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.1. 支撑当前待审文章所报告结果的个体参与者数据：《鸡蛋清牛初乳补充剂减轻轻中度2019冠状病毒病（COVID-19）患者症状：一项双盲随机对照试验》，作者为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。 待审文章摘要：鸡蛋清中的卵转铁蛋白、溶菌酶以及牛初乳中的乳铁蛋白均具备免疫调节与抗病毒特性。本研究提出假设：摄入鸡蛋清与牛初乳可降低轻中度2019冠状病毒病（COVID-19）患者进展为重症的风险。本项双盲随机对照研究中，将重症风险升高且症状发作5天内的新冠病毒检测阳性受试者随机分为两组，分别每日两次摄入鸡蛋清与牛初乳（干预组，n=77）或安慰剂（安慰剂组，n=79），干预周期为5天。在为期6周的随访期间，研究人员分别于入组后第2、4、7、14及28天通过电话收集受试者的症状信息与卡氏评分（Karnofsky score）；并于症状发作后11-13天的临床随访中，通过联合采集鼻与口咽拭子评估病毒清除情况。于入组后第42天通过电话评估新冠后遗症情况。仅1名干预组受试者进展为重症。干预组在入组后第4天（p=0.046）及第11-13天（p=0.007）的方案定义重症型症状数量显著低于安慰剂组。干预组中显著缓解的单一症状包括：胸痛（第4天，p=0.038）、发热/寒战（第7天，p=0.014）、关节痛/乏力不适（第11-13天，p=0.009）以及咽痛（第11-13天，p=0.038）。两组在卡氏评分、病毒清除率及新冠后遗症发生率方面未观察到显著差异。本干预措施可减轻轻中度COVID-19患者的临床症状。本试验已在sanctr.samrc.ac.za平台注册（登记编号：DOH-27-062021-9191）。 2. 试验方案及方案附录。