Study type

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Systematic review and meta-analysis
Study drug and medical condition

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

HYDROXYCHLOROQUINE
LOPINAVIR
RITONAVIR
AZITHROMYCIN HYDROCHLORIDE
REMDESIVIR
INTERFERON ALFA-2B
INTERFERON BETA-1A
INTERFERON BETA-1B
TOCILIZUMAB
SARILUMAB
SILTUXIMAB
SARS-COV-2 CONVALESCENT PLASMA

Medical condition to be studied

COVID-19
Population studied

Age groups

Preterm newborn infants (0 – 27 days)
Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)
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

Hepatic impaired
Immunocompromised
Pregnant women
Renal impaired

Estimated number of subjects

0
Study design details

Main study objective

To compare in-hospital clinical outcomes in patients managed with standard care and various treatments for COVID-19 in non-randomised studies.To compare the results of treatments in non-randomised comparative studies and randomised controlled trials for in-hospital clinical outcomes in COVID-19 patients.

Outcomes

- In hospital death. - In hospital clinical scales and outcomes, mechanical ventilation, renal replacement therapy, admission to ICU, serious complications and serious adverse events.- Duration of hospitalization.- Duration of ICU stay.

Data analysis plan

PAIRWISE META-ANALYSIS OF NON-RANDOMISED COMPARISONS. Fixed or random effects meta-analysis will combine risk, odds and hazard ratios, mean difference and standardised mean differences. The I2 test will assess heterogeneity. Egger´s test and funnel plots for publication and reporting bias.COMPARISON OF META-ANALYSES OF RCTS AND PAIR-WISE NON-RANDOMISED COMPARISONS. Comparison of risk, odds and hazard ratios with 95% confidence interval from meta-analysis of RCTs and pair wise meta-analysis of non-randomised studies, using fixed or random effects. NETWORK META-ANALYSIS OF NON-RANDOMISED COMPARISONS. A network diagram will be made with nodes Transitivity and consistency will be assessed. Heterogeneity will be evaluated with 95% prediction intervals. Interventions will be ranked by surface under the cumulative ranking curve. Heterogeneity and incoherence will be explored. Publication and under-reporting bias will be explored with modified funnel plots.
Documents
Study publications
Nawab Qizilbash, Stuart Pocock, Jesus Lopez Arrieta, Ignacio Mendez, Bélène Pod…