COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04811664

National Institute of Allergy and Infectious Diseases (NIAID)

Not reported

2021-03-23

Completed

RCT

Randomized

Crossover

Open label

multi-center

Prevention

inclusion criteria for main cohort, vaccine declined group general and demographic criteria age of 18 through 29 years. ability and willingness to provide informed consent. prefers not to receive covid-19 vaccine. willingness to be followed for the planned duration of the study. assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire with demonstration of understanding of all questionnaire items answered incorrectly. access to device and internet for completion of study procedures. exclusion criteria for main cohort, vaccine declined group prior administration of a coronavirus (sars-cov-2, sars-cov, mers-cov) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat covid-19 (participation in studies of other investigational research agents allowed). any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, or a volunteer's ability to give informed consent. inclusion criteria for prospective close contact (pcc) cohort age of 18 years or older, at the time of signing the informed consent. willing and able to provide informed consent. expected to be in frequent close physical proximity with main cohort participant during the study. willing to share results of sars-cov-2 testing. access to device and internet for completion of study procedures inclusion criteria for case-ascertained close contact (cacc) cohort age of 18 years or older, at the time of signing the informed consent. willing and able to provide informed consent. access to device and internet for completion of study procedures. willing to share results of sars-cov-2 testing. had close contact with main cohort participant with known pcr-confirmed sars-cov-2 infection (eg, index case). close contacts will have had exposure to the index participant, generally within 72 hours of an index diagnosis, and may include individuals that meet any of the following guidelines: prolonged close physical proximity with main cohort participant within a residence/vehicle/enclosed space without maintaining social distance, medical staff, first responders, or other care persons who cared for the index case without appropriate personal protective equipment. further information on the definition of close contact can be found in the covpn 3006 study specific procedures (ssp).

None

2

National Institute of Allergy and Infectious Diseases (NIAID)

18

29

United States

Healthy volunteers

N/A

1923

Effect of Moderna COVID-19 Vaccine on Mean Peak Nasal Viral Load;Effect of Moderna COVID-19 Vaccine on Median Peak Nasal Viral Load;Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection

None

Phase 3

[{"arm_notes": "100mcg;2;days1-29", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "100mcg;2;days113-141", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]