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| Column | Value |
|---|---|
| Trial registration number | NCT04535674 |
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Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Jan. 16, 2022, 10:30 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Jan. 16, 2022, 10:30 a.m. Source : ClinicalTrials.gov |
carola.straub@apogenix.com |
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-09-02 |
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Recruitment status
Last imported at : Jan. 16, 2022, 10:30 a.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - laboratory confirmed infection with sars-cov-2 or typical radiological signs of sars-cov-2 infection - hospitalisation due to covid-19 - informed consent obtained, the patient understands and agrees to comply with the planned study procedures. if a potential patient is unconscious, the patient information sheet with the informed consent form can be signed by the legal representative, if he/she accompanies the patient. it can be signed by a concilium consisting of doctors (2), investigator and an independent witness in case the legal representative is not available. - ≥18 years of age - willingness to perform effective measures of contraception during the study. - signs of respiratory deterioration such as oxygen saturation ≤94% when breathing ambient air or >3% drop in oxygen saturation in case of chronic obstructive lung disease or need for oxygen supplementation to achieve satisfactory blood oxygen saturation (spo2>90% at room air) as well as the need for non-invasive ventilation, high-flow oxygen devices or mechanical ventilation or radiological or clinical signs of pneumonia. |
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Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
- moribund, or estimated life expectancy <1 month (e.g., terminal cancer, etc.) - patient does not qualify for intensive care, based on local triage criteria - pregnancy or breast feeding - severe liver dysfunction (e.g. alt/ast > 5 times upper limit of normal) - anticipated discharge from hospital within 48 hours - other potent anti-inflammatory treatment, e.g. tnf- blocking therapies - mechanical ventilation for >48 hours - known active hiv or viral hepatitis infection - known active tuberculosis - known hereditary fructose intolerance |
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
4 |
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Apogenix AG |
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Russia;Spain |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Moderate/severe/critical disease at enrollment |
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
5: Moderate/severe/critical disease at enrollment |
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Total sample size
Last imported at : Jan. 16, 2022, 10:30 a.m. Source : ClinicalTrials.gov |
438 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Time to sustained improvement of one category (i.e. two consecutive days) from randomisation |
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.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 : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "25mg", "treatment_id": 132, "treatment_name": "Asunercept", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "100mg", "treatment_id": 132, "treatment_name": "Asunercept", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "400mg", "treatment_id": 132, "treatment_name": "Asunercept", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |