Safety and tolerability of hydroxychloroquine in health care workers and first responders for the prevention of COVID-19: WHIP COVID-19 Study
Background: Health care workers (HCW) are among the highest risk groups for acquisition of COVID-19 because of occupational exposures. The WHIP COVID-19 Study aimed to evaluate the safety and efficacy of hydroxychloroquine (HCQ) as chemoprophylaxis for SARS-CoV-2 infection in this population. Method...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-03-01
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| Series: | International Journal of Infectious Diseases |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S1201971221012431 |
| _version_ | 1819279404694503424 |
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| author | John E. McKinnon Dee Dee Wang Marcus Zervos Matt Saval Laurie Marshall-Nightengale Paul Kilgore Pardeep Pabla Ed Szandzik Kathleen Maksimowicz-McKinnon William W. O'Neill |
| author_facet | John E. McKinnon Dee Dee Wang Marcus Zervos Matt Saval Laurie Marshall-Nightengale Paul Kilgore Pardeep Pabla Ed Szandzik Kathleen Maksimowicz-McKinnon William W. O'Neill |
| author_sort | John E. McKinnon |
| collection | DOAJ |
| description | Background: Health care workers (HCW) are among the highest risk groups for acquisition of COVID-19 because of occupational exposures. The WHIP COVID-19 Study aimed to evaluate the safety and efficacy of hydroxychloroquine (HCQ) as chemoprophylaxis for SARS-CoV-2 infection in this population. Methods: HCW, first responders, and other occupationally high-risk participants were enrolled in a randomized, placebo-controlled clinical study of HCQ from April to October 2020. The trial compared daily versus weekly HCQ with placebo and with a prospective cohort on HCQ for autoimmune diseases. Participants were followed for 8 weeks. Serology or a positive polymerase chain reaction test was used to determine laboratory confirmed clinical cases. Results: A total of 624 participants were randomized to placebo (n = 200), weekly HCQ (n = 201), daily HCQ (n = 197). For the primary safety end point, 279 (44.7%) participants experienced adverse event (AE) level II or lower (total AEs n = 589), similar rates in all randomized groups (P = .188) with no hospitalizations or interventions required. Only 4 laboratory confirmed COVID-19 cases occurred, with 2 in the placebo arm and one in each HCQ randomized arm. Conclusions: This randomized placebo-controlled trial was able to demonstrate the safety of HCQ outpatient chemoprophylaxis in high-risk groups against COVID-19. Future studies of chemoprophylaxis for SARS-CoV-2 are needed as the epidemic continues worldwide. |
| first_indexed | 2024-12-24T00:27:22Z |
| format | Article |
| id | doaj.art-87534f802e834e48aad028e376fb1c46 |
| institution | Directory Open Access Journal |
| issn | 1201-9712 |
| language | English |
| last_indexed | 2024-12-24T00:27:22Z |
| publishDate | 2022-03-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Infectious Diseases |
| spelling | doaj.art-87534f802e834e48aad028e376fb1c462022-12-21T17:24:24ZengElsevierInternational Journal of Infectious Diseases1201-97122022-03-01116167173Safety and tolerability of hydroxychloroquine in health care workers and first responders for the prevention of COVID-19: WHIP COVID-19 StudyJohn E. McKinnon0Dee Dee Wang1Marcus Zervos2Matt Saval3Laurie Marshall-Nightengale4Paul Kilgore5Pardeep Pabla6Ed Szandzik7Kathleen Maksimowicz-McKinnon8William W. O'Neill9Infectious Disease, Henry Ford Hospital, Detroit, Michigan, USA; Corresponding author: John E. McKinnon, Henry Ford Hospital, 2799 West Grand Blvd, Clara Ford Pavilion, 432, Detroit, MI 48202, USA. Office: 313-916-8828.Division of Cardiovascular Disease, Center for Structural Heart, Henry Ford Hospital, Detroit, Michigan, USAInfectious Disease, Henry Ford Hospital, Detroit, Michigan, USADivision of Cardiovascular Disease, Center for Structural Heart, Henry Ford Hospital, Detroit, Michigan, USADivision of Cardiovascular Disease, Center for Structural Heart, Henry Ford Hospital, Detroit, Michigan, USA; Public Health Sciences, Henry Ford Hospital, Detroit, Michigan, USAInfectious Disease, Henry Ford Hospital, Detroit, Michigan, USAPharmacy, Henry Ford Hospital, Detroit, Michigan, USAPharmacy, Henry Ford Hospital, Detroit, Michigan, USARheumatology, Henry Ford Hospital, Detroit, Michigan, USAInfectious Disease, Henry Ford Hospital, Detroit, Michigan, USABackground: Health care workers (HCW) are among the highest risk groups for acquisition of COVID-19 because of occupational exposures. The WHIP COVID-19 Study aimed to evaluate the safety and efficacy of hydroxychloroquine (HCQ) as chemoprophylaxis for SARS-CoV-2 infection in this population. Methods: HCW, first responders, and other occupationally high-risk participants were enrolled in a randomized, placebo-controlled clinical study of HCQ from April to October 2020. The trial compared daily versus weekly HCQ with placebo and with a prospective cohort on HCQ for autoimmune diseases. Participants were followed for 8 weeks. Serology or a positive polymerase chain reaction test was used to determine laboratory confirmed clinical cases. Results: A total of 624 participants were randomized to placebo (n = 200), weekly HCQ (n = 201), daily HCQ (n = 197). For the primary safety end point, 279 (44.7%) participants experienced adverse event (AE) level II or lower (total AEs n = 589), similar rates in all randomized groups (P = .188) with no hospitalizations or interventions required. Only 4 laboratory confirmed COVID-19 cases occurred, with 2 in the placebo arm and one in each HCQ randomized arm. Conclusions: This randomized placebo-controlled trial was able to demonstrate the safety of HCQ outpatient chemoprophylaxis in high-risk groups against COVID-19. Future studies of chemoprophylaxis for SARS-CoV-2 are needed as the epidemic continues worldwide.http://www.sciencedirect.com/science/article/pii/S1201971221012431HydroxychloroquineCOVID-19ChemoprophylaxisRandomized trialHealth care workers |
| spellingShingle | John E. McKinnon Dee Dee Wang Marcus Zervos Matt Saval Laurie Marshall-Nightengale Paul Kilgore Pardeep Pabla Ed Szandzik Kathleen Maksimowicz-McKinnon William W. O'Neill Safety and tolerability of hydroxychloroquine in health care workers and first responders for the prevention of COVID-19: WHIP COVID-19 Study International Journal of Infectious Diseases Hydroxychloroquine COVID-19 Chemoprophylaxis Randomized trial Health care workers |
| title | Safety and tolerability of hydroxychloroquine in health care workers and first responders for the prevention of COVID-19: WHIP COVID-19 Study |
| title_full | Safety and tolerability of hydroxychloroquine in health care workers and first responders for the prevention of COVID-19: WHIP COVID-19 Study |
| title_fullStr | Safety and tolerability of hydroxychloroquine in health care workers and first responders for the prevention of COVID-19: WHIP COVID-19 Study |
| title_full_unstemmed | Safety and tolerability of hydroxychloroquine in health care workers and first responders for the prevention of COVID-19: WHIP COVID-19 Study |
| title_short | Safety and tolerability of hydroxychloroquine in health care workers and first responders for the prevention of COVID-19: WHIP COVID-19 Study |
| title_sort | safety and tolerability of hydroxychloroquine in health care workers and first responders for the prevention of covid 19 whip covid 19 study |
| topic | Hydroxychloroquine COVID-19 Chemoprophylaxis Randomized trial Health care workers |
| url | http://www.sciencedirect.com/science/article/pii/S1201971221012431 |
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