JOURNAL ARTICLE

Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19: A Randomized Trial

Caleb P Skipper, Katelyn A Pastick, Nicole W Engen, Ananta S Bangdiwala, Mahsa Abassi, Sarah M Lofgren, Darlisha A Williams, Elizabeth C Okafor, Matthew F Pullen, Melanie R Nicol, Alanna A Nascene, Kathy H Hullsiek, Matthew P Cheng, Darlette Luke, Sylvain A Lother, Lauren J MacKenzie, Glen Drobot, Lauren E Kelly, Ilan S Schwartz, Ryan Zarychanski, Emily G McDonald, Todd C Lee, Radha Rajasingham, David R Boulware
Annals of Internal Medicine 2020 July 16
32673060

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. Measures : 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 points [95% CI, -0.61 to 0.07 points]; 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).

LIMITATIONS: 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.

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Ruben Amorocho

Its not the article when You downloaded

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