Study type

Study type

Non-interventional study

Scope of the study

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

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(P01BA02) hydroxychloroquine
hydroxychloroquine

Medical condition to be studied

Coronavirus test positive
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)

Estimated number of subjects

185
Study design details

Main study objective

To evaluate whether treatment with hydroxychloroquine in COVID-19 infected health personnel (PCR positive) reduces the time of PCR negativization and therefore the contagiousness of the disease and the duration of symptoms.

Outcomes

To evaluate whether treatment with hydroxychloroquine in COVID-19 infected health personnel (PCR positive) reduces the time of PCR negativization and therefore the contagiousness of the disease and the duration of symptoms. Describe demographic characteristics, underlying pathologies, contraindications of hydroxychloroquine, symptoms and complications and adverse reactions to the treatment in the population study. Analyze the evolution os symptoms and whether the infection is influenced by the hospital's work areas and/or the type of care task they perform.

Data analysis plan

For the analysis of the primary outcome we will use the proportion of patients in thethat the PCR is negative at 7 and 10 days, which will be calculated with the intervals of95% confidence. The analysis of the remaining the categorical variables will be expressed in frequencies and proportions. Numerical variables in means ± standard deviation (SD) or medians and range interquartile (RI). We will consider the statistically significant value of p ≤ 0.05. Statistical analysis is will be carried out through the statistical program SAS® 9.4 (SAS Institute Inc. Cary, NC, USA).