COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05212610

Charles Schuler IV, MD

schulerc@med.umich.edu

2022-01-28

Recruiting

nonRCT

Non-randomized

Single group assignment

Open label

single-center

Prevention

inclusion criteria age over 18. participant must be able to understand and provide informed consent no evidence of infectious illness (defined as fever >38⁰c, vomiting, diarrhea, new cough, new shortness of breath, new congestion, new runny nose, new headache or sore throat) within 14 days of vaccine administration. subjects must have a history of adverse reaction to either the pfizer-biontech mrna covid vaccination or the moderna mrna covid vaccination, a personal history of allergic reaction without prior mrna covid vaccination, or a history of adverse reaction to natural covid infection. females of childbearing potential must have a negative pregnancy test prior to vaccination. exclusion criteria under age 18 inability or unwillingness of a participant to give written informed consent evidence of covid-19 infection within 21 days of vaccination visit history of antibody agent or convalescent plasma for treatment or prevention of covid-19 within 90 days individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the pfizer-biontech mrna covid-19 vaccination or the moderna mrna covid-19 vaccination. history of underlying immune disorder. pregnancy immunocompromised persons with primary or acquired immunodeficiency persons on anti-rejection therapy following solid organ transplant or bone marrow transplant persons on biologic therapeutic agents persons with malignancy and ongoing or recent chemotherapy persons receiving systemic immunosuppressive therapy, including corticosteroids equivalent to 20 mg/day of prednisone for 2 weeks persons with chronic kidney disease stage 3 or higher persons with history of significant pulmonary compromise

None

1

University of Michigan

18

100

United States

Healthy volunteers

N/A

200

Number of participants with treatment-related allergic reaction adverse events;Percent of participants that have a reaction to an initial or additional dose of the Pfizer-BioNTech or Moderna COVID-19 mRNA vaccine

None

Phase 4

[{"arm_notes": "Pfizer-BioNTech mRNA COVID-19 vaccine or Moderna mRNA COVID-19 vaccine", "treatment_id": 831, "treatment_name": "Mrna vaccine", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]