A Study to Evaluate the Efficacy and Safety of Colchicine on Coronavirus SARS-CoV2 Positive Adults

Overview

About this study

This is a phase 3, multi-center, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of colchicine in adult patients diagnosed with COVID-19 infection and have at least one high-risk criterion. Approximately 6000 subjects meeting all inclusion and no exclusion criteria will be randomized to receive either colchicine or placebo tablets for 30 days.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • Males and females, at least 40 years of age, capable and willing to provide informed consent
  • Patient must have received a diagnosis of COVID-19 infection within the last 24 hours
  • Outpatient setting (not currently hospitalized or under immediate consideration for hospitalization)
  • Patient must possess at least one of the following high-risk criteria:
    • 70 years or more of age, obesity (BMI ≥ 30 kg/m2)
    • Diabetes mellitus
    • Uncontrolled hypertension (systolic blood pressure ≥150 mm Hg)
    • Known respiratory disease (including asthma or chronic obstructive pulmonary disease)
    • Known heart failure
    • Known coronary disease
    • Fever of ≥38.4°C within the last 48 hours
    • Dyspnea at the time of presentation
    • Bicytopenia
    • Pancytopenia
    • The combination of high neutrophil count and low lymphocyte count
  • Female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing at least one method of contraception and preferably two complementary forms of contraception including a barrier method (e.g. male or female condoms, spermicides, sponges, foams, jellies, diaphragm, intrauterine device (IUD)) throughout the study and for 30 days after study completion
  • Patient must be able and willing to comply with the requirements of this study protocol.

Exclusion Criteria:

  • Patient currently hospitalized or under immediate consideration for hospitalization
  • Patient currently in shock or with hemodynamic instability
  • Patient with inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea or malabsorption
  • Patient with pre-existent progressive neuromuscular disease
  • Estimated Glomerular filtration rate (eGFR), using the MDRD equation for all subjects being considered for enrollment, with a cut-off of < 30 mL/m in/1.73m2
  • Patient with a history of cirrhosis, chronic active hepatitis or severe hepatic disease
  • Female patient who is pregnant, or breast-feeding or is considering becoming pregnant during the study or for 6 months after the last dose of study medication
  • Patient currently taking colchicine for other indications (mainly chronic indications represented by Familial Mediterranean Fever or gout)
  • Patient with a history of an allergic reaction or significant sensitivity to colchicine
  • Patient undergoing chemotherapy for cancer
  • Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Leigh Speicher, M.D., M.P.H.

Open for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Matthew Rank, M.D.

Contact us for the latest status

Contact information:

Vy Nguyen CCRP

(480) 342-1328

Nguyen.Vy@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Avni Joshi, M.D., M.S.

Open for enrollment

Contact information:

Department of Medicine - Clinical Trials Unit

(507) 266-1944

RSTDOMCTU@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20493022

Mayo Clinic Footer