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Clinical Trials/EUCTR2020-001324-33-FR
EUCTR2020-001324-33-FR
Active, not recruiting
Phase 1

se of a respiratory multiplex PCR and procalcitonin to reduce antibiotic exposure in patients with severe confirmed COVID-19 pneumonia : a multicenter, parallel-group, open-label, randomized controlled trial - MULTI-COV

ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS (APHP)0 sites194 target enrollmentMarch 29, 2020

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Severe confirmed COVID-19 pneumonia
Sponsor
ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS (APHP)
Enrollment
194
Status
Active, not recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 29, 2020
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS (APHP)

Eligibility Criteria

Inclusion Criteria

  • \- Adults (\>\= 18 years) admitted to the ICU;
  • \- Severe confirmed COVID\-19 pneumonia, defined by i) a newly\-appeared pulmonary parenchymal infiltrate; and ii) a positive RT\-PCR (either upper or lower respiratory tract) for COVID\-19 (SARS\-CoV\-2\); iii) and admission to the ICU or intermediate care unit;
  • \- Informed consent or emergency procedure.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range 97
  • F.1\.3 Elderly (\>\=65 years) yes
  • F.1\.3\.1 Number of subjects for this age range 97

Exclusion Criteria

  • \- Pregnancy and breastfeeding women ;
  • \- Congenital immunodeficiency;
  • \- HIV infection with CD4 count below 200/mm3 or unknown in the last year;
  • \- High\-grade hematological malignancy;
  • \- Neutropenia (\<1 leucocyte/mL or \< 0\.5 neutrophil/mL);
  • \- Immunosuppressive drugs within the previous 30 days, including anti\-cancer cytotoxic chemotherapy and anti\-rejection drugs for organ/bone marrow transplant;
  • \- Moribund patient or death expected from underlying disease during the current admission;
  • \- Patient deprived of liberty or under legal protection measure.

Outcomes

Primary Outcomes

Not specified

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