Back تطوير دواء كوفيد-19 Arabic Desenvolupament i recerca de medicaments contra la Covid-19 Catalan گەشەپێدانی دەرمان دژی کۆڤید-١٩ CKB Desarrollo de medicamentos contra la COVID-19 Spanish Koroonaravimite väljatöötamine Estonian گسترش داروهای کووید ۱۹ Persian COVID-19-lääkkeen kehittäminen Finnish Développement et recherche de médicaments contre la Covid-19 French Ci Gaban Magungunan COVID-19 Hausa פיתוח תרופות וחיסונים למחלת COVID-19 HE

COVID-19 drug development

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.

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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]

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]

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  3. ^ "First regulatory workshop on COVID-19 facilitates global collaboration on vaccine development". European Medicines Agency. 18 March 2020. Archived from the original on 20 March 2020. Retrieved 21 March 2020.
  4. ^ a b "Coronavirus (COVID-19) Update: FDA Continues to Facilitate Development of Treatments" (Press release). U.S. Food and Drug Administration (FDA). 19 March 2020. Archived from the original on 20 March 2020. Retrieved 21 March 2020.
  5. ^ "China approves first anti-viral drug against coronavirus Covid-19". Clinical Trials Arena. 18 February 2020. Archived from the original on 21 March 2020. Retrieved 21 March 2020.
  6. ^ "Chinese Vaccine Approved for Human Testing at Virus Epicenter". Bloomberg News. 19 March 2020. Archived from the original on 21 March 2020. Retrieved 21 March 2020.
  7. ^ a b Dhama K, Sharun K, Tiwari R, Dadar M, Malik YS, Singh KP, et al. (June 2020). "COVID-19, an emerging coronavirus infection: advances and prospects in designing and developing vaccines, immunotherapeutics, and therapeutics". Human Vaccines & Immunotherapeutics. 16 (6): 1232–1238. doi:10.1080/21645515.2020.1735227. PMC 7103671. PMID 32186952.
  8. ^ Zhang L, Liu Y (May 2020). "Potential interventions for novel coronavirus in China: A systematic review". Journal of Medical Virology. 92 (5): 479–490. doi:10.1002/jmv.25707. PMC 7166986. PMID 32052466.
  9. ^ Fox M (19 March 2020). "Drug makers are racing to develop immune therapies for Covid-19. Will they be ready in time?". Stat. Archived from the original on 22 March 2020. Retrieved 21 March 2020.
  10. ^ Chan M (19 March 2020). "Chinese military scientists ordered to win global race to develop coronavirus vaccine". South China Morning Post. Archived from the original on 22 March 2020. Retrieved 22 March 2020.
  11. ^ COVID-19 Clinical Research Coalition (April 2020). "Global coalition to accelerate COVID-19 clinical research in resource-limited settings". Lancet. 395 (10233): 1322–1325. doi:10.1016/s0140-6736(20)30798-4. PMC 7270833. PMID 32247324.
  12. ^ a b Maguire BJ, Guérin PJ (2 April 2020). "A living systematic review protocol for COVID-19 clinical trial registrations". Wellcome Open Research. 5: 60. doi:10.12688/wellcomeopenres.15821.1. PMC 7141164. PMID 32292826.
  13. ^ Li G, De Clercq E (March 2020). "Therapeutic options for the 2019 novel coronavirus (2019-nCoV)". Nature Reviews. Drug Discovery. 19 (3): 149–150. doi:10.1038/d41573-020-00016-0. PMID 32127666.
  14. ^ Dong L, Hu S, Gao J (29 February 2020). "Discovering drugs to treat coronavirus disease 2019 (COVID-19)". Drug Discoveries & Therapeutics. 14 (1): 58–60. doi:10.5582/ddt.2020.01012. PMID 32147628. Archived from the original on 20 March 2020. Retrieved 21 March 2020.
  15. ^ Harrison C (April 2020). "Coronavirus puts drug repurposing on the fast track". Nature Biotechnology. 38 (4): 379–381. doi:10.1038/d41587-020-00003-1. PMID 32205870. S2CID 213394680.
  16. ^ Cheng MP, Lee TC, Tan DH, Murthy S (April 2020). "Generating randomized trial evidence to optimize treatment in the COVID-19 pandemic". CMAJ. 192 (15): E405–E407. doi:10.1503/cmaj.200438. PMC 7162442. PMID 32336678.
  17. ^ "The Drug Development Process". U.S. Food and Drug Administration (FDA). 4 January 2018. Archived from the original on 22 February 2020. Retrieved 21 March 2020.
  18. ^ "Call to pool research resources into large multi-centre, multi-arm clinical trials to generate sound evidence on COVID-19 treatments". European Medicines Agency. 19 March 2020. Archived from the original on 21 March 2020. Retrieved 21 March 2020.
  19. ^ "COVID-19 vaccine and treatments tracker (Choose vaccines or treatments tab, apply filters to view select data)". Milken Institute. 21 June 2021. Archived from the original on 24 June 2021. Retrieved 11 June 2021.

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