Study design and participants
neurological disease, convulsions, fever, epilepsy, seizures, throat, laboratory-confirmed SARS-CoV-2 infection, psychosis, allergies
DISORDER, NEUROLOGICAL DISEASE, EPILEPSY, ALLERGIES, CHRONIC DISEASE
This randomized, single-blind, placebo-controlled clinical trial evaluated the efficacy and safety of the SA58 Nasal Spray in healthy adult workers within 72 h of contact with a SARS-CoV-2-infected individual in Beijing, China. The study was conducted from 26 November 2022 to 9 December 2022 at 21 construction sites (median number of workers = 45, range = 9–235) that had COVID-19 outbreaks reported within two days of the first COVID-19 case notified. The construction sites setting was selected because we wanted to evaluate SA58 firstly in healthy adults before expanding to other high-risk populations, and we could enrol a large number of healthy adult workers on construction sites during a short period of time. Moreover, prior to the study the Chinese government sticked on strict containment measures against COVID-19 before issuing the new public health policy on 7 December 2022 [In this study, all healthy workers in the 21 construction sites were offered the opportunity to participate based on the following inclusion/exclusion criteria. Participants were eligible for inclusion if they were aged 18 years or older, had potential exposure to a well-identified individual with laboratory-confirmed SARS-CoV-2 infection (index case), and if the presumable contact occurred within 72 h of the positive reverse transcriptase polymerase chain reaction (RT–PCR) test of the index case. The key exclusion criteria were individuals with known history of severe allergies or reaction to any component of inhaled SA58 Nasal Spray; those currently pregnant, lactating, or expected to be pregnant during the study period; those who participated in any kind of clinical trials of SARS-CoV-2 neutralizing antibody injections in the preceding 180 days before screening or participated in any investigational medicinal product in the preceding four weeks before screening; were unable to take nasal spray inhalation; had reported fever at enrollment or axillary temperature of more than 37.0°C; had severe neurological disease (e.g. epilepsy, convulsions, or seizures) or psychosis, or family history of psychosis; or had any other significant chronic disease, disorder, or finding that, in the judgement of the investigator, significantly increased the risk to the participant because of participation in the study, affected the ability of the participant to participate in the study, or impaired interpretation of the study data. Full eligibility criteria are provided in the Supplementary Material. A nasopharyngeal swab, nasal swab, or throat swab was collected at baseline for detection of SARS-CoV-2 nucleic acid by RT–PCR tests, but the results of baseline RT–PCR tests were not used to determine the eligibility of participants.