The CAN-COVID Clinical Trial

The CAN-COVID clinical trial has been one of the ways Novartis is drawing on its global resources and scientific expertise in response to the COVID-19 pandemic.

Click here for the CAN-COVID media release

While we are disappointed with the outcome of the CAN-COVID trial, we are proud to be part of the international effort being made to address the global pandemic. Novartis and the healthcare industry as a whole play a vital role in developing medicines and offering support to help combat COVID-19.

We are deeply grateful to the patients who participated and their caregivers, as well as the healthcare professionals and hospital staff who made the CAN-COVID trial possible while fighting the pandemic on the front line.

COVID-19 and CRS

Image representing cytokine release syndrome mechanism
CRS mechanism: following COVID-19 infection, the body’s immune response is triggered to fight the virus. This includes release of cytokines, which act as signals for the immune system as part of a normal response. In some people, the response can result in uncontrolled inflammation and a harmful “cytokine storm”, leading to severe illness.

Evidence suggests that some patients who develop severe illness due to COVID-19 do so due to Cytokine Release Syndrome (CRS) – this is when the body produces too many cytokines that can cause damage rather than helping the body fight the virus. This can cause life-threatening complications in these patients.

Stages of COVID-19 and the CAN-COVID trial

Image showing the 3 stages of COVID-19 progression with the CAN-COVID trial focused on Stage 2b
The time course of COVID-19 progression, showing increasing disease severity through the three stages of the disease: early infection, pulmonary and systemic. Adapted from Siddiqi, 2020.

The CAN-COVID trial focused on patients during a specific stage of COVID-19 – severe COVID-19 patients with pneumonia and CRS. This includes people whose lungs are affected and have low blood oxygen levels (Stage IIB). The patients were hospitalized and hypoxic but not requiring intubation or invasive mechanical ventilation.

CAN-COVID was initiated due to evidence of elevated interleukin (IL)-1β levels in patients with COVID-19-induced pneumonia and cytokine release syndrome (CRS) However, the results are consistent with the latest evidence suggesting that targeting interleukins (such as IL-1), which form part of the body’s overactive immune response, is not likely to be beneficial in patients with severe COVID-19.

Frequently asked questions

What is CAN-COVID?

CAN-COVID is a Phase III, multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of canakinumab plus standard of care (SoC) in patients with COVID-19 pneumonia and cytokine release syndrome (CRS), compared with placebo plus SoC.

You can find more detailed information about CAN-COVID here.

Why was CAN-COVID initiated?

CAN-COVID was initiated due to evidence of elevated interleukin (IL)-1β levels in patients with COVID-19-induced pneumonia and cytokine release syndrome (CRS). However, the results are consistent with the latest evidence suggesting that targeting interleukins (such as IL-1), which form part of the body’s overactive immune response, is not likely to be beneficial in patients with severe COVID-19.

What was the outcome of the CAN-COVID study?

The Phase III trial investigating canakinumab plus standard of care (SoC) did not meet its primary endpoint of a greater chance of patient survival without the need for invasive mechanical ventilation, or its key secondary endpoint of reduced COVID-19 mortality, compared with placebo plus SoC.

You will find more information in our CAN-COVID media release.

Were there any safety concerns?

No new safety signals for canakinumab were identified. The safety profile of canakinumab plus standard of care (SoC) observed in the CAN-COVID trial was comparable to placebo plus SoC. canakinumab remains an effective treatment option for its approved indications, with a well-characterized safety profile, based on previously reported clinical trials and over 10 years of patient experience since its first approval in 2009.

Does Novartis have other clinical trials in COVID-19?

We are continuing with the Phase III trial for ruxolitinib, another Novartis medicine, in collaboration with Incyte. Preliminary results from this trial are expected by year end. We are also investigating two medicines in early stage development focused on stopping or slowing the body’s overactive immune response to COVID-19, and we have announced a collaboration with Molecular Partners to develop two DARPin® therapies designed for potential use against COVID-19.

What else is Novartis doing to help combat COVID-19?

For the most up to date information on our ongoing response to the COVID-19 pandemic please take a look at novartis.com/coronavirus.

See our media release for more detailed information on the CAN-COVID trial.

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