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Trial - NCT04530136


Column Value
Trial registration number NCT04530136
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04530136

First author
Last imported at : June 4, 2022, 2 p.m.
Source : ClinicalTrials.gov

Jonathan Bernstein

Contact
Last imported at : June 4, 2022, 2 p.m.
Source : ClinicalTrials.gov

not reported

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-08-28

Recruitment status
Last imported at : June 4, 2022, 2 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : Feb. 17, 2024, 8 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - age 18-85 years, - admitted to the hospital because of confirmed positive sars-cov-2 (covid-19 infection). - evidence of pulmonary involvement on ct scan or x-ray of the chest, - symptom onset within the previous 10 days and at least one additional risk factor for progression to mechanical ventilation: 1) arterial hypertension, 2) >50 years, 3) obesity (bmi>30.0 kg/m2), 4) history of cardiovascular disease, 5) chronic pulmonary disease, 7) chronic renal disease, 6) c-reactive protein of >35mg/l, 7) oxygen saturation at rest in ambient air of <94%

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- contraindications to the class of drugs under study (c1 esterase inhibitor); - history or suspicion of allergy to rabbits; - women who are of childbearing potential and not using methods of contraception during the entire study period; - pregnant or breastfeeding females or has a positive serum β-human chorionic gonadotropin (hcg) pregnancy test at screening; - chronic liver disease (any child-pugh score b or c); - currently admitted to an icu or expected admission within the next 24 hours; and - currently receiving invasive or non-invasive ventilation

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Pharming Technologies B.V.

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

85

Countries
Last imported at : Dec. 12, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : June 4, 2022, 2 p.m.
Source : ClinicalTrials.gov

38

primary outcome
Last imported at : Feb. 17, 2024, 8 a.m.
Source : ClinicalTrials.gov

Number of Participants With Each Score on WHO 7-point Outcome Scale at Day 7

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 319, "treatment_name": "Conestat alfa", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]