Study type

Study type

Non-interventional study

Scope of the study

Drug utilisation
Non-interventional study

Non-interventional study design

Systematic review and meta-analysis
Population studied

Age groups

Children (2 to < 12 years)
Adolescents (12 to < 18 years)
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

Renal impaired

Estimated number of subjects

100
Study design details

Main study objective

the main goal of this systematic review, is to assess the quality of adverse event reporting in clinical trials of COVID-19 drugs

Data analysis plan

we will calculate the proportion of monoclonal, antiviral and immunomodulatory antibodies that are of high, moderate, low or very low quality. For the first secondary objective, we will calculate for each drug, the proportion of studies that use "standardized" methods as the double-blind method according to the quality of their reporting of adverse events. i.e. calculate the proportion of studies using the double-blind method in the category of studies with a high, moderate, low and very low score. Finally, for the second secondary objective, we will make a comparison between the serious adverse events reporting in trial articles published and their associated clinical trial summaries. For that, we will calculate the percentage of consistent and different serious adverse events between the two sources.