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1. Impact of the COVID-19 Pandemic on Non-COVID-19 Clinical Trials

Author

Katia Audisio, Hillary Lia, Newell Bryce Robinson, Mohamed Rahouma, Giovanni Soletti, Gianmarco Cancelli, Roberto Perezgrovas Olaria, David Chadow, Derrick Y. Tam, Dominique Vervoort, Michael E. Farkouh, Deepak L. Bhatt, Stephen E. Fremes, and Mario Gaudino

Subjects
COVID-19, randomized controlled trials, ClinicalTrials.gov, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Randomized controlled trials (RCT) were impacted by the COVID-19 pandemic, but no systematic analysis has evaluated the overall impact of COVID-19 on non-COVID-19-related RCTs. The ClinicalTrials.gov database was queried in February 2020. Eligible studies included all randomized trials with a start date after 1 January 2010 and were active during the period from 1 January 2015 to 31 December 2020. The effect of the pandemic period on non-COVID-19 trials was determined by piece-wise regression models using 11 March 2020 as the start of the pandemic and by time series analysis (models fitted using 2015–2018 data and forecasted for 2019–2020). The study endpoints were early trial stoppage, normal trial completion, and trial activation. There were 161,377 non-COVID-19 trials analyzed. The number of active trials increased annually through 2019 but decreased in 2020. According to the piece-wise regression models, trial completion was not affected by the pandemic (p = 0.56) whereas trial stoppage increased (p = 0.001). There was a pronounced decrease in trial activation early during the pandemic (p < 0.001) which then recovered. The findings from the time series models were consistent comparing forecasted and observed results (trial completion p = 0.22; trial stoppage p < 0.01; trial activation, p = 0.01). During the pandemic, there was an increase in non-COVID-19 RCTs stoppage without changes in RCT completion. There was a sharp decline in new RCTs at the beginning of the pandemic, which later recovered.

Published
2022
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2. Effect of esomeprazole versus placebo on pulmonary exacerbations in cystic fibrosis

Author

Emily DiMango, Claire Keating, Elinor Langfelder-Schwind, Newell Bryce Robinson, Xinhua Liu, Maria Berdella, Patricia Walker, and Diane Levy

Subjects
Adult, Lung Diseases, Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Exacerbation, Cystic Fibrosis, Placebo, Cystic fibrosis, Gastroenterology, Esomeprazole, law.invention, Randomized controlled trial, Double-Blind Method, law, Internal medicine, Medicine, Humans, business.industry, Proton Pump Inhibitors, medicine.disease, 3. Good health, Log-rank test, Exact test, Ambulatory, Disease Progression, Gastroesophageal Reflux, Female, business, medicine.drug, Research Article
Abstract

Background Gastro esophageal reflux (GER) is common in cystic fibrosis (CF) and may contribute to lung disease. Approximately 50% of patients with cystic fibrosis are being treated with proton pump inhibitors (PPIs). Methods In a randomized controlled study in adults, we compared treatment with esomeprazole 40 mg twice daily versus placebo in patients with CF and frequent respiratory exacerbations over a thirty-six week treatment period to determine effect on time to first exacerbation and other health related outcomes. Results 17 patients without symptoms of GER were randomized and 15 completed the study. 13 subjects underwent 24 hour ambulatory pH probe monitoring; 62% had pH probe evidence of GER. Forty one percent of subjects had a pulmonary exacerbation during the study. There was no significant difference in time to first pulmonary exacerbation (log rank test p = 0.3169). Five of nine subjects in the esomeprazole group compared with 2 of eight subjects in the placebo group experienced exacerbations (esomeprazole vs. placebo: odds ratio = 3.455, 95% CI = (0.337, 54.294), Fisher’s exact test: p = 0.334). There was no change in Forced Expiratory Volume in one second, Gastroesophageal Symptom Assessment Score or CF Quality of Life score between the two treatment groups. Conclusions There was a trend to earlier exacerbation and more frequent exacerbations in subjects randomized to esomeprazole compared with placebo. The effect of proton pump inhibitors on pulmonary exacerbations in CF warrants further investigation. Clinical trials registration Clinicaltrials.gov, NCT01983774

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