NCT04534725

COVID-19 Prevention and Treatment in Cancer; a Sequential Multiple Assignment Randomised Trial;

COVID-19 Prevention and Treatment in Cancer; a Sequential Multiple Assignment Randomised Trial; C-SMART Study.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 441 (actual)
• Sponsor: Peter MacCallum Cancer Centre, Australia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multi-centre Australian trial with four arms aims to evaluate several different immune modulating drugs for prevention and treatment of COVID-19 specifically in the cancer population. ARM 1 is evaluating the effect of interferon-alpha (vs placebo) on the incidence of COVID-19 infection in cancer patients with no COVID-19 infection or no known COVID-19 positive contacts. ARM 2 is evaluating the effect of interferon-alpha (vs placebo) on the incidence of COVID-19 infection in cancer patients with confirmed exposure to COVID-19 virus. ARM 3 is evaluating the effect of Selinexor (vs placebo) on the incidence of COVID-19 infection in cancer patients with moderate COVID-19 infection. ARM 4 is evaluating the effect of Lenzilumab (vs placebo) on the treatment of COVID-19 infection in cancer patients with severe COVID-19 infection. Participants may become eligible and transition to different arms and treatments if they become exposed to COVID-19 or are hospitalised with an active moderate/severe COVID-19 infection. It is hoped this research will provide insight into the best practice for prevention and treatment of COVID-19 in cancer patients as emerging standard of care measures are not always suitable to this especially vulnerable population.

Conditions

• Cancer
• Covid19
• Respiratory Viral Infection

Interventions

Type	Name	Description
DRUG	Interferon alfa	intranasal spray
DRUG	Selinexor	oral tablet
DRUG	Lenzilumab	intravenous infusion

Timeline

• Start date: 2020-12-17
• Primary completion: 2022-11-28
• Completion: 2023-04-19
• First posted: 2020-09-01
• Last updated: 2023-08-24

Locations

5 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study