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COVID-19 drug development

COVID-19 drug development is the research process to develop preventative therapeutic prescription drugs that would alleviate the severity of coronavirus disease 2019 (COVID-19). From early 2020 through 2021, several hundred drug companies, biotechnology firms, university research groups, and health organizations were developing therapeutic candidates for COVID-19 disease in various stages of preclinical or clinical research (506 total candidates in April 2021), with 419 potential COVID-19 drugs in clinical trials, as of April 2021.[1]

This article is about potential therapeutic drugs for COVID-19. For COVID-19 vaccines, see COVID-19 vaccine. For drugs that may be repurposed for treating COVID-19, see COVID-19 drug repurposing research.

As early as March 2020, the World Health Organization (WHO),[2] European Medicines Agency (EMA),[3] US Food and Drug Administration (FDA),[4] and the Chinese government and drug manufacturers[5][6] were coordinating with academic and industry researchers to speed development of vaccines, antiviral drugs, and post-infection therapies.[7][8][9][10] The International Clinical Trials Registry Platform of the WHO recorded 536 clinical studies to develop post-infection therapies for COVID-19 infections,[11][12] with numerous established antiviral compounds for treating other infections under clinical research to be repurposed.[7][13][14][15]


In March 2020, the WHO initiated the "SOLIDARITY Trial" in 10 countries, enrolling thousands of people infected with COVID-19 to assess treatment effects of four existing antiviral compounds with the most promise of efficacy.[2][16] A dynamic, systematic review was established in April 2020 to track the progress of registered clinical trials for COVID-19 vaccine and therapeutic drug candidates.[12]


Drug development is a multistep process, typically requiring more than five years to assure safety and efficacy of the new compound.[17] Several national regulatory agencies, such as the EMA and the FDA, approved procedures to expedite clinical testing.[4][18] By June 2021, dozens of potential post-infection therapies were in the final stage of human testing – phase III–IV clinical trials.[19]

(81 candidates)

antibodies

antivirals (31 candidates)

cell-based compounds (34 candidates)

-based compounds (6 candidates)

RNA

scanning compounds to be repurposed (18 candidates)

various other therapy categories, such as anti-inflammatory, , interferon, protein-based, antibiotics, and receptor-modulating compounds.[19]

antimalarial

According to one source (as of August 2020), diverse categories of preclinical or early-stage clinical research for developing COVID-19 therapeutic candidates included:[19]


Pivotal Phase III trials assess whether a candidate drug has efficacy specifically against a disease, and – in the case of people hospitalized with severe COVID-19 infections – test for an effective dose level of the repurposed or new drug candidate to improve the illness (primarily pneumonia) from COVID-19 infection.[2][11][32] For an already-approved drug (such as hydroxychloroquine for malaria), Phase III–IV trials determine in hundreds to thousands of COVID-19-infected people the possible extended use of an already-approved drug for treating COVID-19 infection.[32] As of August 2020, over 500 candidate therapeutics were in preclinical or a stage of Phase I–IV development, with new Phase II–III trials announced for hundreds of therapeutic candidates during 2020.[19]


Numerous candidate drugs under study as "supportive" treatments to relieve discomfort during illness, such as NSAIDs or bronchodilators, are not included in the table below. Others in early-stage Phase II trials or numerous treatment candidates in Phase I trials,[19] are also excluded. Drug candidates in Phase I–II trials have a low rate of success (under 12%) to pass through all trial phases to gain eventual approval.[20][29] Once having reached Phase III trials, therapeutic candidates for diseases related to COVID-19 infection – infectious and respiratory diseases – have a success rate of about 72%.[26]

Do any of the drugs reduce mortality?

Do any of the drugs reduce the time a patient is hospitalized?

Do the treatments affect the need for people with COVID-19-induced pneumonia to be ventilated or maintained in ?

intensive care

Could such drugs be used to minimize the illness of COVID-19 infection in and people at high risk of developing severe illness?

healthcare staff

Cost of drug development

COVID Moonshot

Kaplon H, Reichert JM (2021). . mAbs. 13 (1): 1860476. doi:10.1080/19420862.2020.1860476. PMC 7833761. PMID 33459118.

"Antibodies to watch in 2021"

McCreary EK, Pogue JM (April 2020). . Open Forum Infectious Diseases. 7 (4): ofaa105. doi:10.1093/ofid/ofaa105. PMC 7144823. PMID 32284951.

"Coronavirus Disease 2019 Treatment: A Review of Early and Emerging Options"

Tuccori M, Ferraro S, Convertino I, Cappello E, Valdiserra G, Blandizzi C, et al. (2020). . mAbs. 12 (1): 1854149. doi:10.1080/19420862.2020.1854149. PMC 7755170. PMID 33319649.

"Anti-SARS-CoV-2 neutralizing monoclonal antibodies: clinical pipeline"

Yang L, Liu W, Yu X, Wu M, Reichert JM, Ho M (July 2020). . Antib Ther. 3 (3): 205–12. doi:10.1093/abt/tbaa020. PMC 7454247. PMID 33215063.

"COVID-19 antibody therapeutics tracker: a global online database of antibody therapeutics for the prevention and treatment of COVID-19"

World Health Organization

R&D Blueprint and COVID-19

Coronaviruses by US National Institute for Allergy and Infectious Diseases

Regulatory Affairs Professionals Society

COVID-19 therapeutics tracker

. European Medicines Agency (EMA). 18 February 2021. Archived from the original on 23 October 2021. Retrieved 16 June 2021.

"COVID-19 treatments: research and development"