P675 CT-Scout platform, the digital solution to boost patient recruitment in inflammatory bowel disease clinical trials: A multicentre prospective observational comparative study

Abstract Background The main issue to validating new molecules in the field of IBD is insufficient patient enrollment into clinical trials, resulting in premature trials termination and cost increase. CT-SCOUT™ platform is a web-based solution to help clinicians to pre-screen potential candidates and facilitating the coordination of the research team. Our aim was to compare the number of patients enrolled in IBD clinical trials in sites equipped or not with CT-SCOUT™. Methods We conducted a prospective, multicenter, open-label, observational study in sites participating to phase 3 trials evaluating the efficacy and safety of etrolizumab in ulcerative colitis (UC, Hickory) and in Crohn’s disease (CD, Bergamot). Recruitment figures were provided by the sponsor, and we considered the 21 French sites equipped with CTscout and 134 sites in other countries not equipped with CT-SCOUT™. The primary endpoint was the mean number of patients randomised per site in both trials. Secondary endpoints included a mean number of patients randomised in each study. Patients screened and those finally randomised were compared in sites equipped and non-equipped using one-way ANOVA followed by post-hoc Tukey test and Mann–Whitney test. Results During the observational period of 40 months (September 2015–December 2018), 644 and 289 patients were screened and randomised in Hickory and/or Gardenia, respectively. There were 307 and 149 patients in 78 sites for Hickory, and 337 and 140 patients for Bergamot in 102 sites. The mean numbers of screened and randomised patients in CT-SCOUT™ equipped sites vs. non-equipped are given in the table. The mean number of patients randomised in Hickory in CT-SCOUT™ sites increased by 4.0 folds as compared with non-equipped sites (p < 0.001). The mean number of patients randomised in Bergamot in CT-SCOUT™ equipped sites has been increased by 1.9-folds as compared with non-equipped sites (p = 0.009). Conclusion This multicentric study demonstrated a significant increase in patient recruitment in IBD clinical trials. Randomisation rates were twice to four times higher in equipped sites compared with non-equipped ones. CT-SCOUT™ appears to be a promising digital solution to the global issue of patient enrollment in clinical trials.

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P439 Patient’ recruitment for a Phase 3 inflammatory bowel disease (IBD) programme is significantly increased when accessing the CT-SCOUT™ platform

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.568 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S397-S398

Author(s):

Y Bouhnik ◽

X Roblin ◽

R Mrad ◽

X Hebuterne ◽

D Laharie ◽

...

Keyword(s):

Clinical Trials ◽

Recruitment Rate ◽

Patient Recruitment ◽

Potential Candidate ◽

Open Label ◽

Phase 3 ◽

Web Based ◽

Number Of Patients ◽

The Mean ◽

Post Hoc

Abstract Background The main issue when validating new molecules in the field of IBD is insufficient patient recruitment into clinical trials, resulting in a considerable delay and cost increase. The selection of the best recruiting sites is a long and difficult process, especially since study sponsor has no visibility on the activity of the sites, and the sites have no penalties if the objectives are not achieved. The CT-SCOUT™ platform is a web-based solution to help clinicians to pre-screen potential candidate, facilitating the coordination of the research team and providing sponsor and principal investigator visibility into patient recruitment efforts and status on the site. We aimed to compare the recruitment rate in sites using the application according to Premium or Freemium modalities and in sites not equipped with CT-SCOUT™ for IBD clinical trials. Methods We conducted a prospective, multicentre, open-label, observational and comparative study in 25 sites participating in a selected phase 3 IBD clinical trials in France. All sites were proposed to be equipped with CT-SCOUT™, and the recruitment rate was compared according to 3 modalities: a) the Premium mode, giving access to all the functionalities of the application (including specific inclusion/exclusion criteria, possibility of sending notification to the team) in counterpart of which they undertook to use the application; b) the Freemium mode, a basic functionality that only gives the name of the study in the first selection phase; c) sites who were not interested to be equipped. The primary endpoint was the mean number of patients randomised per site per month. Patients screened and those finally randomised were compared in sites equipped (Premium or Freemium) and non-equipped using one-way ANOVA followed by post-hoc Tukey test. Results During the recruitment period from 4 to 36 months (mean 24.8 months), 221 and 130 patients were screened and randomised, respectively. The mean number of patients screened and randomised per site per month according to CT-SCOUT™ equipment is reported in the figure below. Conclusion This study shows that sites not equipped with CT-SCOUT™ recruit only a few patients. Among the equipped sites, those with Premium access have a significantly higher randomisation rate than those with limited functionality. Sites equipped with digital pre-screening support to facilitate patient recruitment and provide the sponsor visibility are the best candidates for trials.

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Methodological Characteristics of Clinical Trials Supporting the Marketing Authorisation of Advanced Therapies in the European Union

Frontiers in Pharmacology ◽

10.3389/fphar.2021.773712 ◽

2021 ◽

Vol 12 ◽

Author(s):

Carolina Iglesias-Lopez ◽

Antònia Agustí ◽

Antonio Vallano ◽

Merce Obach

Keyword(s):

European Union ◽

Clinical Trials ◽

Added Value ◽

Life Cycle Approach ◽

The European Union ◽

Open Label ◽

Advanced Therapy ◽

Advanced Therapies ◽

Number Of Patients ◽

The Eu

Several advanced therapy medicinal products (ATMPs) have been approved in the European Union (EU). The aim of this study is to analyse the methodological features of the clinical trials (CT) that supported the marketing authorization (MA) of the approved ATMPs in the EU. A systematic review of the characteristics of pivotal CT of ATMPs approved in the EU until January 31st, 2021 was carried out. A total of 17 ATMPs were approved and 23 CT were conducted to support the MA (median, 1, range, 1–3). Of those studies, 8 (34.78%) were non-controlled and 7 (30.43%) used historical controls. Only 7 (30.4%) were placebo or active-controlled studies. Among all CT, 21 (91.3%) were open-label and 13 (56.52%) had a single-arm design. To evaluate the primary endpoint, 18 (78.26%) studies used an intermediate and single variable. The median (IQR) number of patients enrolled in the studies was 75 (22–118). To date, ATMPs’ approval in the EU is mainly supported by uncontrolled, single-arm pivotal CT. Although there is a trend toward an adaptive or a life cycle approach, a switch to more robust clinical trial designs is expected to better define the benefit and the therapeutic added value of ATMPs.

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Modafinil Augmentation for Residual Symptoms of Fatigue in Patients with a Partial Response to Antidepressants

Annals of Pharmacotherapy ◽

10.1345/aph.1h526 ◽

2007 ◽

Vol 41 (6) ◽

pp. 1005-1012 ◽

Cited By ~ 18

Author(s):

Jenny Y Lam ◽

Maisha Kelly Freeman ◽

Marshall E Cates

Keyword(s):

Clinical Trials ◽

Data Extraction ◽

Controlled Clinical Trials ◽

Open Label ◽

Double Blind ◽

Residual Symptoms ◽

Randomized Controlled ◽

Manual Search ◽

Number Of Patients ◽

Residual Fatigue

OBJECTIVE: To evaluate the literature discussing the use of modafinil in the treatment of residual symptoms of fatigue in patients with depression. DATA SOURCES: PubMed (1966–March 2007) and International Pharmaceutical Abstracts(1970–March 2007) were searched using the key words modafinil and depression. A manual search of the reference section of the articles retrieved was conducted to identify articles not indexed in either of these sources. STUDY SELECTION AND DATA EXTRACTION: All articles published in English were evaluated. Studies were included if modafinil was used to treat patients with residual fatigue from depression and the effects were measured with validated fatigue subscales. DATA SYNTHESIS: One retrospective study, 5 open-label trials, and 2 randomized controlled clinical trials met the inclusion criteria for assessment of residual symptoms of fatigue as assessed by commonly used fatigue subscales after modafinil administration. Although improvement with fatigue has occurred with modafinil therapy, literature regarding the topic is limited by the lack of well-controlled clinical trials. Modafinil does appear to improve residual fatigue with depression as evidenced by open-label trials; however, the efficacy of this agent has not been duplicated in randomized controlled trials. The open-label trials that have been conducted often had no comparator and a small number of patients. In addition, outcome measures used in the studies were not consistent between trials. Modafinil appears to be well tolerated, with the main adverse effects being headache and nausea. CONCLUSIONS: Open-label trials indicate that modafinil may be effective in ameliorating fatigue associated with depression; however, this effect has not been reproduced in randomized, double-blind, placebo-controlled clinical trials. Therefore, the use of modafinil for the treatment of residual fatigue is not recommended due to the lack of reproducible data of its efficacy. Long-term, adequately powered clinical trials should be conducted to determine its place in therapy.

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Effect of Patiromer in Hyperkalemic Patients Taking and Not Taking RAAS Inhibitors

Journal of Cardiovascular Pharmacology and Therapeutics ◽

10.1177/1074248418788334 ◽

2018 ◽

Vol 23 (6) ◽

pp. 524-531 ◽

Cited By ~ 5

Author(s):

Robert A. Kloner ◽

Coleman Gross ◽

Jinwei Yuan ◽

Ansgar Conrad ◽

Pablo E. Pergola

Keyword(s):

Adverse Events ◽

Serum Potassium ◽

Common Adverse Event ◽

Open Label ◽

Serious Adverse Events ◽

End Point ◽

The Mean ◽

Baseline Characteristics ◽

Raas Inhibitors ◽

Post Hoc

Introduction: Hyperkalemia (potassium >5.0 mEq/L) affects heart failure patients with renal disease regardless of the use of renin–angiotensin–aldosterone system inhibitors (RAASi). The open-label TOURMALINE study showed that patiromer, a sodium-free, nonabsorbed potassium binder, lowers serum potassium of hyperkalemic patients similarly when given with or without food; unlike prior studies, patients were not required to be taking RAASi. We conducted post hoc analyses to provide the first report of patiromer in patients not taking RAASi. Methods: Hyperkalemic patients received patiromer, 8.4 g/d to start, adjusted to achieve and maintain serum potassium of 3.8 to 5.0 mEq/L. If taking RAASi, stable doses were required. The primary end point was the proportion of patients with serum potassium 3.8 to 5.0 mEq/L at week 3 or 4. This analysis presents data by patients taking or not taking RAASi. Results: Demographics and baseline characteristics were similar in patients taking (n = 67) and not taking RAASi (n = 45). Baseline mean (SD) serum potassium was 5.37 (0.37) mEq/L and 5.42 (0.43) mEq/L in patients taking and not taking RAASi, respectively. Mean (SD) daily patiromer doses were similar (10.7 [3.2] and 11.5 [4.0] g, respectively). The primary end point was achieved in 85% (95% confidence interval [CI]: 74-93) of patients taking RAASi and in 84% (95% CI: 71-94) of patients not taking RAASi. From baseline to week 4, the mean (SE) change in serum potassium was −0.67 (0.08) mEq/L in patients taking RAASi and −0.56 (0.10) mEq/L in patients not taking RAASi (both P < .0001 vs baseline, P = nonsignificant between groups). Adverse events were reported in 26 (39%) patients taking RAASi and 25 (54%) not taking RAASi; the most common adverse event was diarrhea (2% and 11%, respectively; no cases were severe). Five patients (2 taking RAASi) reported 6 serious adverse events; none considered related to patiromer. Conclusions: Patiromer was effective and generally well-tolerated for hyperkalemia treatment, whether or not patients were taking RAAS inhibitors.

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The incidence of occult endocrinopathies in patients with cancer undergoing immunotherapy in community practice.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e14571 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e14571-e14571

Author(s):

Ahmed Abdalla ◽

Aditi Singh ◽

Hussein Gharib ◽

Benjamin Huber ◽

Sindhu Janarthanam Malapati ◽

...

Keyword(s):

Clinical Trials ◽

Testosterone Level ◽

Single Agent ◽

Laboratory Data ◽

Endocrine Function ◽

Hormone Levels ◽

Primary Indication ◽

Number Of Patients ◽

The Mean ◽

Stimulating Hormone

e14571 Background: Immune checkpoint blockade (IO) can induce inflammation of the pituitary, thyroid or adrenal glands. This usually results in non-specific symptoms such as headache, low-energy, nausea and vomiting, which can be difficult to differentiate from symptoms associated with cancer and therapy-related symptoms. Therefore, the exact incidence of endocrinopathies is exceedingly difficult to estimate in community practices. Also, the variable methods of assessment, diagnosis, and monitoring used in different clinical trials make it challenging to precisely measure the incidence of endocrinopathies. Methods: This is a single-center retrospective chart review of patients diagnosed with cancer receiving immunotherapy for cancer treatment who had routine hormone levels checked during their treatment. Data collected includes tumor types and the types of IO agents used. Laboratory data collected included thyroid-stimulating hormone (TSH), testosterone level, follicular stimulating hormone (FSH), luteinizing hormone (LH), cortisol levels. Results: In total, 75 patients were included in the study. The primary indication for IO was lung cancer in 43 patients (57%), genitourinary tumors (12%), melanoma (12%) and head & neck cancers (5.3%). Single-agent nivolumab (39 patients) was the most common IO agent used followed by single-agent pembrolizumab (22 patients), ipilimumab (11 patients), atezolizumab (3 patients), avelumab (1 patient) (There was one patient who got nivolumab initially and then pembrolizumab). Nine patients were treated with ipilimumab/nivolumab combination. The mean number of cycles received was 9.1. The total number of patients who developed at least one abnormal hormone level was 57(76%), with 33 out of 74 (45%) patients had at least one abnormal TSH, 29 out of 44 (66%) patients had at least one abnormal testosterone level, 10 out of 49 (20.4%) patients had at least one abnormal FSH and/or LH level, 36 out of 52 (69%) patients had at least one abnormal cortisol level. The mean number of days from starting IO to develop the first abnormal laboratory result was 106 days. Conclusions: The incidence of endocrinopathy was significantly high in patients receiving IO in this study, which is higher than what is reported in previous clinical trials. This could be due to frequent testing in asymptomatic patients and strict laboratory cut-off values which is not always clinically meaningful. This finding may highlight the importance of routine monitoring of the endocrine function during IO treatment. Routine measurement of hormone levels can detect asymptomatic endocrinopathy which may warrant further work-up and treatment. These findings should be validated in a larger prospective study.

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AGENT: An open-label phase III study of arfolitixorin versus leucovorin in modified FOLFOX-6 for first-line treatment of metastatic colorectal cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.4_suppl.tps268 ◽

2020 ◽

Vol 38 (4_suppl) ◽

pp. TPS268-TPS268

Author(s):

Heinz-Josef Lenz ◽

Peter Gibbs ◽

Sebastian Stintzing ◽

Gerald W. Prager ◽

Peter Nygren ◽

...

Keyword(s):

Colorectal Cancer ◽

Metastatic Colorectal Cancer ◽

Objective Response ◽

Metabolic Activation ◽

Phase Iii ◽

First Line ◽

Open Label ◽

Eligibility Criteria ◽

Number Of Patients ◽

Secondary Endpoints

TPS268 Background: 5-fluorouracil (5FU), in combination with folates, is an established cornerstone of metastatic colorectal cancer (mCRC) treatment. All folates currently approved for mCRC need to be metabolically activated to [6R]-5,10-methylenetetrahydrofolic acid ([6R]-MTHF), the active thymidylate synthase co-substrate that potentiates the effect of 5FU. Arfolitixorin does not require multi-step metabolic activation, and may produce higher, and less inter- and intraindividually variable, concentrations of [6R]-MTHF than leucovorin. Methods: The phase III AGENT trial (NCT03750786) is a randomized, multicenter, parallel-group study comparing the efficacy of arfolitixorin versus leucovorin in mCRC patients treated with first-line 5FU, oxaliplatin, and bevacizumab. Patients are randomized (1:1) to the investigational arm (arfolitixorin + 5FU + oxaliplatin [ARFOX] + bevacizumab) or the comparator arm (leucovorin + 5FU + oxaliplatin [modified FOLFOX-6] + bevacizumab), and treated until disease progression based on RECIST 1.1 criteria. Recruitment is ongoing, and aims to randomize 440 patients in 18 months. Eligibility criteria include non-resectable mCRC; eligibility for 5FU, oxaliplatin, and bevacizumab therapy; ECOG PS 0 or 1. The study will be conducted across approximately 100 sites in Australia, Austria, Canada, France, Germany, Greece, Japan, Spain, Sweden, and USA. The primary endpoint is objective response rate. Key secondary endpoints are progression-free survival and duration of response. Additional secondary endpoints include overall survival, quality of life, safety and tolerability, and number of patients undergoing curative metastasis resection. A translational program will evaluate expression levels of several folate metabolism- and transportation-related genes in mCRC tumor biopsies to determine their relationship to treatment outcome. A broad array of genes will analyzed, including ATP-binding cassette C3 (ABCC3) transporter, methylenetetrahydrofolate dehydrogenase 2 (MTHFD2), proton-coupled folate transporter (PCFT), and serine hydroxymethyltransferase 1 (SHMT1). Interim data are expected in mid 2020. Clinical trial information: NCT03750786.

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The Attitude of Patients from a Romanian Tertiary Cardiology Center Regarding Participation in Biomarker-Based Clinical Trials

Medicina ◽

10.3390/medicina57111180 ◽

2021 ◽

Vol 57 (11) ◽

pp. 1180

Author(s):

Iulia Rusu ◽

Nicoleta-Monica Popa-Fotea ◽

Mihaela Octavia Stanculescu ◽

Diana Rusu ◽

Alexandra Dumitru ◽

...

Keyword(s):

Clinical Trials ◽

Medical Care ◽

Participation Rate ◽

Chronically Ill ◽

Critical Determinant ◽

Number Of Patients ◽

Tailored Approach ◽

Quality Of Medical Care ◽

Patient Enrollment

Background and Objectives: biomarker-based studies are the cornerstone of precision medicine, providing key data for tailored medical care. Enrollment of the planned number of patients is a critical determinant of a successful clinical trial. Moreover, for inclusive medical care, patients from different socio-demographic backgrounds must be recruited. Still, a significant number of trials fail to reach these prerequisites. Designing the informed consent forms based on the patients’ feedback could optimize accrual. We aimed to explore the attitudes of patients from a Romanian tertiary cardiology center towards participation in biomarker-based clinical trials. Materials and Methods: three hundred forty inpatients were interviewed based on a semi-structured questionnaire which included four sections: demographics, personal medical history, attitudes and trust. Results: Roughly, 62.5% of the respondents were interested in enrolling, while altruistic reasons were the most frequently expressed. Clear exposure of the possible risks was most valued (37.78%), followed by the possibility of directly communicating with the research team (23.78%). The most frequently chosen answer by acutely ill patients was improvement of their health, whereas chronically ill individuals indicated the possibility of withdrawal without affecting the quality of medical care. Importantly, the participation rate could be improved if the invitation to enrollment were made by both the current physician and the study coordinator (p = 0.0001). The level of trust in researchers was high in more than 50% of the respondents, and was correlated with therapeutic compliance and with the desire to join a biomarker study. Conclusions: the information gained will facilitate a tailored approach to patient enrollment in future biomarker-based studies in our clinic.

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Online Patient Recruitment in Clinical Trials: Systematic Review and Meta-Analysis

Journal of Medical Internet Research ◽

10.2196/22179 ◽

2020 ◽

Vol 22 (11) ◽

pp. e22179

Author(s):

Mette Brøgger-Mikkelsen ◽

Zarqa Ali ◽

John R Zibert ◽

Anders Daniel Andersen ◽

Simon Francis Thomsen

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Cost Effectiveness ◽

Meta Analysis ◽

Recruitment Rate ◽

Wilcoxon Test ◽

Patient Recruitment ◽

Conversion Rates ◽

Number Of Patients ◽

Online Recruitment

Background Recruitment for clinical trials continues to be a challenge, as patient recruitment is the single biggest cause of trial delays. Around 80% of trials fail to meet the initial enrollment target and timeline, and these delays can result in lost revenue of as much as US $8 million per day for drug developing companies. Objective This study aimed to conduct a systematic review and meta-analysis examining the effectiveness of online recruitment of participants for clinical trials compared with traditional in-clinic/offline recruitment methods. Methods Data on recruitment rates (the average number of patients enrolled in the study per month and per day of active recruitment) and conversion rates (the percentage of participants screened who proceed to enroll into the clinical trial), as well as study characteristics and patient demographics were collected from the included studies. Differences in online and offline recruitment rates and conversion rates were examined using random effects models. Further, a nonparametric paired Wilcoxon test was used for additional analysis on the cost-effectiveness of online patient recruitment. All data analyses were conducted in R language, and P<.05 was considered significant. Results In total, 3861 articles were screened for inclusion. Of these, 61 studies were included in the review, and 23 of these were further included in the meta-analysis. We found online recruitment to be significantly more effective with respect to the recruitment rate for active days of recruitment, where 100% (7/7) of the studies included had a better online recruitment rate compared with offline recruitment (incidence rate ratio [IRR] 4.17, P=.04). When examining the entire recruitment period in months we found that 52% (12/23) of the studies had a better online recruitment rate compared with the offline recruitment rate (IRR 1.11, P=.71). For cost-effectiveness, we found that online recruitment had a significantly lower cost per enrollee compared with offline recruitment (US $72 vs US $199, P=.04). Finally, we found that 69% (9/13) of studies had significantly better offline conversion rates compared with online conversion rates (risk ratio 0.8, P=.02). Conclusions Targeting potential participants using online remedies is an effective approach for patient recruitment for clinical research. Online recruitment was both superior in regard to time efficiency and cost-effectiveness compared with offline recruitment. In contrast, offline recruitment outperformed online recruitment with respect to conversion rate.

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Online Patient Recruitment in Clinical Trials: Systematic Review and Meta-Analysis (Preprint)

10.2196/preprints.22179 ◽

2020 ◽

Author(s):

Mette Brøgger-Mikkelsen ◽

Zarqa Ali ◽

John R Zibert ◽

Anders Daniel Andersen ◽

Simon Francis Thomsen

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Cost Effectiveness ◽

Meta Analysis ◽

Recruitment Rate ◽

Wilcoxon Test ◽

Patient Recruitment ◽

Conversion Rates ◽

Number Of Patients ◽

Online Recruitment

BACKGROUND Recruitment for clinical trials continues to be a challenge, as patient recruitment is the single biggest cause of trial delays. Around 80% of trials fail to meet the initial enrollment target and timeline, and these delays can result in lost revenue of as much as US $8 million per day for drug developing companies. OBJECTIVE This study aimed to conduct a systematic review and meta-analysis examining the effectiveness of online recruitment of participants for clinical trials compared with traditional in-clinic/offline recruitment methods. METHODS Data on recruitment rates (the average number of patients enrolled in the study per month and per day of active recruitment) and conversion rates (the percentage of participants screened who proceed to enroll into the clinical trial), as well as study characteristics and patient demographics were collected from the included studies. Differences in online and offline recruitment rates and conversion rates were examined using random effects models. Further, a nonparametric paired Wilcoxon test was used for additional analysis on the cost-effectiveness of online patient recruitment. All data analyses were conducted in R language, and P<.05 was considered significant. RESULTS In total, 3861 articles were screened for inclusion. Of these, 61 studies were included in the review, and 23 of these were further included in the meta-analysis. We found online recruitment to be significantly more effective with respect to the recruitment rate for active days of recruitment, where 100% (7/7) of the studies included had a better online recruitment rate compared with offline recruitment (incidence rate ratio [IRR] 4.17, P=.04). When examining the entire recruitment period in months we found that 52% (12/23) of the studies had a better online recruitment rate compared with the offline recruitment rate (IRR 1.11, P=.71). For cost-effectiveness, we found that online recruitment had a significantly lower cost per enrollee compared with offline recruitment (US $72 vs US $199, P=.04). Finally, we found that 69% (9/13) of studies had significantly better offline conversion rates compared with online conversion rates (risk ratio 0.8, P=.02). CONCLUSIONS Targeting potential participants using online remedies is an effective approach for patient recruitment for clinical research. Online recruitment was both superior in regard to time efficiency and cost-effectiveness compared with offline recruitment. In contrast, offline recruitment outperformed online recruitment with respect to conversion rate.

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Pelargonium Extract EPs 7630 in the Treatment of Human Corona Virus-Associated Acute Respiratory Tract Infections – A Secondary Subgroup-Analysis of an Open-Label, Uncontrolled Clinical Trial

Frontiers in Pharmacology ◽

10.3389/fphar.2021.666546 ◽

2021 ◽

Vol 12 ◽

Author(s):

Tilman Keck ◽

Andreas Strobl ◽

Andreas Weinhaeusel ◽

Petra Funk ◽

Martin Michaelis

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Nucleic Acids ◽

Common Cold ◽

Subgroup Analysis ◽

Viral Infections ◽

Open Label ◽

Pelargonium Sidoides ◽

Number Of Patients ◽

Tract Infections

Background: Experience in treating human coronavirus (HCoV) infections might help to identify effective compounds against novel coronaviruses. We therefore performed a secondary subgroup-analysis of data from an open-label, uncontrolled clinical trial published in 2015 investigating the proanthocyanidin-rich Pelargonium sidoides extract EPs 7630 in patients with the common cold.Methods: 120 patients with common cold and at least 2 out of 10 common cold symptoms received one film-coated 20 mg tablet EPs 7630 thrice daily for 10 days in an uncontrolled, interventional multicentre trial (ISRCTN65790556). At baseline, viral nucleic acids were detected by polymerase chain reaction. Common cold-associated symptoms and treatment satisfaction were evaluated after 5 days and at treatment end. Based on the data of patients with proof of viral nucleic acids, we compared the course of the disease in patients with or without HCoV infection.Results: In 61 patients, viral nucleic acids were detected. Of these, 23 (37.7%) were tested positive for at least one HCoV (HCoV subset) and 38 (62.3%) for other viruses only (non-HCoV subset). Patients of both subsets showed a significant improvement of common cold symptoms already after 5 days of treatment, although the observed change tended to be more pronounced in the HCoV subset. At treatment end, more than 80% of patients of both groups were completely recovered or majorly improved. In both subsets, less than 22% of patients took concomitant paracetamol for antipyresis. The mean number of patients’ days off work or school/college was similar (0.9 ± 2.6 days in HCoV subset vs 1.3 ± 2.8 days in non-HCoV subset). In both groups, most patients were satisfied or very satisfied with EPs 7630 treatment.Conclusion: EPs 7630 treatment outcomes of common cold patients with confirmed HCoV infection were as favourable as in patients with other viral infections. As this trial was conducted before the pandemic, there is currently no evidence from clinical trials for the efficacy of EPs 7630 in patients with SARS-CoV-2 infection. Dedicated non-clinical studies and clinical trials are required to elucidate the potential of EPs 7630 in the early treatment of HCoV infections.

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