Michaela Fleming

NIH Launches Trial Evaluating Hydroxychloroquine for COVID-19

” was originally published on ContagionLive.

A clinical trial has launched to evaluate the safety and effectiveness of hydroxychloroquine for patients hospitalized with 

, the National Institutes of Health (NIH) 

The study is a blinded, placebo-controlled randomized clinical trial that will seek to enroll more than 500 adult patients. The participants will receive clinical care as indicated and individuals who are randomized to the experimental intervention will receive hydroxychloroquine.

In the hydroxychloroquine treatment group patients will be randomly assigned to receive hydroxychloroquine 400 mg twice daily for 2 doses on day 1 and then 200 mg twice daily for the subsequent 8 doses on days 2 to 5 or placebo twice daily for 5 days.

Effective therapies for COVID-19 are needed, James Kiley, PhD, director of the Division of Lung Diseases at the National Heart, Lung, and Blood Institute (NHLBI), said in a statement.

“Hydroxychloroquine has showed promise in a lab setting against SARS-CoV-2, the virus that causes COVID-19 and preliminary reports suggest potential efficacy in small studies with patients,” Kiley said. “However, we really need clinical trial data to determine whether hydroxychloroquine is effective and safe in treating COVID-19.”

The Outcomes Related to COVID-19 treated with hydroxychloroquine among In-patients with symptomatic Disease (ORCHID) study has started enrolling patients at the Vanderbilt University Medical Center in Nashville, Tennessee. The study is being conducted by the Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network of the NHLBI, part of the NIH.

There are not current therapies that have demonstrated effectiveness in preventing the prevention of COVID-19 to severe illness. There are medicines available in the US, however, that have been proposed as potential therapies.

Hydroxychloroquine is 1 agent that is being evaluated to treat COVID-19. The agent is used to treat malaria and rheumatoid conditions such as arthritis. In previous research, hydroxychloroquine has reportedly demonstrated antiviral activity, the ability to modify the activity of the immune system and has an established safety profile at appropriate doses. However, the drug can cause dermatological reactions, seizures, cardiac arrythmias, and hypoglycemia.

“Many US hospitals are currently using hydroxychloroquine as first-line therapy for hospitalized patients with COVID-19 despite extremely limited clinical data supporting its effectiveness,” Wesley Self, MD, MPH, emergency medicine physician at Vanderbilt University Medical Center and PETAL Clinical Trials Network investigator leading the ORCHID trial, said in the announcement. “Thus, data on hydroxychloroquine for the treatment of COVID-19 are urgently needed to inform clinical practice.”

NIH also launched a trial to study Remdesivir to test the effectiveness and safety of the agent as a possible treatment for COVID-19. In the trial sponsored by the National Institute of Allergy and Infectious Diseases, investigators will test remdesivir versus placebo in an urgent race to find therapies proven effective for treating COVID-19.

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The blinded, placebo-controlled randomized clinical trial will seek to enroll more than 500 adult patients. 

NIH Launches Hydroxychloroquine Trial to Evaluate Efficacy for COVID-19

Sarilumab Will Be Evaluated for Patients With Severe COVID-19

," was originally published on ContagionLive.

A new clinical trial program from Sanofi and Regeneron will evaluate the efficacy of sarilumab (Kevzara), typically used for 

Sarilumab is a monoclonal antibody that works by inhibiting the interleukin-6 (IL-6) pathway through binding and blocking the IL-6 receptor. Currently, it is used for patients who have received a disease-modifying antirheumatic drug that did not work or was not well tolerated.

Investigators hypothesize that IL-6 may drive the inflammatory response within the lungs of patients who are critically ill with COVID-19, investigators hypothesize.

The role of IL-6 has been supported in preliminary results from a single-arm study occurring in China that is using another IL-6 receptor antibody.

The United States-based trial will begin at medical centers in New York, where a large number of COVID-19 cases have occurred in the US outbreak. The trial investigators will evaluate the safety and efficacy of adding sarilumab along with supportive care in comparison with supportive care and placebo.

The study will be a multicenter, double-blind, phase 2/3 trial with 2 parts that seeks to enroll 400 patients. Patients are required to be hospitalized with laboratory confirmed COVID-19 that is classified as severe. Patients who are suffering from multiorgan dysfunction are also eligible. All patients must have pneumonia and fever.

Part 1, which is the phase 2 part of the study, will recruit individuals with severe COVID-19 infection from 16 US sites. Patients will be randomized into 3 groups: high dose, low dose, and placebo. The primary end point is reduction of fever and the secondary end point is a decrease in need for supplemental oxygen.

The second part of the study, which is the phase 3 element, will evaluate if sarilumab use results in longer-term outcomes such as preventing death and reducing the need for ventilation, supplemental oxygen, and/or hospitalization.

“Scientific evidence has emerged to suggest that Kevzara may be a potentially important treatment option for some patients, and this trial will provide the well-controlled, rigorous scientific data we need to determine if IL-6 inhibition with Kevzara is better than current supportive care alone,” John Reed, MD, PhD, global head of research and development at Sanofi said in 

. “Additionally, we expect to rapidly initiate trials outside the US in the coming weeks, including areas most affected by the pandemic such as Italy." 

The announcement notes that Regeneron will lead the United States based trials and Sanofi will lead the upcoming trials taking place outside of the United States.

Sarilumab is typically used for patients with rheumatoid arthritis but could be useful for patients with novel coronavirus.

Trial Underway to Test Efficacy of Sarilumab for Patients with Severe COVID-19

An original version of this article was published by sister publication ContagionLive.

The US Centers for Disease Control and Prevention (CDC) has estimated 29 million influenza (flu) cases have reached the US in the 2019-2020 season.

Though activity remains reportedly high, the CDC indicated overall flu activity has decreased slightly week-over-week.

Overall, visits to clinicians for influenza-like-illness decreased from 6.7% last week to 6.1% this week. However, all US regions remain above baseline in reporting outpatient influenza-like-illness occurrence.

According to the latest FluView data, there have been 280,000 hospitalizations for influenza recorded as of February 15, 2020. This figure is consistent with hospitalization rates at this point in time during recent seasons; however, hospitalization rates among children and young adults are considered higher than in recent seasons.

The CDC also indicates that mortality related to pneumonia and influenza has been low during this respiratory virus season. So far, there have been 16,000 flu-related deaths documented during the US influenza season. Of these, there have been 105 influenza-associated deaths among children.

reported that influenza B/Victoria was the 

 in the US this season. At this point in time, there has been a decrease in the percentage of specimens testing positive for influenza B, although the percentage of specimens testing positive for influenza B is on the rise.  

Nationally, influenza B viruses are being reported more commonly among children and young adults. Among young children aged 0-4, 53% of reported cases have been B viruses and among the 5- to 24-year-old population 68% of reported cases have been B viruses. On the other hand, A(H1N1)pdm09 viruses are the most commonly reported influenza viruses are the most commonly reported viruses among the 25- to 64-year-old population (57% of reported viruses) and 65+ population (64% of reported viruses).

The CDC continues to remind the public that antiviral medications are important to control the spread of seasonal flu. Thus far >99% of influenza viruses tested this season are susceptible to the 4 antiviral medications that are approved by the US Food and Drug Administration and that are recommended for use in the United States this season.

. The report estimates that so far this season the vaccine is 45% effective overall and is 55% effective in children.

Although the authors of the report acknowledged that more effective vaccines are needed, they also noted that the currently available vaccines are providing substantial health benefits.

“It's important to know that this COVID-19 emergence is also occurring simultaneous to our regular seasonal influenza,” Christina Tan, MD, MPH, state epidemiologist, assistant commissioner, New Jersey Department of Health, 

What we're seeing in New Jersey, as well as elsewhere throughout the country, is peak activity of influenza right now. January, February is typically around the time that we see peak activity.”

fight flu in the wake of COVID-19’s emergence

? Tan said that it’s important to take common-sense steps to prevent all respiratory viruses.

“This is an opportunity to remind everybody to be mindful that you know, if you haven't gotten your flu vaccine yet, get vaccinated for flu. Take those easy steps. Cover your coughs and sneezes, make sure you wash your hands all the time. Stay home when you're sick. Those types of precautions are helpful not only for seasonal flu, but also for whatever it might be emerging.”

Though weekly activity has slowed, experts insist the national activity remains high overall.

Flu Cases Near 30 Million in the US, CDC Reports

Although much attention has been on novel coronavirus (

), due to an increasing number of cases across the globe, the numbers indicate that we need to continue to pay attention to 

 of the COVID-19 have been confirmed in the US, yet flu cases for the 2019-20 US season have 

 over a one-week span. And flu activity will only continue to increase in the upcoming weeks.

The US Centers for Disease Control and Prevention’s (CDC) FluView reports that last week the percentage of deaths attributed to pneumonia and influenza stands at 7.1%, just below the epidemic threshold of 7.2%.

Visits to clinicians for influenza-like illness increased from 6% to 6.7% last week with all regions remaining above baseline. However, overall hospitalization rates for the season are similar to previous seasons with a current rate of 35.5 per 100,000.

The percentage of respiratory specimens testing positive for influenza at clinical laboratories also increased last week, rising from 28.4% to 29.8%. At this time, 47 jurisdictions are experiencing high influenza-like illness activity, compared with 44 jurisdictions the previous week.

Recent estimates indicate that of the 22 million flu cases in the US thus far, 210,000 hospitalizations have occurred, and 12,000 deaths have been reported. In total, there have been 78 pediatric deaths so far this season, with 10 new deaths reported last week.

Earlier this season it was reported that 

influenza B/Victoria was the predominant strain

 for the 2019-20 season, yet at this time cases of the A(H1N1)pdm09 virus are approximately equal to the B strain after rising over recent weeks.

CDC officials continue to recommend vaccination as the best way to prevent influenza and reduce duration of illness. According to the agency, approximately 173.3 million doses of the flu vaccine have been administered in the US this season.

“I think something that gets lost in the narrative is that while the flu shot prevents a percentage of infections, and some people will go and develop the flu anyway, even if they do, there's some evidence that it's attenuated, and that the complications from having the flu including death are lessened even if someone develops flu after they've gotten a shot,” Jason C. Gallagher, PharmD, editor in chief of 

and a clinical professor at Temple University of College of Pharmacy, said in a 

 that experts in the influenza division of the agency have developed a portable flu laboratory that can sequence the influenza genome and analyze influenza A viruses in real-time and on-site in the event of an outbreak.

The kit, which is called Mia (Mobile Influenza Analysis), brings influenza sequencing into the field, which will cut the time needed to genetically analyze flu viruses in half and produce real-time actionable data that can be used in a public health response. 

In an animal model study, a team was able to successfully use Mia to extract, sequence, and analyze flu samples in just 14.5 hours, a task that usually takes a week when samples must be sent to a laboratory for examination.

According to the CDC’s statement, the experts who developed the tool estimate that in the event of a flu pandemic, through proactive surveillance and using Mia, there would be an 8-week advantage for flu vaccine manufacturing.

will continue to monitor influenza cases and the 2019-nCoV outbreak. To track the case counts in the COVID-19 outbreak, visit the 

Although much attention is on coronavirus, patients might need to be more concerned with the flu.