1. In this double-blind, randomized trial, hydroxychloroquine did not reduce symptom severity in an adult, outpatient population.
2. More side effects, mainly gastrointestinal symptoms, were experienced by the patients in the treatment group.
Evidence Rating Level: 1 (Excellent)
Study Rundown: There are currently no effective oral therapies for the outpatient treatment of COVID-19. This trial aimed to assess whether hydroxychloroquine could reduce symptom severity of COVID-19 in an adult, outpatient population. Eligibility for the trial included patients with fewer than four days of symptoms, confirmed or high-risk exposure to SARS-CoV-2 and was non-hospitalized. Over the 14 days, hydroxychloroquine treatment did not demonstrate any significant improvement in symptom severity. The treatment group also experienced greater side effects, the most common were GI symptoms. The study was one of the first to investigate outpatient treatment for COVID-19 and underscores an area of unmet need. Limitations of this study included the lack of confirmed SARS-CoV-2 infection in all participants due to a severe shortage in testing kits however, only a minority who did not have COVID-19 contributed to the primary study outcome.
In-Depth [randomized controlled trial]: In this randomized, double-blind, placebo-controlled trial, 491 patients were included and 423 contributed to the primary endpoint. 56% were enrolled within 1 day of symptom onset. Patients were randomized to either hydroxychloroquine (800 mg PO once, followed by 600 mg in 6-8 hrs, then 600 mg daily for 4 days) or placebo. The difference in symptom severity was insignificant over the 14 days (absolute difference: −0.27 points on 10-point scale, [95% CI, −0.61 to 0.07 points], p = 0.117). At the 14-day mark, there was no statistical difference in the proportion of patients still experiencing symptoms (p = 0.21). Medication adherence (threshold of 75% adherence) did not influence symptom severity (-2.57 points vs. -2.70 points). Adverse effects occurred in 43% of patients in the hydroxychloroquine group versus 22% in placebo (p < 0.001) which mainly consisted of GI symptoms such as nausea, upset stomach, vomiting, abdominal pain, and diarrhea. 16% of patients contributing data to the primary endpoint had a confirmed negative PCR test. Taken together, symptom severity in patients with early and mild COVID-19 was not reduced in those taking Hydroxychloroquine.
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