ISRCTN33578935
Active, Not Recruiting
Phase 2
Rationale and investigational study for the treatment of COVID-19 with severe viral pneumonia with isolated, placental, mesenchymal stem cell exosomes
Kimera Labs0 sites64 target enrollmentJune 2, 2020
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Hypercytokinemia in patients with COVID-19 and severe respiratory distress syndrome (SARS) due to CoV-2 infection
- Sponsor
- Kimera Labs
- Enrollment
- 64
- Status
- Active, Not Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. COVID\-19 patients requiring invasive mechanical ventilation for respiratory failure due to pneumonia
- •2\. Requiring treatment with vasopressors
- •3\. Requiring artificial ventilation and PaO2/FiO2 \< 300 mmHg
Exclusion Criteria
- •1\. Recent administration of hydroxychloroquine, chloroquine, or steroids
- •2\. Recent administration of tocilizumab (IL\-6 antibody)
- •3\. Hospital acquired (HAP)\-, Health Care acquired (HCAP)\- or Ventilator associated\-pneumonia (VAP)
- •4\. Pneumonia exclusively of bacterial or fungal origin\* bacterial pneumonia co\-infected with viruses and/or other microorganisms may be entered into the study. \*Due to the short time window (up to 18 hours) between fulfillment of severity criteria (ie initiation of invasive mechanical ventilation or vasopressors administration, whichever comes first) and the start of the first dose of study treatment, patients with a pneumonia of suspected viral origin by any established standard diagnostic method routinely applied at the study site (eg oral swap antigen test, rt\-PCR) can be entered into the study (confirmation of viral origin must be obtained afterwards)
- •5\. Known or suspected Pneumocystis jirovecii (formerly known as Pneumocystis carinii) pneumonia
- •6\. Aspiration pneumonia
- •7\. Known active tuberculosis
- •8\. A history of post\-obstructive pneumonia
- •9\. Cystic fibrosis
- •10\. Any chronic lung disease requiring oxygen therapy at home
Outcomes
Primary Outcomes
Not specified
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