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.

文件：
1. 支撑当前待审文章所报告结果的个体参与者数据：
《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：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：
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。本研究假设，摄入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出现后5天内的新冠病毒检测阳性患者随机分为两组，分别每日两次服用蛋清牛初乳制剂（干预组，n=77）或安慰剂（安慰剂组，n=79），连续服用5天。在6周的随访期内，分别于入组后第2、4、7、14、28天通过电话收集症状与卡氏（Karnofsky）评分信息，并于症状出现后11-13天的门诊随访中，通过联合鼻咽拭子和口咽拭子检测评估病毒清除情况。于入组后第42天通过电话评估新冠后遗症情况。仅1名干预组患者进展为重症。干预组在入组后第4天（p=0.046）及第11-13天（p=0.007）的方案预设重症型症状数量显著少于安慰剂组。干预组中显著减轻的个体症状包括：胸痛（入组后第4天，p=0.038）、发热/寒战（入组后第7天，p=0.014）、关节痛/乏力不适（入组后第11-13天，p=0.009）以及咽痛（入组后第11-13天，p=0.038）。两组在卡氏评分、病毒清除率及新冠后遗症方面均无显著差异。本干预手段可减轻轻中度COVID-19患者的症状。本试验已在sanctr.samrc.ac.za注册（注册号：DOH-27-062021-9191）。
2. 试验方案及方案附录。