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Efficacy of Hydroxychloroquine and Tocilizumab in Patients With COVID-19: Single-Center Retrospective Chart Review.

Identifieur interne : 000619 ( Main/Exploration ); précédent : 000618; suivant : 000620

Efficacy of Hydroxychloroquine and Tocilizumab in Patients With COVID-19: Single-Center Retrospective Chart Review.

Auteurs : Sohaib Roomi [États-Unis] ; Waqas Ullah [États-Unis] ; Faizan Ahmed [États-Unis] ; Soban Farooq [Pakistan] ; Usama Sadiq [États-Unis] ; Asad Chohan [États-Unis] ; Munnam Jafar [États-Unis] ; Maryum Saddique [États-Unis] ; Shristi Khanal [États-Unis] ; Robert Watson [États-Unis] ; Margot Boigon [États-Unis]

Source :

RBID : pubmed:32784192

Descripteurs français

English descriptors

Abstract

BACKGROUND

During the initial phases of the COVID-19 pandemic, there was an unfounded fervor surrounding the use of hydroxychloroquine (HCQ) and tocilizumab (TCZ); however, evidence on their efficacy and safety have been controversial.

OBJECTIVE

The purpose of this study is to evaluate the overall clinical effectiveness of HCQ and TCZ in patients with COVID-19. We hypothesize that HCQ and TCZ use in these patients will be associated with a reduction in in-hospital mortality, upgrade to intensive medical care, invasive mechanical ventilation, or acute renal failure needing dialysis.

METHODS

A retrospective cohort study was performed to determine the impact of HCQ and TCZ use on hard clinical outcomes during hospitalization. A total of 176 hospitalized patients with a confirmed COVID-19 diagnosis was included. Patients were divided into two comparison groups: (1) HCQ (n=144) vs no-HCQ (n=32) and (2) TCZ (n=32) vs no-TCZ (n=144). The mean age, baseline comorbidities, and other medications used during hospitalization were uniformly distributed among all the groups. Independent t tests and multivariate logistic regression analysis were performed to calculate mean differences and adjusted odds ratios with 95% CIs, respectively.

RESULTS

The unadjusted odds ratio for patients upgraded to a higher level of care (ie, intensive care unit) (OR 2.6, 95% CI 1.19-5.69; P=.003) and reductions in C-reactive protein (CRP) level on day 7 of hospitalization (21% vs 56%, OR 0.21, 95% CI 0.08-0.55; P=.002) were significantly higher in the TCZ group compared to the control group. There was no significant difference in the odds of in-hospital mortality, upgrade to intensive medical care, need for invasive mechanical ventilation, acute kidney failure necessitating dialysis, or discharge from the hospital after recovery in both the HCQ and TCZ groups compared to their respective control groups. Adjusted odds ratios controlled for baseline comorbidities and medications closely followed the unadjusted estimates.

CONCLUSIONS

In this cohort of patients with COVID-19, neither HCQ nor TCZ offered a significant reduction in in-hospital mortality, upgrade to intensive medical care, invasive mechanical ventilation, or acute renal failure needing dialysis. These results are similar to the recently published preliminary results of the HCQ arm of the Recovery trial, which showed no clinical benefit from the use of HCQ in hospitalized patients with COVID-19 (the TCZ arm is ongoing). Double-blinded randomized controlled trials are needed to further evaluate the impact of these drugs in larger patient samples so that data-driven guidelines can be deduced to combat this global pandemic.


DOI: 10.2196/21758
PubMed: 32784192
PubMed Central: PMC7470234


Affiliations:


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<term>Aged (MeSH)</term>
<term>Antibodies, Monoclonal, Humanized (pharmacology)</term>
<term>Antibodies, Monoclonal, Humanized (therapeutic use)</term>
<term>Coronavirus Infections (drug therapy)</term>
<term>Coronavirus Infections (mortality)</term>
<term>Female (MeSH)</term>
<term>Hospital Mortality (MeSH)</term>
<term>Hospitalization (statistics & numerical data)</term>
<term>Humans (MeSH)</term>
<term>Hydroxychloroquine (adverse effects)</term>
<term>Hydroxychloroquine (pharmacology)</term>
<term>Hydroxychloroquine (therapeutic use)</term>
<term>Male (MeSH)</term>
<term>Middle Aged (MeSH)</term>
<term>Odds Ratio (MeSH)</term>
<term>Pandemics (MeSH)</term>
<term>Pneumonia, Viral (drug therapy)</term>
<term>Pneumonia, Viral (mortality)</term>
<term>Retrospective Studies (MeSH)</term>
<term>Treatment Outcome (MeSH)</term>
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<term>Adulte d'âge moyen (MeSH)</term>
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<term>Femelle (MeSH)</term>
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<term>Hydroxychloroquine (effets indésirables)</term>
<term>Hydroxychloroquine (pharmacologie)</term>
<term>Hydroxychloroquine (usage thérapeutique)</term>
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<term>Infections à coronavirus (traitement médicamenteux)</term>
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<term>Mâle (MeSH)</term>
<term>Odds ratio (MeSH)</term>
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<term>Pneumopathie virale (mortalité)</term>
<term>Pneumopathie virale (traitement médicamenteux)</term>
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<term>Hydroxychloroquine</term>
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<term>Hydroxychloroquine</term>
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<term>Hydroxychloroquine</term>
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<term>Pneumonia, Viral</term>
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<term>Coronavirus Infections</term>
<term>Pneumonia, Viral</term>
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<term>Infections à coronavirus</term>
<term>Pneumopathie virale</term>
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<term>Anticorps monoclonaux humanisés</term>
<term>Hydroxychloroquine</term>
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<term>Hydroxychloroquine</term>
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<term>Female</term>
<term>Hospital Mortality</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Odds Ratio</term>
<term>Pandemics</term>
<term>Retrospective Studies</term>
<term>Treatment Outcome</term>
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<term>Femelle</term>
<term>Humains</term>
<term>Mortalité hospitalière</term>
<term>Mâle</term>
<term>Odds ratio</term>
<term>Pandémies</term>
<term>Résultat thérapeutique</term>
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<front>
<div type="abstract" xml:lang="en">
<p>
<b>BACKGROUND</b>
</p>
<p>During the initial phases of the COVID-19 pandemic, there was an unfounded fervor surrounding the use of hydroxychloroquine (HCQ) and tocilizumab (TCZ); however, evidence on their efficacy and safety have been controversial.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>OBJECTIVE</b>
</p>
<p>The purpose of this study is to evaluate the overall clinical effectiveness of HCQ and TCZ in patients with COVID-19. We hypothesize that HCQ and TCZ use in these patients will be associated with a reduction in in-hospital mortality, upgrade to intensive medical care, invasive mechanical ventilation, or acute renal failure needing dialysis.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>METHODS</b>
</p>
<p>A retrospective cohort study was performed to determine the impact of HCQ and TCZ use on hard clinical outcomes during hospitalization. A total of 176 hospitalized patients with a confirmed COVID-19 diagnosis was included. Patients were divided into two comparison groups: (1) HCQ (n=144) vs no-HCQ (n=32) and (2) TCZ (n=32) vs no-TCZ (n=144). The mean age, baseline comorbidities, and other medications used during hospitalization were uniformly distributed among all the groups. Independent t tests and multivariate logistic regression analysis were performed to calculate mean differences and adjusted odds ratios with 95% CIs, respectively.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>RESULTS</b>
</p>
<p>The unadjusted odds ratio for patients upgraded to a higher level of care (ie, intensive care unit) (OR 2.6, 95% CI 1.19-5.69; P=.003) and reductions in C-reactive protein (CRP) level on day 7 of hospitalization (21% vs 56%, OR 0.21, 95% CI 0.08-0.55; P=.002) were significantly higher in the TCZ group compared to the control group. There was no significant difference in the odds of in-hospital mortality, upgrade to intensive medical care, need for invasive mechanical ventilation, acute kidney failure necessitating dialysis, or discharge from the hospital after recovery in both the HCQ and TCZ groups compared to their respective control groups. Adjusted odds ratios controlled for baseline comorbidities and medications closely followed the unadjusted estimates.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>CONCLUSIONS</b>
</p>
<p>In this cohort of patients with COVID-19, neither HCQ nor TCZ offered a significant reduction in in-hospital mortality, upgrade to intensive medical care, invasive mechanical ventilation, or acute renal failure needing dialysis. These results are similar to the recently published preliminary results of the HCQ arm of the Recovery trial, which showed no clinical benefit from the use of HCQ in hospitalized patients with COVID-19 (the TCZ arm is ongoing). Double-blinded randomized controlled trials are needed to further evaluate the impact of these drugs in larger patient samples so that data-driven guidelines can be deduced to combat this global pandemic.</p>
</div>
</front>
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<AbstractText Label="BACKGROUND">During the initial phases of the COVID-19 pandemic, there was an unfounded fervor surrounding the use of hydroxychloroquine (HCQ) and tocilizumab (TCZ); however, evidence on their efficacy and safety have been controversial.</AbstractText>
<AbstractText Label="OBJECTIVE">The purpose of this study is to evaluate the overall clinical effectiveness of HCQ and TCZ in patients with COVID-19. We hypothesize that HCQ and TCZ use in these patients will be associated with a reduction in in-hospital mortality, upgrade to intensive medical care, invasive mechanical ventilation, or acute renal failure needing dialysis.</AbstractText>
<AbstractText Label="METHODS">A retrospective cohort study was performed to determine the impact of HCQ and TCZ use on hard clinical outcomes during hospitalization. A total of 176 hospitalized patients with a confirmed COVID-19 diagnosis was included. Patients were divided into two comparison groups: (1) HCQ (n=144) vs no-HCQ (n=32) and (2) TCZ (n=32) vs no-TCZ (n=144). The mean age, baseline comorbidities, and other medications used during hospitalization were uniformly distributed among all the groups. Independent t tests and multivariate logistic regression analysis were performed to calculate mean differences and adjusted odds ratios with 95% CIs, respectively.</AbstractText>
<AbstractText Label="RESULTS">The unadjusted odds ratio for patients upgraded to a higher level of care (ie, intensive care unit) (OR 2.6, 95% CI 1.19-5.69; P=.003) and reductions in C-reactive protein (CRP) level on day 7 of hospitalization (21% vs 56%, OR 0.21, 95% CI 0.08-0.55; P=.002) were significantly higher in the TCZ group compared to the control group. There was no significant difference in the odds of in-hospital mortality, upgrade to intensive medical care, need for invasive mechanical ventilation, acute kidney failure necessitating dialysis, or discharge from the hospital after recovery in both the HCQ and TCZ groups compared to their respective control groups. Adjusted odds ratios controlled for baseline comorbidities and medications closely followed the unadjusted estimates.</AbstractText>
<AbstractText Label="CONCLUSIONS">In this cohort of patients with COVID-19, neither HCQ nor TCZ offered a significant reduction in in-hospital mortality, upgrade to intensive medical care, invasive mechanical ventilation, or acute renal failure needing dialysis. These results are similar to the recently published preliminary results of the HCQ arm of the Recovery trial, which showed no clinical benefit from the use of HCQ in hospitalized patients with COVID-19 (the TCZ arm is ongoing). Double-blinded randomized controlled trials are needed to further evaluate the impact of these drugs in larger patient samples so that data-driven guidelines can be deduced to combat this global pandemic.</AbstractText>
<CopyrightInformation>©Sohaib Roomi, Waqas Ullah, Faizan Ahmed, Soban Farooq, Usama Sadiq, Asad Chohan, Munnam Jafar, Maryum Saddique, Shristi Khanal, Robert Watson, Margot Boigon. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 01.09.2020.</CopyrightInformation>
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<LastName>Roomi</LastName>
<ForeName>Sohaib</ForeName>
<Initials>S</Initials>
<Identifier Source="ORCID">0000-0001-5998-9309</Identifier>
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<Affiliation>Jefferson Health Abington, Abington, PA, United States.</Affiliation>
</AffiliationInfo>
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<LastName>Ullah</LastName>
<ForeName>Waqas</ForeName>
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<Identifier Source="ORCID">0000-0002-4850-0309</Identifier>
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<Affiliation>Jefferson Health Abington, Abington, PA, United States.</Affiliation>
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<Affiliation>Jefferson Health Abington, Abington, PA, United States.</Affiliation>
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<Identifier Source="ORCID">0000-0002-1797-9118</Identifier>
<AffiliationInfo>
<Affiliation>King Edward Medical University, Lahore, Pakistan.</Affiliation>
</AffiliationInfo>
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<Affiliation>Jefferson Health Abington, Abington, PA, United States.</Affiliation>
</AffiliationInfo>
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<ForeName>Asad</ForeName>
<Initials>A</Initials>
<Identifier Source="ORCID">0000-0002-1801-9792</Identifier>
<AffiliationInfo>
<Affiliation>Newark Beth Israel Medical Center, Newark, NJ, United States.</Affiliation>
</AffiliationInfo>
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<Initials>M</Initials>
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<Affiliation>Jefferson Health Abington, Abington, PA, United States.</Affiliation>
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<Identifier Source="ORCID">0000-0003-2412-7842</Identifier>
<AffiliationInfo>
<Affiliation>Einstein Medical Center, Philadelphia, PA, United States.</Affiliation>
</AffiliationInfo>
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<LastName>Khanal</LastName>
<ForeName>Shristi</ForeName>
<Initials>S</Initials>
<Identifier Source="ORCID">0000-0002-0443-1620</Identifier>
<AffiliationInfo>
<Affiliation>Jefferson Health Abington, Abington, PA, United States.</Affiliation>
</AffiliationInfo>
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<LastName>Watson</LastName>
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<Initials>R</Initials>
<Identifier Source="ORCID">0000-0001-8500-5115</Identifier>
<AffiliationInfo>
<Affiliation>Jefferson Health Abington, Abington, PA, United States.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Boigon</LastName>
<ForeName>Margot</ForeName>
<Initials>M</Initials>
<Identifier Source="ORCID">0000-0002-3531-7089</Identifier>
<AffiliationInfo>
<Affiliation>Jefferson Health Abington, Abington, PA, United States.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList>
<PublicationType UI="D016428">Journal Article</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic">
<Year>2020</Year>
<Month>09</Month>
<Day>01</Day>
</ArticleDate>
</Article>
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<Country>Canada</Country>
<MedlineTA>J Med Internet Res</MedlineTA>
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<NameOfSubstance UI="C502936">tocilizumab</NameOfSubstance>
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