COVID-19 therapies for inpatients: a review and quality assessment of clinical guidelines

Wohl, David A.; Espinueva, Aprille; Dau, Lauren; Wang, Chenyu; Lachmann, Alexandra; Bam, Rujuta A.; Rawal, Aaditya; Chappell-Smith, Kerris; Rockstroh, Juergen

doi:10.1183/23120541.00236-2022

Cited by 5 publications

(5 citation statements)

References 58 publications

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“…Our current data demonstrate a decrease in the number of patients receiving tocilizumab between the first and second surge. This observation is likely reflective of the change in evidence and clinical recommendations in the peer-reviewed literature around the time of the second surge of the pandemic [45,46]. Overall, we interpret the variability in beneficial effects of the five prevalent medications investigated in this study during the first and second surge by the notion that each individual medication likely had a lesser impact on the pathophysiology of COVID-19 than other confounding variables.…”

Section: Discussionmentioning

confidence: 63%

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Investigational medications in 9,638 hospitalized patients with severe COVID-19: lessons from the “fail-and-learn” strategy during the first two waves of the pandemic in 2020

Delgado

Cornett²,

Choi³

et al. 2023

Patient Saf Surg

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Background The early surge of the novel coronavirus disease 2019 (COVID-19) pandemic introduced a significant clinical challenge due to the high case-fatality rate in absence of evidence-based recommendations. The empirical treatment modalities were relegated to historical expertise from the traditional management of acute respiratory distress syndrome (ARDS) in conjunction with off-label pharmaceutical agents endorsed under the “emergency use authorization” (EUA) paradigm by regulatory agencies. This study was designed to evaluate the insights from the “fail-and-learn” strategy in 2020 before the availability of COVID-19 vaccines and access to reliable insights from high-quality randomized controlled trials. Methods A retrospective, multicenter, propensity-matched, case-control study was performed on a data registry comprising 186 hospitals from a national health care system in the United States, designed to investigate the efficacy of empirical treatment modalities during the early surge of the COVID-19 pandemic in 2020. Reflective of the time-windows of the initial two surges of the pandemic in 2020, patients were stratified into “Early 2020” (March 1–June 30) versus “Late 2020” (July 1–December 31) study cohorts. Logistic regression was applied to determine the efficacy of prevalent medications (remdesivir, azithromycin, hydroxychloroquine, corticosteroids, tocilizumab) and supplemental oxygen delivery modalities (invasive vs. non-invasive ventilation) on patient outcomes. The primary outcome measure was in-hospital mortality. Group comparisons were adjusted for covariates related to age, gender, ethnicity, body weight, comorbidities, and treatment modalities pertinent to organ failure replacement. Results From a total of 87,788 patients in the multicenter data registry screened in this study, 9,638 patients were included who received 19,763 COVID-19 medications during the first two waves of the 2020 pandemic. The results showed a minimal, yet statistically significant, association with hydroxychloroquine in “Early 2020” and remdesivir in “Late 2020” with reduced odds of mortality (odds ratios 0.72 and 0.76, respectively; P = 0.01). Azithromycin was the only medication associated with decreased odds of mortality during both study time-windows (odds ratios 0.79 and 0.68, respectively; P < 0.01). In contrast, the necessity for oxygen supply showed significantly increased odds of mortality beyond the effect of all investigated medications. Of all the covariates associated with increased mortality, invasive mechanical ventilation had the highest odds ratios of 8.34 in the first surge and 9.46 in in the second surge of the pandemic (P < 0.01). Conclusion This retrospective multicenter observational cohort study on 9,638 hospitalized patients with severe COVID-19 during revealed that the necessity for invasive ventilation had the highest odds of mortality, beyond the variable effects observed by administration of the prevalent EUA-approved investigational drugs during the first two surges of the early 2020 pandemic in the United States.

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Section: Discussionmentioning

confidence: 63%

Section: Discussionmentioning

confidence: 99%

Investigational medications in 9,638 hospitalized patients with severe COVID-19: lessons from the “fail-and-learn” strategy during the first two waves of the pandemic in 2020

Delgado

Cornett²,

Choi³

et al. 2023

Patient Saf Surg

View full text Add to dashboard Cite

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“…dexamethasone), interleukin-6 antagonists (e.g. tocilizumab) and Janus kinase inhibitors (e.g., baricitinib) have been evaluated in guidelines for the treatment of patients with COVID-19 after RCT results became available indicating their benefit in specific populations [ 50 , 51 ]. In Brazil, two guidelines were published for pharmacological treatment in outpatients and hospitalised patients.…”

Section: Discussionmentioning

confidence: 99%

“…Deciding on the best practice has been challenging, given the rapid generation of large amounts of data and sometimes conflicting clinical results [ 51 ]. Nevertheless, despite limited evidence, this guideline recommends using agents in the prophylaxis and treatment of outpatients and hospitalised patients, considering an application context encompassing the Americas.…”

Section: Discussionmentioning

confidence: 99%

Pan-American Guidelines for the treatment of SARS-CoV-2/COVID-19: a joint evidence-based guideline of the Brazilian Society of Infectious Diseases (SBI) and the Pan-American Association of Infectious Diseases (API)

Barbosa,

Chebabo,

Starling

et al. 2023

Ann Clin Microbiol Antimicrob

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Background Since the beginning of the COVID-19 pandemic, therapeutic options for treating COVID-19 have been investigated at different stages of clinical manifestations. Considering the particular impact of COVID-19 in the Americas, this document aims to present recommendations for the pharmacological treatment of COVID-19 specific to this population. Methods Fifteen experts, members of the Brazilian Society of Infectious Diseases (SBI) and the Pan-American Association of Infectious Diseases (API) make up the panel responsible for developing this guideline. Questions were formulated regarding prophylaxis and treatment of COVID-19 in outpatient and inpatient settings. The outcomes considered in decision-making were mortality, hospitalisation, need for mechanical ventilation, symptomatic COVID-19 episodes, and adverse events. In addition, a systematic review of randomised controlled trials was conducted. The quality of evidence assessment and guideline development process followed the GRADE system. Results Nine technologies were evaluated, and ten recommendations were made, including the use of tixagevimab + cilgavimab in the prophylaxis of COVID-19, tixagevimab + cilgavimab, molnupiravir, nirmatrelvir + ritonavir, and remdesivir in the treatment of outpatients, and remdesivir, baricitinib, and tocilizumab in the treatment of hospitalised patients with severe COVID-19. The use of hydroxychloroquine or chloroquine and ivermectin was discouraged. Conclusion This guideline provides recommendations for treating patients in the Americas following the principles of evidence-based medicine. The recommendations present a set of drugs that have proven effective in the prophylaxis and treatment of COVID-19, emphasising the strong recommendation for the use of nirmatrelvir/ritonavir in outpatients as the lack of benefit from the use of hydroxychloroquine and ivermectin.

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“…Some clinical treatments have been recommended in previous guidelines. Monoclonal antibodies (e.g., tixagevimab + cilgavimab), direct-acting antiviral agents (e.g., remdesivir), corticosteroids (e.g., dexamethasone), interleukin-6 antagonists (e.g., tocilizumab) and Janus kinase inhibitors (e.g., baricitinib) have been evaluated in guidelines for the treatment of patients with COVID-19 after RCT results became available indicating their bene t in speci c populations [48,49]. In Brazil, two guidelines were published for pharmacological treatment in outpatients and hospitalised patients.…”

Section: Discussionmentioning

confidence: 99%

Pan-American Guidelines for the Treatment of SARS-CoV-2/COVID-19: A Joint Evidence-Based Guideline of the Brazilian Society of Infectious Diseases (SBI) and the Pan-American Association of Infectious Diseases (API)

Barbosa

Chebabo

Starling

et al. 2023

Preprint

View full text Add to dashboard Cite

Background Since the beginning of the COVID-19 pandemic, therapeutic options for treating COVID-19 have been investigated at different stages of clinical manifestations. Considering the particular impact of COVID-19 in the Americas, this document aims to present recommendations for the pharmacological treatment of COVID-19 specific to this population. Method Fifteen experts, members of the Brazilian Society of Infectious Diseases (SBI) and the Pan-American Association of Infectious Diseases (API) make up the panel responsible for developing this guideline. Questions were formulated regarding prophylaxis and treatment of COVID-19 in outpatient and inpatient settings. The outcomes considered in decision-making were mortality, hospitalisation, need for mechanical ventilation, symptomatic COVID-19 episodes, and adverse events. In addition, a systematic review of randomised controlled trials was conducted. The quality of evidence assessment and guideline development process followed the GRADE system. Results Nine technologies were evaluated, and ten recommendations were made, including the use of tixagevimab + cilgavimab in the prophylaxis of COVID-19, tixagevimab + cilgavimab, molnupiravir, nirmatrelvir + ritonavir, and remdesivir in the treatment of outpatients, and remdesivir, baricitinib, and tocilizumab in the treatment of hospitalised patients with severe COVID-19. The use of hydroxychloroquine or chloroquine and ivermectin was discouraged. Conclusion This guideline provides recommendations for treating patients in the Americas following the principles of evidence-based medicine. The recommendations present a set of drugs that have proven effective in the prophylaxis and treatment of COVID-19, emphasising the strong recommendation for the use of nirmatrelvir/ritonavir in outpatients as the lack of benefit from the use of hydroxychloroquine and ivermectin.

show abstract

COVID-19 therapies for inpatients: a review and quality assessment of clinical guidelines

Cited by 5 publications

References 58 publications

Investigational medications in 9,638 hospitalized patients with severe COVID-19: lessons from the “fail-and-learn” strategy during the first two waves of the pandemic in 2020

Investigational medications in 9,638 hospitalized patients with severe COVID-19: lessons from the “fail-and-learn” strategy during the first two waves of the pandemic in 2020

Pan-American Guidelines for the treatment of SARS-CoV-2/COVID-19: a joint evidence-based guideline of the Brazilian Society of Infectious Diseases (SBI) and the Pan-American Association of Infectious Diseases (API)

Pan-American Guidelines for the Treatment of SARS-CoV-2/COVID-19: A Joint Evidence-Based Guideline of the Brazilian Society of Infectious Diseases (SBI) and the Pan-American Association of Infectious Diseases (API)

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