Impact of Colchicine To Improve long-COVID-19 or ARDS Outcomes
A multi-centre trial of colchicine vs control to improve clinical outcomes in adults with long-SARS-CoV-2 (COVID-19) or ARDS
University of Sydney
1,000 participants
Dec 13, 2021
Interventional
Conditions
Summary
SARS CoV-2 (COVID-19) is highly infectious, with each case transmitting infection to between 2 to 3 other people. Approximately 15% of COVID-19 infected individuals are hospitalised and 1 in 3 require artificial ventilatory support. Up to a third have a poor prognosis with the main cause of death being overwhelming respiratory failure and/or cardiac failure and cardiac arrest associated with a cytokine storm. Approximately 30% of hospitalised individuals will ultimately require artificial ventilatory support for deteriorating respiratory status while under clinical observation. Conservatively, at least one third of intubated people will succumb to the infection with the most common causes of death being overwhelming respiratory failure associated with acute respiratory distress syndrome (ARDS) and/or cardiac failure and cardiac arrest, both associated with cytokine storm. Over 1.9 million individuals of the 46 million infected individuals globally have died from COVID-19 infection (as of January 2021), with many more deaths projected over the next 6-12 months. Fatal outcomes are thought to be driven by inflammatory responses to the virus resulting in host-mediated tissue damage to the lung, heart, and kidney and a prothrombotic milieu. Approximately 10% of patients with COVID-19 suffer from symptoms beyond 3-4 weeks, labelled as ‘long COVID-19.’ A variety of symptoms are experienced including cough, breathlessness, fever, sore throat, chest pain and cognitive deficits. Oral colchicine has demonstrated striking anti-inflammatory properties in patients with vascular disease and a “single shot” of colchicine markedly suppresses monocyte inflammasome activation, which is pivotal in the cascade leading to the cytokine storm. Troublesome side effects with colchicine appears to be rare. Thus, this treatment may reduce the serious complications associated with COVID-19 and non-COVID-19 ARDS.
Eligibility
Inclusion Criteria9
- Aged 18 years and older.
- 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.
- Patients that score 4-5 on the WHO COVID Ordinal Scale for Clinical Improvement.
- Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
- Signed, written informed consent from the participant.
- Aged 18 years and older.
- Hospitalised with non-COVID-19 ARDS with hypoxia (SpO2 less than or equal to 93% on room air) requiring oxygen therapy.
- Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
- Signed, written informed consent from the participant.
Exclusion Criteria11
- Treating team deems enrolment in the study is not in the best interests of the participant.
- Death is deemed to be imminent and inevitable within the next 24 hours.
- Either the patient or their primary treating clinician is not committed to active treatment.
- Current treatment with colchicine.
- Known severe allergic response (e.g. profuse diarrhoea) to colchicine.
- Potential severe drug interaction with colchicine.
- Receiving concurrent Anakinra.
- End-stage renal disease with eGFR less than or equal to 30 ml/min/m2.
- Acute or chronic hepatitis, with liver enzyme abnormalities > 5 x ULN at baseline.
- Known HIV infection or other immunocompromised status (with the exception of steroids including dexamethasone and tocilizumab).
- 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.
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Interventions
Arm A: Colchicine 0.5 mg tablet twice daily given orally or crushed via nasogastric/PEG tube for 6 months + standard of care Arm B: Standard of care
Locations(2)
View Full Details on ANZCTR
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ACTRN12621000637842