COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04952402

Not reported

Not reported

2021-07-07

Completed

nonRCT

Non-randomized

Single group assignment

Open label

multi-center

Prevention

inclusion criteria: for all participants: ability and willingness of participant (or legally authorized representative) to provide informed consent prior to initiation of any study procedures. for participants who are in, or who have completed, the activ-2/a5401 trial: receipt of all selected investigational therapy or active comparator/placebo for that therapy at selected sites. for participants who are in, or who have completed, the activ-2/a5401 trial and receive study-provided moderna mrna-1273 covid-19 vaccine: receipt of the last dose of investigational therapy or active comparator/placebo for that therapy ≥30 days and ≤240 days prior to study entry. for participants who are in, or who have completed, the activ-2/a5401 trial and have received or will be receiving community-provided mrna-based covid-19 vaccine: receipt of the last dose of investigational therapy or active comparator/placebo for that therapy ≥30 and ≤240 days prior to receipt or planned receipt of the first dose of community-provided vaccine.

for participants who are in, or who have completed, the activ-2/a5401 trial: self-report of prior receipt of a non-mrna-based covid-19 vaccine. for participants who are in, or who have completed, the activ-2/a5401 trial: self-report of receipt of the first dose of an mrna-based covid-19 vaccine 140 days or more before a5404 enrollment. for participants who are in, or who have completed, the activ-2/a5401 trial: self-report of a second sars-cov-2 infection after the infection that qualified the participant for activ-2/a5401. for non-a5401/activ-2 participants: self-report of receipt of any prior covid-19 vaccine. for non-a5401/activ-2 participants: known prior history of any sars-cov-2-positive test (e.g., pcr test, nucleic acid amplification test (naat), antigen test, serology test). for participants who receive study-provided moderna mrna-1273 covid-19 vaccine: known allergy to any component of the moderna covid-19 vaccine.

2

National Institute of Allergy and Infectious Diseases (NIAID)

18

100

United States

Healthy volunteers

N/A

43

Neutralizing Antibody (NAb) Level

None

Phase 4

[{"arm_notes": "Cohort: ACTIV-2/A5401", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Cohort: COVID-19 Na\u00efve", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]