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Lack of suitable volunteers ends France’s Covid suppository drug trial

Institut Pasteur in Lille had hypothesised that the drug Clofoctel could reduce the risk of hospitalisation due to Covid

The Institut Pasteur de Lille (IPL) had received authorisation to begin the trial but the recruitment process did not go to plan Pic: EBASCOL / Shutterstock

The Institut Pasteur in Lille, Nord, has stopped working on its clinical trial of an anti-Covid suppository treatment due to issues with recruiting volunteers.

The Institut (IPL)’s clinical trial was authorised by the drug safety authority l’Agence nationale de sécurité du médicament et des produits de santé (ANSM) to take place after June 10, 2021, for the testing of an anti-Covid suppository named Clofoctol. 

But on December 9, the IPL decided to stop the trial after encountering issues with recruiting volunteers.

Clofoctol has long been used to treat other conditions, including bacterial angina and rhinopharyngitis, yet it was pulled from the market in 2005 due to its ‘limited medical interest’. 

The IPL had considered its use as part of its Therapide project in collaboration with the biotechnology start-up Apteeus. The trial had aimed to conclude if the medicine could be effective against Covid-19, as “in vitro” it had shown signs of effectiveness against the virus.

The institute had hypothesised that two suppositories per day over five days could significantly prevent hospitalisations and early hospital care for Covid patients. 

However, the patient recruitment process did not go to plan. The trial had aimed to recruit 346 volunteers who were aged over 50, non-vaccinated against Covid, and who had tested positive within the last three days, but these criteria proved too difficult to apply.

The trial was deemed too difficult and expensive to recruit for, and the IPL decided to “take the decision to stop recruitment to reconfigure the project to adapt to the changing pandemic situation”, according to an internal document released by La Voix du Nord.

The note said: “The delays in obtaining authorisations are at the origin of the great difficulties we have found in recruiting volunteers, with the result that the costs are increasing beyond our financial capacities.”

The stoppage has been seen as the latest blow to French anti-Covid research, after French lab Sanofi has pushed back release of its own Covid vaccination numerous times.

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