COLCORONA [COVID-19]
Research type
Research Study
Full title
COLCHICINE CORONAVIRUS SARS-CoV2 TRIAL
IRAS ID
283523
Contact name
Colin Berry
Contact email
Sponsor organisation
Montreal Health Innovations Coordinating Centre
Eudract number
2020-001689-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 27 days
Research summary
A new coronavirus is responsible for causing coronavirus disease (COVID-19). While the majority of cases are mild, a certain number of people progress to experience severe illness leading to hospital admission or even death.
Adults who suffer major COVID-19 complications may experience a severe inflammatory illness(overreaction of immune system). Therefore, the idea of our study is targeting the inflammatory response with colchicine, an anti-inflammatory medicine, may reduce COVID-19-related complications in adults at risk or with evidence of an inflammatory illness.
The primary objective of the COLCORONA study is to determine whether short-term treatment with colchicine medicine reduces the rate of death and lung complications related to COVID-19. The study design of COLCORONA involves taking either colchicine or an identical placebo tablet. The patients will have an equal chance of taking either colchicine or placebo and the treatment will be assigned at random (equal chance). After giving written informed consent, 6000 patients (3000 to be given colchicine, 3000 to be given placebo) meeting all inclusion and no exclusion criteria will be enrolled. In the UK, we may enroll up to 100 patients. The treatment period is 30 days. The treatment is 0.5 mg tablet, 1 tablet twice daily for the first 3 days and then one tablet daily for the next 27 days. The patients will be contacted twice by phone or video, at 15 and 30 days, to assess for wellbeing and adverse events. The treatment will end at 30 days.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
20/NW/0419
Date of REC Opinion
14 Oct 2020
REC opinion
Favourable Opinion