List of Open Clinical Trials for Patients with COVID-19 in the USA VA and Department of Defense facilities.

There is an urgent need to find effective treatment or a vaccine for COVID-19. Worldwide there are over 1,800 trials addressing COVID-19-related health care. There are 10 trials developed by the US Department of Veterans Affairs (VA), US Department of Defense, and the National Institute of Allergy and Infectious Diseases have provided important data on effective treatment options. The clinical trials listed below are all open as of May 31, 2020.

Adaptive COVID-19 Treatment Trial (ACTT)

This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study will compare different investigational therapeutic agents to a control arm. ID: NCT04280705

Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734) in Participants with Severe Coronavirus Disease (COVID-19)

The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 11 (NCT04292730) or Day 14 (NCT04292899).

Expanded Access Remdesivir (RDV; GS-5734)

The treatment of communicable Novel Coronavirus of 2019 with Remdesivir (RDV; GS-5734) also known as severe acute respiratory syndrome coronavirus 2.

A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia (COVACTA)

This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab  compared with a matching placebo in combination with standard of care in hospitalized patients with severe COVID-19 pneumonia.

Administration of Intravenous Vitamin C in Novel Coronavirus Infection (COVID-19) and Decreased Oxygenation (AVoCaDO)

The study evaluates if Vit C is safe and tolerable in COVID-19 subjects given early or late in the disease course and may reduce the risk of respiratory failure requiring mechanical ventilation and development of ARDS along with reductions in supplemental oxygen demand and inflammatory markers.

Treatment Of CORONAVIRUS DISEASE 2019 (COVID-19) With Anti-Sars-CoV-2 Convalescent Plasma (ASCoV2CP)

This is an expanded access open-label, single-arm, multi-site protocol to provide convalescent plasma as a treatment for patients diagnosed with severe, or life-threatening COVID-19.

A Study to Evaluate the Safety and Efficacy of MSTT1041A (Astegolimab) or UTTR1147A in Patients With Severe COVID-19 Pneumonia (COVASTIL)

This is a Phase II, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of MSTT1041A (astegolimab) or UTTR1147A in combination with standard of care (SOC) compared with matching placebo in combination with SOC in patients hospitalized with severe coronavirus disease 2019 pneumonia.

Adaptive COVID-19 Treatment Trial 2 (ACTT-II)

ACTT-II will evaluate the combination of baricitinib and remdesivir compared to remdesivir alone. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have 3 home visits.  

Click to get more information 

Dr. Brook's interview about becoming a laryngectomee, and coping with COVID-19

Dr. Itzhak Brook is a physician and laryngectomee.

In the interview made for the International Association of Laryngectomees 69th Annual Meeting - Voice Institute 60th meeting on June 13, 2020, he describes how he dealt with throat cancer, and became a laryngectomee. He also discusses how laryngectomees can protect themselves from COVID-19 virus and deal with the challenges of caring for their airways during this period.

Dr. Itzhak Brook is a physician and laryngectomee.

In the interview made for the International Association of Laryngectomees 69th Annual Meeting - Voice Institute 60th meeting on June 13, 2020, he describes how he dealt with throat cancer, and became a laryngectomee. He also discusses how laryngectomees can protect themselves from COVID-19 virus and deal with the challenges of caring for their airways during this period.

Treatments for COVID-19 What helps, what doesn't, and what's in the pipeline for COVID-19

Most who become ill with COVID-19 will be able to recover at home. No specific treatments for COVID-19 exist right now. But some of the same things you do to feel better if you have the flu — getting enough rest, staying well hydrated, and taking medications to relieve fever and aches and pains — also help with COVID-19.

Scientists are working hard to develop effective treatments. Therapies that are under investigation include drugs that have been used to treat malaria and autoimmune diseases; antiviral drugs that were developed for other viruses, and antibodies from people who have recovered from COVID-19.

Enclosed is an update about the current treatments and potential ones for COVID-19 prepared by Harvard Medical School.

Signs and symptoms of COVID-19 infection

COVID-19 affects different people in different ways. Infected people have had a wide range of symptoms reported – from mild symptoms to severe illness.

Symptoms may appear 2-14 days after exposure to the virus. The CDC recommends that people with these symptoms may have COVID-19:

•          Fever or chills
•        Cough
•       Shortness of breath or difficulty breathing
•        Fatigue
•        Muscle or body aches
•        Headache
•        New loss of taste or smell
•       Sore throat
•        Congestion or runny nose
•        Nausea or vomiting
•       Diarrhea

Look for emergency warning signs for COVID-19. If someone is showing any of these signs, seek emergency medical care immediately

•     Trouble breathing
•        Persistent pain or pressure in the chest
•        New confusion
•        Inability to wake or stay awake
•        Bluish lips or face

Call your medical provider for any other symptoms that are severe or concerning to you.

It is helpful to have a plan in place in case one becomes sick. Identifying a caregiver and staying in touch with family, friends, neighbors, and healthcare professionals during the pandemic through email or phone, especially if some lives alone is important. If one is aware of an exposure or are experiencing symptoms such as a sore throat, dry cough, fever, and/or shortness of breath, seek medical help as soon as possible. Trying to contact one’s care team over the phone before coming into a medical center can facilitate their care.

COVID-19 May Be a Blood Vessel Disease. Learn more about this

Many of the infection’s bizarre symptoms have one thing in common. This article is by Dana G Smith.  

Months into the pandemic, there is now a growing body of evidence to support the theory that the novel corona virus can infect blood vessels, which could explain not only the high prevalence of blood clots, strokes, and heart attacks, but also provide an answer for the diverse set of head-to-toe symptoms that have emerged.

In a paper published in April in the scientific journal The Lancet, Mehra and a team of scientists discovered that the SARS-CoV-2 virus can infect the endothelial cells that line the inside of blood vessels. Endothelial cells protect the cardiovascular system, and they release proteins that influence everything from blood clotting to the immune response. In the paper, the scientists showed damage to endothelial cells in the lungs, heart, kidneys, liver, and intestines in people with COVID-19.

Click to read the whole article. 

COVID-19 virus and blood cells

DIAGNOSTIC TESTS FOR CORONA VIRUS INFECTION

The pandemic of coronavirus disease 2019 (COVID-19) continues to affect much of the world. Knowledge of diagnostic tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is still evolving, and a clear understanding of the nature of the tests and interpretation of their findings is important. An article by Sethuraman et al. describes how to interpret 2 types of diagnostic tests commonly in use for SARS-CoV-2 infections—reverse transcriptase–polymerase chain reaction (RT-PCR) and IgM and IgG enzyme-linked immunosorbent assay (ELISA)—and how the results may vary over time.describes how to interpret 2 types of diagnostic tests commonly in use for SARS-CoV-2 infections—reverse transcriptase–polymerase chain reaction (RT-PCR) and IgM and IgG enzyme-linked immunosorbent assay (ELISA)—and how the results may vary over time. 

Click to see the original article

Publication of the "Laryngectomee Guide for COVID-19 Pandemic"

The "Laryngectomee Guide for COVID-19 pandemic” is available.

It provides information about preventing infection, dealing with voice prosthesis leak, social isolation, psychological issues, and hospitalization.

It is available as eBook (free) https://bit.ly/2AY41RO , and paperback at: https://bit.ly/3glrlJf 

The Head and Neck Alliance offers links for Laryngectomees Guide and Laryngectomee Guide for COVID-19 pandemic.

Click this link to obtain The Laryngectomee Guide in 19 languages/dialects: English, French, Russian, Italian, Chinese (traditional and simplified), Korean, Turkish, Arabic, Bulgarian, Romanian, Portuguese, Persian (Farsi), Tagalog, Bosnian, and Spanish (Central American, Andine, Spain, and South American version) and Laryngectomee Guide for COVID-19 Pandemic.

All eBooks are Free.

Dr. Brook's video: Copping with the COVID -19 as a laryngectomee

Click to watch the 16 minutes video about how laryngectomees can protect themselves from getting infected with COVID-19, feal with voice prosthesis leakage, and cope with medical , social and psychological issuses during the pandemic. 

in Spanish: Laringectomía y Total y el nuevo virus corona: Sugerencias para la protección.

Laringectomía y Total y el nuevo virus corona: Sugerencias para la protección.

30 de marzo de 2020. Dr. Itzhak Brook.

Sugerencias sobre cómo los pacientes con cáncer de cabeza y cuello (incluidos los que respiran el cuello) pueden protegerse de la nueva infección por coronavirus (COVID -19).

Los pacientes con cáncer de cabeza y cuello (CCC) y los respiradores de cuello (incluidos las laringectomías) pueden tener un mayor riesgo de sufrir una infección grave por COVID-19. El riesgo de enfermedad grave es especialmente alto en aquellos que actualmente reciben o han recibido recientemente quimioterapia o terapia inmunosupresora.

Es prudente que los pacientes con CCC y los respiradores de cuello sigan las instrucciones del gobierno y las autoridades de salud locales y eviten la exposición al virus siguiendo las indicaciones de aislamiento estrictamente.

Los respiradores de cuello son susceptibles a las infecciones del tracto respiratorio inferior porque el virus puede ingresar a su tracto respiratorio directamente a través del estoma del cuello. Los virus respiratorios también pueden acceder al cuerpo a través de la boca, la nariz y la conjuntiva. Por lo tanto, es imperativo que tales individuos ejerzan un cuidado especial para evitar infectarse.

COVID-19 puede causar una infección grave en personas con vías respiratorias comprometidas. Las vías respiratorias de los laringectomas pueden verse comprometidas porque su tráquea y bronquios a menudo están secos e irritados crónicamente, y su capacidad pulmonar puede verse reducida debido al colapso parcial de sus lóbulos inferiores (atelectasia).

Las medidas que pueden reducir el riesgo de infección incluyen:

Limpieza frecuente de manos:

• Lavarse las manos con frecuencia con jabón y agua caliente durante al menos 20 segundos, especialmente después de estar en un lugar público, o después de limpiarse el estoma del cuello, sonarse la nariz, toser o estornudar.

• Si no hay agua y jabón disponibles, use un desinfectante para manos que contenga al menos 60% de alcohol.

• Evitar tocarse los ojos, la nariz, la boca y el estoma con las manos sin lavar.

Evitar el contacto cercano:

• Evitar el contacto cercano con personas enfermas.

• Poner distancia entre uno mismo y otras personas. Esto es especialmente importante para las personas que corren un mayor riesgo de enfermarse gravemente.

Tomar medidas para proteger a los demás:

• Quedarse en casa cuando está enfermo, excepto para recibir atención médica.

• Cubrirse cuando tosa y estornude

• Cubrirse la boca, la nariz o el estoma con un pañuelo al toser o estornudar o al usar el interior del codo.

• Tirar pañuelos usados a la basura.

• Lavarse las manos inmediatamente (ver arriba)

• Usar una mascarilla cuando está enfermo

Limpieza y desinfección:

• Limpieza y desinfección de superficies frecuentemente tocadas.

• Evite tocar superficies que no estén limpias.

• Lávese las manos inmediatamente después de tocar una superficie que no estaba limpia.

Los laringectomizados pueden protegerse tomando estos pasos adicionales:

• Usar un intercambiador de calor y humedad (HME) 24/7 si pueden. Un HME proporciona humidificación del aire inhalado y cierto nivel de filtración (mecánica) dependiendo del tamaño de la partícula en relación con el tamaño de poro del material HME y la tapa sólida evita el contacto directo entre el dedo y el estoma (es decir, Provox XtraMoist y Provox XtraFlow de Atos Medical).

Las HME con alta eficiencia de filtración funcionarían mejor para reducir el riesgo de inhalar el virus (es decir, Provox Micron de Atos Medical). Provox Micron es un HME que tiene un filtro electrostático integrado que proporciona una eficiencia de filtración de> 99% para bacterias y virus y su cubierta evita el contacto directo de los dedos con el estoma. El filtro electrostático proporciona filtración independientemente de la dirección del flujo de aire, por lo que usarlo también protege a otras personas de infectarse cuando el laringectoma está infectado. (ver foto 1)

• Usar un HME de manos libres, que no requiere tocarse al hablar, en quienes usan el habla traqueoesofágica con una prótesis de voz. Aquellos que usan un HME regular deben lavarse las manos antes de tocar su HME.

• Usar una mascarilla (preferiblemente N95) sobre el estoma (ver fotos 2-4). Se puede modificar una máscara facial con cuatro cuerdas para que se ajuste sobre el estoma. Una de las cadenas se puede extender con una cadena adicional; y el par inferior de cuerdas se puede atar detrás de la espalda.

• Usar mascarilla sobre la nariz y la boca, y anteojos protectores. Esto puede evitar que el virus ingrese al cuerpo a través de estos sitios.

Si se usa correctamente, una máscara facial puede ayudar a bloquear las gotas de partículas grandes, salpicaduras, aerosoles o salpicaduras que pueden contener gérmenes (virus y bacterias). Las mascarillas también pueden ayudar a reducir la exposición de las secreciones respiratorias del usuario a otras personas.

Los pacientes con CCC (incluidos los laringectomas) deben consultar a sus médicos acerca de los pasos adicionales a seguir.

Para protegerse. Las personas deben comunicarse con sus médicos ante cualquier signo de infección respiratoria.

Finalmente, aunque todas estas medidas pueden ser útiles para proteger a los pacientes con CCC y los respiradores de cuello Infección por COVID-19, no son necesariamente infalibles y ciertamente no se garantiza que eviten la adquisición una infección.

Itzhak Brook MD

Departamento de Enfermedades Infecciosas

Profesor de Pediatría y Medicina.

Facultad de medicina de la Universidad de Georgetown

Washington DC

Estados Unidos

Suggestions in Spanish: Laringectomía y Total y el nuevo virus corona: Sugerencias para la protección.

Foto 1 

Foto 2

Foto 3

Foto 4

Neopharyngeal or esophageal narrowing during COVID-19 pandemic

The corona (COVID-19) pandemic presents many challenges for head and neck cancer patients and their medical providers. Because of the reduction or decrease in outpatient services, the availability of neopharyngeal and /or esophageal dilation for esophageal narrowing may not be available.

Enclosed are suggestions how to cope with these challenges:

• Performing dilation at-home using self-dilation device
• Considering treatment that resolve the narrowing (i.e., stent, laser treatment)
• Temporarily altering the diet to soft or liquid one
• Using a gastric tube for feeding

It is helpful to contact one’s speech and language pathologist and/or physician for guidance. Many institutions perform dilation to those who are unable to consume sufficient calories and liquids.

Hopefully these temporary measures will be helpful.

Going outside during the COVID-19 pandemic

Laryngectomee may experience social and medical challenges when they leave their home during the COVID-19 pandemics. Most non-neck breathers do not understand or recognize their medical condition and may react in a negative way toward them. They may be alarmed when the laryngectomee coughs or sneezes, or take care of their stoma in public.

Included are some of the steps that laryngectomees can take when in public:

• Cleaning the stoma and trachea including inserting saline into the trachea and coughing out the secretions before going out
• Taking care of the stoma and it’s secretions at a private location away from others (e.g., bathroom, separate room)
• Covering the stoma (with napkin, cloth or elbow) whenever coughing or sneezing. Preferably this is done away from other people. When coughing forcefully the stoma can produce large amount of droplets that can spread and infect others when the laryngectomee carries a respiratory virus such as COVID-19
• Keeping a distance of at least 6 feet (2 meters) from others
• A useful routine is to use the non-dominant hand to touch the stoma and the dominant hand for other activities (e.g., touching a door handle).
• Wearing a surgical mask or garment over the mouth and nose (in addition another one over the stoma). This is done to protect the laryngectomee from becoming infected, as well as others the laryngectomee is infected. Wearing a mask over the mouth and nose in public prevent the laryngectomee from standing out from others. Wearing the mask on the stoma and face also serves in preventing laryngectomees from touching these locations with unclean hands.

Hopefully these measures can assist laryngectomees in public locations.

As home confinement and other restrictions are being slowly lifted, it would be prudent for laryngectomees to continue to observe these precautionary measures. As more clinical experience in managing COVID-19 infection is gained and new medications and  vaccines are available the consequences of becoming infected may become less dangerous.

Preventing COVID-19 infection in laryngectomees

Most individuals experience less “colds” after laryngectomy. This is believed to be because respiratory viruses generally first infect the nose before spreading to other body sites (including the lungs). Because laryngectomees do not inhale through their noses this mode of transmission is rare.

However, all respiratory viruses (including COVID-19) can also access the body through the nose, mouth, conjunctiva and stoma (in neck breathers) after they are inhaled or introduced by a contaminated object or hand. It is therefore prudent that laryngectomees are extra vigilant in protecting themselves.

Laryngectomees may also be at risk for poor outcomes with COVID-19 due to other medical comorbidity (including chronic pulmonary disease, peripheral vascular disease, cardiac disease, cerebrovascular disease, diabetes, the underlying cancer history), and the propensity for lower lobs collapse (atelectasis) due to loss of upper airway resistance. Additionally, because many laryngectomees have a smoking history, they are also prone to acute infections due to impaired mucociliary function and mucosal irritation from cold, dry inspired air.

There have been several laryngectomees who acquired COVID-19 infection. Those who were diagnosed had a broad spectrum of symptoms from minimal to severe. There were at least 2 who also had comorbidities that died from COVID-19 infection. 

The information and knowledge about the prevention and management of COCID-19 is growing and constantly evolving. Because the recommendations for COVID-19 prevention and treatment may change, it is important to follow the local health department and Center of Disease Control and Prevention updates and consulting with medical professionals. .

If someone in close contact with laryngectomee is exposed or infected with COVID-19, he/she should self-quarantine themselves  and avoid any contact with the neck breather. 

it is important for laryngectomees to protect themselves and others in the community from COVID-19. Due to the increased aerosolization risk from their stoma, the potential to become “super spreaders” necessitates that total laryngectomy patients always cover their stoma in public. The best protection against aerosolization and inhalation of viral particles in the community is to cover the stoma with an HME that includes a bacterial and/or viral filter. Many patients prefer to use laryngectomy tubes, but during this pandemic an HME attached to the stoma with a baseplate allows for a seal that will force all air through the HME, thus further minimizing aerosolization. If the patient is unable to obtain a good seal with the HME base plate, they can use laryngectomy tubes that accept HME filters is an option. It is strongly recommend disposal of HMEs after community exposure.

Laryngectomees can protect themselves and others by taking these steps:

•           Wearing heat and moisture exchanger (HME) 24/7 especially when being around other people. HME with greater filtering ability would work better in reducing the risk of inhaling the virus ( e.g., Provox Micron TM). (picture below) Provox Micron, has an electrostatic filter and >99.9% filtration rate and it’s cover prevents direct finger contact with the stoma when speaking. Wearing it also protects other individuals when the laryngectomee is infected. It has maximal activity during the first 24 hours of use.  A Provox HME Cassette Adaptor enables the use of a Provox HME Cassette to any tracheostomy tube with a 15 mm ISO connector. Those with tracheostomy can protect themselves by using ProTrach XtraCare HME.

Provox micron

•           Wearing hands free tracheostoma valve (because it does not require touching when speaking) in those using trachea esophageal speech. Those who use a regular HME should wash their hands before touching their HME.

•           Wearing a surgical mask (see pictures below), 100% cotton turtleneck, bib, or scarf  
over the stoma (in addition to the HME). Tie the upper strings of the mask around neck, use additional extension string to connect the two lower mask strings together under the arms and behind the back.

•           Wearing an additional surgical mask or respirator over the nose and mouth, and protective glasses or face shield (see pictures below). This can prevent the virus from entering the body through these sites or spread to other people when infected. Men should shave their facial hair prior to wearing surgical mask or respirator. If worn properly, a surgical mask can help block large-particle droplets, splashes, sprays or splatter that may contain germs (viruses and bacteria). While a surgical mask may be effective in blocking splashes and large-particle droplets, it does not filter or block very small particles in the air that may be transmitted by coughs, and sneezes. Wearing the mask on the stoma and face also serves in preventing laryngectomees from touching these locations with unclean hands. 

                                                   
                                                 Wearing protective glasses and surgical mask

Wearing face shield and protective glasses

•           Washing hands often with soap and water for at least 20 seconds. Use an alcohol-based hand sanitizer that contains at least 60% alcohol if soap and water are not available. This is especially important before managing the stoma, and touching the HME when speaking using tracheoesophageal speech.

•           Avoiding touching the stoma, HME, eyes, nose, and mouth with unwashed hands. A useful routine is to use the non dominant hand to touch the stoma and the dominant hand for other activities (e.g., touching a door handle).

•           Avoiding close contact with sick people and avoid public and crowded places.

•          Staying at least 6 feet from other who don't live with you.

•           Cleaning and disinfecting frequently touched objects and surfaces.

Those in close contact with neck breathers can expose them to the virus when they become asymptomatic carrier or infected with COVID-19. These individuals as well as the neck breathers should observe meticulous hand hygiene and wear face masks, gloves, eye shields, and other protective items whenever they are in contact with each other.



Additional sources about protection of laryngectomees:

Oral Oncology editorial about protection of laryngectomees 

Tracheotomy Education Website: Laryngectomy and Coronavirus Disease (COVID-19)
Message from the Japanese Head and Neck Support Society. (in Japanese and English)

Message from the Singapore Cancer Society

Message from Atos in Spanish: Laringectomía y Total y el nuevo virus corona: Sugerencias para la protección.

Message from Nu Voice ( University of Southern California)  Los Angeles.

                                                                           Wearing a modified face mask over the stoma

Protection using Provox Micron, N95 face mask and protective glasses.