Interferon-α Nasal Spray Prophylaxis Reduces COVID-19 in Cancer Patients: A Randomized, Double-Blinded, Placebo-Controlled Trial

Yong et al., Clinical Infectious Diseases, doi:10.1093/cid/ciaf409, NCT04534725, Aug 2025

https://c19early.org/yong3.html

RCT 433 adult cancer patients showing lower risk of COVID-19 infection with daily interferon-alpha nasal spray prophylaxis compared to placebo over 90 days. There was no significant difference for hospitalization. Authors hypothesize that interferon-alpha's broad antiviral and immunomodulatory effects, particularly its role in innate immunity against respiratory viruses, explain the protective effect against COVID-19. Data is unclear - the count and percentage is inconsistent for infection-related hospitalization in the placebo group (authors report 7/216 (3.7%) and repeat 3.7% in the main text).

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risk of hospitalization, 13.8% higher, RR 1.14, p = 1.00, treatment 8 of 217 (3.7%), control 7 of 216 (3.2%).

risk of case, 42.2% lower, RR 0.58, p = 0.0498, treatment 18 of 217 (8.3%), control 31 of 216 (14.4%), NNT 17.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Yong et al., 28 Aug 2025, Double Blind Randomized Controlled Trial, placebo-controlled, Australia, peer-reviewed, 21 authors, trial NCT04534725 (history). Contact: michelle.yong@unimelb.edu.au, michelle.yong@petermac.org.au.

This Paper Miscellaneous All

Interferon-α Nasal Spray Prophylaxis Reduces COVID-19 in Cancer Patients: A Randomized, Double-Blinded, Placebo-Controlled Trial

Michelle K Yong, Karin Thursky, Megan Crane, Tim Spelman, Robert K Mahar, Julie A Simpson, Andrew M Scott, Simon J Harrison, Jeff Szer, Marc Pellegrini, Senthil Lingaratnam, Ken C Pang, Surekha Tennakoon, Beatrice Z Sim, Emily Blyth, Hui K Gan, Hang Quach, Michelle P Mcintosh, Hayley Page, Rachel Woolstencroft, Monica Slavin

doi:10.1093/cid/ciaf409/8241089

Background. We evaluated whether a daily nasal spray of interferon-alpha (IFN-α) would reduce the incidence of COVID-19 or community-acquired respiratory viral infections in adult cancer patients. Methods. In this multicenter, randomized, double-blinded, placebo-controlled trial, participants were randomized 1:1 to receive daily 40 000 IU IFN-α nasal spray or normal saline placebo. Participants who developed influenza-like symptoms selfcollected nasal swabs for PCR testing of SARS-CoV-2, influenza A/B, respiratory syncytial virus, parainfluenza, adenovirus, seasonal coronavirus, picornavirus, human metapneumovirus, and/or SARS-CoV-2 rapid antigen testing. Co-primary endpoints were incidence of COVID-19 and/or other respiratory viruses ≤90 days of randomization. Results. Four hundred and thirty-three participants were randomized to IFN-α (n = 217) or placebo (n = 216). 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 (relative risk [RR]: .60; 95% credible interval [CrI]: .33-.97). Other respiratory viral infection incidence was 5.1% and 5.1% in both groups (RR: 1.12; .43-2.34). In the per-protocol cohort (n = 389), the incidence of COVID-19 in IFN-α and placebo groups was 7.7% and 16.0% (RR: .50; .26-.84) with other respiratory virus incidence of 4.6% and 5.7%, respectively. Subgroup analysis demonstrated lower COVID-19 in the IFN-α group for ages <65 years (RR: .48; .20-.92), female sex (RR: .44;), but no difference by underlying malignancy. No differences were observed in secondary endpoints of severity, hospitalization, and mortality. IFN-α was well tolerated and safe. Conclusions. IFN-α nasal spray prophylaxis reduced the incidence of COVID-19 among adult cancer patients. Clinical Trials Registration. ClinicalTrials.

Supplementary Data Supplementary materials are available at Clinical Infectious Diseases online. Consisting of data provided by the authors to benefit the reader, the posted materials are not copyedited and are the sole responsibility of the authors, so questions or comments should be addressed to the corresponding author. Notes Acknowledgments. The authors thank all the study participants and their carers.

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DOI record: { "DOI": "10.1093/cid/ciaf409", "ISSN": [ "1058-4838", "1537-6591" ], "URL": "http://dx.doi.org/10.1093/cid/ciaf409", "abstract": "Abstract\n \n Background\n We evaluated whether a daily nasal spray of interferon-alpha (IFN-α) would reduce the incidence of COVID-19 or community-acquired respiratory viral infections in adult cancer patients.\n \n \n Methods\n In this multicenter, randomized, double-blinded, placebo-controlled trial, participants were randomized 1:1 to receive daily 40 000 IU IFN-α nasal spray or normal saline placebo. Participants who developed influenza-like symptoms self-collected nasal swabs for PCR testing of SARS-CoV-2, influenza A/B, respiratory syncytial virus, parainfluenza, adenovirus, seasonal coronavirus, picornavirus, human metapneumovirus, and/or SARS-CoV-2 rapid antigen testing. Co-primary endpoints were incidence of COVID-19 and/or other respiratory viruses ≤90 days of randomization.\n \n \n Results\n Four hundred and thirty-three participants were randomized to IFN-α (n = 217) or placebo (n = 216). 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 (relative risk [RR]: .60; 95% credible interval [CrI]: .33–.97). Other respiratory viral infection incidence was 5.1% and 5.1% in both groups (RR: 1.12; .43–2.34). In the per-protocol cohort (n = 389), the incidence of COVID-19 in IFN-α and placebo groups was 7.7% and 16.0% (RR: .50; .26–.84) with other respiratory virus incidence of 4.6% and 5.7%, respectively. Subgroup analysis demonstrated lower COVID-19 in the IFN-α group for ages &lt;65 years (RR: .48; .20–.92), female sex (RR: .44; .19–.85), and COVID-19 vaccinated (RR: .50; .26–.82), but no difference by underlying malignancy. No differences were observed in secondary endpoints of severity, hospitalization, and mortality. IFN-α was well tolerated and safe.\n \n \n Conclusions\n IFN-α nasal spray prophylaxis reduced the incidence of COVID-19 among adult cancer patients.\n \n \n Clinical Trials Registration\n ClinicalTrials.gov identifier: NCT04534725 (ANZCTR: ACTRN12620000843954)\n ", "article-number": "ciaf409", "author": [ { "ORCID": "https://orcid.org/0000-0002-8692-4145", "affiliation": [ { "name": "Department of Infectious Diseases, Peter MacCallum Cancer Centre , Melbourne, Victoria ,", "place": [ "Australia" ] }, { "name": "Sir Peter MacCallum Department of Oncology, The University of Melbourne , Melbourne, Victoria ,", "place": [ "Australia" ] }, { "name": "Department of Infectious Diseases, Royal Melbourne Hospital , Melbourne, Victoria ,", "place": [ "Australia" ] }, { "name": "National Centre for Infections in Cancer, Peter MacCallum Cancer Centre , Melbourne, Victoria ,", "place": [ "Australia" ] } ], "authenticated-orcid": false, "family": "Yong", "given": "Michelle K", "sequence": "first" 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Please send us corrections, updates, or comments. c19early involves the extraction of 200,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. IMA and WCH provide treatment protocols.

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