Colchicine for the treatment of COVID‐19

Background The development of severe coronavirus disease 2019 (COVID‐19) and poor clinical outcomes are associated with hyperinflammation and a complex dysregulation of the immune response. Colchicine is an anti‐inflammatory medicine and is thought to improve disease outcomes in COVID‐19 through a wide range of anti‐inflammatory mechanisms. Patients and healthcare systems need more and better treatment options for COVID‐19 and a thorough understanding of the current body of evidence. Objectives To assess the effectiveness and safety of Colchicine as a treatment option for COVID‐19 in comparison to an active comparator, placebo, or standard care alone in any setting, and to maintain the currency of the evidence, using a living systematic review approach. Search methods We searched the Cochrane COVID‐19 Study Register (comprising CENTRAL, MEDLINE (PubMed), Embase, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, and medRxiv), Web of Science (Science Citation Index Expanded and Emerging Sources Citation Index), and WHO COVID‐19 Global literature on coronavirus disease to identify completed and ongoing studies without language restrictions to 21 May 2021. Selection criteria We included randomised controlled trials evaluating colchicine for the treatment of people with COVID‐19, irrespective of disease severity, age, sex, or ethnicity. We excluded studies investigating the prophylactic effects of colchicine for people without severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) infection but at high risk of SARS‐CoV‐2 exposure. Data collection and analysis We followed standard Cochrane methodology. We used the Cochrane risk of bias tool (ROB 2) to assess bias in included studies and GRADE to rate the certainty of evidence for the following prioritised outcome categories considering people with moderate or severe COVID‐19: all‐cause mortality, worsening and improvement of clinical status, quality of life, adverse events, and serious adverse events and for people with asymptomatic infection or mild disease: all‐cause mortality, admission to hospital or death, symptom resolution, duration to symptom resolution, quality of life, adverse events, serious adverse events. Main results We included three RCTs with 11,525 hospitalised participants (8002 male) and one RCT with 4488 (2067 male) non‐hospitalised participants. Mean age of people treated in hospital was about 64 years, and was 55 years in the study with non‐hospitalised particip