Study | Design | Study period and study site | Study population | Total participants randomised (Colchicine/Control) | Age in years Mean+SD or median IQR* | Gender male (%) | Coexisting conditions (%) | Severity status (%) | Colchicine drug dose | Comparator | Outcome evaluated | Follow-up |
Deftereos et al19 | RCT open label | 3 April 2020–27 April 2020 (Greece) | Hospitalised COVID-19 patients | 55/50 | Col: 63 (55-70)* SC: 65 (54-80)* | Col: 56.4 SC: 60 | Col: DM-16.4%, HT-40%, dyslipidaemia- 30.9%, CAD-16.4%, COPD-5.5% SC: DM-24%, HT-50%, dyslipidaemia-32%, CAD-10%, COPD- 4% | WHO R&D Blueprint Ordinal Clinical Scale : 4 median (3–4) in both groups | 0.5 mg two times a day for 3 weeks | SC | Mortality, ventilatory support, ICU admission, length of hospital stay, AEs, SAEs, diarrhoea | 21 days |
Horby et al20 | RCT open label | November 2020–March 2021 (UK, Nepal, Indonesia) | Hospitalised COVID-19 patients | 5610/5730 | Col: 63.3±13.8 SC: 63.5±13.7 | Col: 69 SC: 70 | Col: DM-25%, CHD-21%, Chronic Lung disease-22% SC: DM-26%, CHD-21%, Chronic lung disease-21% | Respiratory support Col: none/oxygen- 68%, non-invasive ventilation-27%, Invasive ventilation-5% SC: None/oxygen – 69%, non-invasive ventilation-26%, invasive ventilation-5% | 1 mg stat followed by 0.5 mg two times a day for 10 days | SC | Mortality, ventilatory support, length of hospital stay | 28 days |
Lopes et al21 | RCT Double blinded placebo controlled | April 2020–August 2020 (Brazil) | Hospitalised COVID-19 patients | 36/36 | Col: 54.5 (42.5–64.5)* SC: 55 (42–67)* | Col: 53 SC: 39 | Col: DM-36%, dyslipidaemia-28%, CVD-47%, RD-11% SC: DM-42%, dyslipidaemia-33%, CVD-44%, RD-14% | SOFA score Col: 2.5 (1–3) SC: 2.0 (1–3) | 0.5 mg three times a day for 5 days then 0.5 mg two times a day for 5 days | SC/placebo | Mortality, ventilatory support, ICU admission, length of hospital stay, AEs, SAEs, diarrhoea | 10 days |
Salehzadeh et al22 | RCT open label | May 2020–June 2020 (Iran) | Hospitalised COVID-19 patients | 50/50 | Col: 56.56 SC: 55.56 | Col: 38 SC: 44 | Col: DM-10%, HT-6%, IHD-12%, Cancer-2% SC: DM-12%, HT-16%, IHD-18%, Cancer-2% | Time from symptoms to enrolment Col: 6.28 days SC: 8.12 days | 1 mg for 6 days | SC-HCQ | Mortality | 15 days |
Tardif et al23 | RCT double blind | March 2020–December 2020 (6 countries)19 | OPD-based COVID-19 patients | 2235/2253 | Col: 54.4±9.7 SC: 54.9±9.9 | Col: 44.6 SC: 47.5 | Col: DM-19.9%, HT-34.9%, RD-26.1% SC: DM-20%, HT-37.6%, RD-26.9% | Mild, non-hospitalised patients in both groups | 0.5 mg two times a day for 3 days then once a day for 27 days | SC-placebo | Mortality, ventilatory support, AEs, SAEs, diarrhoea | 30 days |
Mareev et al24 | RCT open label | May 2020 (Russia) | Hospitalised COVID-19 patients | 21/22 | Col: 61.9±10.6 SC: 59.9±18.8 | Col: 66.7 SC: 72.7 | Col: DM-14.3%, HT-66.7%, CAD-14.3% SC: DM-9.09%, HT-59.1%, CAD-18.2% | NEWS2 score Col:4.95 (2.66) SC: 4.85 (2.68) SHOCS score Col: 7.21 (2.15) SC: 7.71 (2.61) | 1 mg/day for 3 days then 0.5 mg/day | Placebo | Mortality, length of hospital stay | 12 days |
*Inter-Quartile Range (IQR)
AE, adverse event; CAD, coronary artery disease; Col, colchicine drug arm; COPD, Chronic Obstructive Pulmonary Disease; CRP, C reactive protein; CVD, cardio vascular disease; DM, diabetes mellitus; HCQ, Hydroxycholoroquine; HT, hypertension; ICU, intensive care unit; IHD, ischaemic heart disease; NEWS2, National Early Warning Score 2; OPD, out patient department; RD, respiratory disease; R&D, Research and Development; SAE, serious adverse event; SC, supportive care; SHOCS, Symptomatic Hospital and Outpatient Clinical Score for COVID-19; SOFA, Sequential Organ Failure Assessment.