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Clinical Trials/ISRCTN33578935
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.

Registry
who.int
Start Date
June 2, 2020
End Date
December 31, 2020
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Kimera Labs

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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