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Brazilian who leads study with remdesivir says that the drug is the most promising …

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Brazilian who leads study with remdesivir says that the drug is the most promising ...

André Kalil has already lost ten kilos in just over two months. He sleeps about four hours a night, runs 10 kilometers every morning and, several times a week, forgets to have lunch.

"It happens when you get very intense at work, but this time, it's not for a day or a week, it's months. We have to remember a little bit of what is normal."

At 54, 30 of them in the USA, the Brazilian infectologist at the University of Nebraska Medical Center leads research with antiviral remdesivirfirst remedy released by the American government for emergency use against Covid-19.

In an interview with Folha, Kalil states that the drug is today the most promising for the treatment of the disease, but further studies are still needed for the drug to be authorized for standard use.
"We are close, but we still need some time."

Preliminary results from the first phase of his research showed that patients who took remdesivir recovered four days before those who received placebo. Now Kalil announces the second phase of the study.

In it, all volunteers will receive the antiviral, but only half will also take an anti-inflammatory to assess whether the combination of the drugs further improves the recovery and survival of patients.

"If the data remains strong and consistent, it is possible that the drug will be approved as a standard drug."

Graduated in medicine from the University of Pelotas, the Bagé-born gaucho moved to the USA at the age of 24, to take a course in Miami. There he met the American Patricia, with whom he married and had three children.

At the University of Nebraska, where he has worked for almost 20 years, he went from being an assistant professor to the world reference in research with highly contagious diseases, leading the team that treated Ebola patients, five years ago, to Covid-19, since February.

Kalil points out that remdesivir should not be seen as a cure, but as a treatment, and that the vaccine against Covid-19 should still be delayed.

"We don't know how long the pandemic will last, so we have to maintain energy to continue the battle. If you are going to run a marathon and accelerate in the first 10 km, you are not done. The idea is to maintain a speed at which you can produce effectively, but not runs out ahead of time. "

How did your research start with remdesivir?
Due to Covid-19. In late January, we contacted the National Institutes of Health (NIH), a federal conglomerate that handles medical research in the U.S., and we were able to write the clinical trial protocol and have all NIH approval levels and the university in a few weeks. We received 15 patients from the Diamond Princess cruise in our quarantine unit and started the protocol with one of them on February 21st.

The initial results for remdesivir were not so conclusive. What has changed?
The study has expanded a lot. Today there are 68 hospitals, 50 in the USA and 18 in countries like Singapore, South Korea, Japan, Germany. The first part of the research was redemsivir versus placebo, with more than a thousand patients. Preliminary data from 500 patients show that there was a four-day faster recovery of those who received remdesivir compared to those who received placebo, from 15 to 11 days (of recovery). It was significant.

In mortality, it did not reach what we call statistical significance, in the sense that a larger number of patients observed would be needed. But the trial was not designed just to see mortality, it was done to see patients' clinical recovery. The fact that mortality was also lower for those taking the antiviral — 8% of remdesivir versus 11.6% of placebo— also corroborates the fact that if patients are able to recover more quickly, medication may be helping in their survival.

What is the next step?
We decided that the clinical trial will have a change in design and we are going to the second part. Now, there is no more placebo. All patients will receive remdesivir and half will also receive an anti-inflammatory used against rheumatoid arthritis, and the other half will receive more placebo. The idea is to know if, by adding an anti-inflammatory together with remdesivir, it will have made it even more beneficial.

Is remdesivir the most promising substance against Covid-19 today?
From a scientific point of view, there is currently no other randomized double-blind, placebo-controlled study, such as ours, that has shown effective medication. It is the most favorable scientific evidence for the treatment of Covid-19.

Experts say that no medication will be the cure for Covid-19 and that we need to wait for the vaccine, which still takes time. Mr. agree?
That's right. Remdesivir is not a cure, it is treatment. The cure eliminates the disease and has a 100% survival rate. This is not the case with remdesivir or any other medication.

When will we have a robust result so that remdesivir is prescribed in a standard way in the USA?
Between the end of May and the middle of June. The benefits are significant for patients. If the data remains strong and consistent, it may be a drug to be approved as a standard drug.

But, to get to that point, we have to have data from everyone in the trial, from ours and from others. We're close, but we still need some time.

The American government analyzed the data from its study and released emergency use to remedy it. Why wasn't there the same enthusiasm and action towards chloroquine, which was championed by President Donald Trump?
There is no scientific data to prove the benefits of chloroquine and hydroxychloroquine in patients with Covid-19. The difference is where there is data and where there is not.

Trump and Bolsonaro advocated the use of chloroquine without scientific evidence in Covid-19 cases. Can government action impact science and push for results?
I don't feel any pressure. For me, science will have to be done properly and in a way that protects my patients. There will always be people with different opinions, be it politicians, friends, family, colleagues, but we have to deal with this situation, bow our heads and do the work that must be done.

X-ray

André Kalil, 54, is an infectologist and researcher at the University of Nebraska Medical Center, USA. He graduated in medicine from the Federal University of Pelotas (RS); studied general medicine at the University of Miami and specialized in infectious diseases at Harvard University

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