To study the treatment of COVID-19 with severe viral pneumonia by using purified stem cell exosomes

Phase 2

• Conditions: Hypercytokinemia in patients with COVID-19 and severe respiratory distress syndrome (SARS) due to CoV-2 infection; Infections and Infestations

• Registration Number: ISRCTN33578935
• Lead Sponsor: Kimera Labs

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-02
• Last Update Posted: 22 June 2020
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 64

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
11. Presence of infection in another organ location caused by same pathogen (eg
12. Pneumococcal meningitis in the context of pneumococcal pneumonia)
13. Expected to have rapidly fatal disease within 72 hours after randomization
14. Inability to maintain a mean arterial pressure 50 mmHg prior to Screening despite the presence of vasopressors and intravenous fluids
15. Not expected to survive for 3 months due to other pre-existing medical conditions such as end-stage neoplasm or other diseases
16. A history of malignancy in the 5 years prior to screening, except for successfully surgically treated non-melanoma skin malignancies
17. Known primary immunodeficiency disorder or with HIV infection and acquired immune deficiency syndrome (AIDS) with CD4 count <200 cells/mm3 or not receiving highly active antiretroviral therapy (HAART) for HIV
18. Receiving immunosuppressant therapy (including chronic treatment with anti-TNFa) or on chronic high doses of steroids (single administration of 2 mg/kg body weight or 20 mg/day of prednisone or equivalent for 2 weeks)
19. Granulocyotopenia, not due to sepsis, as evidenced by leukocyte absolute neutrophil count <500 per µL>21 days prior to onset of pneumonia symptoms
20. Received stem cell therapy, or allogeneic transplantation (organ or bone marrow transplant) within the past 6 months
21. Receiving treatment with a biological agent (eg antibodies, cells), immunotherapy or plasma exchange treatment within the last 8 weeks
22. A known liver function impairment associated with liver cirrhosis (Child Pugh C) or known esophageal varices
23. Hospitalized within the previous 15 days
24. Conditions resulting in a New York Heart Association or Canadian Cardiovascular Society Class IV functional status
25. End-stage neuromuscular disorders (eg motor neuron diseases, myasthenia gravis, etc) or cerebral disorders that impair weaning
26. Patients with quadriplegi

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Safety and adverse events measured using i.v. administration of 0.2mg/kg of placental, mesenchymal stem cell-derived exosome preparations (KTA 100,= XoGlo®) at day 1 and day 3<br> 2. Improved respiration measured using PaO2/FiO2 at day 1, 2, and onwards daily<br>