ESTHER study: Hen egg white bovine colostrum supplement reduces symptoms in individuals with mild or moderate coronavirus disease of 2019: A double-blind randomized control trial

Files: 1. Individual participant data that underlie the results reported in the article currently under review : Hen egg white bovine colostrum supplement reduces symptoms in individuals with mild or moderate coronavirus disease of 2019: A double-blind randomized control trial Jaclyn Kelly Mann, Tarylee Reddy, Mary van der Stok, Ayanda Ngubane, Takalani Mulaudzi, Nobuhle Mchunu, Portia Nevhungoni, Nithendra Manickchund, Pariva Manickchund, Chelline Helena Louise Cairns, Vaneshree Govender, Thumbi Ndung’u, Mahomed Yunus Suleman Moosa, Bernadett Isabel Gosnell Abstract from the article under review: Ovotransferrin and lysozyme in hen egg white and lactoferrin in bovine colostrum have immunomodulatory and antiviral properties. It was hypothesized that consumption of hen egg white and bovine colostrum would reduce risk of progression to severe disease in patients with mild/moderate coronavirus disease of 2019 (COVID-19). In this double-blind randomized control study, COVID-19 positive individuals at increased risk of severe disease and within 5 days of symptom onset were randomly assigned to consume hen egg white and bovine colostrum (n = 77) or placebo (n = 79) twice daily for 5 days. During the 6-week follow-up, information on symptoms and Karnofsky status were collected telephonically on days 2, 4, 7, 14 and 28 post-enrollment, as well as at a clinic visit at 11-13 days post-symptom onset, during which viral clearance was assessed via combined nasal and oropharyngeal swabs. Post-COVID-19 symptoms were assessed telephonically at day 42. Only 1 participant (active arm) progressed to severe disease. There were significantly fewer protocol-defined severe-type symptoms in the active arm at day 4 (p = 0.046) and day 11-13 (p = 0.007). The individual symptoms that were significantly reduced in the active arm were chest pain (day 4, p = 0.038), fever/chills (day 7, p = 0.014), joint pain/malaise (day 11-13, p = 0.009), and sore throat (day 11-13, p = 0.038). No significant differences in Karnofsky score, viral clearance or post-COVID-19 sequelae were observed. The intervention reduced symptoms in individuals with mild/moderate COVID-19. The trial was registered at sanctr.samrc.ac.za (DOH-27-062021-9191). 2. The trial protocol and protocol appendices.