COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-003386-35/DK

CHIP - Rigshospitalet, University of Copenhagen - Jens Lundgren

jens.lundgren@regionh.dk

2021-07-13

Terminated

RCT

Randomized

Parallel

Open label

multi-center

Prevention

1. Participating in the TICO trial and received a selected blinded investigational agent or placebo for that agent at selected sites. NOTE: A list of selected investigational agents will be posted on the INSIGHT website. 2. Willingness to strictly adhere to the randomly allocated dosage number and schedule for vaccine administration 3. Participant is between Day 28 and Day 90 TICO visits inclusive at the time of randomization 4. At the time of screening for this protocol, experienced sustained recovery (i.e. the primary endpoint in TICO) for at least two consecutive weeks, i.e. having returned uninterrupted to the person’s premorbid living facility (or equivalent) for at least 2 consecutive weeks 5. Ability and willingness of participant (or legally authorized representative [LAR]) to provide informed consent prior to initiation of any study procedures

1. Receipt of a SARS-CoV-2 (also known as COVID-19) vaccine after enrollment into TICO. Participants who received a SARS-CoV-2 vaccine prior to enrollment in TICO may be enrolled in this substudy 2. Known allergy to any component of the study eligible vaccine(s)

2

Regents of the University of Minesota

18

100

Denmark;Georgia;Nigeria;Peru;Singapore;Spain;Sweden;Uganda;Ukraine;United Kingdom;United States

Close contacts to covid patients

N/A

50

The primary outcome measure is neutralizing antibody levels specific to the Moderna or Pfizer vaccine at Week 48 after randomization. Comparisons will be evaluated using the ratio of geometric mean responses. Antibody levels will be log10 transformed and summarized with stratified analysis of covariance

Declared number of arm (4.0) differs from found arms (2.0)

Phase 4

[{"arm_notes": "", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]