Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-24 @ 7:19 PM
NCT ID:
NCT04352803
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patients ≥ 18 years of and less than 90
2. COVID 19 diagnosis confirmed
3. Ability to give informed consent
4. Hospitalized
Exclusion Criteria:
1. Mild Illness
1. Patients with uncomplicated upper respiratory tract viral infection, may have non-specific symptoms such as fever, fatigue, cough (with or without sputum production), anorexia, malaise, muscle pain, sore throat, dyspnea, nasal congestion, or headache. Rarely, patients may also present with diarrhea, nausea and vomiting.
2. The elderly and immunosuppressed candidates may present with atypical symptoms. Symptoms due to physiologic adaptations of pregnancy or adverse pregnancy events, such as e.g. dyspnea, fever, GI-symptoms or fatigue, may overlap with COVID-19 symptoms. Still, they will be excluded, unless they progress to Inclusion Criteria within 72 hours from recruitment.
2. Pneumonia (uncomplicated):
a. Adults with pneumonia but no signs of severe pneumonia AND NO need for supplemental oxygen
3. Reported pregnant or positive pregnancy test
4. Other chronic respiratory disorders such as COPD, emphysema, lung cancer, or cystic fibrosis
5. BMI lower than 21
6. Skinfold test \< 3 cm at harvest area
7. Patients with Do-Not-Resuscitate orders that limit mechanical ventilation assistance in place at hospital admission
8. Males and females \< 18 years of age
9. Patients who are currently breastfeeding
10. Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection viruses.
11. History of systemic malignant neoplasms within the last 5 years.
12. Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason
13. Participating in another clinical research study
14. History of Bleeding disorder which in PI's opinion would render the patient unsuitable for the study
15. PT (plasma) \< 9 or \>11.6 seconds and in the opinion of the PI and attending physician that lipoaspiration would be contraindicated. May be eligible for re-screening if coagulopathy improves within 72 hours of consent
16. PTT \< 23 or \>32 seconds and in the opinion of the PI and attending physician that lipoaspiration would be contraindicated. May be eligible for re-screening if coagulopathy improves within 72 hours of consent
17. Platelets count less than 70,0000
18. History of DVT
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04352803
Study Brief:
Protocol Section:
NCT04352803