People around the world are pinning their hopes on researchers to find ways to fight COVID-19 disease. At last count, the number of confirmed cases worldwide stands at more than 4.7 million.1 As new options are being explored at an unprecedented pace, the global pandemic has brought home the importance of clinical trials in assessing whether potential treatments and preventive vaccines are safe and effective before they can reach the public.
On International Clinical Trials Day, Sanofi recognizes the importance of trial sites and study participants for their role in advancing new medicines. Finding a vaccine and treatments for COVID-19 is only possible through clinical research, which is equally important for other diseases. The people who conduct, organize and coordinate clinical trials around the world as well as trial participants are making a great difference for public health.
“Thank you to the healthcare professionals and patients participating in clinical research,” said Lionel Bascles, Senior Vice President, Global Head of Clinical Sciences and Operations at Sanofi. “Our call to action for all the patients we serve has never been more profound.”
Leveraging clinical trials to explore treatments
Sanofi is supporting clinical trials to determine whether two of its medicines can help patients with COVID-19. One option is currently being tested to evaluate its impact on symptoms in patients with severe COVID-19 in a number of countries, with a second trial led by Sanofi’s partner Regeneron for patients in the US.
The second product is one of several medicines being investigated by the World Health Organization in its international clinical trial to find a solution for COVID-19. To support this research, Sanofi has launched two additional clinical studies and is also providing the medicine to some participating investigator sites and other independent research centers.
Maintaining critical clinical trials during the pandemic
Clinical trials for COVID-19 have been launched with unprecedented speed, but Sanofi has also worked in parallel to maintain, where possible, the continuity of critical clinical trials for other diseases.
Together with clinical study sites, investigators and health authorities, Sanofi’s teams have created patient-focused solutions to overcome obstacles caused by the pandemic.
In China, an ongoing flu vaccine study initiated in early January had to be halted due to the COVID-19 outbreak. Sanofi’s local team worked closely with the sites to adapt the initial plan and the first site was able to resume enrollment of participants mid-March. Investigators, in charge of conducting clinical trials, and the local Sanofi team worked tirelessly, including through a public holiday, to make up for lost time. Having recruited more than 5,000 participants, their efforts paid off and the study completed enrollment early May, within the deadline to meet a critical milestone to secure a vaccine for this year’s flu season.
For other clinical trials, solutions were also needed to resupply the investigational product for participating patients. In close collaboration with regulators, ethics committees, suppliers and clinical trials sites in many parts of the world, Sanofi’s teams came up with a model that allowed for the drug to be supplied to the patients’ home, where they were monitored remotely using telemedicine.
Bringing the medicine to the patients was also part of the solution in Europe for rare disease patients who could no longer receive infusions at clinical sites during the pandemic due to co-existing health conditions. Working with local health authorities, Sanofi’s team put in place a special procedure so that nurses could bring the treatment and supplies needed for the infusion directly to the patients’ home. The medical follow-up was done by phone and through videoconferencing with the investigators before, during, and after infusion.
But for some patients, telemedicine was not the solution. With lockdown in place, a rare disease patient in Europe was no longer able to take a plane or cross the border by car to continue in a trial at a study site in a neighboring country. The site, together with Sanofi’s team, came up with an alternative solution: the patient was driven to the border, walked across it and continued in another car, making it to the scheduled visit and getting the medication in a journey that lasted five hours.
Sanofi is fully committed to the patients in its clinical trials. Sixty percent of Sanofi’s approximately 300 ongoing clinical studies are in the recruiting stage. The company is keeping in close contact with clinical trial sites to provide support and guidance to ensure the safety of the patients in its trials.
It’s thanks to the commitment of clinical trial site staff, patients and healthy volunteers, as well as many patient organizations that Sanofi can bring new medicines to those in need.
Find out more
A Clinical Trial: How does it Work?
A clinical trial or study normally takes place after preclinical testing-in the lab and in animal studies-have proved satisfactory. Often, the medicine is compared to a placebo (a substance with no pharmacological activity) or to existing treatments, to determine whether it is effective. It determines the effective dose regimen, possible toxicity and the nature and frequency of adverse events it may cause. It usually lasts a couple of years.
1 https://covid19.who.int/, last accessed on May 20, 2020
2 https://www.ecrin.org/international-clinical-trials-day-ictd, https://www.who.int/bulletin/volumes/82/10/791.pdf?ua=1, last accessed May 20, 2020