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10.7326/M20-4207

http://scihub22266oqcxt.onion/10.7326/M20-4207
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32673060!7384270!32673060
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suck abstract from ncbi


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pmid32673060      Ann+Intern+Med 2020 ; 173 (8): 623-631
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  • Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 : A Randomized Trial #MMPMID32673060
  • Skipper CP; Pastick KA; Engen NW; Bangdiwala AS; Abassi M; Lofgren SM; Williams DA; Okafor EC; Pullen MF; Nicol MR; Nascene AA; Hullsiek KH; Cheng MP; Luke D; Lother SA; MacKenzie LJ; Drobot G; Kelly LE; Schwartz IS; Zarychanski R; McDonald EG; Lee TC; Rajasingham R; Boulware DR
  • Ann Intern Med 2020[Oct]; 173 (8): 623-631 PMID32673060show ga
  • BACKGROUND: No effective oral therapy exists for early coronavirus disease 2019 (COVID-19). OBJECTIVE: To investigate whether hydroxychloroquine could reduce COVID-19 severity in adult outpatients. DESIGN: Randomized, double-blind, placebo-controlled trial conducted from 22 March through 20 May 2020. (ClinicalTrials.gov: NCT04308668). SETTING: Internet-based trial across the United States and Canada (40 states and 3 provinces). PARTICIPANTS: Symptomatic, nonhospitalized adults with laboratory-confirmed COVID-19 or probable COVID-19 and high-risk exposure within 4 days of symptom onset. INTERVENTION: Oral hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 more days) or masked placebo. MEASUREMENTS: Symptoms and severity at baseline and then at days 3, 5, 10, and 14 using a 10-point visual analogue scale. The primary end point was change in overall symptom severity over 14 days. RESULTS: Of 491 patients randomly assigned to a group, 423 contributed primary end point data. Of these, 341 (81%) had laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or epidemiologically linked exposure to a person with laboratory-confirmed infection; 56% (236 of 423) were enrolled within 1 day of symptoms starting. Change in symptom severity over 14 days did not differ between the hydroxychloroquine and placebo groups (difference in symptom severity: relative, 12%; absolute, -0.27 point [95% CI, -0.61 to 0.07 point]; P = 0.117). At 14 days, 24% (49 of 201) of participants receiving hydroxychloroquine had ongoing symptoms compared with 30% (59 of 194) receiving placebo (P = 0.21). Medication adverse effects occurred in 43% (92 of 212) of participants receiving hydroxychloroquine versus 22% (46 of 211) receiving placebo (P < 0.001). With placebo, 10 hospitalizations occurred (2 non-COVID-19-related), including 1 hospitalized death. With hydroxychloroquine, 4 hospitalizations occurred plus 1 nonhospitalized death (P = 0.29). LIMITATION: Only 58% of participants received SARS-CoV-2 testing because of severe U.S. testing shortages. CONCLUSION: Hydroxychloroquine did not substantially reduce symptom severity in outpatients with early, mild COVID-19. PRIMARY FUNDING SOURCE: Private donors.
  • |*Betacoronavirus[MESH]
  • |*Outpatients[MESH]
  • |*Pandemics[MESH]
  • |Adult[MESH]
  • |Antimalarials/therapeutic use[MESH]
  • |COVID-19[MESH]
  • |Coronavirus Infections/*drug therapy/epidemiology[MESH]
  • |Double-Blind Method[MESH]
  • |Female[MESH]
  • |Follow-Up Studies[MESH]
  • |Humans[MESH]
  • |Hydroxychloroquine/*therapeutic use[MESH]
  • |Male[MESH]
  • |Middle Aged[MESH]
  • |Pneumonia, Viral/*drug therapy/epidemiology[MESH]
  • |Retrospective Studies[MESH]
  • |Risk Factors[MESH]
  • |SARS-CoV-2[MESH]


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