Shanghai Jiao Tong University School of Medicine recently concluded an open label, prospective, non-randomized and interventional Phase III study investigating the preventive effect of recombinant human interferon alpha nasal drops on the infection rates of COVID-19 in medical staff on the front lines in the epidemic zone in China. Studying a total of 2,944 medical staff working at Taihe Hospital in Shiyan City, Hubei Province, China, a low-risk and high-risk group were separated: the low-risk group receiving recombinant human interferon alpha-1b nasal drops while the high-risk group received identical treatment to the low-risk group (rhlFN- α nasal drops) and combined with thymosin α1 (1.6 mg, hypodermic injection, once a week) along with secondary-level or third-level protection. Incredibly, among the two study groups not one medical staff contracted SARS-CoV-2 in the 28-day study period. Moreover, the 28-day incidence of new-onset clinical symptoms with negative images for pneumonia was also zero in both groups. The study team used a control group of 2,035 medical personal that had confirmed COVID-19 cases from the same area observed between January 21 to February 23, 2020. The investigators concluded in this yet-to-be peer-reviewed study that the use of rhIFN-α nasal drops may effectively prevent COVID-19 in medical staff used as an enhancement protection on the basis of standard physical isolation. Questions arise about the study design and control group. Given there is still no way to prevent COVID-19 and the world finds itself at major risk, will this study result become peer reviewed and hence discussed by a wider audience?
The Research Sponsor & Site
This study was sponsored by Shanghai Jiao Tong University School of Medicine. A major research university in Shanghai, it was established back in 1896 as Nanyang Public School by the then Emperor Guangxu. Referred to as the “MIT of the East” since the 1930s, it is renowned as one of China’s oldest and most prestigious universities. The study was conducted at Taihe Hospital, Hubei University of Medicine and led by Principal Investigator Zhongji Meng.
Titled “An Clinic Trial of Recombinant Human Interferon Alpha Nasal Drops to Prevent Coronavirus Disease 2019 in Medical Staff in Epidemic Area,” the study was an experimental and prospective, non-randomized, parallel assignment , open-label study involving the enrollment of 2,944 medical staff conducted at Taihe Hospital in Shiyan City, Hubei Province, China. The participants were divided into low-risk group and high-risk group based on whether they were directly exposed to SARS-CoV-2 infected patients. The low-risk cohort was given recombinant human interferon alpha-1b nasal drops (2-3 drops/nostril/time, 4 times/day), and the high-risk group will be given preventive intervention with interferon nasal drops and thymosin- α (thymosin was injected subcutaneously once/week), and the intervention is 28 days. At the end of 28 days no medical staff contracted COVID-19 according to this study while many did in a control group.
The study commenced back on January 21, 2020 right at the onset of the pandemic and just met its primary completion date, hence the summary in the preprint server.
Published and uploaded to the preprint server medRxiv, a group of authors report on some pretty incredible results if A) the study is designed correctly, and B) this data is accurate. A group of authors concluded based on the observations from this investigator-initiated open-label study that rhIFN-α nasal drops demonstrate promise for not only using to protect healthcare staff in the front lines against COVID-19 but also show potential for “protecting susceptible healthy people during the coronavirus pandemic.”
This study was funded by the “National Science and Technology Major Project” in China
Lead Research Investigator
Zhongji Meng, Hubei University of Medicine
Call to Action: Note this is not a peer reviewed study. There are questions as to the study design, the control group and other methodologies and underlying assumptions. Nonetheless, the authors are really making somewhat of a striking claim, hence the exposure here.