THE WASHINGTON FOREIGN PRESS CENTER, WASHINGTON, D.C.
MODERATOR: Good morning. I’m Cheryl Neely. Welcome to the Foreign Press Center’s video conference briefing with Dr. George Diaz on remdesivir as a treatment for COVID-19. The meeting host will now mute all journalists’ microphones. Please keep your microphone muted until you are called on to ask a question. You may record the briefing by clicking on the record button at the bottom of the Zoom screen. The meeting host will now mute all journalists’ microphones, please. I’m going to unmute Dr. Diaz. Okay, we’re hearing a lot of noise. (INTERRUPTION) Okay, continuing on, if the Zoom session fails or disconnects, everyone please go back to the link and click on it to join again. If you have technical problems during the briefing, you can use the chat feature to chat with Bryce, my colleague, or the meeting host, and they will try to assist you.
The ground rules for this briefing are – is that the briefing is on the record. Non–governmental guests invited to address FPC member journalists offer their views in a personal or organizational capacity and do not represent the official views of the Foreign Press Center or the U.S. Government.
So I’d like to introduce our briefer today, Dr. George Diaz. And first, Dr. Diaz, I’d really like to thank you for your time today, for being with us, and thank you as one of the very first First Responders in the U.S. for this pandemic. We really appreciate everything you do.
Dr. Diaz is section chief of infectious diseases at Providence Regional Medical Center in Everett in the state of Washington. Dr. Diaz is currently investigating the use of remdesivir in a clinical trial, and his experience using remdesivir on U.S. Patient One was published in the New England Journal of Medicine. Dr. Diaz is a leading expert on the treatment of COVID-19, and he will provide a brief overview of his experience treating the novel coronavirus and his partnership with the U.S. Centers for Disease Control and Prevention (which as you all know we call the CDC) – his experience working with them to treat the first confirmed U.S. patient. Then we will take questions and answers. And as you all know, the U.S. Food and Drug Administration just approved the use of remdesivir to treat COVID-19 patients under emergency use regulations while global clinical trials continue.
At the end of the briefing after we complete the English portion of the briefing, we will stay on – those who want to – to participate in a Spanish–language dialogue with Dr. Diaz. And with that, I will let the doctor give a brief opening statement, and then I will come back to open the question and answer session. Dr. Diaz.
MR DIAZ: Thank you. I’d like to thank the U.S. State Department and the collaboration with the CDC that we’ve had throughout this entire time that we’ve had the pandemic in the U.S. Our story in Everett began in – on January 20th. At that point we had the first confirmed patient with COVID-19 in our county. We immediately were contacted by the CDC, who recommended that we admit the patient for observation to our hospital. While he was admitted to the 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.
We had recently gotten reports out of China that a large number of patients progressed to severe pneumonia as well as a need for care in the intensive unit – intensive care unit. Because of this, we reviewed this data from China with the patient as well as the use of remdesivir. It had not yet been previously used in patients with COVID-19, however it had been tested in healthy volunteers during the Ebola outbreak. At that time, the drug appeared to be safe, but unfortunately was not very active against the Ebola virus disease. So we could at least provide to the patient some safety data regarding the medication. In addition 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. For these reasons, the patient agreed to receive remdesivir, and Gilead, the manufacturer, and the FDA were able to provide it to us with – under ‘compassionate use.’
Because of the proximity to Gilead to Seattle, we were able to receive the drug and begin infusing the medication within 24 hours. Before infusion, the patient had been having high-grade fevers and low oxygen levels, and we 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. Within about five days of the first dose, he was able to discharge to 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.
After the patient went home, we began seeing larger numbers of patients within our county and our area, which is western Washington, and over the next few weeks began adding patients to treatment through the Compassionate Use Program with Gilead. And then after a few weeks in early March, Gilead was able to help us stand up a clinical trial here in our area, at both Providence and Swedish Medical Center for treatment of patients with severe pneumonia.
We have been treating patients who present with a pneumonia on x-ray, low oxygen levels less than 94 percent, and a positive COVID test. We have enrolled quite a few patients since the volume of patients in our area has – had significantly increased as we were one of the first epicenters of the pandemic in the U.S.
On treatment with remdesivir, we 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’s limited our 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, we 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, we weren’t able to enroll patients who were already on the ventilator when we received them for care.
In the past week or so, there has been some data that has come out from the NIHi on their trial, which has indicated that the recovery time for COVID-19 patients is reduced by roughly four days. They’re – they may also be seeing a mortality benefit, although that’s not yet been published, and that they’re undergoing further analysis of their patients to make that determination.
In addition, the – Gilead, the manufacturer of remdesivir, also last week announced some top–line results from their pneumonia trial which indicated that five days of therapy of – with remdesivir, pneumonia appears to be equivalent to 10 days of remdesivir in pneumonia. They also added additional data as well in their press release that indicated 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. Given these findings, the FDA has granted Emergency Use Authorization for the use of remdesivir in patients with severe pneumonia.
MODERATOR: Great. Is that the end of your opening statement?
MR DIAZ: Yes.
MODERATOR: Okay. Thank you so much, Dr. Diaz. Dr. Diaz, we do have one request from a TV station that during the question and answer period you look directly at the camera. It’s better for them. Thank you very much.
MR DIAZ: Sure.
MODERATOR: And so we will start the question and answer period. To ask a question, again, please click on the “Raise Hand” button at the bottom of the participant list. If you don’t know where that is, open the participant tab in Zoom. The link is at the bottom. Click on “Participants” and it will open a screen, usually to the right. Click on the “Raise Hand” button and I will call on you one by one. Please make sure that your name and outlet show in the participant list. I will prioritize calling on those who have identified themselves. If you have called in by telephone, we will try to give an opportunity at the end to ask a question, but it’s better if you use the link and log in on the website or the app. Okay. So with that, we will —
MR DIAZ: I’d like to —
MR DIAZ: I’d like to add one more statement from – on my brief.
MR DIAZ: So my hospital belongs to a large health system, Providence St. Joseph Health. We have 51 hospitals on the West Coast, the area that’s been most rapidly hit by COVID-19. Since we had a number of hospitals participating in these clinical trials with remdesivir, we’ve been conducting a retrospective review of our patients admitted to our hospitals with COVID-19. We have very preliminary results, but we also appear to be seeing a mortality benefit with remdesivir use as compared to standard-of-care therapy. So those results are early but very promising, and we are awaiting a peer review before discussing further data.
MODERATOR: Thank you. And for clarification, did you say ‘mortality benefit?’
MR DIAZ: Yes.
MODERATOR: Could you define that for our journalists?
MR DIAZ: Yeah. So we appear to be seeing that patients that receive remdesivir appear to have an improved or reduced mortality compared to those patients who do not receive remdesivir.
MODERATOR: Okay. Thank you so much. Okay, I will begin now calling on journalists. And just to remind everyone, we’ll have an English portion of the briefing that will last for a while, and then we will end the English portion and we will have an availability for those from Spanish-language outlets to ask questions in Spanish.
So if I will call first on Nikhila Natarajan from the Indo-Asian News Service.
QUESTION: Yeah, thank you. Thank you, Dr. Diaz. I’m Nikhila from Indo-Asian News Service and I also work with a think-tank called Observer Research Foundation, both headquartered in India. I live and work in the U.S.
Two things that you said stood out to me. You said that within the first 24 hours of remdesivir, you noted significant changes. I’d like you to hold that thought and tell me exactly what kind of changes you saw which made you feel that this is a significant improvement, material improvement. The second point you said is about giving it early. Now, that’s a theme we’ve been noticing across doctors’ chatter, even on social media, about giving it early and doing those randomized controlled trials. So I want you to just elaborate on both these pieces: 24 hours, what were those changes; and what does giving it early mean? At what point do you say this is early enough? Thank you.
MR DIAZ: Thank you. So with respect to the findings in our patient that made us feel that he was improving, he had his fevers entirely resolved, so he no longer had fevers during the admission. Prior to treatment with remdesivir, he was having fevers as high as 103 degrees Fahrenheit, 39 degrees Celsius. Thereafter, his temperatures remained roughly 37 degrees Celsius. He was also able to come off of oxygen, so he no longer needed oxygen supplementation to maintain to saturations above 94 percent. In addition, he generally felt much better, like he was resolving the infection, and he no longer felt short of breath. Those were the three sort of features that we saw that made us feel that he was improving.
With respect to early treatment, with the clinical trial that we’ve been involved in the inclusion criteria is the presence of pneumonia on x-ray, the positive COVID results, and also the finding of hypoxemia, meaning a saturation of 94 percent or less. And so those are the criteria that we use to enroll patients in the remdesivir trial. In our institution and in our health system, the majority of patients that would have qualified for the other trial, the moderate trial, for example, those patients that had saturations above 94 percent, the vast majority of those patients were able to go home. And preliminarily, very few of them appear to be returning to the hospital, and those are data that we’re looking at to try to identify these people that don’t have severe disease, can they go home?
With respect to remdesivir and severe pneumonia, in our institutions we would, as rapidly as possible when they make these inclusion criteria, we would start them on remdesivir, and ideally the treatment would begin as soon as those criteria were met. And oftentimes those were within 10 days of symptom onset, and frequently they were usually around day five or so of symptom onset. After about day ten of symptoms, we can see a dramatic worsening of symptoms with progressive respiratory failure and requirement for mechanical ventilation, for example. And so what the Gilead severe study appeared to show is that patients that were started on treatment before that 10th day of symptoms, that cohort of patients had a higher likelihood of being able to be discharged to home, meaning, I think, partly clinical success.
QUESTION: Thank you so much.
MODERATOR: Thank you. Okay, next we’ll have Magda Sakowska from Polish TV. Magda, I’m trying to un-mute you. There you are.
QUESTION: Okay, thank you. Good afternoon. Thank you for doing this briefing. My name is Magda Sakowska. I am correspondent to Polish TV Polsat News.
Dr. Diaz, I have a question. Do you know or could you tell us what kind of side effects remdesivir can cause? And in your opinion, what will be first – the cure for COVID-19 or vaccine?
DR DIAZ: I’m not sure that we with therapeutics can discuss a cure in 100 percent of patients. Dr. Tony Fauci of the NIH has indicated that remdesivir didn’t appear to be a knockout 100 percent drug, but it did in his hands have effect, that it did have the ability to stop the virus, and they saw an improvement in recovery times.
We have this therapeutic now here, and because the FDA has provided Emergency Use Authorization it will become available worldwide very shortly, and Gilead is working with local governments to provide this medication to those patients most in need. Vaccine work often takes over a year to determine its safety and effectiveness, and within the U.S. there is many vaccine trials that are ongoing and enrolling patients already. We’re hopeful that within a year we’ll have a vaccine. In the interim period, it’s important to find any therapies that we may have available for treatment of COVID, and remdesivir appears to be one that does have activity against the virus.
QUESTION: And what about the side effects?
DR DIAZ: Yeah. So the largest side effect that we’ve seen has been nausea. At my center we did not have to discontinue that medication for that reason. Other side effects that one can see include transient rises in the liver function tests of a patient. In our experience locally, those rises have been relatively mild and not – have not needed discontinuation of the drug. We also know that COVID-19 by itself also can cause liver inflammation as well, and so it’s a little unclear what the interplay between drug and the virus is in the liver. But inflammation of the liver can also be another side effect.
But the issue that most commonly excludes patients from remdesivir has been abnormal renal function, and we have many patients who are elderly that present to the hospital dehydrated and have borderline renal functions receive the drug, and so there are quite a few patients where we’ve enrolled them and their kidney function has just barely been adequate for treatment with remdesivir. We’ve seen similar results to those patients that have received treatment, and generally speaking we haven’t seen substantial increases in abnormal renal function after starting treatment with remdesivir, even in those patients. And that would be another concern is in patients at risk for renal disease, they could potentially need to discontinue that medication due to renal issues.
QUESTION: Thank you very much.
MODERATOR: Okay, next I’ll call on – I’m afraid, please forgive me if I mispronounce your name. Is it Weier Ge from China Business Network? I’m trying to un-mute you.
QUESTION: Can everyone hear me?
MODERATOR: Okay, yes, now I can.
QUESTION: Thank you. Thank you, Doctor, for the briefing. My question is: So when we talk about that in early days when we give the patient remdesivir, it shows more improvement. But as far as I know, like in New York City, people are not admitted to hospital, like some of my friends who got this COVID-19, they have fever, they have cough or – but most of the time they will not be admitted to the hospital. And we also have some other reports showing that in certain period of time, their situation, the condition, will worse suddenly.
So for those patients, I’m just curious about at what stage right now or in the future your suggestion patients to getting remdesivir? And also because right now we have to get this prescription at a hospital, because it’s in a vial, it’s not a tablet. So I would just ask your thoughts on this. Thank you.
MR DIAZ: Yeah, that’s a really good question. What we have seen in our hospitals is that patients may present with mild symptoms initially – for example, no pneumonia in X-ray and normal oxygen levels, but symptomatic. In the patients that are high-risk, meaning those people that are age over 60 or have illnesses that places them at high risk for disease, those patients within our health system we’ve been discharging them with pulse oximetry and telehealth monitoring.
So we have telehealth nurses that will contact them by phone or by video to talk to them to see how they’re doing, to interview them, and also to measure their vital signs, including their oxygen saturations. The purpose of this is to try to detect any changes early before a patient becomes ill enough to warrant ICU-level care. So we want to detect the change at the earliest stage of when someone develops what we could consider a severe illness.
A large majority of these patients who are discharged from the emergency department who have COVID end up having mild disease. And so what we want to know is in the patients that are in this category, that they don’t qualify for admission and don’t qualify for remdesivir, can we find the ones that are going to become sick and get them back into the hospital as quickly as possible?
And so one way of keeping close track of our patients is to monitor them actively outside the hospital with oxygen levels and vital signs and history taking to safely bring them in as soon as we see a change in the condition that would warrant admission and potentially treatment with remdesivir.
QUESTION: Thank you.
MODERATOR: Thank you. Okay, now I’m going to switch to a different region and call on – I believe it’s Niyi Fote, from The News2 Brazil.
QUESTION: Good afternoon. Thank you, Doctor George Diaz. I speak a little Spanish too, but I speak Portuguese very well. So my question is, Doctor, for example, there’s these ongoing reopening phase of some states in the United States, and so – and the fear of the COVID-19, the resurgence of this COVID-19. So with your knowledge on this new treatment that you’ve discovered, so do you think that the mass use of this remdesivir drug will give assurance to the Americans that, ‘oh, we can go back to work,’ and at least we have a treatment that can, I don’t know, help us out with that?
MR DIAZ: Yeah, those are good questions. I would say that any medication that we use to treat an infection, whether it be to treat bacteria or viruses, we want to make sure that these medicines are treated – used appropriately, because widespread inappropriate 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 we try to use this medication as appropriately as possible. And to this point, it’s only been shown to have some effectiveness in people who have severe pneumonia.
So I would say that we need to be very careful in how we use this medication and use it very wisely, because widespread inappropriate use could result in potentially the development of resistance to the antiviral, as we’ve seen on occasion to, for example, treatments for influenza.
So thankfully, 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.
QUESTION: Thank you very much.
MODERATOR: Okay. Now we’ll go to a different region. We’ll call on Jahanzaib Ali from Pakistan with ARY News.
QUESTION: Thank you so much, Cheryl. Thank you so much and thank you so much for arranging this briefing. So my question is: Is it available in all of America, I mean in all the hospitals? And is there clinical trials also going on? Thank you.
MR DIAZ: Yeah, so it’s currently available in the U.S. under numerous sites or part of the clinical trials. There’s also availability through an extended–use program promoted by Gilead, so hospitals can apply to that program, and it’s now available by Emergency Use Authorization, which means that hospitals will now be able to order the antiviral through the normal processes of ordering any medication that they would otherwise bring into their pharmacy.
So yes, it should be available to any hospital that requests it. Gilead is currently on working with international governments also to make it available to other countries that would want to have access to this medication as well, and I’m sure they’re working on ramping up supply chain to meet the substantial demand that may be coming.
MODERATOR: Thank you very much. We will now take one or two more questions in English, and then we’ll switch to the Spanish virtual pull-asides. Next we have Mladen Petkov from Bulgarian National Radio. And let’s see, are you un-muted? Yes. Please, go ahead, Mladen.
QUESTION: Can you hear me okay? Hello?
MODERATOR: You sound very far away.
QUESTION: Okay. Is this better?
MODERATOR: Can you speak a little louder? Maybe move closer to your microphone.
QUESTION: Yes, yes. Yeah, thank you so much for doing this, Dr. Diaz. And you talked about availability in the U.S. But I want to ask you if you can talk about the priorities, those areas that will have a priority. And also you mentioned about international cooperation and now currently Gilead working with local governments. Can you tell more, tell us more, about this cooperation going on? Thank you.
MR DIAZ: I think the question had to do about international cooperation for access of remdesivir to foreign governments. I can’t say that I know the specifics of what that plan is. I would refer you to the Gilead media department. They can probably provide a statement as to what their plan is for distribution for worldwide use.
MODERATOR: Thank you. We will try to find that media relations email address and send it out to those of you RSVP’d.
Let’s see. Let’s keep with – let’s go to Olivia Zhang with Caixin Media, China. Okay. Go ahead, Olivia.
QUESTION: Thank you. Thank you very much for doing this. My question is: I wonder whether you are paying attention to the clinical trial in China of remdesivir which has shown that there’s no significant benefits to this – the disease. And also wondering – you mentioned about the next steps. I’m not sure – I probably – you probably touched on that. I’m just wondering what’s the next focus on this remdesivir trial, if you can elaborate more on that. Thank you.
MR DIAZ: Sure. That’s a really good question about the trial in China. There was a double-blinded control study in China that results were published in the Lancet about a week–and-a-half ago. That study showed no benefit to remdesivir. Unfortunately, the study could not complete enrollment of all the patients that were recommended. I think one of the ways that studies determine if there is a benefit is by making calculations to be able to detect a difference in a treatment or non-treatment, and so those numbers are very important to be able to find a statistical difference. The researchers in China were not able to complete the enrollment and only enrolled about half the number of patients that was recommended. The authors in that paper indicated that it could’ve been due to several factors – one, that the measures that were in place in the region where the study was being conducted were such that few patients after a certain date were being admitted to the hospital; and also those patients that were admitted later in the study when the numbers decreased entered the hospital very late and were sick. And so they expressed concern about their finding being valid because of those two factors: one, they weren’t able to complete their enrollment; and two, they – the patients they were admitting appeared to be sicker and had waited longer than had been expected before the study started.
With respect to next steps, we are currently awaiting the publication of the study from Gilead looking at five versus ten days of therapy. Those results have not yet been published. We’re awaiting the results of the NIH trial. Dr. Fauci had alluded to some beneficial effects in that study. And we’re working on our study within our Providence Saint Joseph Health System, which was also looking at mortality as an outcome, and we are ourselves waiting for a peer review before formally announcing the results of that study.
QUESTION: Can I just do a very quick follow-up?
MODERATOR: Yes, quickly, please.
QUESTION: Yeah. I just wondering, is this trial just going to be do like separately and you are going to pay attention to the research results from other countries, or there is actually going to be actual cooperation on those trials with China and probably other countries too?
MR DIAZ: Yeah, so the Gilead severe study was a multinational study involving countries from all over Asia, Europe, and the United States. And so that study’s been actively enrolling patients worldwide and I would anticipate that further studies will still continue to be multinational.
MODERATOR: Okay. We’ll take one final question for the English portion of our briefing. I will call on – we have a reporter from Poland again, Marcin Wrona with TVN Polish TV.
QUESTION: Thank you. Doctor, remdesivir seems to be the first step. Do you see it as a path to a more effective cure, or this is as much as we can get with remdesivir and we need to look for something else more effective if we really want to have like a miracle drug that would cure it 100 percent? Thank you.
MR DIAZ: My personal opinion is that remdesivir has activity against the virus and that there are benefits to using the medicine that improve the lives of patients who receive it. There are patients where we know that present with severe disease or later disease where they have – are on a ventilator, very ill, and a large number of these patients will expire. Part of that disease process is something called Cytokine Release Syndrome, where the virus triggers an immune response in the body that causes severe and rapid decompensation, which is a process that is mediated by specific hormones in the body. There are ongoing studies now with other therapeutics to try to reduce that inflammatory cascade in the body. These are a class of antibodies that target specific cytokines called IL-6. These trials are currently ongoing in the U.S., and it may be that in the future in some of these very, very ill patients there may be an additive effect of using therapeutics like that.
There are a number of other studies that are being looked at as well for this disease, including convalescent plasma and other therapies that are also experimental. They’re not quite as far along at this point as remdesivir is. Thankfully, it appears that we have at least one therapeutic at this point that we appear to know has benefit, and so there’s going to be further data from remdesivir coming out, and over the next few months we will likely have further data on alternate therapeutics as well.
QUESTION: Thank you.
MODERATOR: Okay, thank you very much. So I want to ask master control and our tech people to continue the livestream and continue the recording. That concludes the official part of the briefing in English. If anyone did not get to ask a question, you may email any remaining questions to email@example.com and we will forward those to Dr. Diaz.
For those who would like to join the Spanish–language – we’re calling them “virtual pull-asides” – please stay after the others leave the meeting. All others may leave the meeting to disconnect. A transcript of the official briefing in English will hopefully be ready this afternoon or tomorrow morning, and the video and transcript will be posted on the Foreign Press Center website as usual. We will not have a transcript of the Spanish portion, but we will post the video on our website.