Updates

Editor’s Note: This page is updated weekly with new information related to COVID-19 testing and potential treatments in development. Click the arrow next to the date to expand the text. 

April 1, 2020

Several tests for diagnosing COVID-19 have now been granted emergency use authorization (EUA) from the FDA. As of March 31, the Advanced Medical Technology Association estimated that 17 tests had received EUAs, with more in the works. The same day, Bodysphere announced it was rolling out a test that returned results within two minutes, saying it was granted an EUA, but the FDA later refuted that claim. The test at this point has not received any FDA authorization.

The FDA issued a warning last week that it has not authorized any test for people to use at home for COVID-19 and that people should be aware of such fraudulent tests. It also provided a list of fraudulent COVID-19 products including those that claim to prevent or treat the disease.

The agency also announced the creation of an emergency program called the Coronavirus Treatment Acceleration Program to assist in the development of treatments for COVID-19. According to the FDA, as of March 31, it is reviewing 10 therapies already in trials and 15 others in preclinical stages.

Sandoz’s malaria treatment hydroxychloroquine sulfate and Bayer Pharmaceuticalschloroquine phosphate have been granted an EUA by the FDA for the treatment of COVID-19. Both companies have donated supplies of the medications to the U.S. Department of Health and Human Services for use. Although clinical trials are needed to prove their efficacy in treating COVID-19, these therapies have shown some benefit in the lab and clinic, according to anecdotal evidence.

Among the trials recently launched for COVID-19 are a global Phase 2/3 trial (NCT04315298) testing rheumatoid arthritis treatment Kevzara (sarilumab) and a U.K.-based Phase 2 trial testing antiviral SNG001, an inhaled formulation of interferon-beta-1a. The first patients have already been treated in both trials. Another Phase 2/3 trial (NCT04315298) testing Kevzara is recruiting an estimated 400 participants in the U.S.

A Phase 2 trial (NCT04311697), taking place in New York and Haifa, Israel, will test aviptadil for the treatment of COVID-19-associated acute respiratory distress syndrome.

Johnson & Johnson announced plans to start a Phase 1 trial by September to test its vaccine candidate Ad26 SARS-CoV-2 against COVID-19. If the trial is successful, the first batch of the vaccine could be available in early 2021 for emergency use, according to the company.

March 27, 2020

The CDC has developed a diagnostic panel for use by CDC-qualified laboratories in the U.S. and made available under an emergency use authorization (EUA) from the FDA

Other new tests include Roche Diagnostics’ cobas SARS-CoV-2 test, also granted an EUA, and the U.S. Department of Health and Human Services is funding the development of two other diagnostic tests that can detect the presence of SARS-CoV-2 within one hour.

The National Institute of Allergy and Infectious Diseases is sponsoring a randomized, controlled Phase 2 trial in the U.S. to evaluate the safety and efficacy of the broad-spectrum anti-viral treatment remdesivir by Gilead Sciences to treat the disease. Gilead has also launched two global Phase 3 trials to evaluate remdesivir’s safety and efficacy in adults with COVID-19. 

Other treatments being investigated for COVID-19 include a novel mRNA-1273 nanoparticle-encapsulated vaccine (NCT04283461), thalidomide (NCT04273581), sildenafil (NCT04304313), eculizumab (NCT04288713), recombinant human interferon-alpha 1 beta (NCT04293887), bevacizumab (NCT04305106), and antibodies from cured patients (NCT04264858), among others.

Researchers are also looking at new synthetic biology approaches by using self-assembling nanoparticles coated with viral antigens that can precisely target SARS-CoV-2. This approach can potentially overcome some of the limitations of conventional vaccines such as short shelf-life and viral evolution. 

 

COVID-19, short for coronavirus disease 2019, is an infection caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SARS-CoV-2 is a newly identified pathogen that has not previously been seen in humans and is highly contagious. Though it belongs to the same category of viruses as SARS coronavirus (SARS-CoV) and influenza viruses, SARS-CoV-2 is a different strain with its own characteristics. 

COVID-19 was first reported in Wuhan, China, in December 2019, and the outbreak has spread quickly across the world, prompting the World Health Organization (WHO) to declare COVID-19 a pandemic.

How does COVID-19 spread?

Because COVID-19 is a new virus, nobody has prior immunity to it, meaning the entire human population is prone to infection.

COVID-19 is primarily spread via respiratory droplets when people cough or sneeze. Scientists have yet to understand how easily and sustainably the disease can spread among people. Based on available evidence, researchers do not think that airborne spread is a major transmission route

Individuals over age 60 are also at the highest risk of developing a severe case of COVID-19, while children do not seem to be at a higher risk than adults.

There are currently no reports about how susceptible pregnant women may be to COVID-19 or about the transmission of the virus through breast milk.

What are the symptoms of COVID-19?

Common symptoms of COVID-19 begin two to 14 days after exposure. They include fever, tiredness, and dry cough. Other symptoms include sputum production, shortness of breath, sore throat, headache, myalgia (muscle pain) or arthralgia (joint pain), chills, vomiting, and nasal congestion. Less frequent symptoms include diarrhea, hemoptysis (coughing up blood from the respiratory tract), and conjunctival congestion.

Most of these symptoms are usually mild, and about 80% of people who get the virus will typically recover without needing any special treatment. However, about 1 in 6 patients become seriously ill and develop breathing difficulties.

What general preventive measures should people take?

The following simple preventive measures can help minimize the spread of COVID-19: 

  • Wash your hands often with soap, lathering both the front and the back of the hands and fingers for at least 15 to 20 seconds. If soap is not available, use a hand sanitizer that contains at least 60% alcohol. The European Centre for Disease Prevention and Control produced a poster detailing effective handwashing.
  • Avoid close contact with someone who is ill. (Maintain a distance of at least 6 feet, or 1.8 meters).
  • Stay at home if you are sick.
  • Use a tissue to cover your mouth and nose if you cough or sneeze and dispose of it properly afterward.
  • Disinfect surfaces and objects you touch frequently. 
  • Avoid touching your eyes, nose, and mouth with unwashed hands.

The U.S. Centers for Disease Control (CDC) does not recommend that healthy people wear a face mask.

What about cancer patients?

Because the COVID-19 outbreak is new, there is not much information available on how this virus affects cancer patients. However, patients with cancer are considered among the groups at high risk of developing a more serious illness. Patients with hematological malignancies such as acute myeloid leukemia (AML), lymphoma, and myeloma may be particularly vulnerable as their immune system is weakened by the cancer itself and its treatments.

Those undergoing active treatments such as bone marrow transplants, chemotherapy, and radiation therapy are also at high risk. Even those who are not receiving active therapy still need to be cautious. This is because the effects of past therapy are usually long-lasting. Boosting the immune system by keeping stress levels low, getting adequate sleep, moderate physical exercise, and good nutrition can be helpful.

While cancer patients should follow the general guidelines to prevent the spread of COVID-19, it is important that they consult their doctor on information specific to their condition.

Advice for family members and caregivers

Family members and caregivers of people with cancer should take appropriate precautions and take extra care to avoid bringing COVID-19 home. They should constantly monitor patients and stock medicines and other necessary supplies that can last for several weeks. Storing extra non-perishable food can help minimize trips to the grocery store.  

People who show symptoms of COVID-19 should avoid visiting their family members until the self-isolation period is complete.

What should sick individuals do?

If symptoms are present and a COVID-19 diagnosis is confirmed, patients should follow these steps to prevent the spread of the infection:

  • Stay at home, preferably in a separate room not shared with others, and isolate themselves, with the exception of getting medical care.
  • Avoid public areas and public transport.
  • Limit contact with pets and animals.
  • Avoid sharing personal items.
  • Cover coughs and sneezes with tissues and dispose of them properly.
  • Sanitize hands regularly. 
  • Disinfect surfaces such as phones, keyboards, toilets, and tables.

People should call ahead before visiting the hospital for an appointment. This way, the hospital can take necessary steps to prevent the spread of the infection.

Patients who have confirmed COVID-19 should wear face masks when going out. The WHO’s website has a resource explaining the proper use of a face mask. 

What tests are available?  

Many tests for the detection of COVID-19 have been made available under the FDA’s emergency use authorization, including rapid tests that are being developed to detect the presence of the virus within minutes.

The Foundation for Innovative New Diagnostics provides an up-to-date list of different manual and automated tests that are available or currently in development.

Is there a treatment?

There are currently no vaccines available for human coronaviruses including COVID-19. This makes the prevention and containment of the virus very important.

Oxygen therapy is the major treatment intervention for patients with severe disease. Mechanical ventilation may be necessary in cases of respiratory failure.

Are there new treatments in the pipeline?

Several clinical trials have been launched or are being planned to test a variety of potential treatments and vaccines for COVID-19. A complete list of all ongoing clinical trials pertaining to the virus is available here.

 

Last updated: March 20, 2020

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Immuno-oncology News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.

Total Posts: 4
Özge has a MSc. in Molecular Genetics from the University of Leicester and a PhD in Developmental Biology from Queen Mary University of London. She worked as a Post-doctoral Research Associate at the University of Leicester for six years in the field of Behavioural Neurology before moving into science communication. She worked as the Research Communication Officer at a London based charity for almost two years.