A Cluster-Randomized Trial of Hydroxychloroquine for Prevention of Covid-19
Copyright © 2020 Massachusetts Medical Society..
BACKGROUND: Current strategies for preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are limited to nonpharmacologic interventions. Hydroxychloroquine has been proposed as a postexposure therapy to prevent coronavirus disease 2019 (Covid-19), but definitive evidence is lacking.
METHODS: We conducted an open-label, cluster-randomized trial involving asymptomatic contacts of patients with polymerase-chain-reaction (PCR)-confirmed Covid-19 in Catalonia, Spain. We randomly assigned clusters of contacts to the hydroxychloroquine group (which received the drug at a dose of 800 mg once, followed by 400 mg daily for 6 days) or to the usual-care group (which received no specific therapy). The primary outcome was PCR-confirmed, symptomatic Covid-19 within 14 days. The secondary outcome was SARS-CoV-2 infection, defined by symptoms compatible with Covid-19 or a positive PCR test regardless of symptoms. Adverse events were assessed for up to 28 days.
RESULTS: The analysis included 2314 healthy contacts of 672 index case patients with Covid-19 who were identified between March 17 and April 28, 2020. A total of 1116 contacts were randomly assigned to receive hydroxychloroquine and 1198 to receive usual care. Results were similar in the hydroxychloroquine and usual-care groups with respect to the incidence of PCR-confirmed, symptomatic Covid-19 (5.7% and 6.2%, respectively; risk ratio, 0.86 [95% confidence interval, 0.52 to 1.42]). In addition, hydroxychloroquine was not associated with a lower incidence of SARS-CoV-2 transmission than usual care (18.7% and 17.8%, respectively). The incidence of adverse events was higher in the hydroxychloroquine group than in the usual-care group (56.1% vs. 5.9%), but no treatment-related serious adverse events were reported.
CONCLUSIONS: Postexposure therapy with hydroxychloroquine did not prevent SARS-CoV-2 infection or symptomatic Covid-19 in healthy persons exposed to a PCR-positive case patient. (Funded by the crowdfunding campaign YoMeCorono and others; BCN-PEP-CoV2 ClinicalTrials.gov number, NCT04304053.).
Medienart: |
E-Artikel |
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Erscheinungsjahr: |
2021 |
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Erschienen: |
2021 |
Enthalten in: |
Zur Gesamtaufnahme - volume:384 |
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Enthalten in: |
The New England journal of medicine - 384(2021), 5 vom: 04. Feb., Seite 417-427 |
Sprache: |
Englisch |
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Beteiligte Personen: |
Mitjà, Oriol [VerfasserIn] |
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Links: |
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Themen: |
4QWG6N8QKH |
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Anmerkungen: |
Date Completed 09.02.2021 Date Revised 09.02.2021 published: Print-Electronic ClinicalTrials.gov: NCT04304053 Citation Status MEDLINE |
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doi: |
10.1056/NEJMoa2021801 |
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funding: |
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Förderinstitution / Projekttitel: |
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PPN (Katalog-ID): |
NLM318556294 |
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520 | |a Copyright © 2020 Massachusetts Medical Society. | ||
520 | |a BACKGROUND: Current strategies for preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are limited to nonpharmacologic interventions. Hydroxychloroquine has been proposed as a postexposure therapy to prevent coronavirus disease 2019 (Covid-19), but definitive evidence is lacking | ||
520 | |a METHODS: We conducted an open-label, cluster-randomized trial involving asymptomatic contacts of patients with polymerase-chain-reaction (PCR)-confirmed Covid-19 in Catalonia, Spain. We randomly assigned clusters of contacts to the hydroxychloroquine group (which received the drug at a dose of 800 mg once, followed by 400 mg daily for 6 days) or to the usual-care group (which received no specific therapy). The primary outcome was PCR-confirmed, symptomatic Covid-19 within 14 days. The secondary outcome was SARS-CoV-2 infection, defined by symptoms compatible with Covid-19 or a positive PCR test regardless of symptoms. Adverse events were assessed for up to 28 days | ||
520 | |a RESULTS: The analysis included 2314 healthy contacts of 672 index case patients with Covid-19 who were identified between March 17 and April 28, 2020. A total of 1116 contacts were randomly assigned to receive hydroxychloroquine and 1198 to receive usual care. Results were similar in the hydroxychloroquine and usual-care groups with respect to the incidence of PCR-confirmed, symptomatic Covid-19 (5.7% and 6.2%, respectively; risk ratio, 0.86 [95% confidence interval, 0.52 to 1.42]). In addition, hydroxychloroquine was not associated with a lower incidence of SARS-CoV-2 transmission than usual care (18.7% and 17.8%, respectively). The incidence of adverse events was higher in the hydroxychloroquine group than in the usual-care group (56.1% vs. 5.9%), but no treatment-related serious adverse events were reported | ||
520 | |a CONCLUSIONS: Postexposure therapy with hydroxychloroquine did not prevent SARS-CoV-2 infection or symptomatic Covid-19 in healthy persons exposed to a PCR-positive case patient. (Funded by the crowdfunding campaign YoMeCorono and others; BCN-PEP-CoV2 ClinicalTrials.gov number, NCT04304053.) | ||
650 | 4 | |a Journal Article | |
650 | 4 | |a Randomized Controlled Trial | |
650 | 4 | |a Research Support, Non-U.S. Gov't | |
650 | 7 | |a Anti-Infective Agents |2 NLM | |
650 | 7 | |a Hydroxychloroquine |2 NLM | |
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700 | 1 | |a Gamboa, Itziar |e investigator |4 oth | |
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700 | 1 | |a Griñan, Kilian |e investigator |4 oth | |
700 | 1 | |a Castells-Büchle, Sara |e investigator |4 oth | |
700 | 1 | |a Alonso-Vallés, Alex |e investigator |4 oth | |
700 | 1 | |a Rebato, Carolina |e investigator |4 oth | |
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700 | 1 | |a Aragón, Cristina |e investigator |4 oth | |
700 | 1 | |a Vilageli, Mireia |e investigator |4 oth | |
700 | 1 | |a Martínez, Paula |e investigator |4 oth | |
700 | 1 | |a Naqui, Cristina |e investigator |4 oth | |
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700 | 1 | |a Puche, Paula |e investigator |4 oth | |
700 | 1 | |a Yana, Emma |e investigator |4 oth | |
700 | 1 | |a Urrea, Magalí |e investigator |4 oth | |
700 | 1 | |a Barjau, Carmen |e investigator |4 oth | |
700 | 1 | |a Utrillo, Roser |e investigator |4 oth | |
700 | 1 | |a Torra, Joan Enric |e investigator |4 oth | |
700 | 1 | |a Gilabert, Marta |e investigator |4 oth | |
700 | 1 | |a Domènech, Carme |e investigator |4 oth | |
700 | 1 | |a Cartiel, Judit |e investigator |4 oth | |
700 | 1 | |a López, Israel |e investigator |4 oth | |
700 | 1 | |a Pérez, Olga |e investigator |4 oth | |
700 | 1 | |a Rosell, Santiago |e investigator |4 oth | |
700 | 1 | |a Cobarsi, Patricia |e investigator |4 oth | |
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700 | 1 | |a Domínguez, Didier |e investigator |4 oth | |
700 | 1 | |a Pons, Lourdes |e investigator |4 oth | |
700 | 1 | |a Becerra, Juan Carlos |e investigator |4 oth | |
700 | 1 | |a Diaz Soler, Esther |e investigator |4 oth | |
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