- Proof-of-concept of a virtual Phase 2 double-blind placebo-controlled clinical trial
- Hesperidin 1g daily reduced COVID-19 symptoms compared to placebo
Montreal, December 22, 2021. Ingenew Pharma announces it has completed a double-blind placebo-controlled clinical trial designed to evaluate the benefits of hesperidin therapy in symptomatic non-vaccinated COVID-19 subjects. The rationale and interest for using hesperidin in the treatment and even in the prevention of COVID-19 have been previously highlighted, both for its anti-oxidant and anti-inflammatory properties, and for its ability to block the entry and replication of SARS-CoV-2.
In the trial, 216 subjects were randomized to receive either Hesperidin 1000 mg once-daily or placebo for 14 days. Thirteen symptoms including fever, cough, shortness of breath and anosmia (“Group A symptoms”) were monitored.Group A symptoms in the placebo vs hesperidin groups were 88.8% vs 88.5% at day 1 and reduced to 58.5 vs 49.4 % at day 14, respectively. At that timepoint, 15 subjects in the placebo group and 28 subjects in the hesperidin group failed to report their symptoms, which may be due to symptomatic improvement and decreased willingness to cooperate for the participants that felt better. No safety issues were observed in either cohort. If missing values are assumed to represent “no symptoms”, the hesperidin group shows a statistically significant reduction of 14.5 % of Group A symptoms from 50.9% to 36.4% (p = 0.03).
The trial was conducted and coordinated by the Montreal Health Innovations Coordinating Center (MHICC) in a virtual mode, a patient-centred approach allowing patients to participate in clinical trials from the comfort of their own homes, facilitating recruitment, retention and follow-up of participants with digital tools.
“This clinical trial was successfully executed under challenging conditions imposed by the pandemic and is an early example illustrating the potential of virtual clinical trials that do not require in-person visits” stated Pierre Laurin president of Ingenew Pharma. “Scientists were able to monitor the effect of a potential treatment for COVID-19 without putting at risk the subjects and the healthcare professionals involved in the study”.
Dr Jocelyn Dupuis, principal investigator of the study, concluded: “These results are very encouraging when taking into account the attrition bias analysis and a best-case scenario where subjects with missing values have no symptom. We cannot exclude that hesperidin could have beneficial effects and further studies are encouraged including earlier treatment of longer duration and/or higher dosage.”
More about Ingenew Pharma
Ingenew Pharma is a biopharmaceutical company focused on addressing unmet medical needs and serving patients and families affected by serious and debilitating illness. Its primary therapeutic areas of interest include oncology and immunology. Ingenew’s current research and development efforts are evaluating proprietary preparations and delivery systems designed to improve the clinical efficacy and reduce toxicity and side effects associated with standard of care. At Ingenew Pharma, we leverage the extensive and successful track record of our scientists and apply adaptive-creative research and development principles to advance tangible and affordable medical solutions. (www.ingenewpharma.com)
About the Montreal Health Innovations Coordinating Center (MHICC)
The Montreal Health Innovations Coordinating Center (MHICC) is a leading academic clinical research organization and an integral part of the Montreal Heart Institute. The MHICC possesses an established network of collaborators in over 4500 clinical sites in more than 30 countries. It has specific expertise in precision medicine, low-cost high-quality clinical trials, and drug repurposing. (www.mhicc.org)