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Clinical Trials/EUCTR2020-001765-37-ES
EUCTR2020-001765-37-ES
Active, Not Recruiting
Phase 1

Pragmatic clinical trial to evaluate the efficacy of hydroxychloroquine in the treatment of COVID-19 infection in two cohorts: patients with oncohaematological disease and SARS-CoV-2 positive without radiological alteration and sars-cov-2 positive professionals without radiological alteration

Institut Català d’Oncologia0 sites103 target enrollmentApril 13, 2020

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Institut Català d’Oncologia
Enrollment
103
Status
Active, Not Recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 13, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Patient Cohort
  • 1\) Patients diagnosed with onco\-haematological disease
  • 2\) Age: over 18 years old.
  • 3\) ECOG performance status \< 2 (Karnofsky\>60%)
  • 4\) Life expectancy \> 3 months for the neoplastic disease.
  • 5\) Patients with laboratory confirmed Covid\-19 diagnosis (PCR)
  • 6\) Patients with clinical signs compatible with Covid\-19: fever, cough, dyspnea.
  • 7\) Patients should have chest radiological imaging (plaque or CT scan) with no affectation compatible with Covid\-19\.
  • 8\) NIT\-1\-2 patients
  • 9\) Mild functional alteration of organs, defined as:

Exclusion Criteria

  • Patient cohort and professional cohort
  • ? Uncontrolled intercurrent disease including infections other than CoVID19, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric or social disorder that may limit study requirements
  • ? To be receiving any other drug or product under study
  • ? Allergy to one or more of the medications in the trial
  • ? Chronic concomitant immunosuppressive medication

Outcomes

Primary Outcomes

Not specified

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