Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Disease epidemiology
Drug utilisation
Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

HYDROXYCHLOROQUINE SULFATE
LOPINAVIR
RITONAVIR
TOCILIZUMAB
DARUNAVIR
AZITHROMYCIN
INTERFERON BETA-1B

Medical condition to be studied

Pneumonia

Additional medical condition(s)

COVID-19 evaluation
Population studied

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Special population of interest

Renal impaired
Hepatic impaired
Immunocompromised
Pregnant women

Estimated number of subjects

2300
Study design details

Main study objective

To describe the patient outcomes at one month after symptom onset.

Outcomes

The primary outcome is the proportion of patients alive and without oxygen supply at 1 month after symptom onset. -The proportion of patients alive and without oxygen at hospital discharge, two months, 6 months and 1 year after symptom onset.-Specific secondary outcomes: Acute Respiratory Distress Syndrome, Respiratory Insufficiency and its grade, Cardiac Insufficiency, acute myocardial injury, Septic Shock, Acute Kidney Injury and secondary infections.-Patients who suffer grade 3 or superior AE

Data analysis plan

Descriptive statistics will be used for the proportions. A logistic univariate regression will be used to identify the candidate variables to enter in a multivariate logistic regression model to establish significant associations with the variables. Mortality and efficacy outcomes will be analyzed using Kaplan-Meier survival curves and Cox regression (analysis of factors associated with clinical outcomes). A propensity score test will be used to analyze the influence of the treatment regimens in clinical outcomes. A two tails p-value of 0.05 will be considered as the significance value. We have not planned an intermediate analysis. The data will be validated externally y comparing them with those from other hospitals who have been invited to share a similar protocol.