Therapeutics

What are the latest developements in the area of therapeutics?  These are investigational in nature.  According to the CDC website:  "There are no drugs or other therapeutics presently approved by the U.S. Food and Drug Administration (FDA) to prevent or treat COVID-19."

"FDA has created a special emergency program for possible coronavirus therapies, the Coronavirus Treatment Acceleration Program (CTAP). The program uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful. "

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1 Corresponds to number of safe to proceed INDs. Excludes INDs related to vaccines
2 For additional information, please see Cellular & Gene Therapy Products
3 Includes INDs with more than one product

“Coronavirus Treatment Acceleration Program (CTAP).” Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 7 Aug. 2020, www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap

Antiviral drugs keep viruses from multiplying and are used to treat many viral infections (such as HIV, Herpes, Hepatitis C, and influenza).

Immunomodulators are aimed at tamping down the body’s own immune reaction to the virus, in cases where the body’s reaction basically goes overboard and starts attacking the patient’s own organs.

Neutralizing antibody therapies may help individuals fight the virus and include manufactured antibodies, animal-sourced antibody therapies, and blood-derived products such as convalescent plasma and hyperimmune globulin, which contain antibodies taken from people who have previously had COVID-19.

Cell therapy products include cellular immunotherapies and other types of both autologous and allogeneic cells, such as stem cells, and related products.

Gene therapy products seek to modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use.

The diversity of therapeutic approaches being investigated is important because it rapidly expands our understanding of the effect of different categories of potential treatments.

Infectious Disease Education and Assessment: See drug summary here

"The rationale to use convalescent COVID-19 antibody-positive plasma to treat persons with active COVID-19 is based on the prior experience treating other similar respiratory viruses." Research conducted by University of Washington, assessed by IDEA. FDA approved: NOT for COVID-19 

"Plasma is the liquid portion of blood. Consists of water, proteins (antibodies, albumin, gamma globulin, and coagulation factor), mineral salts, sugars, fats, and hormones."

“Convalescent Plasma; FDA Approved, but NOT for COVID-19.” Infectious Diseases Education & Assessment (IDEA) Program, University of Washington, covid.idea.medicine.uw.edu/page/treatment/drugs/human-coronavirus-immune-plasma-hcip.

"What’s in the works, and when might a coronavirus treatment be ready for the general public? Paul Gisbert Auwaerter, M.B.A., M.D., an expert in infection prevention, provides an overview of what the future might hold."

The Race to Develop Vaccines for COVID-19 | Paul B. Rothman, dean of the medical faculty and CEO of Johns Hopkins Medicine, interviews Ruth Karron, director of the Center for Immunization Research and the Johns Hopkins Vaccine Initiative.

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“Coronavirus Treatment: What's in Development.” Health | What Is Coronavirus?, Johns Hopkins Medicine, 19 Apr. 2020, www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/coronavirus-treatment-whats-in-development.

"The National Institutes of Health have published interim guidelines for the medical management of COVID-19 prepared by the COVID-19 Treatment Guidelines Panel. These guidelines contain information about investigational therapeutics and will be updated as new information emerges and drugs and other therapeutic interventions are approved for use by FDA."

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“Information for Clinicians on Investigational Therapeutics for Patients with COVID-19.” Therapeutic Options for COVID-19 Patients, Centers for Disease Control and Prevention, 25 Apr. 2020, www.cdc.gov/coronavirus/2019-ncov/hcp/therapeutic-options.html.

Photo: COVID-19 Treatment Guidelines, NIH/NIAID-RML, 30 July 2020, www.covid19treatmentguidelines.nih.gov/.

Access: See listed clinical studies related to the coronavirus disease (COVID-19)

"ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details."

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As of 8.12.2020. Click the map to visit ClinicalTrials.gov for current data.

"They said aviptadil is shown as the first COVID therapeutic to block replication of the SARS-CoV-2 virus in human lung cells and monocytes while also preventing synthesis of cytokines in the lung. It is a patented formulation of aviptadil (synthetic human Vasoactive Intestinal Polypeptide, VIP), which has been granted FDA fast track designation, FDA emergency use IND authorisation, and an expanded access protocol."

“RLF-100 (Aviptadil) Clinical Trial Showed Rapid Recovery from Respiratory Failure and Inhibition of Coronavirus Replication in Human Lung Cells.” NeuroPharma, NeuroRx, Inc; Relief Therapeutics Holding AG, 4 Aug. 2020,

www.neurorxpharma.com/press-releases/rlf-100-aviptadil-clinical-trial-showed-rapid-recovery-from-respiratory-failure-and-inhibition-of-coronavirus-replication-in-human-lung-cells/.

Walker, Molly. “RLF-100: Hope or Hype for COVID-19 Patients?” Medical News and Free CME Online, MedpageToday, LLC., 10 Aug. 2020, www.medpagetoday.com/infectiousdisease/covid19/87990.

U.S. HHS | Operation Warp Speed vaccine development plan

"Operation Warp Speed (OWS) aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics."

COVID-19 Vaccine | Secretary Azar Explains Operation Warp Speed As Secretary Azar explains, President Trump has announced Operation Warp Speed – a plan to bring #coronavirus vaccines, therapeutics, and diagnostics to the American people in record time.

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Operation Warp Speed

View Fact Sheet PDF

Visit HHS.gov to learn more

Johnson, Carolyn Y. “Operation Warp Speed Is Pushing for Covid-19 Therapeutics by Early Fall.” The Washington Post, WP Company, 13 July 2020, www.washingtonpost.com/health/2020/07/13/operation-

warp-speed-is-pushing-covid-19-therapeutics-by-early-fall/.

“Fact Sheet: Explaining Operation Warp Speed.” HHS.gov, US Department of Health and Human Services, 12 Aug. 2020, www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html.

Content created by Assistant Secretary for Public Affairs (ASPA)

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