ABSTRACT
Background. Outpatient treatment with SARS-CoV-2-neutralizing antibody combination AZD7442 (tixagevimab/cilgavimab) in adults with mild to moderate COVID-19 significantly reduced progression to severe disease or death through Day 29 and was well-tolerated in the Phase 3 TACKLE study primary analysis (NCT04723394). AZD7442 administered earlier in the disease course leads to more favorable outcomes and has the potential to prevent COVID-19 hospitalizations and reduce hospital burden. We report key secondary efficacy results with longerterm safety data from TACKLE over 6 months. Methods. In TACKLE, non-hospitalized adults with mild to moderate COVID-19 were randomized 1:1 and dosed <=7 days from symptom onset with a single 600-mg AZD7442 dose (2 consecutive intramuscular injections, 300 mg of each antibody;n=452) or placebo (n=451). The key secondary endpoint was death from any cause or hospitalization for COVID-19 complications or sequelae through Day 169, analyzed using a Cochran-Mantel-Haenszel test stratified by time from symptom onset and risk of severe COVID-19 progression. Results. Death from any cause or hospitalization for COVID-19 complications or sequalae occurred in 20 (5.0%) versus 40 (9.8%) participants receiving AZD7442 versus placebo, respectively, translating to a relative risk reduction (RRR) of 49.1% (95% confidence interval [CI] 14.5-69.7) versus placebo (P=0.009). A sensitivity analysis excluding participants who were unblinded prior to Day 169 for consideration of vaccination yielded a similar RRR of 50.7% (95% CI 17.5-70.5;P=0.006). For baseline seronegative participants, an RRR of 58.6% (95% CI 27.6-76.4;P=0.001) was observed. The median (range) safety follow-up was 170 (1-330) days with AZD7442 and 170 (1-326) days with placebo. Adverse events occurred in 38.5% of AZD7442 participants and 43.5% of placebo participants, and were mostly mild to moderate. Conclusion. A single 600-mg AZD7442 dose demonstrated statistically significant protection against death from any cause or hospitalization for COVID-19 through 6 months, and was well-tolerated. These data provide further support of AZD7442 in the COVID-19 outpatient treatment setting, with potential to reduce hospital burden.
ABSTRACT
Background: Swab collection is a challenging task, and the health-care workers (HCWs) have to face many difficulties while collecting swab samples of suspected patients. They often need to counsel the suspects as some think they do not have an infection but carry fear. Appropriate precautions should be taken in collecting specimens since this may expose HCWs to respiratory secretions from the suspects. Purpose: The purpose of the study was to assess awareness, anxiety, and stress among HCWs deployed in swab collection during the COVID-19 pandemic in Andhra Pradesh, India. Materials and Methods: A total of 102 HCWs filled out the questionnaire in this cross-sectional study. Google Forms were sent through WhatsApp and email. The participants were asked to forward the link to other known people who were also deployed in swab collection. The study took place in Nellore, Andhra Pradesh, for 1 month. Results: About 73.5% of HCWs underwent training in swab collection. 90% of the undergraduates and 89% of the postgraduates were unhappy while staying away from family. Most of the study participants continued to wear personal protective equipment until completion of the working period. 39 of 44 undergraduates felt that swab collection was a high-risk job, and 42 of 55 postgraduates felt the same. Conclusion: Most of the HCWs are unhappy staying away from their family while deployed in swab collection. Majority of them reported swab collection as a high-risk job. As they are frontline workers, an enhanced variety of support should be offered. Psychosocial support and effective measures should be made readily available to them.