Evaluating the efficacy and safety of a novel prophylactic nasal spray in the prevention of SARS-CoV-2 infection: A multi-centre, double blind, placebo-controlled, randomised trial.
Damian Balmforth, James A Swales, Laurence Silpa, Alan Dunton, Kay E Davies, Stephen G Davies, Archana Kamath, Jayanti Gupta, Sandeep Gupta, M Abid Masood, Áine Mcknight, Doug Rees, Angela J Russell, Manu Jaggi, Rakesh Uppal
Journal of Clinical Virology, doi:10.1016/j.jcv.2022.105248
Evaluating the efficacy and safety of a novel prophylactic nasal spray in the prevention of SARS-CoV-2 infection: A multi-centre, double blind, placebo-controlled, randomised trial.,
A statistically significant reduction in experiencing any clinical symptom was seen in those treated with the test agent compared to placebo [57 cases (17.6%) vs 112 cases (34.6%); OR 0.40, (95% CI; 0.27-0.59), p<0.0001]. As per the primary endpoint, these results were reflected across sex (male 15.3% vs 31.8% p= 0.0001; female 21.7% vs 39% p= 0.0048) and all age groups (18-35; 26.5% vs 43.6% p= 0.009: 36-65; 19.4% vs 36.9% p= 0.0018: 65+; 6.9% vs 33/3% p= 0.0407). A breakdown of all symptoms experienced in either treatment arm is given in Appendix 2; Supplementary information. Mean time to resolution of symptoms was 1.74 days in the test agent group compared to 1.95 days for the placebo (p=0.1729) (table 4). A comparison of SARS-CoV-2 IgGS antibody status and symptom status for each treatment group is shown in table 5 . This analysis shows that for participants who did not contract SARS-CoV-2 infection during the study period as evidenced by a negative IgGS antibody result, reported symptoms were significantly lower in the test agent group [n=35 (14.5%)] than in the placebo group [n= 67 (36.4%)] (p<0.001). No significant difference was seen in the proportion of patients who reported symptoms amongst patients who tested positive for IgGS. Acceptability testing showed that subjects had a positive experience of using both the test agent and placebo nasal sprays (figure 2 ). Both sprays were comfortable to use, easy to carry, easy to use and had an acceptable odour..
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