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| Column | Value |
|---|---|
| Trial registration number | NCT04676971 |
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Full text link
Last imported at : Dec. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Dec. 2, 2021, 11:30 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Dec. 2, 2021, 11:30 p.m. Source : ClinicalTrials.gov |
Byoungok Ahn, ahnbo@immunemed.co.kr (PI email not reported) |
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Registration date
Last imported at : Dec. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
2020-12-21 |
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Recruitment status
Last imported at : Dec. 2, 2021, 11:30 p.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : Dec. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Dec. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Dec. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Dec. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : Dec. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : Dec. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: signed written informed consent from any patient capable of giving consent, or, when the patient is incapable of doing so, by his or her legal/authorized representative. note: in accordance with the european medicines agency (ema) "guidance on the management of clinical trials during the covid-19 (coronavirus) pandemic version 3 28/04/2020", if written consent by the trial participant is not possible (for example because of physical isolation due to covid-19 infection), consent may be given orally by the trial participant in the presence of an impartial witness. age 18 years or older. patient is currently hospitalized. diagnosis of covid-19 pneumonia including a positive rt-pcr test for sars-cov-2 of any specimen and lung involvement confirmed with chest imaging (x-ray or computed tomography [ct] scan). able to comply with the study protocol. female patients must be postmenopausal (24 months of amenorrhea), surgically sterile or must agree to use an effective method of contraception throughout the study and for up to 120 days after stopping treatment. effective contraception includes an established hormonal therapy or intrauterine device for females, and the use of a barrier contraceptive (i.e. diaphragm or condoms) with spermicide. |
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Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
patients with known or suspected hypersensitivity to hzvsf-v13 or to any of its excipients. active tuberculosis or suspected active bacterial, fungal, viral, or other infection (besides covid-19). anti-rejection or immunomodulatory drugs within the past 3 months. absolute neutrophil count (anc) < 1000/µl at screening. platelet count < 50,000/ µl at screening. alt or ast > 5 x upper limit of normal (uln) within 24 hours at screening. serum creatinine > 2 mg/dl (> 176.8 μmol/l) or estimated creatinine clearance < 30 ml/min measured or calculated by cockroft gault equation. pregnancy or breastfeeding. treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (approved/investigational covid-19 antivirals and other off-label drugs recommended by local health authorities are permitted). patients who in the opinion of the treating physician should not participate in this program (ex: severe acute respiratory distress syndrome [ards], septicaemia). |
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Number of arms
Last imported at : Dec. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : Dec. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
ImmuneMed, Inc. |
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Inclusion age min
Last imported at : Dec. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Dec. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Dec. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Italy;Russia |
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Type of patients
Last imported at : Dec. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Moderate/severe disease at enrollment |
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Severity scale
Last imported at : Dec. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
4: Moderate/severe disease at enrollment |
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Total sample size
Last imported at : Dec. 2, 2021, 11:30 p.m. Source : ClinicalTrials.gov |
115 |
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primary outcome
Last imported at : Dec. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Clinical failure at Day 28 |
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Notes
Last imported at : Dec. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 2 |
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Arms
Last imported at : Dec. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "100mg", "treatment_id": 616, "treatment_name": "Hzvsf-v13", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "200mg", "treatment_id": 616, "treatment_name": "Hzvsf-v13", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |