Table 1.
Registered clinical trials investigating colchicine in COVID-19 infection
| Study | Design | Country | Target enrollment | Colchicine dose | Setting | Primary outcome |
|---|---|---|---|---|---|---|
| COLHEART-19/NCT04355143 | Randomized, open label clinical trial | United Stated | 150 | 0.6 mg every 12 h for 30 days | Inpatient | Maximum troponin level |
| COLCOVID/NCT04328480 | Randomized, open label clinical trial | Argentina | 2500 |
In patients not receiving lopinavir/ritonavir, loading dose of 1.5 mg followed by 0.5 mg after 2 h (day 1); then next day 0.5 mg bid for 14 days or until discharge. In patients receiving lopinavir/ritonavir, loading dose of 0.5 mg (day 1); after 72 h from the loading dose, 0.5 mg every 72 h for 14 days or until discharge. In patients under treatment with colchicine that are starting with lopinavir/ritonavir; dose of 0.5 mg 72 h after starting lopinavir/ritonavir; continue with 0.5 mg every 72 h for 14 days or until discharge. |
Inpatient | All-cause mortality |
| NCT04360980 | Randomized, double-blind clinical trial | Iran | 80 | 1.5 mg loading dose then 0.5 mg twice daily | Inpatient | C-reactive protein × neutrophil-to-lymphocyte ratio change |
| COL-COVID/NCT04350320 | Randomized, open label clinical trial | Spain | 102 |
Initial dose of 1.5 mg (1 mg and 0.5 mg 2 h after), followed by 0.5 mg every 12 h during the next 7 days and 0.5 mg every 24 h until the completion of 28 days of total treatment In patients receiving ritonavir or lopinavir or with reduced renal clearance (< 50 ml/min/1.37m2), weight < 70 kg or age > 75 years old, the dose will be adjusted to the half |
Inpatient | Changes in the patients’ clinical status through the 7 points ordinal scale |
| COLCORONA/NCT04322682 | Randomized, placebo-controlled clinical trial |
Canada Spain United States |
6000 | 0.5 mg twice daily for the first 3 days and then once daily for the last 27 days | Outpatient | Number of participants who die or require hospitalization due to COVID-19 infection |
| ColchiVID/NCT04367168 | Randomized, placebo-controlled, double blind clinical trial | Mexico | 174 | 1.5 mg at day 1 followed by 0.5 mg PO twice daily to complete 10 days of treatment | Inpatient | Number of patients with improvement in body temperature, myalgia, arthralgia, total lymphocyte count, D-dimer, fibrinogen and ferritin levels |
| ColCOVID-19/NCT04322565 | Randomized, open label clinical trial | Italy | 310 | 1 mg (or 0.5 mg in chronic kidney disease) per day | Inpatient | Time to clinical improvement defined as time from randomization to an improvement of two points from the status at randomization on a seven-category ordinary scale |
| COMBATCOVID19/NCT04363437 | Randomized, open label clinical trial | United States | 70 | Starting dose of 1.2 mg followed, by 0.6 mg after 2 h if they do not have significant gastrointestinal symptoms, on day 1. Then, 0.6 mg twice a day for 14 days or until discharged or release from the hospital | Inpatient | Percentage of Patients requiring supplemental oxygen beyond 8 l nasal cannula |
| GRECCO-19/NCT04326790 | Randomized, open label clinical trial | Greece | 180 | 0.5 mg twice daily | N/A | Clinical deterioration in the semi-quantitative ordinal scale |
| COLVID-19/NCT04375202 | Randomized, open label clinical trial | Italy | 308 | 0.5 mg three times a day if weight is less than 100 kg; 1 mg twice a day if weight is more than 100 kg for 30 days or up to discharge | Inpatient | Composite of respiratory failure requiring mechanical ventilation; organ failure requiring ICU monitoring and treatment; death |