COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12621000637842.aspx

Prof Anthony Keech

cmt@ctc.usyd.edu.au

2021-05-27

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

Inclusion criteria for COVID-19 participants: 1. Aged 18 years and older. 2. Hospitalised with confirmed COVID-19 respiratory infection by swab-positive PCR with hypoxia (SpO2 less than or equal to 93% on room air) requiring oxygen therapy. 3. Patients that score 4-5 on the WHO COVID Ordinal Scale for Clinical Improvement. 4. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments. 5. Signed, written informed consent from the participant. Inclusion criteria for non-COVID-19/ARDS participants: 1. Aged 18 years and older. 2. Hospitalised with non-COVID-19 ARDS with hypoxia (SpO2 less than or equal to 93% on room air) requiring oxygen therapy. 3. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments. 4. Signed, written informed consent from the participant.

1. Treating team deems enrolment in the study is not in the best interests of the participant. 2. Death is deemed to be imminent and inevitable within the next 24 hours. 3. Either the patient or their primary treating clinician is not committed to active treatment. 4. Current treatment with colchicine. 5. Known severe allergic response (e.g. profuse diarrhoea) to colchicine. 6. Potential severe drug interaction with colchicine. 7. Receiving concurrent Anakinra. 8. End-stage renal disease with eGFR less than or equal to 30 ml/min/m2. 9. Acute or chronic hepatitis, with liver enzyme abnormalities > 5 x ULN at baseline. 10. Known HIV infection or other immunocompromised status (with the exception of steroids including dexamethasone and tocilizumab). 11. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.

2

University of Sydney

18

100

Australia;India

Severe disease at enrollment

6: Severe disease at enrollment

1000

To compare COVID-19 WHO score greater than or equal to 2 (for participants with COVID-19) or Dyspnoea Management Questionnaire-30 (for participants with ARDS) breathlessness scores at 6 months. This is composite primary outcome. [6 months post randomisation ];Maximum oxygen requirement (increase or decrease) over 6 months defined as follows: - An increase in oxygen requirement will be defined by 1. Increasing oxygen flow rate or FiO2 using the same oxygen delivery device; or 2. Escalation to invasive and non-invasive mechanical ventilation/ECMO or vasopressor/ionotropic support.- A decrease in oxygen requirement will be defined as a decrease in oxygen flow rate or FiO2 using the same oxygen delivery device; or cessation of oxygen support requirement. The peak oxygen requirement (i.e. increase from that at baseline) will be recorded; irrespective of the time of occurrence up until discharge and 6 months. Likewise; the greatest decrease will also be recorded; irrespective of the time of occurrence up until discharge and 6 months.[6 months post randomisation ];Death at 6 months and end of study. This will be ascertained by assessment of medical records. [6 months post randomisation and end of study. ]

Phase 3

[{"arm_notes": "", "treatment_id": 310, "treatment_name": "Colchicine", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]