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| Column | Value |
|---|---|
| Trial registration number | NCT04679909 |
|
Full text link
Last imported at : Dec. 24, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : July 16, 2021, 6 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : July 16, 2021, 6 a.m. Source : ClinicalTrials.gov |
information@altimmune.com |
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Registration date
Last imported at : Dec. 24, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
2020-12-22 |
|
Recruitment status
Last imported at : Aug. 17, 2023, 10:09 a.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : Dec. 24, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Dec. 24, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Dec. 24, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Dec. 24, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : Dec. 24, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Dec. 24, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - men and women ages 18 to 55 years, inclusive - good general health status - screening laboratory results within institutional normal range or grade 1 abnormality if the investigator documents clinical insignificance. grade 2 laboratories may be permissible if considered not clinically significant by the investigator. - for women who have not been surgically sterilized or who do not have laboratory confirmation of postmenopausal status, negative pregnancy test - willingness to practice a highly effective method of contraception - ability and willingness to comply with all aspects of the study, including nasopharyngeal swabs and blood and urine samples, through the entire study period |
|
Exclusion criteria
Last imported at : Dec. 24, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
- subjects at increased risk of exposure to sars-cov-2, including healthcare workers, emergency response personnel, and those with known contact with covid-19 patients - pregnant or lactating women or planning to conceive a child during the next 3 months - body mass index (bmi) > 30.0 kg/m2 - acute covid-19, a positive test result for sars-cov2 infection, a positive sars-cov-2 serology for prior sars-cov-2 infection at screening, or exposure within 14 days to an individual with acute covid-19 - an acute respiratory illness - positive result for hiv, hepatitis b virus, or hepatitis c virus at screening - chronic or current cigarette smoking - any medical, psychiatric, or social condition or occupational or other responsibility that in the judgment of the investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety (including reactogenicity), or a subject's ability to give informed consent |
|
Number of arms
Last imported at : Dec. 24, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
7 |
|
Funding
Last imported at : Dec. 24, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Altimmune, Inc. |
|
Inclusion age min
Last imported at : Dec. 24, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Dec. 24, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
55 |
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Countries
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
United States |
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Type of patients
Last imported at : Dec. 24, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : Dec. 24, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : July 16, 2021, 6 a.m. Source : ClinicalTrials.gov |
92 |
|
primary outcome
Last imported at : Dec. 24, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Adverse Events (AEs);Reactogenicity |
|
Notes
Last imported at : Dec. 24, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 1 |
|
Arms
Last imported at : Dec. 24, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "low dose;1", "treatment_id": 29, "treatment_name": "Adcovid", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Medium dose;1", "treatment_id": 29, "treatment_name": "Adcovid", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "High dose;1", "treatment_id": 29, "treatment_name": "Adcovid", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "low dose;2", "treatment_id": 29, "treatment_name": "Adcovid", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "medium dose;2", "treatment_id": 29, "treatment_name": "Adcovid", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "high dose;2", "treatment_id": 29, "treatment_name": "Adcovid", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |