Evaluation of the initial response in clinical trial efforts for COVID-19 in Brazil
OBJECTIVE: To describe the methodological characteristics and good research practices of COVID-19 interventional studies developed in Brazil in the first months of the pandemic.
METHODS: We reviewed the bulletin of the National Research Ethics Committee - Coronavirus Special Edition (Comissão Nacional de Ética em Pesquisa - CONEP-COVID) (May 28, 2020) and the databases of the International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov, and Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clínicos - ReBEC) to identify interventional studies registered in Brazil that assessed drug type, biological therapy, or vaccines. We described their methodological characteristics and calculated their power for different effect magnitudes.
RESULTS: A total of 62 studies were included, 55 retrieved from the CONEP website, and 7 from registry databases. The most tested pharmacological interventions in these studies were: chloroquine/hydroxychloroquine, azithromycin, convalescent plasma, tocilizumab, sarilumab, eculizumab, vaccine, corticosteroids, anticoagulants, n-acetylcysteine, nitazoxanide, ivermectin, and lopinavir/ritonavir. Out of 22 protocols published on registry databases until May 2020, 18 (82%) were randomized clinical trials, and 13 (59%) had an appropriate control group. However, 9 (41%) of them were masked, and only 5 (24%) included patients diagnosed with a specific laboratory test (for example, reverse transcription polymerase chain reaction - RT-PCR). Most of these studies had power > 80% only to identify large effect sizes. In the prospective follow-up, 60% of the studies available at CONEP until May 2020 had not been published on any registry platform (ICTRP/ReBEC/ClinicalTrials) by July 21, 2020.
CONCLUSION: The interventions evaluated during the Brazilian research response reflect those of international initiatives, but with a different distribution and a large number of studies assessing hydroxychloroquine/chloroquine. Limitations in methodological design and sample planning represent challenges that could affect the research outreach.
| Errataetall: |
ErratumIn: Rev Bras Epidemiol. 2021 May 24;24:e200104ERRATUM. - PMID 34037115 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:23 |
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| Enthalten in: |
Revista brasileira de epidemiologia = Brazilian journal of epidemiology - 23(2021) vom: 08., Seite e200104 |
| Sprache: |
Portugiesisch |
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| Weiterer Titel: |
Avaliação da resposta inicial de desenvolvimento de ensaios clínicos para COVID-19 no Brasil |
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| Beteiligte Personen: |
Ribeiro, Tatiane Bomfim [VerfasserIn] |
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| Links: |
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| Themen: |
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| Anmerkungen: |
Date Completed 15.01.2021 Date Revised 07.12.2022 published: Electronic-eCollection ErratumIn: Rev Bras Epidemiol. 2021 May 24;24:e200104ERRATUM. - PMID 34037115 Citation Status MEDLINE |
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| doi: |
10.1590/1980-549720200104 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 245 | 1 | 0 | |a Evaluation of the initial response in clinical trial efforts for COVID-19 in Brazil |
| 246 | 3 | 3 | |a Avaliação da resposta inicial de desenvolvimento de ensaios clínicos para COVID-19 no Brasil |
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| 500 | |a Date Revised 07.12.2022 | ||
| 500 | |a published: Electronic-eCollection | ||
| 500 | |a ErratumIn: Rev Bras Epidemiol. 2021 May 24;24:e200104ERRATUM. - PMID 34037115 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a OBJECTIVE: To describe the methodological characteristics and good research practices of COVID-19 interventional studies developed in Brazil in the first months of the pandemic | ||
| 520 | |a METHODS: We reviewed the bulletin of the National Research Ethics Committee - Coronavirus Special Edition (Comissão Nacional de Ética em Pesquisa - CONEP-COVID) (May 28, 2020) and the databases of the International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov, and Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clínicos - ReBEC) to identify interventional studies registered in Brazil that assessed drug type, biological therapy, or vaccines. We described their methodological characteristics and calculated their power for different effect magnitudes | ||
| 520 | |a RESULTS: A total of 62 studies were included, 55 retrieved from the CONEP website, and 7 from registry databases. The most tested pharmacological interventions in these studies were: chloroquine/hydroxychloroquine, azithromycin, convalescent plasma, tocilizumab, sarilumab, eculizumab, vaccine, corticosteroids, anticoagulants, n-acetylcysteine, nitazoxanide, ivermectin, and lopinavir/ritonavir. Out of 22 protocols published on registry databases until May 2020, 18 (82%) were randomized clinical trials, and 13 (59%) had an appropriate control group. However, 9 (41%) of them were masked, and only 5 (24%) included patients diagnosed with a specific laboratory test (for example, reverse transcription polymerase chain reaction - RT-PCR). Most of these studies had power > 80% only to identify large effect sizes. In the prospective follow-up, 60% of the studies available at CONEP until May 2020 had not been published on any registry platform (ICTRP/ReBEC/ClinicalTrials) by July 21, 2020 | ||
| 520 | |a CONCLUSION: The interventions evaluated during the Brazilian research response reflect those of international initiatives, but with a different distribution and a large number of studies assessing hydroxychloroquine/chloroquine. Limitations in methodological design and sample planning represent challenges that could affect the research outreach | ||
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| 700 | 1 | |a Silva, Nayara Aparecida de Oliveira |e verfasserin |4 aut | |
| 700 | 1 | |a Stein, Airton Tetelbom |e verfasserin |4 aut | |
| 700 | 1 | |a Diaz-Quijano, Fredi Alexander |e verfasserin |4 aut | |
| 700 | 1 | |a Melo, Daniela Oliveira de |e verfasserin |4 aut | |
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