COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05669261

Anthony Dudzinski

tdudzinski@americancryostem.com

2022-12-30

Not recruiting

RCT

Randomized

Crossover

Blind label

single-center

Long covid

inclusion criteria: active duty service members: military retirees, deers eligible dependents who are tricare beneficiaries only (department of defense (dod) investigational sites only) participants ages of 18 years and above documentation of a positive covid-19 polymerase chain reaction (pcr) test or strong history of sars-cov-2 exposure with positive supportive serology male or female or other gender individuals with established diagnosis of pasc subjects with moderate to severe levels of pasc based on synthesis of multiple assessment modalities provided by the multispecialty study team. pasc phenotype to include signs and symptoms of fatigue and low endurance and either autonomic disorder or dyspnea or both. subjects who are able to comprehend the consent procedure and follow the treatment process. female participants of childbearing potential and at risk of pregnancy during the study must agree to use 2 highly effective methods of contraception throughout the study and for 112 days after the last study visit. female participant who are not of childbearing potential (i.e,. must meet at least one (1) of the following criteria): have undergone a hysterectomy and/or bilateral oophorectomy, or ovarian failure . for male subjects who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception, willingness to use a barrier method of contraception (condom) from the start of study therapy until ≥ 90 days after the end of the study and to refrain from sperm donation until ≥ 90 days after the end of the study. achieved postmenopausal status defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or psychological cause and have a serum follicle stimulating hormone (fsh) level confirming the post-menopausal state. individuals who are willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests, and other study procedures through the end of the final study visit. individuals with the following vital signs: systolic blood pressure of > 100 or < 140 (mmhg) diastolic blood pressure of > 60 or <90 (mmhg) heart rate of > 60 or < 100 (bpm) (beats per minute) temperature of < 38°c (afebrile) respiratory rate of > 12 or < 20 (bpm) (breaths per minute) pulse ox greater than >95% on room air bmi < 28

5.3.7.4

2

American CryoStem Corporation

18

100

None

Patients recovered from covid

N/A

20

Assessment of change in Health Status using the 36 item Short Form Health Survey (SF-36);Assessment of change in Health Status using the 36 item Short Form Health Survey (SF-36);Assessment of change in Health Status using the 36 item Short Form Health Survey (SF-36);Assessment of change in Health Status using the 36 item Short Form Health Survey (SF-36);Assessment of the Incidence of Serious Adverse Events (SAEs)

None

Phase 1

[{"arm_notes": "nan", "treatment_id": 2674, "treatment_name": "Adipose tissue harvest", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]