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| Column | Value |
|---|---|
| Trial registration number | NCT04969250 |
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Full text link
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : Feb. 25, 2022, 7 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Feb. 25, 2022, 7 p.m. Source : ClinicalTrials.gov |
tico@insight-trials.org |
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Registration date
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
2021-07-20 |
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Recruitment status
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Factorial |
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Masking
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Long covid |
|
Inclusion criteria
Last imported at : March 29, 2024, midnight Source : ClinicalTrials.gov |
inclusion criteria: participating in the activ-3/tico trial and received a selected blinded investigational agent, or placebo for that agent, at selected sites. willingness to strictly adhere to the randomly allocated dosage number and schedule for vaccine administration. participant is between day 28 and day 90 tico visits inclusive at time of randomization. at time of screening for this study, has 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. ability and willingness of participant (or legally authorized representative) to provide informed consent prior to initiation of any study procedures. |
|
Exclusion criteria
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
receipt of a sars-cov-2 (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 study. known allergy to any component of the study eligible vaccine(s). |
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Number of arms
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
8 |
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Funding
Last imported at : March 29, 2024, midnight Source : ClinicalTrials.gov |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Inclusion age min
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Feb. 2, 2022, 1 p.m. Source : ClinicalTrials.gov |
Nigeria;Singapore;Spain;Switzerland;Uganda;United States |
|
Type of patients
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Patients recovered from covid |
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Severity scale
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
66 |
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primary outcome
Last imported at : March 29, 2024, midnight Source : ClinicalTrials.gov |
Ratio of 48-Week to Baseline Neutralizing Antibody (NAb) Levels |
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Notes
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Phase 4 |
|
Arms
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "30 \u00b5g;1;IM;Vaccination at study entry", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "30 \u00b5g;2;IM;Vaccination at study entry and week 4", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "30 \u00b5g;1;IM;Vaccination at week 12", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "30 \u00b5g;2;IM;Vaccination at week 12 and 16", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "100 \u00b5g;1;IM;Vaccination at study entry", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "100 \u00b5g;2;IM;Vaccination at study entry and week 4", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "100 \u00b5g;1;IM;Vaccination at week 12", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "100 \u00b5g;2;IM;Vaccination at week 12 and 16", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}] |