Logical Analysis Report

Key Focus

Multiple additional sensitivity analyses, including analyses that used a different baseline at 48 hours after presentation and analyses with treatment defined as receipt of the first dose of hydroxychloroquine before study baseline, showed similar results (Table S3).
In this analysis involving a large sample of consecutive patients who had been hospitalized with Covid-19, the risk of intubation or death was not significantly higher or lower among patients who received hydroxychloroquine than among those who did not (hazard ratio, 1.04; 95% CI, 0.82 to 1.32)
In our analysis involving a large sample of consecutive patients who had been hospitalized with Covid-19, hydroxychloroquine use was not associated with a significantly higher or lower risk of intubation or death (hazard ratio, 1.04; 95% CI, 0.82 to 1.32).

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High Level Topics

HYDROXYCHLOROQUINE

COVID-19

PROPENSITY-SCORE

MODEL

High Level Abstractions

HYDROXYCHLOROQUINE(15, 0 Order)

( HYDROXYCHLOROQUINE )(15, 0 Order) top

( HYDROXYCHLOROQUINE, COVID-19 )(6, 1st Order) top

( HYDROXYCHLOROQUINE, COVID-19, RISK )(2, 2nd Order) top

( HYDROXYCHLOROQUINE, COVID-19, MEDICAL )(1, 2nd Order) top

( HYDROXYCHLOROQUINE, COVID-19, HOSPITALS )(2, 2nd Order) top

( HYDROXYCHLOROQUINE, COVID-19, CHLOROQUINE )(2, 2nd Order) top

( HYDROXYCHLOROQUINE, COVID-19, UNITED_STATES )(1, 2nd Order) top

( HYDROXYCHLOROQUINE, COVID-19, UNDERPOWERED )(1, 2nd Order) top

( HYDROXYCHLOROQUINE, COVID-19, SINGLE-GROUP )(1, 2nd Order) top

( HYDROXYCHLOROQUINE, COVID-19, RHEUMATIC )(1, 2nd Order) top

( HYDROXYCHLOROQUINE, COVID-19, QTC )(1, 2nd Order) top

( HYDROXYCHLOROQUINE, COVID-19, PROLONGATION )(1, 2nd Order) top

( HYDROXYCHLOROQUINE, COVID-19, OPEN-LABEL )(1, 2nd Order) top

( HYDROXYCHLOROQUINE, MEDICAL )(1, 1st Order) top

( HYDROXYCHLOROQUINE, INSURANCE )(2, 1st Order) top

( HYDROXYCHLOROQUINE, CHLOROQUINE )(2, 1st Order) top

( HYDROXYCHLOROQUINE, BODY-MASS )(2, 1st Order) top

( HYDROXYCHLOROQUINE, SMOKING )(2, 1st Order) top

( HYDROXYCHLOROQUINE, RISK )(2, 1st Order) top

( HYDROXYCHLOROQUINE, RACE )(2, 1st Order) top

( HYDROXYCHLOROQUINE, PATIENT-REPORTED )(1, 1st Order) top

( HYDROXYCHLOROQUINE, NEW_YORK_CITY )(1, 1st Order) top

( HYDROXYCHLOROQUINE, MODEL )(1, 1st Order) top

( HYDROXYCHLOROQUINE, INPATIENT )(1, 1st Order) top

COVID-19(8, 0 Order)

( COVID-19 )(8, 0 Order) top

( COVID-19, RISK )(2, 1st Order) top

( COVID-19, MEDICAL )(1, 1st Order) top

( COVID-19, HOSPITALS )(2, 1st Order) top

( COVID-19, CHLOROQUINE )(2, 1st Order) top

( COVID-19, UNITED_STATES )(1, 1st Order) top

( COVID-19, UNDERPOWERED )(1, 1st Order) top

( COVID-19, STUDY_COHORT )(1, 1st Order) top

( COVID-19, STATISTICAL_COMPUTING )(1, 1st Order) top

( COVID-19, SOFTWARE )(1, 1st Order) top

( COVID-19, SINGLE-GROUP )(1, 1st Order) top

( COVID-19, RHEUMATIC )(1, 1st Order) top

PROPENSITY-SCORE(1, 0 Order)

( PROPENSITY-SCORE )(1, 0 Order) top

MODEL(2, 0 Order)

( MODEL )(2, 0 Order) top

References

( HYDROXYCHLOROQUINE ) top
( HYDROXYCHLOROQUINE, COVID-19 ) top
( HYDROXYCHLOROQUINE, COVID-19, RISK ) top
(Read more) top
In this analysis involving a large sample of consecutive patients who had been hospitalized with Covid-19, the risk of intubation or death was not significantly higher or lower among patients who received hydroxychloroquine than among those who did not (hazard ratio, 1.04; 95% CI, 0.82 to 1.32)
(Read more) topIn our analysis involving a large sample of consecutive patients who had been hospitalized with Covid-19, hydroxychloroquine use was not associated with a significantly higher or lower risk of intubation or death (hazard ratio, 1.04; 95% CI, 0.82 to 1.32).
( HYDROXYCHLOROQUINE, COVID-19, MEDICAL ) top
(Read more) top
We examined the association between hydroxychloroquine use and intubation or death at a large medical center in New York City.
( HYDROXYCHLOROQUINE, COVID-19, HOSPITALS ) top
(Read more) top... original report of hydroxychloroquine as a treatment for Covid-19 described 26 patients who had been treated in an open-label, single-group study that involved contemporaneous, but nonrandomized controls in hospitals in France.6 Patients were treated with hydroxychloroquine at a dose of 200 mg three times daily for 10 days
(Read more) top
As we noted in the introduction, the findings from an early study showing a benefit of hydroxychloroquine in 26 patients who had been treated in French hospitals are difficult to interpret, given the small size of that study, the lack of a randomized control group, and the omission of 6 patients from the analysis.6 A clinical trial testing two doses of chloroquine...
( HYDROXYCHLOROQUINE, COVID-19, CHLOROQUINE ) top
(Read more) top
The aminoquinolines chloroquine and hydroxychloroquine are widely used in the treatment of malaria and rheumatic diseases, and they have been suggested as effective treatments for coronavirus disease 2019 (Covid-19) on the grounds...
(Read more) top ... hospitals are difficult to interpret, given the small size of that study, the lack of a randomized control group, and the omission of 6 patients from the analysis.6 A clinical trial testing two doses of chloroquine in patients with Covid-19 planned to include 440 patients but was halted after 81 patients had been enrolled because of excessive QTc prolongation and an indication of higher mortality in the high-dose...
( HYDROXYCHLOROQUINE, COVID-19, UNITED_STATES ) top
(Read more) top... of malaria and rheumatic diseases, and they have been suggested as effective treatments for coronavirus disease 2019 (Covid-19) on the grounds of both antiinflammatory and antiviral effects.1-4 In the United States, the Food and Drug Administration issued an Emergency Use Authorization on March 30, 2020, that allowed the use of these drugs in patients with Covid-19 who were not enrolled in clinical trials
( HYDROXYCHLOROQUINE, COVID-19, UNDERPOWERED ) top
(Read more) top... date, there have been no robust clinical trials that have shown efficacy of these agents for this illness, and the data that are available come from small studies that have either been uncontrolled or underpowered to detect meaningful clinical effects.
The original report of hydroxychloroquine as a treatment for Covid-19 described 26 patients who had been treated in an open-label, single-group study that...
( HYDROXYCHLOROQUINE, COVID-19, SINGLE-GROUP ) top
(Read more) top
The original report of hydroxychloroquine as a treatment for Covid-19 described 26 patients who had been treated in an open-label, single-group study that involved contemporaneous, but nonrandomized controls in hospitals in France.6 Patients were treated with hydroxychloroquine at a dose of 200 mg three times daily for 10 days
( HYDROXYCHLOROQUINE, COVID-19, RHEUMATIC ) top
(Read more) top
The aminoquinolines chloroquine and hydroxychloroquine are widely used in the treatment of malaria and rheumatic diseases, and they have been suggested as effective treatments for coronavirus disease 2019 (Covid-19) on the grounds of both antiinflammatory and antiviral effects.1-4 In the United States, the Food...
( HYDROXYCHLOROQUINE, COVID-19, QTC ) top
(Read more) top ... from the analysis.6 A clinical trial testing two doses of chloroquine in patients with Covid-19 planned to include 440 patients but was halted after 81 patients had been enrolled because of excessive QTc prolongation and an indication of higher mortality in the high-dose group (in which patients received 600 mg twice daily for 10 days) than in the low-dose group (in which patients received 450 mg daily...
( HYDROXYCHLOROQUINE, COVID-19, PROLONGATION ) top
(Read more) top ... from the analysis.6 A clinical trial testing two doses of chloroquine in patients with Covid-19 planned to include 440 patients but was halted after 81 patients had been enrolled because of excessive QTc prolongation and an indication of higher mortality in the high-dose group (in which patients received 600 mg twice daily for 10 days) than in the low-dose group (in which patients received 450 mg daily for 4 days...
( HYDROXYCHLOROQUINE, COVID-19, OPEN-LABEL ) top
(Read more) top
The original report of hydroxychloroquine as a treatment for Covid-19 described 26 patients who had been treated in an open-label, single-group study that involved contemporaneous, but nonrandomized controls in hospitals in France.6 Patients were treated with hydroxychloroquine at a dose of 200 mg three times daily for 10 days
( HYDROXYCHLOROQUINE, MEDICAL ) top
(Read more) top See ( HYDROXYCHLOROQUINE , COVID-19 , MEDICAL )
( HYDROXYCHLOROQUINE, INSURANCE ) top
(Read more) top The data obtained included patients'demographic details, insurance status, vital signs, laboratory test results, medication administration data, historical and current medication lists, historical and current diagnoses, clinical notes, historical discharge disposition...
(Read more) topIn the unmatched sample, hydroxychloroquine exposure differed according to age group, sex, race and ethnic group, body-mass index, insurance, smoking status, and current use of other medications.
( HYDROXYCHLOROQUINE, CHLOROQUINE ) top
(Read more) top See ( HYDROXYCHLOROQUINE , COVID-19 , CHLOROQUINE )
( HYDROXYCHLOROQUINE, BODY-MASS ) top
(Read more) top ... of inspired oxygen (Pao2:Fio2) at admission, estimated with the use of methods developed by Brown and colleagues8,9 (see the Data Extraction section in the Supplementary Appendix); the first recorded body-mass index as calculated for measured height and weight (the body-mass index is the weight in kilograms divided by the square of the height in meters), grouped on the basis of the Centers for Disease Control...
(Read more) topIn the unmatched sample, hydroxychloroquine exposure differed according to age group, sex, race and ethnic group, body-mass index, insurance, smoking status, and current use of other medications.
( HYDROXYCHLOROQUINE, SMOKING ) top
(Read more) top ... height in meters), grouped on the basis of the Centers for Disease Control and Prevention guidelines for adults; the first recorded inpatient laboratory tests; past and current diagnoses; patient-reported smoking status; and medication administration at baseline. Details of the variables assessed are provided in the were defined as receiving hydroxychloroquine if they were receiving it at study baseline or received...
(Read more) topIn the unmatched sample, hydroxychloroquine exposure differed according to age group, sex, race and ethnic group, body-mass index, insurance, smoking status, and current use of other medications.
( HYDROXYCHLOROQUINE, RISK ) top
(Read more) top See ( HYDROXYCHLOROQUINE , COVID-19 , RISK )
( HYDROXYCHLOROQUINE, RACE ) top
(Read more) top
From the clinical data warehouse, we obtained the following data elements for each patient: age; sex; patient-reported race and ethnic group; current insurance carrier; the first recorded vital signs on presentation; the ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen (Pao2:Fio2) at admission,...
(Read more) topIn the unmatched sample, hydroxychloroquine exposure differed according to age group, sex, race and ethnic group, body-mass index, insurance, smoking status, and current use of other medications
( HYDROXYCHLOROQUINE, PATIENT-REPORTED ) top
(Read more) top
From the clinical data warehouse, we obtained the following data elements for each patient: age; sex; patient-reported race and ethnic group; current insurance carrier; the first recorded vital signs on presentation; the ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen (Pao2:Fio2) at...
( HYDROXYCHLOROQUINE, NEW_YORK_CITY ) top
(Read more) top
We examined the association between hydroxychloroquine use and intubation or death at a large medical center in New York City.
( HYDROXYCHLOROQUINE, MODEL ) top
(Read more) top... emergency department as well as analyses that defined the exposure as receipt of the first dose of hydroxychloroquine before study baseline only. Multiple imputation was used to handle missing data, and model estimates and standard errors were calculated with Rubin's rules.11 The nonparametric bootstrap method was used to obtain 95% pointwise confidence intervals for the inverse-probability-weighted Kaplan-Meier...
( HYDROXYCHLOROQUINE, INPATIENT ) top
(Read more) top ... signs, laboratory test results, medication administration data, historical and current medication lists, historical and current diagnoses, clinical notes, historical discharge disposition for previous inpatient hospitalizations, and ventilator use data.
Variables Assessed
From the clinical data warehouse, we obtained the following data elements for each patient: age; sex; patient-reported race and...
( COVID-19 ) top
( COVID-19, RISK ) top
(Read more) top See ( HYDROXYCHLOROQUINE , COVID-19 , RISK )
( COVID-19, MEDICAL ) top
(Read more) top See ( HYDROXYCHLOROQUINE , COVID-19 , MEDICAL )
( COVID-19, HOSPITALS ) top
(Read more) top See ( HYDROXYCHLOROQUINE , COVID-19 , HOSPITALS )
( COVID-19, CHLOROQUINE ) top
(Read more) top See ( HYDROXYCHLOROQUINE , COVID-19 , CHLOROQUINE )
( COVID-19, UNITED_STATES ) top
(Read more) top See ( HYDROXYCHLOROQUINE , COVID-19 , UNITED_STATES )
( COVID-19, UNDERPOWERED ) top
(Read more) top See ( HYDROXYCHLOROQUINE , COVID-19 , UNDERPOWERED )
( COVID-19, STUDY_COHORT ) top
(Read more) top. Study Cohort.
Of 1446 consecutive patients with Covid-19 who were admitted to the hospital between March 7 and April 8, 2020, a total of 70 patients were excluded from this study because they had already had intubation...
( COVID-19, STATISTICAL_COMPUTING ) top
(Read more) top The statistical analyses were performed with the use of R software, version 3.6.1 (R Project for Statistical Computing).
Results
Characteristics of the Cohort
Figure 1. Study Cohort.
Of 1446 consecutive patients with Covid-19 who were admitted to the hospital between March 7 and April 8, 2020, a total of 70 patients were excluded from...
( COVID-19, SOFTWARE ) top
(Read more) topThe statistical analyses were performed with the use of R software, version 3.6.1 (R Project for Statistical Computing).
Results
Characteristics of the Cohort
Figure 1
( COVID-19, SINGLE-GROUP ) top
(Read more) top See ( HYDROXYCHLOROQUINE , COVID-19 , SINGLE-GROUP )
( COVID-19, RHEUMATIC ) top
(Read more) top See ( HYDROXYCHLOROQUINE , COVID-19 , RHEUMATIC )
( PROPENSITY-SCORE ) top
(Read more) top There was also no significant association between treatment with azithromycin and the composite end point (hazard ratio, 1.03; 95% CI, 0.81 to 1.31). Additional multivariable propensity-score analyses yielded similar results (Table 2). Multiple additional sensitivity analyses, including analyses that used a different baseline at 48 hours after presentation and analyses with treatment defined...
( MODEL ) top
(Read more) topAn initial multivariable Cox regression model included demographic factors, clinical factors, laboratory tests, and medications. In addition, to help account for the nonrandomized treatment administration of hydroxychloroquine, we used propensity-score...
(Read more) top See ( HYDROXYCHLOROQUINE , MODEL )