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People with Certain Medical ConditionsUpdated Oct. 16, 2020 Print

Adults of any age with certain underlying medical conditions are at increased risk for severe illness from the virus that causesCOVID-19:

Adults of any age with the following conditions are at increased risk of severe illness from the virus that causes COVID-19:

Cancer

Chronic kidney disease

COPD (chronic obstructive pulmonary disease)

Heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies

Immunocompromised state (weakened immune system) from solid organ transplant

Obesity (body mass index [BMI] of 30 kg/m or higher but < 40 kg/m )

Severe Obesity (BMI ≥ 40 kg/m )

Sickle cell disease

Smoking

Type 2 diabetes mellitus

COVID-19 is a new disease. Currently there are limited data and information about the impact of underlying medicalconditions and whether they increase the risk for severe illness from COVID-19. Based on what we know at this time, adults ofany age with the following conditions might be at an increased risk for severe illness from the virus that causes COVID-19:

Asthma (moderate-to-severe)

Summary of Recent ChangesRevisions were made on October 6, 2020 to re�ect recent data supporting increased risk of severe illness from the virusthat causes COVID-19 among adults with COVID-19 who have obesity, who have overweight, or who smoke or have ahistory of smoking. These revisions also make the document more explicit about data and implications for adults and forchildren. The listed underlying medical conditions in children were also revised to indicate that these conditions mightincrease risk to better re�ect the quality of available data currently. This re�ects the fact that there are less data availablefor children and does not imply that children are not at risk. We are learning more about COVID-19 every day, and as newinformation becomes available, CDC will update the information below.

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2

MENUCoronavirus Disease 2019 (COVID-19) ˞

EXHIBIT A.

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Cerebrovascular disease (a�ects blood vessels and blood supply to the brain)

Cystic �brosis

Hypertension or high blood pressure

Immunocompromised state (weakened immune system) from blood or bone marrow transplant, immune de�ciencies,HIV, use of corticosteroids, or use of other immune weakening medicines

Neurologic conditions, such as dementia

Liver disease

Overweight (BMI > 25 kg/m , but < 30 kg/m )

Pregnancy

Pulmonary �brosis (having damaged or scarred lung tissues)

Thalassemia (a type of blood disorder)

Type 1 diabetes mellitus

Want to see the evidence behind these lists?

Reduce your risk of getting COVID-19It is especially important for people at increased risk of severe illness from COVID-19, and those who live with them, to protectthemselves from getting COVID-19.

The best way to protect yourself and to help reduce the spread of the virus that causes COVID-19 is to:

Limit your interactions with other people as much as possible.

Take precautions to prevent getting COVID-19 when you do interact with others.

If you start feeling sick and think you may have COVID-19, get in touch with your healthcare provider within 24 hours.

Venturing out into a public setting? What to consider beforeyou go.As communities and businesses across the United States are opening, you may be thinking about resuming some activities,running errands, and attending events and gatherings. There is no way to ensure you have zero risk of infection, so it isimportant to understand the risks and know how to be as safe as possible.

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While children have been less a�ected by COVID-19 compared to adults, children can be infected with the virus thatcauses COVID-19 and some children develop severe illness. Children with underlying medical conditions are at increasedrisk for severe illness compared to children without underlying medical conditions. Current evidence on which underlyingmedical conditions in children are associated with increased risk is limited. Children with the following conditions mightbe at increased risk for severe illness: obesity, medical complexity, severe genetic disorders, severe neurologic disorders,inherited metabolic disorders, congenital (since birth) heart disease, diabetes, asthma and other chronic lung disease,and immunosuppression due to malignancy or immune-weakening medications.

We do not yet know who is at increased risk for developing the rare but serious complication associated with COVID-19 inchildren called Multisystem In�ammatory Syndrome in Children (MIS-C), nor do we know what causes MIS-C. Learn aboutMIS-C.

The list of underlying conditions is meant to inform clinicians to help them provide the best care possible for patients,and to inform individuals as to what their level of risk may be so they can make individual decisions about illnessprevention. We are learning more about COVID-19 every day. This list is not exhaustive and only includes conditions withsu�cient evidence to draw conclusions; it is a living document that may be updated at any time, subject to potentiallyrapid change as the science evolves.


October 18, 2020 2 min read

Inhaled formulation of vardena�l for as-needed use showspromise in PAHAn inhaled formulation of the PDE5 inhibitor vardena�l, in development for as-needed use for episodic

symptoms of pulmonary arterial hypertension, yielded improvements in pulmonary hemodynamics,

according to results of a phase 2a trial.

At the virtual CHEST Annual Meeting, Nathan Dwyer, MBBS, with Royal Hobart Hospital in Australia,

reported data from a phase 2a, multicenter, open-label, dose-escalating trial that evaluated acute changes

in pulmonary vascular resistance and other hemodynamic parameters after inhalation of RT234 (Respira

Therapeutics) in patients with PAH receiving stable maintenance dual therapy including a long-term oral

endothelin receptor antagonist combined with an oral PDE5 inhibitor.

Source: Adobe Stock.

Researchers enrolled 15 patients with PAH (mean age, 54 years; 79% women; 57% functional class II; mean

pulmonary artery pressure, 46 mm Hg; mean PVR, 584). In part A of the trial, patients received 0.2 mg, 0.6

mg or 1.2 mg RT234 during right heart catheterization and researchers recorded hemodynamic parameters

every 5 to 15 minutes for 1 hour after dose 1 and for 2 hours after dose 2. In part B of the trial, patients

returned 2 weeks later for a 6-minute talk test after inhalation of the highest tolerated dose from part A,

Dwyer said during a presentation.

The researchers observed a substantial decrease in PVR of greater than 10% within 5 minutes of dosing of

RT234 0.6 mg and 1.2 mg. A peak decrease in PVR of 27% at 30 minutes, with an acceptable reduction in PVR

sustained for at least 1 hour was observed with the 0.6 mg dose, according to Dwyer.

“0.6 mg of RT234 has comparable hemodynamic improvements as a 20 mg oral tablet of vardena�l while

exhibiting greater pulmonary selectivity — that is, a lower reduction in systemic vascular response and

systemic arterial pressure, as well as an improved partial pressure of arterial oxygen,” Dwyer said.

EXHIBIT BCase 20-11779-LSS Doc 310-2 Filed 10/26/20 Page 1 of 2

The second dosing did not demonstrate any additional bene�t, he said, noting that the researchers

continue to analyze those data to �nd an explanation for that �nding.

Baseline 6-minute walk test distance was 426 m. After a single inhalation of RT234, 6-minute walk test

distance improved by 36 m.

“This is a larger increase than observed after multiple doses of inhaled treprostinil, even out to week 12 of

therapy,” Dwyer said.

In other �ndings, RT234 was well tolerated, with no signi�cant changes in systemic blood pressure or heart

rate and no evidence of airway irritation or in�ammation. Mild, transient headache occurred in one patient.

“Our study has validated that RT234 has a rapid reduction in PVR within 5 minutes of administration,

which is associated with an acute improvement in 6-minute walk distance of 35 m, has a duration of action

of at least 1 to 2 hours post-administration, has minimal local and systemic safety and tolerability issues

when administered on top of background PAH therapies and has an easy-to-use delivery system with

administration less than 1 minute,” Dwyer said. “RT234 has a safety and e�cacy pro�le suitable for

continued clinical development as an on-demand pulmonary vasodilator.”

RT234 is vardena�l administered as a dry powder inhaled treatment. Respira Therapeutics received FDA

orphan drug designation for the active ingredient in RT234, vardena�l, a potential PDE5 inhibitor

vasodilator that is FDA approved in an oral form for a non-PAH indication, according to a company press

release.

References:Keogh A, et al. CHEST. 2020;doi:10.1016/j.chest.2020.08.1860.

Press Release.

pulmonary hypertension pulmonary vascular disease cardiac catheterization


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