Some 50% of the patients needed have been recruited to complete a Phase III trial of an American-developed drug that “might be a game changer” in the battle against COVID-19, says Hadassah University Medical Center’s Prof. Yosef Caraco.
Caraco told The Jerusalem Post that his team recently completed its part of a successful Phase II trial of the orally available antiviral drug candidate Molnupiravir, developed by Merck Pharmaceuticals (legally known internationally as MSD), a drug meant to slow the progression of coronavirus from mild to severe disease.
The professor presented the data from the study at the European Congress of Clinical Microbiology & Infectious Diseases in July. The study was conducted at 80 medical centers around the world in which about 300 coronavirus patients in mild or moderate condition took part. Some received Molnupiravir and others a placebo.
“The general conclusion from this stage is that, first of all, the drug is safe,” Caraco said. “We did not observe anything unusual. We also saw that those who were treated by the drug were less likely to need hospitalization compared to those who received a placebo.”
As such, he said, “We can cautiously say that the drug has the potential to prevent hospitalization if it is given to mildly or moderately ill patients, especially if given early in the course of the disease.”
The Phase II trial ran from late fall of 2020 through April 2021. The Phase III trial that started in June is expected to last another few months. Fifty percent of the patients have already been recruited, Caraco said.
He added that the drug is active against the coronavirus and can stop infection from progressing from mild or moderate to severe.
“Up until now, we have been very busy trying to research drugs to treat the most severe patients in the hospital,” Caraco said. “This is quite obvious because we are speaking about people at risk of death.”
However, he said that after all this time, the results have not been encouraging. While doctors are using a cocktail of drugs to treat severe COVID-19, what they found is that the most important aspect in the prognosis of these patients is the level of intensive care treatment that they can provide.
“The success rate of all of these drugs we have been trying is really disappointing,” he said.
Molnupiravir is an effort to change the course of treatment, turning attention to the nearly 90% of COVID patients that are in mild or moderate condition.
“The idea is that if we can treat them, we can prevent the progression to severe disease,” Caraco explained. “This is a total change in the way we are trying to tackle the disease. This is a paradigm change.”
The Phase III study involves many more patients. Caraco said it has been challenging to reach these patients in Israel, as many have already been vaccinated and therefore do not qualify for the study. In addition, most patients who have mild symptoms think they can “take Tylenol and tea” and the virus will disappear on its own.
“The average mild patient thinks, ‘Why should I get any treatment? I was told this is a simple and easy disease,’” Caraco explained.
But he said that if the Phase III trial validates the findings of the Phase II trial, “this is going to be a game changer… When there is a plague, the most important and efficient way to struggle against it is to prevent it. That is why we are giving so much attention to the vaccines. But the vaccines are not 100% foolproof. The next best thing to preventing infection is preventing deterioration.”
He said the research team also hypothesizes that the drug could help reduce the contagiousness of the patients and therefore the likelihood of their spreading the virus to household contacts. They also believe it might have a positive impact on preventing long COVID.
“If we can avoid deterioration to a more severe disease,” Caraco concluded, “this could also alleviate the fear of these patients ending up in the hospital as severe patients.”