Status: Ongoing
First registered on:
07/05/2020
Last updated on:
24/06/2020
1. Study identification
EU PAS Register NumberEUPAS35147
Official titleReal-time systematic review and meta-analysis of non-randomised comparative treatment studies for COVID-19
Study title acronym
Study typeOther: Systematic Review and Meta-analysis
Brief description of the studyA real-time systematic review and meta-analysis of non-randomised studies to compare in-hospital clinical outcomes in patients managed with standard care and various treatments for COVID-19.
To compare the results of treatments in non-randomised comparative studies and randomised controlled trials for in-hospital clinical outcomes in COVID-19 patients.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsOXON
Department/Research groupOXON Epidemiology
Organisation/affiliationOXON Epidemiology Ltd.
Details of (Primary) lead investigator
Title Dr
Last name Qizilbash MRCP MSc DPhil(Oxon)
First name Nawab
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
International study
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed08/05/202008/05/2020
Start date of data collection08/05/202020/05/2020
Start date of data analysis
Date of interim report, if expected
Date of final study report10/05/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesGSK10
Charities
Government body
Research councils
EU funding scheme
OtherOXON Epidemiology90
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Qizilbash MRCP MSc DPhil(Oxon)
First name Nawab
Address line 1Keppel St, Bloomsbury,
Address line 2
Address line 3
CityLondon
PostcodeWC1E 7HT
CountryUnited Kingdom
Phone number (incl. country code)34-913459395
Alternative phone number34-629846059
Fax number (incl. country code)34-913459394
Public Enquiries
Title Dr
Last name Qizilbash MRCP MSc DPhil(Oxon)
First name Nawab
Address line 1Calle Dr. Fleming 51
Address line 2
Address line 3
CityMadrid
Postcode28036
CountrySpain
Phone number (incl. country code)34-913459395
Alternative phone number34-629846059
Fax number (incl. country code)34-913459394
6. Study drug(s) information
Single-Constituent (Substance INN)HYDROXYCHLOROQUINE
Single-Constituent (Substance INN)LOPINAVIR/RITONAVIR
Single-Constituent (Substance INN)AZITHROMYCIN HYDROCHLORIDE
Single-Constituent (Substance INN)REMDESIVIR
Single-Constituent (Substance INN)INTERFERON ALFA
Single-Constituent (Substance INN)INTERFERON BETA
Single-Constituent (Substance INN)TOCILIZUMAB
Single-Constituent (Substance INN)SARILUMAB
Single-Constituent (Substance INN)SILTUXIMAB
Single-Constituent (Substance INN)SARS-CoV-2 convalescent plasma
7. Medical conditions to be studied
Medical condition(s)Yes
COVID-19
8. Population under study
Age
Preterm newborns
Term newborns (0-27 days)
Infants and toddlers (28 days - 23 months)
Children (2 - 11 years)
Adolescents (12 - 17 years)
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
Other population
Renal impaired
Hepatic impaired
Immunocompromised
Pregnant women
9. Number of subjects
Estimated total number of subjects0
Additional information
Will vary according to the treatments analysed
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
We will search MEDLINE (PubMed), EMBASE, Cochrane Library, and newer sources since the COVID-19 Pandemic: MedRxiv.
11. Scope of the study
What is the scope of the study?
Effectiveness evaluation
Systematic Review and Meta-analysis
Primary scope : Effectiveness evaluation
12. Main objective(s)
What is the main objective of the study?
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.
Are there primary outcomes?Yes
- In hospital death.
Are there secondary outcomes?Yes
- 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.
13. Study design
What is the design of the study?
Systematic Review and Meta-analysis
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
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.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
