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International COVID19 Clinical Evaluation Registry, (HOPE COVID 19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04334291
Recruitment Status : Recruiting
First Posted : April 6, 2020
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
IVAN J NUÑEZ GIL, St Carlos Hospital, Madrid, Spain

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.


Condition or disease Intervention/treatment
COVID 19 Combination Product: Observational (registry)

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Weeks
Official Title: International COVID19 Clinical Evaluation Registry: HOPECOVID19. (Health Outcome Predictive Evaluation for COVID19)
Actual Study Start Date : March 23, 2020
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 5, 2020

Intervention Details:
  • Combination Product: Observational (registry)
    Observational study.


Primary Outcome Measures :
  1. Death [ Time Frame: through study completion, an average of 1 month ]
    All cause


Secondary Outcome Measures :
  1. In hospital stay. [ Time Frame: through study completion, an average of 1 month ]
    Days

  2. Heart failure [ Time Frame: through study completion, an average of 1 month ]
    According the attending physician.

  3. Renal failure [ Time Frame: through study completion, an average of 1 month ]
    According the attending physician.

  4. Respiratory Insufficiency. [ Time Frame: through study completion, an average of 1 month ]
    According the attending physician.

  5. Upper respiratory tract involvement [ Time Frame: through study completion, an average of 1 month ]
    According the attending physician.

  6. Pneumonia [ Time Frame: through study completion, an average of 1 month ]
    According the attending physician.

  7. Sepsis [ Time Frame: through study completion, an average of 1 month ]
    According the attending physician.

  8. Systemic inflammatory response Syndrome. [ Time Frame: through study completion, an average of 1 month ]
    According the attending physician.

  9. Clinically relevant bleeding [ Time Frame: through study completion, an average of 1 month ]
    According the attending physician.

  10. Other complications. [ Time Frame: through study completion, an average of 1 month ]
    According the attending physician.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Confirmed diagnosis or a COVID-19 high suspicion.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04334291


Contacts
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Contact: IVAN J NUNEZ GIL, MD, PhD, MSc 0034 913303002 ext 3283 ibnsky@yahoo.es

Locations
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Spain
Hospital Lclinico San Carlos Recruiting
Madrid, Spain, 28040
Contact: IVAN J NUÑEZ J NUÑEZ GIL, MD    913303002 ext 3283    ibnsky@yahoo.es   
Sponsors and Collaborators
IVAN J NUÑEZ GIL
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: IVAN J NUÑEZ GIL, Principal Investigator. Attending Physician. MD, PhD, FESC, St Carlos Hospital, Madrid, Spain
ClinicalTrials.gov Identifier: NCT04334291    
Other Study ID Numbers: 20/241-E
EUPAS34399 ( Other Identifier: EMA )
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD are to be share among HOPE researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No