Preview

FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology

Advanced search

A systematic review of real-world clinical practice data in COVID-19: non-interventional studies

https://doi.org/10.17749/2070-4909/farmakoekonomika.2022.099

Abstract

Introduction. As defined by the Food and Drug Administration, real-world data (RWD) is data related to a patient's health and/or health care delivery, usually collected from various sources as part of real-world clinical practice research.

Objective: to describe the feasible and the most sought-after designs of non-interventional real-world clinical practice trials that provide evidence for the efficacy and safety of drug administration in the therapy of novel coronavirus infection.

Material and methods. A search strategy for the terms “COVID-19 AND real-life”, “COVID-19 AND real-data”, “COVID-19 AND real-world” was developed to extract articles published between December 1, 2020 and March 12, 2021 from the databases: PubMed/MEDLINE, the Cochrane Database of Systematic Reviews, and the ClinicalTrials.gov database.

Results. The search yielded 137 non-repetitive articles, 32 of them were included in the review. All randomized clinical trials (pragmatic and simplified large ones), studies of the effectiveness of laboratory diagnostic methods, medical triage, social distancing and other sanitary and epidemiological measures to cope with the epidemic were excluded.

Conclusion. High-quality, non-randomized RWD studies can enhance the external validity of registration randomized clinical trials by complementing them with a broader range of indicators, which is essential in supporting medical and public health decision-making in the COVID-19 pandemic. 

About the Authors

S. A. Mishinova
Pavlov University
Russian Federation

Assistant Professor, Chair of Clinical Pharmacology and Evidence-Based Medicine, 

6-8 Lev Tolstoy Str., Saint Petersburg 197022



Yu. M. Gomon
Pavlov University; St. George the Martyr City Hospital
Russian Federation

Dr. Med. Sc., Associate Professor, Chair of Clinical Pharmacology and Evidence-Based Medicine, 6-8 Lev Tolstoy Str., Saint Petersburg 197022;

Clinical Pharmacologist, 1 Severnyy Ave., Saint Petersburg 194354



A. S. Kolbin
Pavlov University; Saint Petersburg State University
Russian Federation

Dr. Med. Sc., Professor, Chief of Chair of Clinical Pharmacology and Evidence-Based Medicine, 6-8 Lev Tolstoy Str., Saint Petersburg 197022;

Professor, Chair of Pharmacology, Faculty of Medicine, 8 21st Line of Vasilyevskiy Island, Saint Petersburg 199106



V. V. Strizheletsky
St. George the Martyr City Hospital; Saint Petersburg State University
Russian Federation

Dr. Med. Sc., Chief Physician, 1 Severnyy Ave., Saint Petersburg 194354;

Professor, Chair of Hospital Surgery, 8 21st Line of Vasilyevskiy Island, Saint Petersburg 199106



I. G. Ivanov
St. George the Martyr City Hospital; Saint Petersburg State University
Russian Federation

 Deputy Chief Physician, 1 Severnyy Ave., Saint Petersburg 194354;

Assistant Professor, Chair of Propaedeutics of Internal Diseases, 8 21st Line of Vasilyevskiy Island, Saint Petersburg 199106



References

1. European Centre for Disease Prevention and Control. COVID-19. Situation updates. Available at: https://www.ecdc.europa.eu/en/covid19-pandemic (accessed 29.11.2021).

2. Coronavirus Vaccine Tracker. Available at: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html (accessed 29.11.2021).

3. Kolbin A.S. COVID-19 and clinical pharmacology. Klinicheskaya farmakologiya i terapiya / Clinical Pharmacology and Therapy. 2020; 29 (3): 1–11 (in Russ.). https://doi.org/10.32756/0869-5490-2020-3- 14-24.

4. Mishinova S.A., Zhuravkov A.A., Zhuravko V.K. Use of unlicensed drugs and off-label drug use: focus on COVID-19. Kachestvennaya klinicheskaya praktika / Good Clinical Practice. 2020; 4S: 120–9 (in Russ.). https://doi.org/10.37489/2588-0519-2020-S4-120-129.

5. Global Coronavirus COVID-19 Clinical Trial Tracker. Available at: https://www.covid-trials.org/ (accessed 29.11.2021).

6. Framework for FDA’S Real-World Evidence Program. Available at: https://www.fda.gov/media/120060/download (accessed 29.11.2021).

7. Kolbin A.S. (Ed.) Studies of real clinical practice. Мoscow: Izdatel’svo ОКI; 2020: 208 pp. (in Russ.).

8. PRISMA transparent reporting of systematic reviews and metaanalyses. Available at: http://www.prisma-statement.org/ (accessed 29.11.2021).

9. Ip A., Berry D.A., Hansen E., et al. Hydroxychloroquine and tocilizumab therapy in COVID-19 patients – an observational study. PloS One. 2020; 15 (8): e0237693. https://doi.org/10.1371/journal.pone.0237693.

10. Monreal Е., Sainz de la Maza S., Natera-Villalba E., et al. High versus standard doses of corticosteroids in severe COVID-19: a retrospective cohort study. Eur J Clin Microbiol Infect Dis. 2021; 40 (4): 761–9. https://doi.org/10.1007/s10096-020-04078-1.

11. Khunti K., Knighton P., Zaccardi F., et al. Prescription of glucoselowering therapies and risk of COVID-19 mortality in people with type 2 diabetes: a nationwide observational study in England. Lancet Diabetes Endocrinol. 2021; 9 (5): 293–303. https://doi.org/10.1016/S2213-8587(21)00050-4.

12. Francis N.А., Stuart B., Knight M., et al. Predictors of clinical deterioration in patients with suspected COVID-19 managed in a ‘virtual hospital’ setting: a cohort study. BMJ Open. 2021; 11 (3): e045356. https://doi.org/10.1136/bmjopen-2020-045356.

13. Shu Z., Chang K., Zhou Y., et al. Add-On Chinese Medicine for Coronavirus Disease 2019 (ACCORD): a retrospective cohort study of hospital registries. Am J Chin Med. 2021; 49 (3): 543–75. https://doi.org/10.1142/S0192415X21500257.

14. Sun J., Deng X., Chen X., et al. Incidence of adverse drug reactions in COVID-19 patients in China: an active monitoring study by Hospital Pharmacovigilance System. Clin Pharmacol Ther. 2020; 108 (4): 791– 7. https://doi.org/10.1002/cpt.1866.

15. Liu X., Liu Y., Wang L., et al. Analysis of the prophylactic effect of thymosin drugs on COVID-19 for 435 medical staff: a hospital-based retrospective study. J Med Virol. 2021; 93 (3): 1573–80. https://doi.org/10.1002/jmv.26492.

16. Annie F.H., Sirbu C., Frazier K.R., et al. Hydroxychloroquine in hospitalized patients with COVID-19: real-world experience assessing mortality. Pharmacotherapy. 2020; 40 (11): 1072–81. https://doi.org/10.1002/phar.2467.

17. Trifirò G., Massari M., Da Cas R., et al. Renin-angiotensinaldosterone system inhibitors and risk of death in patients hospitalised with COVID-19: a retrospective italian cohort study of 43,000 patients. Drug Saf. 2020; 43 (12): 1297–308. https://doi.org/10.1007/s40264-020-00994-5.

18. Garcia P., Revet A., Yrondi A., et al. Psychiatric disorders and hydroxychloroquine for coronavirus disease 2019 (COVID-19): a VigiBase study. Drug Saf. 2020; 43 (12): 1315–22. https://doi.org/10.1007/s40264-020-01013-3.

19. Rubio-Rivas M., Ronda M., Padulles A., et al. Beneficial effect of corticosteroids in preventing mortality in patients receiving tocilizumab to treat severe COVID-19 illness. Int J Infect Dis. 2020; 101: 290–7. https://doi.org/10.1016/j.ijid.2020.09.1486.

20. Zhou F., Yu T., Du R., et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020; 395 (10229): 1054–62. https://doi.org/10.1016/S0140-6736(20)30566-3.

21. Biran N., Ip A., Ahn J., et al. Tocilizumab among patients with COVID-19 in the intensive care unit: a multicentre observational study. Lancet Rheumatol. 2020; 2 (10): e603–12. https://doi.org/10.1016/S2665-9913(20)30277-0.

22. Gervasoni C., Meraviglia P., Riva A., et al. Clinical features and outcomes of patients with human immunodeficiency virus with COVID-19. Clin Infect Dis. 2020; 71 (16): 2276–8. https://doi.org/10.1093/cid/ciaa579.

23. Russo V., Cardillo G., Viggiano G.V., et al. Fondaparinux use in patients with COVID-19: a preliminary multicenter real-world experience. J Cardiovasc Pharmacol. 2020; 76 (4): 369–71. https://doi.org/10.1097/FJC.0000000000000893.

24. Chouchana L., Boujaafar S., Gana I., et al. plasma concentrations and safety of lopinavir/ritonavir in COVID-19 patients. Ther Drug Monit. 2021; 43 (1): 131–5. https://doi.org/10.1097/FTD.0000000000000838.

25. Tsukamoto M., Suzuki K., Tsunoda K., et al. Value of labial salivary gland histopathology for diagnosis of Sjögren's syndrome in patients with anti-centromere antibody positivity. Int J Rheum Dis. 2020; 23 (8): 1024–9. https://doi.org/10.1111/1756-185X.13895.

26. Cook G., Ashcroft A.J., Pratt G., et al. Real-world assessment of the clinical impact of symptomatic infection with severe acute respiratory syndrome coronavirus (COVID-19 disease) in patients with multiple myeloma receiving systemic anti-cancer therapy. Br J Haematol. 2020; 190 (2): e83–6. https://doi.org/10.1111/bjh.16874.

27. Gironi L.C., Damiani G., Zavattaro E., et al. Tetracyclines in COVID-19 patients quarantined at home: literature evidence supporting real-world data from a multicenter observational study targeting inflammatory and infectious dermatoses. Dermatol Ther. 2021: 34 (1): e14694. https://doi.org/10.1111/dth.14694.

28. Rivera-Caravaca J.M., Núñez-Gil I.J., Vivas D., et al. Clinical profile and prognosis in patients on oral anticoagulation before admission for COVID-19. Eur J Clin Invest. 2021; 51 (1): e13436. https://doi.org/10.1111/eci.13436.

29. Zeng Q.L., Li G.M., Ji F., et al. Clinical course and treatment efficacy of COVID-19 near Hubei Province, China: a multicentre, retrospective study. Transbound Emerg Dis. 2020; 67 (6): 2971–82. https://doi.org/10.1111/tbed.13674.

30. Rentsch C.T., Beckman J.A., Tomlinson L., et al. Early initiation of prophylactic anticoagulation for prevention of coronavirus disease 2019 mortality in patients admitted to hospital in the United States: cohort study. BMJ. 2021; 372: n311. https://doi.org/10.1136/bmj.n311.

31. Caraballo C., McCullough M., Fuery M.A., et al. COVID-19 infections and outcomes in a live registry of heart failure patients across an integrated health care system. PloS One. 2020; 15 (9): e0238829. https://doi.org/10.1371/journal.pone.0238829.

32. Flisiak R., Zarębska-Michaluk D., Berkan-Kawińska A., et al. Remdesivir-based therapy improved recovery of patients with COVID-19 in the SARSTer study. Pol Arch Intern Med. 2021; 131 (1): 103–10. https://doi.org/10.20452/pamw.15735.

33. De Vito A., Geremia N., Princic E., et al. Does angiotensin II receptor blockers increase the risk of SARS-CoV-2 infection? A real-life experience. Eur Rev Med Pharmacol Sci. 2021; 25 (1): 523–6. https://doi.org/10.26355/eurrev_202101_24424.

34. Antonov V.N., Ignatova G.L., Pribytkova O.V., et al. Experience of olokizumab use in COVID-19 patients. Therapeutic Archive. 2020; 92 (12): 148–54 (in Russ.). https://doi.org/10.26442/00403660.2020.12. 200522.

35. Tanriverdi E., Çörtük M., Yildirim B.Z., et al. Hydroxychloroquine plus azithromycin and early hospital admission are beneficial in COVID-19 patients: Turkish experience with real-life data. Turk J Med Sci. 2021; 51 (1): 10–5. https://doi.org/10.3906/sag-2005-82.

36. Nachega J.B., Ishoso D.K., Otokoye J.O., et al. Clinical characteristics and outcomes of patients hospitalized for COVID-19 in Africa: early insights from the Democratic Republic of the Congo. Am J Trop Med Hyg. 2020; 103 (6): 2419–28. https://doi.org/10.4269/ajtmh.20-1240.

37. Gore V., Kshirsagar D.P., Bhat S.M., et al. Itolizumab treatment for cytokine release syndrome in moderate to severe acute respiratory distress syndrome due to COVID-19: clinical outcomes, a retrospective study. J Assoc Physicians India. 2021; 69 (2): 13–8.

38. Karolyi M., Pawelka E., Mader T., et al. Hydroxychloroquine versus lopinavir/ritonavir in severe COVID-19 patients. Wien Klin Wochenschr. 2021; 133 (7): 284–91. https://doi.org/10.1007/s00508-020-01720-y.

39. Garcia-Vidal C., Meira F., Cózar-Llistó A., et al. Real-life use of remdesivir in hospitalized patients with COVID-19. Rev Esp Quimioter. 2021; 34 (2): 136–40. https://doi.org/10.37201/req/018.2021.

40. Hughes R., Whitley L., Fitovski K., et al. COVID-19 in ocrelizumabtreated people with multiple sclerosis. Mult Scler Relat Disord. 2021; 49: 102725. https://doi.org/10.1016/j.msard.2020.102725.

41. WHO R&D Blueprint. Novel coronavirus. COVID-19 therapeutic trial synopsis. Available at: https://www.who.int/blueprint/priority-diseases/key-action/COVID-19_Treatment_Trial_Design_Master_Protocol_ synopsis_Final_18022020.pdf (accessed 29.11.2021).

42. Martsevich S.Y., Lukina Yu.V., Kutishenko N.P. Once again about the hierarchy of evidences in medicine or whether it is possible to choose the most effective and safe drug with the help of observational studies. Rational Pharmacotherapy in Cardiology. 2017; 13 (2): 270–4 (in Russ.). https://doi.org/10.20996/1819-6446-2017-13-2-270-274.

43. Franklin J.M., Lin K.J., Gatto N.M., et al. Real-world evidence for assessing pharmaceutical treatments in the context of COVID-19. Clin Pharmacol Ther. 2021; 109 (4): 816–28. https://doi.org/10.1002/cpt.2185.

44. “Guiding principles of real-word evidence supporting drug development and review (trial)” is formally promulgated by NMPA. Available at: https://www.accestra.com/guiding-principles-of-realworld-evidence-supporting-drug-development-and-review-trial-isformally-promulgated-by-nmpa/ (accessed 29.11.2021).


Review

For citations:


Mishinova S.A., Gomon Yu.M., Kolbin A.S., Strizheletsky V.V., Ivanov I.G. A systematic review of real-world clinical practice data in COVID-19: non-interventional studies. FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2022;15(1):145-161. (In Russ.) https://doi.org/10.17749/2070-4909/farmakoekonomika.2022.099

Views: 351


ISSN 2070-4909 (Print)
ISSN 2070-4933 (Online)