COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04806113

Ines Colmegna, DR

ines.colmegna@mcgill.ca

2021-03-19

Completed

nonRCT

Non-randomized

Single group assignment

Open label

single-center

Prevention

inclusion criteria (all of the following): adults ages 18 years and older; for the cases, established diagnosis of: ra done by a rheumatologist according to the 2010 american college of rheumatology (acr) /european league against rheumatism (eular) criteria, or sle done by a rheumatologist according to the 1997 revised acr criteria and/or the 2013 slicc lupus classification criteria and/or the 2019 eular/acr criteria; for the cases, stable treatment (≥3 months prior to enrollment for biologics/small molecules and mmf; >3 weeks of a specific dose in case of steroids); for the controls, people without a diagnosis of a chronic rheumatic disease who can have comorbidities as in patients with rheumatic diseases; able to comprehend the investigational nature of the protocol and provide informed consent; male or non-pregnant female; women of childbearing potential must agree to use at least one acceptable primary form of contraception. exclusion criteria (any of the following): positive pregnancy test either at screening or just prior to each vaccine administration. any medical disease or condition that, in the opinion of the site principal investigator (pi) or appropriate sub-investigator, precludes study participation. acute illness, as determined by the site pi or appropriate sub-investigator, with or without fever [oral temperature >38.0°c (100.40f)] within 72 hours prior to each vaccination. diagnosis of hepatitis b, hepatitis c virus, or human immunodeficiency virus (hiv). history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines. participation in another clinical trial or plan to do so during the study. if a patient was on a drug trial, recruitment could occur following 2 half-lives of the study drug. vaccines within the 2 weeks prior to any dose of covid-19 vaccine or until 30 days after any dose of covid-19 vaccine. lactating female. immunoglobulin therapy or blood products within the past month. prior diagnosis of covid-19 in the past 3 months. planned changes in baseline drug treatments (except prednisone) for rheumatic diseases prior to d57. for patients required to be on cohort 8: planned reduction of prednisone dose below 10 mg prior to d21.

None

1

McGill University Health Centre/Research Institute of the McGill University Health Centre

18

100

Canada

High risk patients

N/A

220

Frequency and grade of any unsolicited AEs (including 'significant disease flares'*);Frequency and grade of each solicited local and systemic adverse events (AEs)

None

Phase 3

[{"arm_notes": "2;days1-28", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]