ABSTRACT
Background This study has assessed the protective effect of a new Anti-COVID-19 SA58 Nasal Spray (SA58 Nasal Spray) against SARS-CoV-2 infection under continuous exposure.
Methods This is an exploratory open-label, single-arm trial. To evaluate the safety and effectiveness of SA58 against SARS-CoV-2 family transmission, SA58 was administered to all enrolled family contacts at 3∼6-hour intervals. The frequency of administration and adverse events (AEs) were self-reported by online questionnaire, and RT-PCR tests were used to diagnose SARS-CoV-2 infection. The effectiveness was assessed in comparison to a contemporaneous control group whose information was collected through three follow-up visits. Total effectiveness and single-day effectiveness were calculated.
Results The incidence of SARS-CoV-2 infection was 62.9% (44/70) in the experimental group and 94.8% (343/362) in the control group. Using SA58 nasal spray at least three times per day could possibly reduce the risk of household transmission of SARS-CoV-2 by 46.7%∼56.5%. The incidence of AEs was 41.4% and the severity of all AEs was mild.
Conclusion Even under the scenario of continuous exposure to SARS-CoV-2, SA58 nasal spray remained effective in blocking viral transmission and was well tolerated.
Competing Interest Statement
Lianhao Wang, Keqiang Sun, Yafeng Bao, Can Wu, Junfan Pu, Junlan Wu and Qiang Gao are employees of Sinovac Life Sciences Co., Ltd. Yuansheng Hu, Gang Zeng, Jianfeng Wang and Xing Han are employees of Sinovac Biotech Co., Ltd.
Clinical Trial
NCT05667714
Funding Statement
This study was funded by Sinovac Life Sciences Co., LTD.
Author Declarations
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
The clinical trial protocol and informed consent form were approved by the Ethics Committee of Beijing Ditan Hospital, Capital Medical University (Reference No. DTEC-YW2022-024-01).
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
Yes
Footnotes
Funding: This study was funded by Sinovac Life Sciences Co., LTD.
Potential conflict of interest: Lianhao Wang, Keqiang Sun, Yafeng Bao, Can Wu, Junfan Pu, Junlan Wu and Qiang Gao are employees of Sinovac Life Sciences Co., Ltd. Yuansheng Hu, Gang Zeng, Jianfeng Wang and Xing Han are employees of Sinovac Biotech Co., Ltd.
Data Availability
All data produced in the present study are available upon reasonable request to the authors