COVID-19 Prevention and Treatment in Cancer; a Sequential Multiple Assignment Randomised Trial;
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.
Timeline
- Start
- 2020-12-17
- Primary completion
- 2022-11-28
- Completion
- 2023-04-19
Outcome
Mixed primary results
paper The incidence of COVID-19 was lower in the IFN-α group versus placebo (8.3% vs 14.4%), indicating a 40% reduced risk of infection PMID 40874769 ↗
paper relative risk [RR]: .60; 95% credible interval [CrI]: .33-.97 PMID 40874769 ↗
paper Other respiratory viral infection incidence was 5.1% and 5.1% in both groups (RR: 1.12; .43-2.34). PMID 40874769 ↗
Publications
- Yong MK, Thursky K, Crane M, Spelman T, Mahar RK, Simpson JA, Scott AM, Harrison SJ, Szer J, Pellegrini M, Lingaratnam S, Pang KC, Tennakoon S, Sim BZ, Blyth E, Gan HK, Quach H, McIntosh MP, Page H, Woolstencroft R, Slavin M. Interferon-alpha Nasal Spray Prophylaxis Reduces COVID-19 in Cancer Patients: A Randomized, Double-Blinded, Placebo-Controlled Trial. Clin Infect Dis. 2026 Feb 25;82(2):e208-e216. doi: 10.1093/cid/ciaf409.
- Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenzilumab | Monoclonal antibody | — | Intravenous |
| Subject | Selinexor | Other / unclassified | — | Oral |
| Subject | interferon alfa | Protein / enzyme biologic | 40000 iu | Intranasal |