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Int J Infect Dis ; 128: 223-229, 2023 Mar.
Article in English | MEDLINE | ID: covidwho-2231594


OBJECTIVES: Effective and widely available therapies are still needed for outpatients with COVID-19. We aimed to evaluate the efficacy and safety of lopinavir/ritonavir (LPV/r) for early treatment of non-hospitalized individuals diagnosed with COVID-19. METHODS: This randomized, placebo (Plb)-controlled, double-blind, multi-site decentralized clinical trial enrolled non-hospitalized adults with confirmed SARS-CoV-2 infection and six or fewer days of acute respiratory infection symptoms who were randomized to either twice-daily oral LPV/r (400 mg/100 mg) or Plb for 14 days. Daily surveys on study days 1 through 16 and again on study day 28 evaluated symptoms, daily activities, and hospitalization status. The primary outcome was longitudinal change in an ordinal scale based on a combination of symptoms, activity, and hospitalization status through day 15 and was analyzed by use of a Bayesian longitudinal proportional odds logistic regression model for estimating the probability of a superior recovery for LPV/r over Plb (odds ratio >1). RESULTS: Between June 2020 and December 2021, 448 participants were randomized to receive either LPV/r (n = 216) or Plb (n = 221). The mean symptom duration before randomization was 4.3 days (SD 1.3). There were no differences between treatment groups through the first 15 days for the ordinal primary outcome (odds ratio 0.96; 95% credible interval: 0.66 to 1.41). There were 3.2% (n = 7) of LPV/r and 2.7% (n = 6) of Plb participants hospitalized by day 28. Serious adverse events did not differ between groups. CONCLUSION: LPV/r did not significantly improve symptom resolution or reduce hospitalization in non-hospitalized participants with COVID-19. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04372628.

COVID-19 , Ritonavir , Adult , Humans , Lopinavir , Bayes Theorem , SARS-CoV-2 , COVID-19 Drug Treatment , Treatment Outcome
Trials ; 23(1): 273, 2022 Apr 08.
Article in English | MEDLINE | ID: covidwho-2098437


BACKGROUND: Coronavirus disease 2019 (COVID-19) has a heterogeneous outcome in individuals from remaining asymptomatic to death. In a majority of cases, mild symptoms are present that do not require hospitalization and can be successfully treated in the outpatient setting, though symptoms may persist for a long duration. We hypothesize that drugs suitable for decentralized study in outpatients will have efficacy among infected outpatients METHODS: The TREAT NOW platform is designed to accommodate testing multiple agents with the ability to incorporate new agents in the future. TREAT NOW is an adaptive, blinded, multi-center, placebo-controlled superiority randomized clinical trial which started with two active therapies (hydroxychloroquine and lopinavir/ritonavir) and placebo, with the hydroxychloroquine arm dropped shortly after enrollment began due to external evidence. Each arm has a target enrollment of 300 participants who will be randomly assigned in an equal allocation to receive either an active therapy or placebo twice daily for 14 days with daily electronic surveys collected over days 1 through 16 and on day 29 to evaluate symptoms and a modified COVID-19 ordinal outcome scale. Participants are enrolled remotely by telephone and consented with a digital interface, study drug is overnight mailed to study participants, and data collection occurs electronically without in-person interactions. DISCUSSION: If effective treatments for COVID-19 can be identified for individuals in the outpatient setting before they advance to severe disease, it will prevent progression to more severe disease, reduce the need for hospitalization, and shorten the duration of symptoms. The novel decentralized, "no touch" approach used by the TREAT NOW platform has distinction advantages over traditional in-person trials to reach broader populations and perform study procedures in a pragmatic yet rigorous manner. TRIAL REGISTRATION: ClinicalTrials.gov NCT04372628. Registered on April 30, 2020. First posted on May 4, 2020.

COVID-19 Drug Treatment , Antiviral Agents/adverse effects , Hospitalization , Humans , Hydroxychloroquine/adverse effects , Outpatients , Randomized Controlled Trials as Topic , SARS-CoV-2 , Treatment Outcome
Emerg Radiol ; 29(2): 227-234, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1604573


PURPOSE: The use of lung ultrasound for diagnosis of COVID-19 has emerged during the pandemic as a beneficial diagnostic modality due to its rapid availability, bedside use, and lack of radiation. This study aimed to determine if routine ultrasound (US) imaging of the lungs of trauma patients with COVID-19 infections who undergo extended focused assessment with sonography for trauma (EFAST) correlates with computed tomography (CT) imaging and X-ray findings, as previously reported in other populations. METHODS: This was a prospective, observational feasibility study performed at two level 1 trauma centers. US, CT, and X-ray imaging were retrospectively reviewed by a surgical trainee and a board-certified radiologist to determine any correlation of imaging findings in patients with active COVID-19 infection. RESULTS: There were 53 patients with lung US images from EFAST available for evaluation and COVID-19 testing. The overall COVID-19 positivity rate was 7.5%. COVID-19 infection was accurately identified by one patient on US by the trainee, but there was a 15.1% false-positive rate for infection based on the radiologist examination. CONCLUSIONS: Evaluation of the lung during EFAST cannot be used in the trauma setting to identify patients with active COVID-19 infection or to stratify patients as high or low risk of infection. This is likely due to differences in lung imaging technique and the presence of concomitant thoracic injury.

COVID-19 , Focused Assessment with Sonography for Trauma , Lung Diseases , Lung , Wounds and Injuries , COVID-19/complications , COVID-19/diagnostic imaging , COVID-19/epidemiology , False Positive Reactions , Feasibility Studies , Humans , Lung/diagnostic imaging , Lung Diseases/diagnostic imaging , Lung Diseases/etiology , Pandemics , Prospective Studies , Retrospective Studies , SARS-CoV-2 , Sensitivity and Specificity , Tomography, X-Ray Computed , Trauma Centers , Wounds and Injuries/complications , Wounds and Injuries/diagnostic imaging