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| Column | Value |
|---|---|
| Trial registration number | NCT05639166 |
|
Full text link
Last imported at : Dec. 8, 2022, 4 a.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : May 11, 2023, 8 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : May 11, 2023, 8 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Dec. 8, 2022, 4 a.m. Source : ClinicalTrials.gov |
2022-12-06 |
|
Recruitment status
Last imported at : May 23, 2023, 4 p.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : Dec. 8, 2022, 4 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Dec. 8, 2022, 4 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Dec. 8, 2022, 4 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Dec. 8, 2022, 4 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : Dec. 8, 2022, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : Dec. 8, 2022, 4 a.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Dec. 8, 2022, 4 a.m. Source : ClinicalTrials.gov |
inclusion criteria: are ≥18 years of age at the time of randomization subject has a household contact with a confirmed covid-19 cohabiting individual as subject. initial diagnosis of the covid-19 positive individual has been within 3 days of screening. covid-19 positive result (pcr or antigen) must have been performed by an accredited lab or medical professional. current and uninterrupted household contacts were defined as family members or close relatives who had unprotected contact with the index case. subject must have a negative result with the study provided rapid antigen test at baseline and be covid-19 symptom free. are men or non-pregnant women. reproductive and contraceptive agreements and guidance is provided in appendix 2. contraceptive use by men or women should be consistent with local regulations for those participating in clinical studies. understand and agree to comply with planned study procedures agree to the collection of nasopharyngeal swabs the participant or legally authorized representative gives signed informed consent as described in section 10.1.1.2 which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. |
|
Exclusion criteria
Last imported at : Dec. 9, 2022, 4 a.m. Source : ClinicalTrials.gov |
a positive covid-19 result (pcr or antigen test) within 30 days of screening. presence of typical covid-19 symptoms which cannot be explained by another underlying condition (fever >38°c, oxygen saturation (spo2) below 93%, dyspnea, difficulty breathing, chills, ageusia, anosmia, cough, myalgia) in the past 48 hours prior to screening. hypersensitivity to any component of ibio123 participants who have been previously administered ibio123. have received treatment with a sars-cov-2 specific monoclonal antibody have participated, within the last 30 days, in a clinical study involving an investigational intervention. if the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed. are pregnant or breast feeding are investigator site personnel directly affiliated with this study. |
|
Number of arms
Last imported at : Dec. 8, 2022, 4 a.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Dec. 8, 2022, 4 a.m. Source : ClinicalTrials.gov |
Immune Biosolutions Inc |
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Inclusion age min
Last imported at : Dec. 8, 2022, 4 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Dec. 8, 2022, 4 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : May 2, 2023, 8 p.m. Source : ClinicalTrials.gov |
South Africa;Ukraine |
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Type of patients
Last imported at : Dec. 8, 2022, 4 a.m. Source : ClinicalTrials.gov |
Close contacts to covid patients |
|
Severity scale
Last imported at : Dec. 8, 2022, 4 a.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : May 2, 2023, 8 p.m. Source : ClinicalTrials.gov |
200 |
|
primary outcome
Last imported at : Dec. 8, 2022, 4 a.m. Source : ClinicalTrials.gov |
Characterize the effect of IBIO123 compared to placebo on laboratory-confirmed COVID-19 infections between baseline and Day 14 |
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Notes
Last imported at : Dec. 8, 2022, 4 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Dec. 8, 2022, 4 a.m. Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : Dec. 8, 2022, 4 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 2411, "treatment_name": "Ibio123", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |