SARS-CoV-2 disrupts clinical research: the role of a rare disease-specific trial network

Koningsbruggen-Rietschel, Silke van; Dunlevy, Fiona; Bulteel, Veerle; Downey, D.G.; Dupont, Lieven

doi:10.1183/13993003.02114-2020

Cited by 16 publications

(23 citation statements)

References 3 publications

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“…Testing rates by age group are not available from the ECDC. Conversely, we also know that many CF teams switched to conducting care and clinical trial visits remotely as much as possible to minimize the risk of exposure [ 19 , 24 ] which could have led to missed opportunities to test asymptomatic and mildly ill pwCF for SARS-CoV-2 infection. Fourth, comparing incidence by country (either in our study or in other published reports) is difficult due to differing impacts of the pandemic, case definitions and public health measures between countries.…”

Section: Discussionmentioning

confidence: 99%

Incidence of SARS-CoV-2 in people with cystic fibrosis in Europe between February and June 2020

Naehrlich

Orenti

Dunlevy³

et al. 2021

Journal of Cystic Fibrosis

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Background Viral infections can cause significant morbidity in cystic fibrosis (CF). The current Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic could therefore have a serious impact on the health of people with CF (pwCF). Methods We used the 38-country European Cystic Fibrosis Society Patient Registry (ECFSPR) to collect case data about pwCF and SARS-CoV-2 infection. Results Up to 30 June 2020, 16 countries reported 130 SARS-CoV-2 cases in people with CF, yielding an incidence of 2.70/1000 pwCF. Incidence was higher in lung-transplanted patients (n=23) versus non-transplanted patients (n=107) (8.43 versus 2.36 cases/1000). Incidence was higher in pwCF versus the age-matched general population in the age groups <15, 15-24, and 25-49 years (p<0.001), with similar trends for pwCF with and without lung transplant. Compared to the general population, pwCF (regardless of transplantation status) had significantly higher rates of admission to hospital for all age groups with available data, and higher rates of intensive care, although not statistically significant. Most pwCF recovered (96.2%), however 5 died, of whom 3 were lung transplant recipients. The case fatality rate for pwCF (3.85%, 95% CI: 1.26-8.75) was non-significantly lower than that of the general population (7.46%; p=0.133). Conclusions SARS-CoV-2 infection can result in severe illness and death for pwCF, even for younger patients and especially for lung transplant recipients. PwCF should continue to shield from infection and should be prioritized for vaccination.

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Section: Discussionmentioning

confidence: 99%

Incidence of SARS-CoV-2 in people with cystic fibrosis in Europe between February and June 2020

Naehrlich

Orenti

Dunlevy³

et al. 2021

Journal of Cystic Fibrosis

Self Cite

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“…The easing of public restrictions has resulted in a second wave. New cases are increasing since early August, which may carry with a lot of newer restrictions (17). Thus, countries need to be prepared for what is coming in the next winter.…”

Section: Adaptation Of Rare Disease Research With the New Normalmentioning

confidence: 99%

“…Many have paused on their ongoing clinical research to focus on SARS-CoV-2 related research or made substantial modifications to ensure safe clinical care in the hospital. As a result, the research and development on other diseases, e.g., cancer, cardiovascular conditions, and rare diseases, may experience (and already is experiencing) disruption-potentially causing the people living with these diseases to suffer delayed access to new drugs and/or management strategies (17). While combatting the pandemic mainly focusing on the general people, collaborations between the patient, scientific communities, government, diagnostic service providers, and rare disease research need prioritization to ensure proper management of rare diseases.…”

mentioning

confidence: 99%

Research and Management of Rare Diseases in the COVID-19 Pandemic Era: Challenges and Countermeasures

Chowdhury

Sium

Anwar

2021

Front. Public Health

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The ongoing coronavirus disease 2019 (COVID-19) pandemic has disrupted every aspect of our life. The need to provide high-level care for an enormous number of patients with COVID-19 infection during this pandemic has impacted resourcing for and restricted the routine care of all non-COVID-19 conditions. Since the beginning of the pandemic, the people living with rare disorders, who represent a marginalized group of the population even in a normal world, have not received enough attention that they deserve. Due to the pandemic situation, they have experienced (and experiencing) an extreme inadequacy of regular clinical services, counseling, and therapies they need, which have made their life more vulnerable and feel more marginalized. Besides, the clinicians, researchers, and scientists working on rare genetic diseases face extra challenges due to the pandemic. Many ongoing research projects and clinical trials for rare and genetic diseases were stalled to avoid patients' and research staff's transmission to COVID-19. Still, with all the odds, telehealth and virtual consultations for rare disease patients have shown hope. The clinical, organizational, and economic challenges faced by institutions, patients, their families, and the caregivers during the pandemic indicate the importance of ensuring continuity of care in managing rare diseases, including adequate diagnostics and priority management strategies for emergencies. In this review, we endeavored to shed light on the issues the rare disease community faces during the pandemic and the adaptations that could help the rare disease community to better sustain in the coming days.

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“…The Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) global pandemic significantly impacted the conduct of CF clinical research worldwide [1] , [2] , [3] , in addition to disrupting many other aspects of daily life [4] . Underlying pulmonary diseases like cystic fibrosis (CF) are seen as risk factors for severe illness from SARS-CoV-2, resulting in heightened awareness of a need to minimize exposure to this virus [5] .…”

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confidence: 99%

The impact of SARS-CoV-2 on the cystic fibrosis foundation therapeutics development network

Pearson

Mayer-Hamblett²,

Goss

et al. 2021

Journal of Cystic Fibrosis

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The Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) global pandemic significantly impacted CF clinical research within the Cystic Fibrosis Foundation Therapeutics Development Network (CFF TDN). A Research Electronic Data Capture (REDCap) survey was developed and sent to network sites to monitor and understand the impact on research teams, ongoing and anticipated clinical research, and specific clinical and research procedures. Key findings indicated an early impact on participant enrollment, research team stability, and procedures such as spirometry and sputum induction. These trends steadily improved over the months as research activities began to recover across the TDN. While SARS-CoV-2 created a significant challenge it also highlights new opportunities to expand CF research with greater focus on data collection outside of research centers and increased access for remote participation.

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SARS-CoV-2 disrupts clinical research: the role of a rare disease-specific trial network

Cited by 16 publications

References 3 publications

Incidence of SARS-CoV-2 in people with cystic fibrosis in Europe between February and June 2020

Incidence of SARS-CoV-2 in people with cystic fibrosis in Europe between February and June 2020

Research and Management of Rare Diseases in the COVID-19 Pandemic Era: Challenges and Countermeasures

The impact of SARS-CoV-2 on the cystic fibrosis foundation therapeutics development network

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