The search for a cure against Covid sounded promosing, Lille Institut Pasteur scientists were confident: they thought they found in Clofoctol a drug enabling to stop the virus from replicating itself in airways. The health organization was conducting their second phase of their clinical trials, but they have had to stop it prematurely.
"This is not really stopping, but a change of strategy. We were heading for disaster..." IPL CEO Xavier Nassif told Voix du Nord this Thursday December 9.
Different issues forced the team of scientists to halt their work. "Many procedures delayed the likely beginning of the clinical trial aiming at assessing the effectiveness of Clofoctol during Covid-19. The timeframe to get the approval are the cause of these major difficulties we had to recruit volunteers and leading to an increase in cost exceeding our financial means..." the IPL explains in a release.
Finding volunteers to test the therapy ended up too harsh: the patients were to be over 50 years of age, not vaccinated and positive for at least three days. The IPL needed 346 people answering these criteria.
The institute has paused their study, while waiting to find new work methods to resume their research without losing as much money and time as before.
An aborted search
For the record, on Tuesday September 29, 2020 searchers from the Institut Pasteur de Lille told RTL they may have found a cure against coronavirus, a molecule to be exact, that seems active against the virus. A treatment already used on the European continent for other uses and that could be produced on a larger scale to be commercialized in 2021 after approval from the concerned higher bodies.
On Monday September 6, 2021, the Institute - which clinical trial is entering phase two - has announced they have recruited their first volunteer for this new phase. All in all, the institute expects to recruits 350 to 700 volunteers, via GPs and laboratories. A recruitmnt that only involves Hauts-de-France so far, but as Lille Institut Pasteur explains, "we are looking to expand to more regions, especially the West Indies". Recruitment might take longer than expected... And for good reason, authorizations took a long time, and criteria applying to volunteers no longer fit to non-vaccinees or hospitalized people.
The clinical trial eventually goes on in French West Indies as they lack candidates in Hauts-de-France with tests that started in October, as our peers from Médiacités Lille explain. A first volunteer has even been recruited in Martinique.
The Institut Pasteur was granted approvals this past June. In the meantime, searchers yet managed to get the national research priority label, forcing the ANSM to approve in-human trials or not within eight days. A battle fought by the Institute since February, after a ministerial committee, Capnet has decided - according to La Voix du Nord - slow down the research and especially the process to approve the cure before marketing. Why? "It seems the committee doesn't get what repositioning is" Apteeus president Terence Beghyn explains as he works with Institut Pasteur on the project, La Voix du Nord explains. "The committee suggests amendments to the clinical development strategy and mainly a new initial design of the trial" Institut Pasteur Lille explains.
As for Institut Pasteur, they try to remain optimistic: "We'll loose a few weeks, but the main thing is we can move on" institute director Xavier Nassif says, explaining that he takes "the body's recommendations very seriously". This wait could pay off if everything goes as planned. Since then, clinical trials started and involve about a hundred patients in the region with a specific profile: "Having recenlty been tested positive, being over 50, having at least one symptom, and not being vaccinated", Lille Institut Pasteur Scientific Head Benoît Deprez told our peers from La Voix du Nord. Out of the hundred patients, about fifty of them will be given the therapy, the other half, a placebo.
What you need to know about Clofoctol
What is this treatment? It involves Clofoctol, as Xavier Nassif told our peers from France 3 Hauts-de-France this Tuesday April 12. This antiviral has been discovered “by a repositioning technique, it means we take medicines we find in pharmacies and see if – miraculously – there is not a molecule that could be effective on the virus whereas it was not created on this purpose” he explains. “We want to keep the name of the medicine secret to avoid a parallel market and prescriptions under control and manage stocks” a searcher said this past November.
How does it work? Once again, Xavier Nassif answers: “We used the product that is not very popular. The active substance comes and piles up in the airways, lungs, where the virus is found in the early stages of the disease” he explains. He goes on “in every test ran, this molecule inhibits the replication of the virus. […] This is a very little-used molecule and it does not present specific issues in terms of side effects. It could be administered risk-free”.
He told France 3, this Tuesday April 13, that "antivirals do not affect the same compounds of coronavirus as vaccines. They are not sensitive to variants because they attacks the fundamental compounds enabling the virus to replicate itself. They do not vary, or very little". This effectiveness could make a cure against variants - starting to resist vaccines available on the market - easier.
What about trials? After testing the treatment on infected human cells, that ended up quite successful, this mysterious treatment is subject to preclinical study since October 2020 on monkeys. As for trials on humans, according to Benoit Déprez they will take place "as double blind trials, against placebo, doctors nor patients will know if they are using the medicine or the placebo that has no active substance" as written in December in Sciences et Avenir.
Nassif also detailed the question on Tuesday April 13: "There will be randomized trials with two groups of patients including a random draw: some will get the medicine with the active ingredient, the others won't. Patients will be followed-up for three weeks for a double-blinded trial. We need 600 to 700 volunteers in Hauts-de-France to conduct these trials", he told France 3. As for results, if everything goes well, and the health authorities closely follow the works, trials could occur in 2021.
When will it be commercialized? According to the Institut Pasteur de Lille director, by spring 2021: “We are designing the trial, then we will request the requiring authorizations, but it will take quite a while” he says. He adds: “We are wondering who will get this molecule, mild sick or asymptomatic carriers so that they secrete the virus for less time, or very sick people. If we run the clinical trials quickly, we target late winter 2021”. This date has been delayed, since trials barely recently started.
