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For patients with chronic diseases such as pulmonary fibrosis, coronavirus disease 2019 (COVID-19) represents a threat beyond the immediate risk of infection. These individuals have a greater likelihood of developing serious complications as a result of the virus, and those awaiting organ transplantation and other surgical interventions may face delays because of the risk of viral exposure and strained resources in the current healthcare environment.
In addition, clinical trials investigating potential therapies for various diseases including pulmonary fibrosis have been disrupted considerably since the pandemic emerged. According to data from the WIRB-Copernicus Group (WCG), the number of clinical research sites open to enrollment for non-COVID-19 trials decreased from 62% on March 24, 2020, to 11% on May 1, 2020.1 Although enrollment has begun to resume since that period, these developments have prompted experts to consider ways to address such issues in the context of ongoing and future trials.
To learn about clinical trial disruptions and potential solutions in the pulmonary fibrosis space, we interviewed Gregory P. Cosgrove, MD, FCCP, chief medical officer of the Pulmonary Fibrosis Foundation (PFF) based in Chicago, Illinois, and associate professor in the Division of Pulmonary, Critical Care and Sleep Medicine at National Jewish Health in Denver, Colorado.
How has research for pulmonary fibrosis-related therapies been disrupted as a result of COVID-19?
The immediate focus of the scientific community is, appropriately, on COVID-19. As expected, there was a drastic increase in the number of non-COVID-19 trials disrupted in the first half of 2020, including those specific to pulmonary fibrosis. This disruption will delay the evaluation of many pulmonary fibrosis-related therapies. Unfortunately, there is no delay in the impact of pulmonary fibrosis on our community, and we must continue to advance the understanding and treatment of the disease.
How can the field adjust to continue investigating promising therapies for these patients, and what are the implications for future research efforts?
In response to COVID-19, sponsors, advocacy groups like the PFF, and regulatory agencies are beginning to consider ways to adapt, such as implementing a phased approach to restarting clinical research, prioritizing the safety of those participating and staffing any trial. Differences in the prevalence of COVID-19 and the resources of each individual institution or trial site will affect whether a site can reinitiate enrollment in clinical trials.
In addition, the adoption of telemedicine in clinical trial sites is shifting dramatically. According to WCG, a recent survey of clinical trial sites revealed that the adoption of telemedicine by US sites more than doubled during COVID-19, with 73% of sites now indicating they plan to use telemedicine going forward.1
We must adapt how trials will be performed in the post-COVID-19 era and increase the rate of enrollment to restore the tremendous momentum we experienced over the past several years. Some aspects of clinical trials may remain the same, but many of us hope for a transformation to allow trials to be more convenient, more efficient, and more accessible to larger number of volunteers. In doing so, promising agents can be evaluated and — we hope — deemed safe and effective for the treatment of pulmonary fibrosis.
Is anyone currently studying patients with pulmonary fibrosis who develop COVID-19? What have their outcomes been like thus far?
The PFF is closely monitoring the COVID-19 impact on the pulmonary fibrosis community. While we know that patients with pulmonary fibrosis are at a higher risk, there are still many unknowns. If infected with COVID-19, it is not clear how individual patients with pulmonary fibrosis will be affected. It also is not known how COVID-19 may affect pulmonary fibrosis disease progression. We are directing patients to our COVID-19 resource page for up-to-date information.
Several reports suggest pulmonary fibrosis following severe COVID-19 can lead to respiratory failure and prolonged mechanical ventilation.2,3 The initial thought is that these patients are suffering from SARS-CoV-2-associated acute respiratory distress syndrome (ARDS) with fibroproliferation, a syndrome that has been extensively studied in the past.2 Previously, patients with fibroproliferative ARDS have not demonstrated progressive pulmonary fibrosis, as occurs with other causes of ARDS.4 Several observational series are being coordinated to understand the effect of SARS-CoV-2, the development of COVID-19, and the risk of pulmonary fibrosis in those with and without ARDS.2,3 We will gain a better understanding with more time and experience during the pandemic.
How does the current situation compare to previous health crises — for example, how did HIV, SARS, or Ebola affect clinical trials?
In contrast to the HIV, SARS, and Ebola epidemics, the COVID-19 pandemic has disrupted clinical research in a manner not previously experienced. In those epidemics, regional changes where the disease was more prevalent affected clinical trial enrollment but with further understanding of the diseases, safety precautions were instituted, and research resumed relatively quickly. The broad and overwhelming impact of the current pandemic is affecting the operational aspects of clinical trials broadly. As such, a phased approach to restarting research is necessary to account for the regional, national, and international impact of the pandemic.
Note: The PFF will be hosting a webinar about COVID-19 and the PFF’s response on July 29 at 12 pm CT. Dr Cosgrove will be presenting alongside Ellen Eaton, MD, from the Division of Infectious Diseases at the University of Alabama at Birmingham, and Amy Hajari Case, MD, FCCP, from the Division of Pulmonary Critical Care and Sleep Medicine at Piedmont Healthcare in Atlanta, Georgia. Click here to register.
References
1. WCG. COVID-19 trial insights from the WCG knowledge base. https://www.wcgclinical.com/covid-19/covid-19-trial-insights/ Accessed on July 17, 2020.
2. Spagnolo P, Balestro E, Aliberti S, et al. Pulmonary fibrosis secondary to COVID-19: a call to arms? [published online May 15, 2020]. Lancet Respir Med. doi:10.1016/S2213-2600(20)30222-8
3. George PM, Wells AU, Jenkins RG. Pulmonary fibrosis and COVID-19: the potential role for antifibrotic therapy. [published online May 15, 2020]. Lancet Respir Med. doi:10.1016/S2213-2600(20)30225-3
4. Pulmonary Fibrosis Foundation Statement on COVID-19. The Pulmonary Fibrosis Foundation. April 6, 2020. Accessed July 23, 2020. https://www.prnewswire.com/news-releases/pulmonary-fibrosis-foundation-statement-on-covid-19-301035924.html.
