A Multi-center, Longitudinal, Clinical Real-World Study to Evaluate Mortality and Clinical Outcomes in Hospitalized Adults with COVID-19 Infection in the United States

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Coronavirus test positive

Population studied

• Short description of the study population:
  RWD from adult patients ≥ 18 years of age hospitalized in the US for COVID-19 infection will be analyzed.; Inclusion criteria will include:; 1. Male or female patients aged 18 years and older; 2. Patients diagnosed with the following ICD-10 codes consistent with COVID-19 (B97.29, other coronavirus as the causes of diseases classified elsewhere; B34.2, coronavirus infection, unspecified; and U07.1, 2019-nCoV acute respiratory disease); 3. Patients hospitalized after the first COVID-19 index patient was diagnosed in the US on 20 January 2020; ; Exclusion criteria will include:; 1. Patients diagnosed with the ICD-9 code 079.89, other specific viral infections (079.89 defined patients were automatically brought into the dataset when B97.29 was used because of the ICD-9 mapping to ICD-10 terms); 2. Patients who were enrolled in a clinical trial on or after 20 January 2020
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  COVID-19 patients
• Estimated number of subjects:
  153

Study design details

• Main study objective:
  The primary objectives of this study were to estimate the mortality rate in hospitalized adults aged ≥ 18 years with coronavirus disease 2019 (COVID-19) in the United States (US) using real-world data (RWD) and to compare the mortality rate of hospitalized patients from the RWD clinical setting to patients participating in remdesivir (RDV, GS-5734™, Veklury®) studies including compassionate use.
• Outcomes:
  1) To estimate the mortality rate in hospitalized adults aged ≥ 18 years with COVID-19 in the US using RWD and 2) To compare the mortality rate of hospitalized patients from the RWD clinical setting to patients participating in RDV studies including compassionate use, 1) To describe the health status of hospitalized adult patients with COVID-19 at baseline, defined as time of initial hospitalization, in the US and 2) To describe the changes in health status in the hospitalized patients with COVID-19 using a 6-point ordinal scale at baseline and at end of follow-up
• Data analysis plan:
  Summary statistics were generated for the cohort overall and by baseline oxygen support status subgroup. For categorical variables, numbers and percentages of patients were reported. For continuous variables, the mean, standard deviation (SD), minimum, first and third quartile (Q1, Q3), median, and maximum were calculated, together with the total number of observations and the number of missing values. Mortality rates and Kaplan-Meier survival curves for various at-risk groups were estimated and then compared as mortality rate ratios using Poisson regression. The results are summarized in the interim study report. There are no plans to develop a final study report.

Documents

Study results

GS-US-540-5835-Summary-Report-Interim-1_f-redact