REMDESIVIR drug approved by FDA to treat Covid-19 patients

The first confirmed patient with COVID-19 in the US was admitted into hospital in Everett and when his situation got worse, the use of remdesivir drug treatment was suggested and under five days of the first dose, he was discharged to go home, and he was sent home on home quarantine with – under the care of the county health department.  And since then he’s done quite well and has had no apparent sequela from the infection after discharge.   

Dr George Dias, a section chief of infectious diseases at Providence Regional Medical Center in Everett in the state of Washington, who is currently investigating the use of remdesivir in a clinical trial is the first doctor to apply the use of this treatment on the first confirmed Covid-19 patient in the USA. 

According to Dr Dias, in a video conference on May 4, the first Covid-19 patient confirmed case was on January 20th in Everett when contacted by CDC (Centers for Disease and Control and Prevention) to put that patient on an observatory state in their hospital, “he initially had symptoms typical of COVID-19 with fever, cough, and generalized fatigue.  He intermittently had diarrhea as well. A few days into his illness, the patient developed pneumonia.  He developed shortness of breath, and he developed low oxygen levels when we checked his oxygen levels on pulse oximetry.  Because of these findings, we suspected that he had progressed to pneumonia secondary to COVID, and at that point, with the CDC expertise on hand, they suggested we consider the use of remdesivir.”

Although, there had been relatively recently released studies looking at the use of remdesivir in animal models, and it appeared to reduce the effect of the virus in the lung in these animals, it has never been used or applied on patients with Covid-19. Even though it had been tested in healthy volunteers during the Ebola outbreak, the drug appeared to be safe, but unfortunately was not very active against the Ebola virus disease.

Therefore, for these reasons, the first confirmed US Covid-19 patient agreed to receive remdesivir, and Gilead, the manufacturer, and the FDA ( US Food and Drug Administration ) were able to provide the drug under ‘compassionate use.’  

Before the infusion, the patient had been having high-grade fevers and low oxygen levels, and they infused it that day. He did not have any symptoms from the infusion itself, and by the next day the patient felt much better overall.  His fevers significantly improved, and the patient stayed afebrile the rest of the time he was in the hospital.  He did not have any ill effects from the antiviral, and he was able to come off oxygen within about 24 hours. 

After this, the numbers of Covid-19 patients increased in Western Washington and  they were added to treatment through the Compassionate Use Program with Gilead. And in early March, Gilead was able to help stand up a clinical trial at both Providence and Swedish Medical Center for treatment of patients with severe pneumonia. Some patients who present with a pneumonia on x-ray, low oxygen levels less than 94 percent, and a positive COVID test were been treated. 

On treatment with remdesivir, they have seen little in the way of substantial side effects from treating large numbers of patients. The primary symptom really is nausea in less than 10 percent of patients. There are some exclusion criteria for use of the drug, and that has limited their ability to give some patients this medication. And the primary reason for not providing this medication has been due to abnormally low kidney function.  Otherwise, they have primarily been using it in patients who have COVID pneumonia.  After the first 400 patients were enrolled, the company added the option to use remdesivir in patients on the ventilator.  Prior to that, they weren’t able to enroll patients who were already on the ventilator when they received them for care. 

In the past week, according to NIHi data, on their trial, which has indicated that the recovery time for COVID-19 patients is reduced by roughly four days. They may also be seeing a mortality benefit; patients that receive remdesivir appear to have an improved or reduced mortality compared to those patients who do not receive remdesivir, 

 although that’s not yet been published, and that they’re undergoing further analysis of their patients to make that determination. 

Furthermore, Gilead, remdesivir’s manufacturer, in their pneumonia’s trial data, shows that patients who received remdesivir early – meaning during their first 10 days of symptoms – were more likely to discharge [from] the hospital than those that were started after 10 days of symptoms had elapsed. The difference in the ability to discharge to the hospital was measured at 13 percent. 

So, with these findings, the FDA has granted Emergency Use Authorization for the use of remdesivir in patients with severe pneumonia on May 1. And even with the use of this drug, inappropriate widespread use of any medicine can result in resistance to that particular medication.  And so, as the FDA has approved this medication on Emergency Use Authorization, it’ll be really important that they try to use it as appropriately as possible.  And up to this point, it’s only been shown to have some effectiveness in people who have severe pneumonia. 

As many states all around the US are in the reopening stage, people shouldn’t use the discovery of remdesivir as an excuse to no follow the already set health guidelines. According to Dr Dias, “it appears that we do have an agent in our armamentarium against COVID, but we have to use it very wisely.  This should not be used as a crutch to – for patients to say, well – or people to say, “I can now do whatever I want because we have a treatment.”  No, the people of the world need to continue to follow the guidance of the infection control and public health people that are advising them about social-distancing, because that is the most effective treatment we have for COVID-19 at this point. “

By Niyi Fote /Thenews2