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ABSTRACT
Following the national dynamic zero-COVID strategy adjustment, the utilization of broad-spectrum nasal neutralizing antibodies may offer an alternative approach to controlling the outbreak of Omicron variants between late 2022 and early 2023 in China. This study involved an investigator-initiated trial (IIT) to assess the pharmacokinetic, safety and efficacy of the F61 nasal spray. A total of 2,008 participants were randomly assigned to receive F61 nasal spray (24 mg/0.8 mL/dose) or normal saline (0.8 mL/dose) and 1336 completed the follow-up in the IIT. Minimal absorption of F61 antibody into the bloodstream was detected in individuals receiving F61 nasal spray for seven consecutive days. No treatment-emergent adverse reactions of grade 3 severity or higher were reported. In the one-dose cohort, the 7-day cumulative SARS-CoV-2 infection rate was 79.0% in the F61 group and 82.6% in the placebo group, whereas, in the multiple-dose (once daily for 7 consecutive days) cohort, the rates were 6.55% in the F61 group and 23.83% in the placebo group. The laboratory-confirmed efficacy of F61 was 3.78% (−3.74%–10.75%) in the one-dose cohort and 72.19% (57.33%–81.87%) in the multiple-dose cohort. In the real-world study, 60,225 volunteers in four different regions were administered the F61 nasal spray based on the subject's wishes, over 90% efficacy rate was observed against different Omicron variants. The F61 nasal spray, with its favourable safety profile, could be a promising prophylactic monoclonal antibody against SARS-CoV-2 VOCs.
Acknowledgements
We thank the trial participants, and all investigators, statistician involved in this trial. X.M.Y., M.F.L., K.D., C.L.H., initiated, coordinated, conceived, and designed the project and approved the final version of the manuscript. X.X.N., Q.L.Y., J.Y.Z., wrote the draft manuscript and revision. Y.L., W.L., S.N.R., Y.B.P., X.Y., W.C., Q.L.L., F.G., C.W., S.Z.W., L.N.S, Z.F.J., Z.Y.Z., Y.K.Y., F.G.L., W.J.W., took responsibility for the recruitment, follow-up, and data collection. M.F.L took responsibility for the integrity and the accuracy of the data analysis. X.M.Y., and K.D., provided administrative, technical, or material support.
Declaration of competing interest
The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: J.Y.Z., K.D., Y.B.P., X.X.N., X.Y., W.C., Q.L.L., F.G., C.W., Z.F.J., Z.J.W., Z.Y.Z., are employees of Wuhan Institute of Biological Products Co. Ltd., the company developed the antibody and sponsored the trial. X.M.Y., Y.K.Y., F.G.L., are employees of the China National Biotec Group Company Limited, which is the parent company of Wuhan Institute of Biological Products Co. Ltd., All other authors declare no competing interest.