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) |