A Multicenter, Multi-countiy Retrospective Cohort Study to Evaluate the Clinical Outcomes in Adults with Severe COVID-19

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:
  COVID-19

Population studied

• Short description of the study population:
  Adults with severe COVID-19.; Adult participants with COVID-19 confirmed by PCR who meet the following criteria:; 1. Hospitalized; 2. COVID-19 confirmed by PCR; 3. SpO2 ≤94% on room air or require supplemental oxygen at admission; 4. Radiographic evidence of pulmonary infiltrates; 5. Did not receive remdesivir (RDV) at any time during illness
• 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:
  3500

Study design details

• Main study objective:
  The primary objectives of this study were to assess the clinical course and outcome of adults with severe COVID-19 assessed by: 1) a 7-point ordinal scale on Day 14, and 2) all-cause mortality at Day 28.
• Outcomes:
  1) Recovery rate assessed by a 7-point ordinal scale (Death, Hospitalized on invasive ventilation/ECMO, Hospitalized on non-invasive ventilation, Hospitalized requiring oxygen, Hospitalized not requiring oxygen but requiring ongoing medical care, Hospitalized not requiring oxygen and not requiring ongoing medical care, and Not hospitalized) on Day 14 and 2) All-cause mortality at Day 28. •Proportion of subjects with recovery at Day14 •Proportion of subjects with SpO2 > 94% at Day14 •Proportion of subjects on room air at Day14 •Proportion of subjects with negative SARS-CoV-2 PCR at Day14 •Proportion of subjects on ventilation at Day14 •Proportion of subjects with ≥1-point improvement in clinical status on Day14 • Change in O2 support status up to Day14 •Duration of hospitalization
• Data analysis plan:
  Retrospective Cohort Study (RCS) Data Analysis: Summary statistics were generated for the cohort overall and by contributing site/country. For categorical variables, numbers & percentages of patients were reported including the 95% confidence intervals (CI). For continuous variables, mean, standard deviation, minimum, first and third quartile (Q1, Q3), median, maximum & 95% CIs were calculated, together with the total number of observations & the number of missing values. Descriptive statistics were summarized demographics and baseline characteristics. Analysis to compare standard of care (SOC) from RCS & agents potentially active against SARC CoV-2: Data from this retrospective cohort study might be used to compare the efficacy of potential investigational antiviral agents against this cohort which did not receive such agents. Such analyses would use appropriate statistical methods for comparisons of non-randomized cohorts, such as weighted analysis & propensity score analysis.

Documents

Study results

GS-US-540-5807-csr-synopsis-final_f-redact