Study design
SARS-CoV-2 infection
SARS-COV-2 INFECTION
In this study, an open-label, non-randomized, two-arm, blank-controlled, investigator-initiated trial was designed to assess the efficacy and safety of the intranasal spray cocktail A8G6 in preventing SARS-CoV-2 infection among close contacts with COVID-19 patients. The clinical trial was conducted at 6 designated quarantine hotels in Yuzhong District, Chongqing, China from November 27, 2022 and was completed on December 12, 2022.Recruited participants in the treatment group self-administrated a three doses of 0.7 mg (140 μl) A8G6 nasal spray per day for 7 treatment days. The drug was supplied by Chongqing Mingdao Haoyue Biotechnology Co., LTD (Chongqing, China), stored at 2–8 °C. In the blank control group, participants did not receive any treatment. After enrollment, SARS-CoV-2 infection was confirmed by a reverse transcription polymerase chain reaction (RT-PCR) test of oropharyngeal swab. During this trial, with the adaption of the anti-COVID-19 policy, not only RT-PCR, but also rapid antigen tests were used to confirm the SARS-CoV-2 infection status.The trial was carried out in accordance with all applicable national and local regulatory requirements. Data and Safety Monitoring Board of The Second Affiliated Hospital of Chongqing Medical University oversaw trial conduct and documentation. The protocol has been approved by the Chinese clinical test registration center (the world health organization international clinical trials registered organization registered platform (ICTRP), the registration number: ChiCTR2200066416) and the Ethics Committees of The Second Affiliated Hospital of Chongqing Medical University (the approval number: 2022127-1).