Remdesivir was one of the first drugs identified as having an impact on SARS-CoV-2, the new coronavirus that causes Covid-19, in laboratory tests. The world is awaiting the results of Gilead’s clinical trials, and positive results would likely lead to quick approvals by the Food and Drug Administration and other regulatory agencies. If it is safe and effective, it could become the first approved treatment for the disease.
The University of Chicago Medicine recruited 125 people with Covid-19 in two Gilead phase 3 clinical trials. Among these people, 113 suffered from a serious illness. All patients were treated with daily infusions of remdesivir.
“The best news is that most of our patients have already been out, which is great. We only had two patients who perished, “said Kathleen Mullane, an infectious disease specialist at the University of Chicago, who is overseeing studies on remdesivir for the hospital.
His comments were made this week during a video discussion of the trial results with other faculty members at the University of Chicago. The discussion was recorded and STAT obtained a copy of the video.
The results provide only an overview of the effectiveness of remdesivir. The same trials are being conducted simultaneously in other institutions, and it is impossible to determine with certainty the full results of the study. However, no other clinical data from the Gilead studies has been published to date, and the excitement is high. Last month, President Donald Trump touted the potential of remdesivir – as he has done for many unproven treatments – and said it “appeared to be working very well.”
Gilead said on Thursday, “What we can say at this point is that we are looking forward to the availability of data from ongoing studies. “
Gilead said he expected results for his trial of serious cases in April. Mullane said during his presentation that the data for the first 400 patients in the study would be “locked” by Gilead on Thursday, which means the results could arrive any day.
Mullane, although encouraged by the data from the University of Chicago, has clearly expressed his own reluctance to draw too many conclusions.
“It’s always difficult,” she said, as the severe trial does not include a placebo group for comparison. “But certainly when we start [the] medication, we see the fever curves drop, “she said. “Fever is no longer a requirement for people to have a test, we see when patients come in with a high fever, they do [reduce] fast enough. We saw people coming off the ventilators one day after starting treatment. So in this area, overall, our patients have done very well. “
She added, “Most of our patients are severe, and most of them leave at six days, so the treatment does not have to be 10 days. We have very few that lasted 10 days, maybe three, ”she said.
Reached by STAT, Mullane confirmed the authenticity of the streak but declined to comment further.
When asked about the data, Eric Topol, director of the Scripps Research Translational Institute, described it as “encouraging”.
“Severely affected patients are at such a risk of death. So while it is true that many of the 113 patients fell into this category and were discharged, this is another positive signal that the drug is working, “he said, adding that it will be important to see more data from randomized controlled studies.
Gilead’s severe Covid-19 study included 2,400 participants from 152 different clinical trial sites around the world. Its moderate Covid-19 study includes 1,600 patients in 169 different centers, also around the world.
The trial investigates the five and 10 day treatment cycles of remdesivir. The main objective is a statistical comparison of patient improvement between the two treatment arms. Improvement is measured using a seven-point numeric scale that includes death (at worst) and discharge from hospital (best result), with varying degrees of supplemental oxygen and intubation between of them.
The absence of a control arm in the study could make the interpretation of the results more difficult.
A lack of data led to yo-yoing expectations for the drug. Two studies in China had their enrollment suspended mid-term because there were not enough patients available. A recent report from patients who received the drug as part of a special program to make it accessible to those who are very ill has aroused both excitement and skepticism.
In scientific terms, all of the data is anecdotal until the full essay is read, which means it should not be used to draw final conclusions. But some anecdotes are dramatic.
Slawomir Michalak, a 57-year-old factory worker from a western Chicago suburb, was one of the participants in the Chicago study. One of her daughters started to feel sick in late March and was later diagnosed with mild Covid-19. Michalak, on the other hand, came down with a high fever and reported shortness of breath and severe back pain.
“It was like someone hit me in the lungs,” he told STAT.
At the urging of his wife, Michalak went to the University of Chicago Medical Hospital on Friday April 3. His fever had increased to 104 and he was having trouble breathing. At the hospital, he received additional oxygen. He also agreed to participate in Gilead’s severe Covid-19 clinical trial.
Her first remdesivir infusion was on Saturday April 4. “My fever dropped almost immediately and I started to feel better,” he said.
By his second dose on Sunday, Michalak said he was being weaned off oxygen. He received two additional daily infusions of remdesivir and recovered enough to be discharged from hospital on Tuesday, April 7.
“Remdesivir was a miracle,” he said.
The world is waiting to know if this is really the case.