The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations
Background and Objective Over the past 2 years, several drugs have been approved for coronavirus disease 2019 (COVID-19) treatment, but their safety during pregnancy remains poorly understood. This study aims to assess the relative risk of obstetric, neonatal, and infant outcomes associated with the...
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| Veröffentlicht in: | Drug safety 2024-03, Vol.47 (3), p.195-204 |
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| creator | Wyszynski, Diego F. Papageorghiou, Aris T. Renz, Cheryl Metz, Torri D. Hernández-Díaz, Sonia |
| description | Background and Objective
Over the past 2 years, several drugs have been approved for coronavirus disease 2019 (COVID-19) treatment, but their safety during pregnancy remains poorly understood. This study aims to assess the relative risk of obstetric, neonatal, and infant outcomes associated with the use of drugs specifically indicated for the treatment of COVID-19 compared with other drug treatment strategies. The purpose of this article is to present elements of the study protocol.
Methods
The COVID-19 International Drug Pregnancy Registry (COVID-PR) is a noninterventional, postmarketing cohort study. Pregnant women receiving treatment with monoclonal antibodies (mAbs) or antiviral drugs for mild, moderate, or severe COVID-19 are matched 1:1 with pregnant women not receiving these study-specific drugs, based on calendar time, country, gestational age at enrollment, and COVID-19 severity. Participants complete online questionnaires at enrollment, during pregnancy, and for 12 months after delivery of liveborn infants. The study began enrolling participants on 1 December 2021 and is set to span 5 years for each drug of interest.
Discussion
The COVID-PR is designed to evaluate the safety profile of each studied drug. Additionally, it may allow for an analysis of the effects of COVID-19 drug exposure during relevant gestational periods on specific neonatal outcomes. Although the sample size will be too small to detect associations with rare outcomes, the study has the potential to generate hypotheses for future research. Ultimately, these data can provide valuable insights for evidence-based decisions about COVID-19 treatment during pregnancy.
Trial registration:
ClinicalTrials.gov: NCT05013632. EU PAS EUPAS42517. |
| doi_str_mv | 10.1007/s40264-023-01377-2 |
| format | Article |
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Over the past 2 years, several drugs have been approved for coronavirus disease 2019 (COVID-19) treatment, but their safety during pregnancy remains poorly understood. This study aims to assess the relative risk of obstetric, neonatal, and infant outcomes associated with the use of drugs specifically indicated for the treatment of COVID-19 compared with other drug treatment strategies. The purpose of this article is to present elements of the study protocol.
Methods
The COVID-19 International Drug Pregnancy Registry (COVID-PR) is a noninterventional, postmarketing cohort study. Pregnant women receiving treatment with monoclonal antibodies (mAbs) or antiviral drugs for mild, moderate, or severe COVID-19 are matched 1:1 with pregnant women not receiving these study-specific drugs, based on calendar time, country, gestational age at enrollment, and COVID-19 severity. Participants complete online questionnaires at enrollment, during pregnancy, and for 12 months after delivery of liveborn infants. The study began enrolling participants on 1 December 2021 and is set to span 5 years for each drug of interest.
Discussion
The COVID-PR is designed to evaluate the safety profile of each studied drug. Additionally, it may allow for an analysis of the effects of COVID-19 drug exposure during relevant gestational periods on specific neonatal outcomes. Although the sample size will be too small to detect associations with rare outcomes, the study has the potential to generate hypotheses for future research. Ultimately, these data can provide valuable insights for evidence-based decisions about COVID-19 treatment during pregnancy.
Trial registration:
ClinicalTrials.gov: NCT05013632. EU PAS EUPAS42517.</description><identifier>ISSN: 0114-5916</identifier><identifier>EISSN: 1179-1942</identifier><identifier>DOI: 10.1007/s40264-023-01377-2</identifier><identifier>PMID: 37973784</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Antiviral agents ; Cohort analysis ; Cohort Studies ; Coronaviruses ; COVID-19 ; COVID-19 Drug Treatment ; Data collection ; Disease transmission ; Drug Safety and Pharmacovigilance ; Drugs ; Enrollments ; Female ; Gestational age ; Hospitalization ; Humans ; Infant, Newborn ; Infants ; Infections ; Medicine ; Medicine & Public Health ; Monoclonal antibodies ; Mortality ; NCT ; NCT05013632 ; Neonates ; Obstetrics ; Pandemics ; Pharmacology/Toxicology ; Pregnancy ; Protocol ; Registries ; Safety ; SARS-CoV-2 ; Severe acute respiratory syndrome coronavirus 2 ; Treatment Outcome ; Viral diseases ; Womens health</subject><ispartof>Drug safety, 2024-03, Vol.47 (3), p.195-204</ispartof><rights>The Author(s), under exclusive licence to Springer Nature Switzerland AG 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</rights><rights>2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.</rights><rights>Copyright Springer Nature B.V. Mar 2024</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c375t-43b63e43882121e61b1e34fe59fec5165892e87b6bac6f8d50486352c5c053aa3</citedby><cites>FETCH-LOGICAL-c375t-43b63e43882121e61b1e34fe59fec5165892e87b6bac6f8d50486352c5c053aa3</cites><orcidid>0000-0002-7051-1653 ; 0000-0003-1458-7642 ; 0000-0001-8143-2232 ; 0000-0002-8161-2353 ; 0000-0001-6293-3429</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s40264-023-01377-2$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s40264-023-01377-2$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27923,27924,41487,42556,51318</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37973784$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Wyszynski, Diego F.</creatorcontrib><creatorcontrib>Papageorghiou, Aris T.</creatorcontrib><creatorcontrib>Renz, Cheryl</creatorcontrib><creatorcontrib>Metz, Torri D.</creatorcontrib><creatorcontrib>Hernández-Díaz, Sonia</creatorcontrib><title>The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations</title><title>Drug safety</title><addtitle>Drug Saf</addtitle><addtitle>Drug Saf</addtitle><description>Background and Objective
Over the past 2 years, several drugs have been approved for coronavirus disease 2019 (COVID-19) treatment, but their safety during pregnancy remains poorly understood. This study aims to assess the relative risk of obstetric, neonatal, and infant outcomes associated with the use of drugs specifically indicated for the treatment of COVID-19 compared with other drug treatment strategies. The purpose of this article is to present elements of the study protocol.
Methods
The COVID-19 International Drug Pregnancy Registry (COVID-PR) is a noninterventional, postmarketing cohort study. Pregnant women receiving treatment with monoclonal antibodies (mAbs) or antiviral drugs for mild, moderate, or severe COVID-19 are matched 1:1 with pregnant women not receiving these study-specific drugs, based on calendar time, country, gestational age at enrollment, and COVID-19 severity. Participants complete online questionnaires at enrollment, during pregnancy, and for 12 months after delivery of liveborn infants. The study began enrolling participants on 1 December 2021 and is set to span 5 years for each drug of interest.
Discussion
The COVID-PR is designed to evaluate the safety profile of each studied drug. Additionally, it may allow for an analysis of the effects of COVID-19 drug exposure during relevant gestational periods on specific neonatal outcomes. Although the sample size will be too small to detect associations with rare outcomes, the study has the potential to generate hypotheses for future research. Ultimately, these data can provide valuable insights for evidence-based decisions about COVID-19 treatment during pregnancy.
Trial registration:
ClinicalTrials.gov: NCT05013632. 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Papageorghiou, Aris T. ; Renz, Cheryl ; Metz, Torri D. ; Hernández-Díaz, Sonia</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c375t-43b63e43882121e61b1e34fe59fec5165892e87b6bac6f8d50486352c5c053aa3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Antiviral agents</topic><topic>Cohort analysis</topic><topic>Cohort Studies</topic><topic>Coronaviruses</topic><topic>COVID-19</topic><topic>COVID-19 Drug Treatment</topic><topic>Data collection</topic><topic>Disease transmission</topic><topic>Drug Safety and Pharmacovigilance</topic><topic>Drugs</topic><topic>Enrollments</topic><topic>Female</topic><topic>Gestational age</topic><topic>Hospitalization</topic><topic>Humans</topic><topic>Infant, Newborn</topic><topic>Infants</topic><topic>Infections</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Monoclonal antibodies</topic><topic>Mortality</topic><topic>NCT</topic><topic>NCT05013632</topic><topic>Neonates</topic><topic>Obstetrics</topic><topic>Pandemics</topic><topic>Pharmacology/Toxicology</topic><topic>Pregnancy</topic><topic>Protocol</topic><topic>Registries</topic><topic>Safety</topic><topic>SARS-CoV-2</topic><topic>Severe acute respiratory syndrome coronavirus 2</topic><topic>Treatment Outcome</topic><topic>Viral diseases</topic><topic>Womens health</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Wyszynski, Diego F.</creatorcontrib><creatorcontrib>Papageorghiou, Aris T.</creatorcontrib><creatorcontrib>Renz, Cheryl</creatorcontrib><creatorcontrib>Metz, Torri D.</creatorcontrib><creatorcontrib>Hernández-Díaz, Sonia</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Docstoc</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><jtitle>Drug safety</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Wyszynski, Diego F.</au><au>Papageorghiou, Aris T.</au><au>Renz, Cheryl</au><au>Metz, Torri D.</au><au>Hernández-Díaz, Sonia</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations</atitle><jtitle>Drug safety</jtitle><stitle>Drug Saf</stitle><addtitle>Drug Saf</addtitle><date>2024-03-01</date><risdate>2024</risdate><volume>47</volume><issue>3</issue><spage>195</spage><epage>204</epage><pages>195-204</pages><issn>0114-5916</issn><eissn>1179-1942</eissn><abstract>Background and Objective
Over the past 2 years, several drugs have been approved for coronavirus disease 2019 (COVID-19) treatment, but their safety during pregnancy remains poorly understood. This study aims to assess the relative risk of obstetric, neonatal, and infant outcomes associated with the use of drugs specifically indicated for the treatment of COVID-19 compared with other drug treatment strategies. The purpose of this article is to present elements of the study protocol.
Methods
The COVID-19 International Drug Pregnancy Registry (COVID-PR) is a noninterventional, postmarketing cohort study. Pregnant women receiving treatment with monoclonal antibodies (mAbs) or antiviral drugs for mild, moderate, or severe COVID-19 are matched 1:1 with pregnant women not receiving these study-specific drugs, based on calendar time, country, gestational age at enrollment, and COVID-19 severity. Participants complete online questionnaires at enrollment, during pregnancy, and for 12 months after delivery of liveborn infants. The study began enrolling participants on 1 December 2021 and is set to span 5 years for each drug of interest.
Discussion
The COVID-PR is designed to evaluate the safety profile of each studied drug. Additionally, it may allow for an analysis of the effects of COVID-19 drug exposure during relevant gestational periods on specific neonatal outcomes. Although the sample size will be too small to detect associations with rare outcomes, the study has the potential to generate hypotheses for future research. Ultimately, these data can provide valuable insights for evidence-based decisions about COVID-19 treatment during pregnancy.
Trial registration:
ClinicalTrials.gov: NCT05013632. EU PAS EUPAS42517.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>37973784</pmid><doi>10.1007/s40264-023-01377-2</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-7051-1653</orcidid><orcidid>https://orcid.org/0000-0003-1458-7642</orcidid><orcidid>https://orcid.org/0000-0001-8143-2232</orcidid><orcidid>https://orcid.org/0000-0002-8161-2353</orcidid><orcidid>https://orcid.org/0000-0001-6293-3429</orcidid></addata></record> |
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| subjects | Antiviral agents Cohort analysis Cohort Studies Coronaviruses COVID-19 COVID-19 Drug Treatment Data collection Disease transmission Drug Safety and Pharmacovigilance Drugs Enrollments Female Gestational age Hospitalization Humans Infant, Newborn Infants Infections Medicine Medicine & Public Health Monoclonal antibodies Mortality NCT NCT05013632 Neonates Obstetrics Pandemics Pharmacology/Toxicology Pregnancy Protocol Registries Safety SARS-CoV-2 Severe acute respiratory syndrome coronavirus 2 Treatment Outcome Viral diseases Womens health |
| title | The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations |
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