Treatment of moderate to severe cases of COVID-19 with colchicine

Treatment of moderate to severe cases of the disease caused by the new coronavirus-2019 (COVID-19) with colchicine: a controlled open trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-10k2w2c5

Enrollment

Unknown

Registered

2021-09-28

Start date

2020-10-06

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus disease 2019 (COVID-19)

Interventions

Patients in the Colchicine group will receive colchicine at a dose of 0.020 to 0.033 mg/kg in the first 24 hours, followed by 0.015 to 0.033 mg/kg/day for four days and 0.012 to 0.020 mg/kg/day for fi

D03.132.225

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with COVID-19; over 18 years old; at least 50 kg of body weight; moderate or severe form of COVID-19; in need of treatment in a hospital environment; women between 18 and 50 years old should have a negative serum or urine test for beta human chorionic gonadotropin

Exclusion criteria

Exclusion criteria: Mild form of COVID-19; allergy to colchicine; diagnosis of porphyria, myasthenia gravis or uncontrolled arrhythmia on admission; pregnancy or lactancy; use of cyclosporine, digoxin, amiodarone, verapamil, metoprolol or protease inhibitors; history of chronic liver disease with liver dysfunction; unable to understand the information contained in the consent form.

Design outcomes

Primary

Measure	Time frame
Need and time for non-invasive and invasive ventilatory support, verified through the need to use oxygen supplementation through nasal catheter, high flow mask or orotracheal intubation. ;Length of hospital stay, verified through the number of days from hospital admission to discharge or death.;Length of stay in the ICU, verified by counting the days from admission to the ICU until discharge to the ward or death.;Death rate, through the frequency of patients who died among all those recruited for the study.	—

Measure

Time frame

Need and time for non-invasive and invasive ventilatory support, verified through the need to use oxygen supplementation through nasal catheter, high flow mask or orotracheal intubation. ;Length of hospital stay, verified through the number of days from hospital admission to discharge or death.;Length of stay in the ICU, verified by counting the days from admission to the ICU until discharge to the ward or death.;Death rate, through the frequency of patients who died among all those recruited for the study.

—

Secondary

Measure	Time frame
Frequency and nature of adverse events, by noting all unexpected signs, symptoms and laboratory changes as related to the underlying disease (COVID-19). ;Frequency of treatment interruption due to an adverse event, through cases where the medication was discontinued due to a side effect of its use, not attributable to COVID-19.	—

Countries

Brazil

Contacts

Public ContactRenê Oliveira

rdroliveira@hcrp.usp.br+55-016-36022766

Outcome results

None listed

Source: REBEC (via WHO ICTRP)