Study identification

PURI

https://redirect.ema.europa.eu/resource/35740

EU PAS number

EUPAS34399

Study ID

35740

Official title and acronym

INTERNATIONAL COVID-19 CLINICAL EVALUATION REGISTRY: HOPE-COVID 19. (Health Outcome Predictive Evaluation for COVID 19) (HOPE COVID 19)

DARWIN EU® study

No

Study countries

Australia
Canada
China
Ecuador
Germany
Italy
Spain

Study description

PURPOSE The main objective of the present study is to carefully characterize the clinical profile of patients infected with COVID-19 in order to develop a simple prognostic clinical score allowing, in selected cases, rapid logistic decision making (discharge with follow-up, referral to provisional/field hospitals or admission to more complex hospital centers).As secondary objectives, the analysis of the risk-adjusted influence of treatments and previous comorbidities of patients infected with the disease will be performed.DESIGNCross-sectional and ambispective registry, a real life “all comers” type, with voluntaryparticipation, without funding or conflicts of interest. It is a study initiated by researcher thatwill have advanced statistical support from the IMAS foundation (Institute for the Improvementof Health Care, Madrid, Spain).International level.PATIENTS We propose to select all the patients attended in any health center (with in hospital beds), whohave been discharged or have died at the time of the evaluation.All will be considered eligible with a positive COVID 19 test (any type) or if their attendingphysicians consider them highly likely to have presented the infection.There are no exclusion criteria, except for the patient's explicit refusal to participate.

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Ivan J. Nuñez Gil

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

TBD
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable