v3.0.7
Please consider this website is continuously evolving and still under development
to harmonize automatic data extraction and integrate manual data annotation.
| Column | Value |
|---|---|
| Trial registration number | NCT04839042 |
|
Full text link
Last imported at : April 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : May 7, 2022, 5 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : May 7, 2022, 5 a.m. Source : ClinicalTrials.gov |
rrother@tetherex.com |
|
Registration date
Last imported at : April 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2021-04-09 |
|
Recruitment status
Last imported at : July 14, 2021, 6 a.m. Source : ClinicalTrials.gov |
Recruiting |
|
Study design
Last imported at : April 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
nonRCT |
|
Allocation
Last imported at : April 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Non-randomized |
|
Design
Last imported at : April 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Sequential assignment |
|
Masking
Last imported at : April 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Open label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : April 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : June 16, 2023, 8 a.m. Source : ClinicalTrials.gov |
key inclusion criteria: adult males and females, 18 to 60 years of age (inclusive) body mass index ≥ 18.0 and ≤ 32.0 kg/m2, with a body weight ≥ 50 kg at screening must have been fully vaccinated against covid-19 and received last dose not less than 3 months prior to day 1 (high dose #3 i.m. and i.n. booster arms only), not less than 5 months prior to day 1 (high dose #4 i.n. booster arm only) and not less than 6 months prior to day 1 (i.h. booster arms only) key |
|
Exclusion criteria
Last imported at : May 7, 2022, 5 a.m. Source : ClinicalTrials.gov |
history or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease history of chronic respiratory disorders including asthma, emphysema, interstitial lung disease, pulmonary hypertension, recurrent pneumonia, or recent (≤14 days prior to screening) or ongoing respiratory tract infection history of thrombosis (e.g., deep vein thrombosis, pulmonary embolism, etc.), any coagulation dysregulation disorder, or a history of thrombosis noted in immediate family members history of any neurological disorders or seizures including guillain-barre syndrome, with the exception of febrile seizures during childhood known previous infection with sars-cov-2 or presence of antibodies against sars-cov-2 or a positive sars-cov-2 pcr test (non-booster arms only) any history of malignant disease ≤5 years prior to registration history of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia |
|
Number of arms
Last imported at : June 16, 2023, 8 a.m. Source : ClinicalTrials.gov |
16 |
|
Funding
Last imported at : Aug. 24, 2023, 4 a.m. Source : ClinicalTrials.gov |
Moat Biotechnology Corporation |
|
Inclusion age min
Last imported at : April 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : July 14, 2021, 6 a.m. Source : ClinicalTrials.gov |
55 |
|
Countries
Last imported at : April 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Australia |
|
Type of patients
Last imported at : April 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
|
Severity scale
Last imported at : April 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : June 16, 2023, 8 a.m. Source : ClinicalTrials.gov |
190 |
|
primary outcome
Last imported at : April 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Humoral response to SARS-CoV-2 as measured by neutralizing antibodies using wild-type virus assay;Incidence and severity of adverse events (AEs), including withdrawals due to safety or tolerability reasons;Number of participants with solicited local and systemic adverse events for 7 days Following Each Dose |
|
Notes
Last imported at : April 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : April 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Phase 1 |
|
Arms
Last imported at : June 16, 2023, 8 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "SC-Ad6-1 Low Dose Intramuscular", "treatment_id": 1172, "treatment_name": "Sc-ad6-1", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "SC-Ad6-1 Medium Dose Intramuscular", "treatment_id": 1172, "treatment_name": "Sc-ad6-1", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "SC-Ad6-1 High Dose #1 Intramuscular", "treatment_id": 1172, "treatment_name": "Sc-ad6-1", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "SC-Ad6-1 High Dose #2 Intramuscular", "treatment_id": 1172, "treatment_name": "Sc-ad6-1", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "SC-Ad6-1 Multiple Dose Intramuscular (Day 1 and Day 22)", "treatment_id": 1172, "treatment_name": "Sc-ad6-1", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "SC-Ad6-1 High Dose #3 Intramuscular Booster", "treatment_id": 1172, "treatment_name": "Sc-ad6-1", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "SC-Ad6-1 Low Dose Intranasal", "treatment_id": 1172, "treatment_name": "Sc-ad6-1", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "SC-Ad6-1 Medium Dose Intranasal", "treatment_id": 1172, "treatment_name": "Sc-ad6-1", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "SC-Ad6-1 High Dose #1 Intranasal", "treatment_id": 1172, "treatment_name": "Sc-ad6-1", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "SC-Ad6-1 High Dose #2 Intranasal", "treatment_id": 1172, "treatment_name": "Sc-ad6-1", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "SC-Ad6-1 Multiple Dose Intranasal (Day 1 and Day 22)", "treatment_id": 1172, "treatment_name": "Sc-ad6-1", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "SC-Ad6-1 High Dose #3 Intranasal Booster", "treatment_id": 1172, "treatment_name": "Sc-ad6-1", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "SC-Ad6-1 High Dose #4 Intranasal Booster", "treatment_id": 1172, "treatment_name": "Sc-ad6-1", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "SC-Ad6-1 Low Dose Inhaled", "treatment_id": 1172, "treatment_name": "Sc-ad6-1", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "SC-Ad6-1 Medium Dose Inhaled", "treatment_id": 1172, "treatment_name": "Sc-ad6-1", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "SC-Ad6-1 High Dose Inhaled", "treatment_id": 1172, "treatment_name": "Sc-ad6-1", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}] |