recovered COVID-19 survivors, there is a lack of data on the extent of cardiovascular, respiratory, and psychiatric complications in recently infected individuals or whether these risks can be reduced.
Exploring the therapeutic options available is necessary to prevent Long COVID. Colchicine is a cost-effective, widely available therapeutic agent with known anti-inflammatory properties that promise to reduce the inflammation and complications related to Long COVID.
Aim
- To assess the superiority of colchicine compared to placebo in improving functional outcomes in individuals with persistent symptoms more than three weeks post-acute infection with SARS-CoV-2.
- To assess the efficacy of colchicine compared to placebo to reduce COVID-19-related pulmonary abnormalities, constitutional symptoms, and mental health disorders.
Research Methodology
Colchicine trial is a Phase-3, multi-centre parallel-arm, 1:1 individual randomised, placebo-controlled double-blind. All potential participants will be assessed based on the functional limitation of individuals with a history of COVID-19 infection using the self-reported flow chart or questionnaire of the PCFS scale. We also capture EQ-5D-5L, pulmonary vital capacity dyspnoea scale, and six-minute walk test to assess the effects of Long COVD on various health systems such as general and mental health, respiratory, and constitutional symptoms.
The study aims to recruit 350 post-COVID-19 adults. Further, 100 out of the 350 participants will be selected for the Cardiac MRI sub-study. The trial started recruitment in January 2022. The participants will be followed up for 12 months post-randomisation, and the tentative close-out date for the trial is December 2023.
Current Status
The study was registered in CTRI in November 2021. The study has been activated in 11 sites across India. Each site is actively screening the participants from Post COVID-19 OPDs or the COVID-19 registry. As of June 9, 2022, more than 300 potential participants have been screened, and 32 participants have been randomised into this study. To recruit study participants, the George Institute is working closely with long-COVID patient groups and sharing the information about the study on social messaging portals like Telegram or WhatsApp groups.
