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.
Investigators
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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