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. 2021 Nov 24;4:100031. doi: 10.1016/j.bbiosy.2021.100031

Table 1.

Patient inclusion and exclusion criteria.

Inclusion Criteria Exclusion Criteria
Age (years) of male or female subjects age >18 years at the time of signing the Informed Consent Form Have moderate-to-severe respiratory distress syndrome due to COVID-19
Clinical diagnosis of COVID-19 by the qualitative reverse-transcription polymerase chain reaction (RT-PCR) Females who are pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods
At least 1 of the mild or moderate COVID-19 clinical symptoms according to the NIH categories previously described Females with a positive blood pregnancy test at screening which will be within 72 h of the intraperitoneal (IP) infusion
The main symptoms of mild illness are the following:
•low-grade fever (<38ºC, 37.5–37.9)
•dry cough
•fatigue
•feeling slightly breathless
•muscle pain
•headache
•sore throat
•diarrhea
Inability to perform any of the assessments required
The main symptoms of moderate illness are the following:
•fever (≥38ºC)
•a dry and more consistent cough several times an hour
•tiredness and need to stay in bed
•breathless with moderate exercise
•muscle pain
•headache
•soreness from coughing
•diarrhea
•dry mouth
Active listing (or expected future listing) for transplant of any organ
Adequate venous access Be a solid organ transplant recipient. (This does not include prior cell-based therapy (>12 months prior to enrollment) or bone, skin, ligament, tendon, or corneal grafting)
For women of child-bearing potential only, agree to use FDA-recommended birth control until 6 months post treatment Have a history of organ or cell transplant rejection
For male subjects, agree to use contraceptives and not donate sperm during the study History of substance (drug or alcohol) abuse
Agree to comply with all protocol requirements and be willing to complete all study visits Taking prescription medications not being used appropriately for a pre-existing medical condition
Untreated HIV infection. (Patients could be enrolled if they have been treated for HIV and test negative for HIV viral load but still test positive for antibodies)