drugset / Trial / NCT04331899
Single-Blind Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19
RandomizedParallel-groupSingle-blindTreatment
Summary
To evaluate the efficacy of a single dose of subcutaneous injections of 180 ug of Peginterferon Lambda-1a, compared with placebo in reducing the duration of viral shedding of SARS-CoV-2 virus in patients with uncomplicated COVID-19 disease.
Timeline
- Start
- 2020-04-25
- Primary completion
- 2020-08-14
- Completion
- 2021-05-06
Outcome
Missed primary endpoint
paper In this study, a single dose of subcutaneous Peginterferon Lambda-1a neither shortened the duration of SARS-CoV-2 viral shedding PMID 33785743 ↗
registry analysis (other test); Lambda vs Placebo; p = 0.29; Cox Proportional Hazard 0.81 (95% CI 0.56 to 1.19); NCT04331899 ↗
Publications
- Results Jagannathan P, Andrews JR, Bonilla H, Hedlin H, Jacobson KB, Balasubramanian V, Purington N, Kamble S, de Vries CR, Quintero O, Feng K, Ley C, Winslow D, Newberry J, Edwards K, Hislop C, Choong I, Maldonado Y, Glenn J, Bhatt A, Blish C, Wang T, Khosla C, Pinsky BA, Desai M, Parsonnet J, Singh U. Peginterferon Lambda-1a for treatment of outpatients with uncomplicated COVID-19: a randomized placebo-controlled trial. Nat Commun. 2021 Mar 30;12(1):1967. doi: 10.1038/s41467-021-22177-1.
- McCarthy MW. Interferon lambda as a potential treatment for COVID-19. Expert Opin Biol Ther. 2023 May;23(5):389-394. doi: 10.1080/14712598.2023.2211709. Epub 2023 May 8.
- van der Ploeg K, Kirosingh AS, Mori DAM, Chakraborty S, Hu Z, Sievers BL, Jacobson KB, Bonilla H, Parsonnet J, Andrews JR, Press KD, Ty MC, Ruiz-Betancourt DR, de la Parte L, Tan GS, Blish CA, Takahashi S, Rodriguez-Barraquer I, Greenhouse B, Singh U, Wang TT, Jagannathan P. TNF-alpha+ CD4+ T cells dominate the SARS-CoV-2 specific T cell response in COVID-19 outpatients and are associated with durable antibodies. Cell Rep Med. 2022 Jun 21;3(6):100640. doi: 10.1016/j.xcrm.2022.100640. Epub 2022 May 3.
- Jacobson KB, Rao M, Bonilla H, Subramanian A, Hack I, Madrigal M, Singh U, Jagannathan P, Grant P. Patients With Uncomplicated Coronavirus Disease 2019 (COVID-19) Have Long-Term Persistent Symptoms and Functional Impairment Similar to Patients with Severe COVID-19: A Cautionary Tale During a Global Pandemic. Clin Infect Dis. 2021 Aug 2;73(3):e826-e829. doi: 10.1093/cid/ciab103.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Peginterferon Lambda-1a | Protein / enzyme biologic | 180 ug | Subcutaneous |