Clinical trial NCT04334291: International COVID19 Clinical Evaluation Registry,
Official title: International COVID19 Clinical Evaluation Registry: HOPECOVID19. (Health Outcome Predictive Evaluation for COVID19)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID 19
Lead sponsor: St Carlos Hospital, Madrid, Spain
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 8168
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Confirmed diagnosis or a COVID-19 high suspicion.

Brief summary: The investigators propose to select all COVID 19 patients attended in any health center (with in hospital beds), who have been discharged or have died at the time of the evaluation.

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.

Detailed description: INTRODUCTION. The disease caused by the new respiratory virus (coronavirus) designated as SARS-CoV-2 has recently been classified as a pandemic by the WHO.

With an increasing number of confirmed cases in most countries worldwide, it is responsible for a significant morbidity and mortality and has motivated the implementation of measures at national and international levels with a great impact on the way of life of people throughout the whole planet.

In addition, this condition currently threatens many countries with the collapse of health systems, producing serious logistical problems due to extensive affectation of the population, which can worsen the prognosis of those primarily affected by COVID 19 and other patients with different pathologies and who may have difficulties to get healthcare.

Limited clinical information is available and generally limited to the Asian population, since the first cases were identified in Wuhan (Hubei, China).

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 (ie. ACEIs, ARBs) and previous comorbidities of patients infected with the disease will be performed.

DESIGN AND STATISTICAL ANALYSIS Cross-sectional and ambispective registry, a real life "all comers" type, with voluntary participation, without funding or conflicts of interest. It is a study initiated by researcher that will have advanced statistical support from the IMAS foundation (Institute for the Improvement of Health Care, Madrid, Spain), that will serve as statistical core.

International level.

PARTICIPANTS PROTOCOL. The study has been approved by Hospital Clinico San Carlos Ethic´s Committee (20/241-E) and the institutional board of each participating center. It has received an AEMPS classification (EPA-0D).

The researchers aimto select all the patients attended in any health center (with in hospital beds), who have 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 attending physicians consider them highly likely to have presented the infection.

Given the anonymous characteristics of the registry and the health alarm situation generated by the virus, in principle, it is not considered necessary to provide written informed consent.

- Inclusion criteria Patients discharged (deceased or alive) from any hospital center with a confirmed diagnosis or a COVID-19 high suspicion.

There are no exclusion criteria, except for the patient's explicit refusal to participate.

DATA BASE. An anonymized database is presented in electronic format, to be filled in at each participating center (www.HopeProjectMD.com).

In theory, all information could be obtained from electronic records (medical history).

If deemed necessary, the investigator may call patients in order to establish their vital status (strongly warranted), as well as the results of the RNA test (or antibody) , if they were pending during their stay.

SAMPLE SIZE. It would not be possible to estimate for the sample size based on literature reports. Thus, HOPE will aim to get the maximum numbers of patients possible.

OUTCOMES. Primary: All-cause mortality. The major contributors of increased mortality will be assessed.

Secondary: In stay events, defined by the attending physician.

* In hospital stay.
* Heart failure.
* Renal failure.
* Respiratory Insufficiency.
* Upper respiratory tract involvement.
* Pneumonia.
* Sepsis.
* Systemic inflammatory response Syndrome.
* Clinically relevant bleeding.
* Hemoptysis.
* Embolic event
* Other complications.
* Causes of death. Depending the results of the main interim analysis, the main DB could be slightly modified and several sub analyses could be proposed after sensitivity analyses.

Eligibility criteria: Inclusion Criteria:

* Patients discharged (deceased or alive) from any hospital center with a confirmed diagnosis or a COVID-19 high suspicion.

Exclusion Criteria:

* There are no exclusion criteria, except for the patient's explicit refusal to participate.

Primary outcomes:
measure: Death
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
measure: In hospital stay.
timeFrame: through study completion, an average of 1 month
measure: Heart failure
timeFrame: through study completion, an average of 1 month
measure: Renal failure
timeFrame: through study completion, an average of 1 month
measure: Respiratory Insufficiency.
timeFrame: through study completion, an average of 1 month
measure: Upper respiratory tract involvement
timeFrame: through study completion, an average of 1 month
measure: Pneumonia
timeFrame: through study completion, an average of 1 month
measure: Sepsis
timeFrame: through study completion, an average of 1 month
measure: Systemic inflammatory response Syndrome.
timeFrame: through study completion, an average of 1 month
measure: Clinically relevant bleeding
timeFrame: through study completion, an average of 1 month
measure: Other complications.
timeFrame: through study completion, an average of 1 month
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Lclinico San Carlos
Study officials:
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