ABSTRACT
BACKGROUND: No effective treatments for coronavirus disease 2019 (COVID-19) exist. We aimed to determine whether early treatment with hydroxychloroquine (HCQ) would be efficacious for outpatients with COVID-19. METHODS: Multicenter open-label, randomized, controlled trial conducted in Catalonia, Spain, between 17 March and 26 May 2020. Patients recently diagnosed with <5-day of symptom onset were assigned to receive HCQ (800 mg on day 1 followed by 400 mg once daily for 6 days) or usual care. Outcomes were reduction of viral load in nasopharyngeal swabs up to 7 days after treatment start, disease progression up to 28 days, and time to complete resolution of symptoms. Adverse events were assessed up to 28 days. RESULTS: A total of 293 patients were eligible for intention-to-treat analysis: 157 in the control arm and 136 in the intervention arm. The mean age was 41.6 years (SD, 12.6), mean viral load at baseline was 7.90 log10 copies/mL (SD, 1.82), and median time from symptom onset to randomization was 3 days. No differences were found in the mean reduction of viral load at day 3 (-1.41 vs -1.41 log10 copies/mL in the control and intervention arm, respectively) or at day 7 (-3.37 vs -3.44). Treatment did not reduce risk of hospitalization (7.1% control vs 5.9% intervention) nor shorten the time to complete resolution of symptoms (12 days, control vs 10 days, intervention). No relevant adverse events were reported. CONCLUSIONS: In patients with mild COVID-19, no benefit was observed with HCQ beyond the usual care.
Subject(s)
COVID-19 Drug Treatment , Hydroxychloroquine , Adult , Humans , Hydroxychloroquine/therapeutic use , SARS-CoV-2 , Treatment OutcomeABSTRACT
INTRODUCTION: Many reports have described a decrease in the numbers of patients seeking medical attention for typical emergencies during the COVID-19 pandemic. These reports primarily relate to urban areas with widespread community transmission. The impact of COVID-19 on nonurban areas with minimal community transmission is less well understood. METHODS: Using a prospectively maintained prehospital quality improvement database, we reviewed our hospital EMS transports with a diagnosis of stroke from January to April 2019 (baseline) and January to April 2020 (pandemic). We compared the volume of patients, transport/presentation times, severity of presenting symptoms, and final diagnosis. RESULTS: In January, February, March, and April 2019, 10, 11, 17, and 19 patients, respectively, were transported in comparison to 19, 14, 10, and 8 during the same months in 2020. From January through April 2019, there was a 53% increase in transports, compared to a 42% decrease during the same months in 2020, constituting significantly different trend-line slopes (3.30; 95% CI 0.48-6.12 versus -3.70; 95% CI -5.76--1.64, p = 0.001). Patient demographics, comorbidities, and symptom severity were mostly similar over the two time periods, and the number of patients with a final diagnosis of stroke was also similar. However, the median interval from EMS dispatch to ED arrival for patients with a final diagnosis of stroke was significantly longer in January to April 2020 (50 ± 11.7 min) compared to the same time period in 2019 (42 ± 8.2 min, p = 0.01). Discussion/Conclusion. Our data indicate a decrease in patient transport volumes and longer intervals to EMS activation for suspected stroke care. These results suggest that even in a nonurban location without widespread community transmission, patients may be delaying or avoiding care for severe illnesses such as stroke. Clinicians and public health officials should not ignore the potential impact of pandemic-like illnesses even in areas of relatively low disease prevalence.
ABSTRACT
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.).