Mirjam Grimm, Lucie Ziegler, A. Seglias, M. Mademilov, Kamila Magdieva, G. Mirzalieva, A. Taalaibekova, Simone Suter, S. Schneider, Fiona Zoller, Vera Bissig, Lukas Reinhard, Meret Bauer, Julian Müller, T. Ulrich, A. Carta, P. Bader, K. Bitos, Aurelia E Reiser, B. Champigneulle, Damira Ashyralieva, P. Scheiwiller, Silvia Ulrich, T. Sooronbaev, M. Furian, K. Bloch
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High Alt Med Biol. 00:00-00, 2024. Background: Throughout the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) pandemic, virus transmission during clinical research was of concern. Therefore, during high-altitude field studies performed in 2021, we took specific COVID-19 precautions and investigated the occurrence of SARS-CoV-2 infection. Methods: From May to September 2021, we performed studies in patients with chronic obstructive pulmonary disease (COPD) and in healthy school-age children in Kyrgyzstan in high-altitude facilities at 3,100 m and 3,250 m and at 760 m. The various implemented COVID-19 safety measures included systematic SARS-CoV-2 rapid antigen testing (RAT). Main outcomes were SARS-CoV-2-RAT-positive rate among participants and staff at initial presentation (prevalence) and SARS-CoV-2-RAT-positive conversion during and within 10 days after studies (incidence). Results: Among 338 participants and staff, SARS-CoV-2-RAT-positive prevalence was 15 (4.4%). During mean ± SD duration of individual study participation of 3.1 ± 1.0 day and within 10 days, RAT-positive conversion occurred in 1/237(0.4%) participants. Among staff working in studies for 31.5 ± 29.3 days, SARS-CoV-2-RAT-positive conversion was 11/101(10.9%). In all 338 individuals involved in the studies over the course of 15.6 weeks, the median SARS-CoV-2-RAT-positive incidence was 0.00%/week (quartiles 0.00; 0.64). Over the same period, the median background incidence among the total Kyrgyz population of 6,636 million was 0.06%/week (0.03; 0.11), p = 0.013 (Wilcoxon rank sum test). Conclusions: Taking precautions by implementing specific safety measures, SARS-CoV-2 transmission during clinical studies was very rare, and the SARS-CoV-2 incidence among participants and staff was lower than that in the general population during the same period. The results are reassuring and may help in decision-making on the conduct of clinical research in similar settings.","PeriodicalId":12975,"journal":{"name":"High altitude medicine & biology","volume":null,"pages":null},"PeriodicalIF":1.6000,"publicationDate":"2024-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"SARS-CoV-2 Transmission during High-Altitude Field Studies.\",\"authors\":\"Mirjam Grimm, Lucie Ziegler, A. Seglias, M. Mademilov, Kamila Magdieva, G. Mirzalieva, A. Taalaibekova, Simone Suter, S. Schneider, Fiona Zoller, Vera Bissig, Lukas Reinhard, Meret Bauer, Julian Müller, T. Ulrich, A. Carta, P. Bader, K. Bitos, Aurelia E Reiser, B. Champigneulle, Damira Ashyralieva, P. Scheiwiller, Silvia Ulrich, T. Sooronbaev, M. Furian, K. 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Methods: From May to September 2021, we performed studies in patients with chronic obstructive pulmonary disease (COPD) and in healthy school-age children in Kyrgyzstan in high-altitude facilities at 3,100 m and 3,250 m and at 760 m. The various implemented COVID-19 safety measures included systematic SARS-CoV-2 rapid antigen testing (RAT). Main outcomes were SARS-CoV-2-RAT-positive rate among participants and staff at initial presentation (prevalence) and SARS-CoV-2-RAT-positive conversion during and within 10 days after studies (incidence). Results: Among 338 participants and staff, SARS-CoV-2-RAT-positive prevalence was 15 (4.4%). During mean ± SD duration of individual study participation of 3.1 ± 1.0 day and within 10 days, RAT-positive conversion occurred in 1/237(0.4%) participants. Among staff working in studies for 31.5 ± 29.3 days, SARS-CoV-2-RAT-positive conversion was 11/101(10.9%). 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引用次数: 0
摘要
Grimm, Mirjam, Lucie Ziegler, Annina Seglias, Maamed Mademilov, Kamila Magdieva, Gulzada Mirzalieva, Aijan Taalaibekova, Simone Suter, Simon R. Schneider, Fiona Zoller, Vera Bissig, Lukas Reinhard, Meret Bauer, Julian Müller, Tanja L.Ulrich, Arcangelo F. Carta, Patrick R. Bader, Konstantinos Bitos, Aurelia E. Reiser, Benoit Champigneulle, Damira Ashyralieva, Philipp M. Scheiwiller, Silvia Ulrich, Talant M. Sooronbaev, Michael Furian, and Konrad E. Bloch.高海拔野外研究中的 SARS-CoV-2 传播。00:00-00, 2024.背景:在严重急性呼吸系统综合征冠状病毒 2 型(SARS-CoV-2)大流行期间,临床研究中的病毒传播问题一直备受关注。因此,在 2021 年进行的高海拔野外研究中,我们采取了 COVID-19 特定预防措施,并调查了 SARS-CoV-2 感染的发生情况。研究方法2021 年 5 月至 9 月,我们在吉尔吉斯斯坦海拔 3100 米、3250 米和 760 米的高海拔设施中对慢性阻塞性肺病(COPD)患者和健康学龄儿童进行了研究。主要结果是参与者和工作人员初次就诊时的 SARS-CoV-2-RAT 阳性率(患病率)和研究期间及研究后 10 天内的 SARS-CoV-2-RAT 阳性转换率(发生率)。结果:在 338 名参与者和工作人员中,SARS-CoV-2-RAT 阳性率为 15(4.4%)。在平均(± SD)为 3.1 ± 1.0 天的个人研究参与时间和 10 天内,有 1/237(0.4%)名参与者出现 RAT 阳性转化。在工作了 31.5 ± 29.3 天的研究人员中,有 11/101 人(10.9%)转为 SARS-CoV-2 RAT 阳性。在历时 15.6 周的所有 338 名参与研究的人员中,SARS-CoV-2-RAT 阳性发生率的中位数为 0.00%/周(四分位数 0.00; 0.64)。同期,吉尔吉斯总人口 66.36 亿人中的背景发病率中位数为 0.06%/周(0.03; 0.11),P = 0.013(Wilcoxon 秩和检验)。结论通过采取特定的安全措施,在临床研究期间传播 SARS-CoV-2 的情况非常罕见,参与者和工作人员中的 SARS-CoV-2 感染率低于同期的普通人群。这些结果令人欣慰,有助于在类似情况下开展临床研究的决策。
SARS-CoV-2 Transmission during High-Altitude Field Studies.
Grimm, Mirjam, Lucie Ziegler, Annina Seglias, Maamed Mademilov, Kamila Magdieva, Gulzada Mirzalieva, Aijan Taalaibekova, Simone Suter, Simon R. Schneider, Fiona Zoller, Vera Bissig, Lukas Reinhard, Meret Bauer, Julian Müller, Tanja L. Ulrich, Arcangelo F. Carta, Patrick R. Bader, Konstantinos Bitos, Aurelia E. Reiser, Benoit Champigneulle, Damira Ashyralieva, Philipp M. Scheiwiller, Silvia Ulrich, Talant M. Sooronbaev, Michael Furian, and Konrad E. Bloch. SARS-CoV-2 Transmission during High-Altitude Field Studies. High Alt Med Biol. 00:00-00, 2024. Background: Throughout the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) pandemic, virus transmission during clinical research was of concern. Therefore, during high-altitude field studies performed in 2021, we took specific COVID-19 precautions and investigated the occurrence of SARS-CoV-2 infection. Methods: From May to September 2021, we performed studies in patients with chronic obstructive pulmonary disease (COPD) and in healthy school-age children in Kyrgyzstan in high-altitude facilities at 3,100 m and 3,250 m and at 760 m. The various implemented COVID-19 safety measures included systematic SARS-CoV-2 rapid antigen testing (RAT). Main outcomes were SARS-CoV-2-RAT-positive rate among participants and staff at initial presentation (prevalence) and SARS-CoV-2-RAT-positive conversion during and within 10 days after studies (incidence). Results: Among 338 participants and staff, SARS-CoV-2-RAT-positive prevalence was 15 (4.4%). During mean ± SD duration of individual study participation of 3.1 ± 1.0 day and within 10 days, RAT-positive conversion occurred in 1/237(0.4%) participants. Among staff working in studies for 31.5 ± 29.3 days, SARS-CoV-2-RAT-positive conversion was 11/101(10.9%). In all 338 individuals involved in the studies over the course of 15.6 weeks, the median SARS-CoV-2-RAT-positive incidence was 0.00%/week (quartiles 0.00; 0.64). Over the same period, the median background incidence among the total Kyrgyz population of 6,636 million was 0.06%/week (0.03; 0.11), p = 0.013 (Wilcoxon rank sum test). Conclusions: Taking precautions by implementing specific safety measures, SARS-CoV-2 transmission during clinical studies was very rare, and the SARS-CoV-2 incidence among participants and staff was lower than that in the general population during the same period. The results are reassuring and may help in decision-making on the conduct of clinical research in similar settings.
期刊介绍:
High Altitude Medicine & Biology is the only peer-reviewed journal covering the medical and biological issues that impact human life at high altitudes. The Journal delivers critical findings on the impact of high altitude on lung and heart disease, appetite and weight loss, pulmonary and cerebral edema, hypertension, dehydration, infertility, and other diseases. It covers the full spectrum of high altitude life sciences from pathology to human and animal ecology.