August 12, 2020

Developing COVID-19 Treatments


KEY TAKEAWAYS

  • Congress has provided funds to support the development of safe and effective treatments for COVID-19.
  • Researchers worldwide are exploring more than 300 potential treatments for the disease.
  • Treatment options range from existing drugs that have been widely used for other diseases to entirely new products that seek to tackle the virus in novel ways. 

Researchers and drug manufacturers are working to expedite the development of effective and safe treatments for COVID-19. At the same time, several vaccines have entered clinical trials, and researchers are working on producing better and faster tests to identify who has the disease. Currently, researchers are testing more than 300 potential treatments worldwide. These include existing medications that could potentially be repurposed for COVID-19, as well as new drugs.

Congress has provided money through three recent laws to support the research and development of COVID-19 tests, treatments, and vaccines at the National Institutes of Health and the Biomedical Advanced Research and Development Authority. The Coronavirus Preparedness and Response Supplemental Appropriations Act; the Coronavirus Aid, Relief, and Economic Security Act; and the Paycheck Protection Program and Health Care Enhancement Act included a total of more than $3 billion for NIH and $6.5 billion for BARDA. The Coronavirus Preparedness and Response Supplemental Appropriations Act and the CARES Act also provided the Food and Drug Administration with $141 million to better facilitate the development and review of medical products for use against COVID-19. Through Operation Warp Speed, the Trump administration continues to support the efforts of federal agencies and private to deliver vaccines against and treatments for COVID-19. NIH is leading a public-private partnership called Accelerating COVID-19 Therapeutic Interventions and Vaccines to help coordinate the efforts of federal agencies, pharmaceutical manufacturers, academic institutions, private and public organizations, and the European Medicines Agency to develop COVID-19 treatments and vaccines.

multiplying options to treat COVID-19

So far, the FDA has not approved any treatments for COVID-19. One antiviral drug, remdesivir, is authorized to be used for certain patients under an emergency use authorization issued by the FDA. Gilead Sciences, the drug’s manufacturer, has donated doses to the Department of Health and Human Services, which is distributing them to states and territories. The FDA has said that it will not issue EUAs for COVID-19 drugs and biologics without strong clinical data supporting their safety and effectiveness.

The FDA has created the Coronavirus Treatment and Acceleration Program to help facilitate the development and review of COVID-19 treatments. Many of the possible treatment options fall into one of several categories:

Treatments COVID-19

Antibody-based treatments assist the body’s immune system in fighting an infection by introducing naturally derived or lab-produced antibodies. These are proteins that recognize and bind to a virus to prevent it from spreading throughout the body.

One example of this kind of treatment is convalescent plasma, in which blood is collected from donors who have recovered from a previous infection. The blood is manipulated to remove the serum – plasma without clotting properties – which is then administered to patients who are still sick. On May 1, the FDA issued final guidance detailing the circumstances under which health care providers and investigators can use convalescent plasma for COVID-19. The Trump administration also is working with the American Red Cross and other organizations to encourage people who have recovered from the disease to donate blood.

A number of researchers are working to identify specific antibodies that can keep the virus from infecting human cells. Once these antibodies are isolated, the hope is that they can be manufactured on a large scale. These types of products are referred to as monoclonal antibody cocktails, and they are being studied for both the treatment and prevention of COVID-19 infections. Both BARDA and the National Institute of Allergy and Infectious Diseases are sponsoring studies of monoclonal antibody cocktails for COVID-19.

Treatments COVID-19

Antiviral treatments are small-molecule drugs that help block a virus from replicating and spreading throughout the body. Antivirals can limit the severity of an infection and help prevent serious health problems. A placebo-controlled trial of remdesivir for the treatment of COVID-19 showed statistically significant improvement for hospitalized patients on oxygen. NIH’s COVID-19 treatment guidelines currently recommend the use of remdesivir to treat patients who require supplemental oxygen or a ventilator in the hospital. The FDA has allowed the drug to be given to the most severely sick COVID-19 patients in hospitals, based on its determination that the benefits are likely to outweigh the risks.

Treatments COVID-19

RNA-based treatments offer another way to block the virus from spreading throughout the body by introducing altered RNA molecules. RNA is responsible for the production of proteins and facilitate viral replication during an infection. This approach is also being used for some experimental COVID-19 vaccines. Several researchers worldwide are working to better understand RNA in the context of the novel coronavirus and are developing RNA-based treatments and vaccines for COVID-19. 

Treatments COVID-19

Devices and machines can also help manage the symptoms of COVID-19 and improve the condition of patients with the disease. These include several products that filter the blood to remove excess proteins and toxins that can lead to complications in COVID-19 patients. Other devices have received EUAs for specific types of patients, such as those at risk of heart failure from the disease.

Treatments COVID-19

Repurposing drug compounds to treat the novel coronavirus. Researchers are screening existing products to see if any of them show promise against COVID-19. These include drugs that have been approved for other diseases or were under investigation as treatments for something else. Operation Warp Speed is supporting some of these efforts, and BARDA has partnered with Janssen, a subsidiary of Johnson & Johnson, to screen libraries of existing compounds. At least one study has shown that dexamethasone – a steroid that is available in generic form – may provide benefits for COVID-19 patients on oxygen or ventilators. The NIH has added dexamethasone to its treatment guidelines.

Issue Tags: COVID-19, Health Care