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Trial - NCT04536350


Column Value
Trial registration number NCT04536350
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04536350

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

Jörg D Leuppi, Professor

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

joerg.leuppi@ksbl.ch

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

2020-09-02

Recruitment status
Last imported at : May 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Recruiting

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 : Oct. 26, 2020, 11:31 p.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: - covid-19 infection diagnosed - risk factors for the development of an ards according to an adapted eali (early acute lung injury score) ≥ 2 points (with at least one point from the eali score) eali score: - 2-6l o2 supplementation to achieve a sao2>90%: 1 point - >6l o2 supplementation to achieve a sao2>90%: 2 points - respiratory rate ≥ 30/min: 1 point - immunosuppression: 1 point modification (for adapting for risk factors for ards in sars-cov-2 affected patients - arterial hypertension: 1 point - diabetes: 1 point - fever > 39°c: 1 point - age > 18 years - ability to adequate compliance with the inhalation manoeuvre - ability to sign the informed consent

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

- known or highly suspected bacterial infection (antibiotic treatment to avoid bacterial superinfection may be allowed) - pct ≥ 1μg/l - mechanical ventilation - inability to conduct inhalation therapy - hemodynamic instability with requirement of vasopressor therapy - severe comorbidities interfering with the safe participation at the trial according to the treating physician - pregnancy - systemic immunosuppression

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

Prof. Dr. Jörg Leuppi

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

100

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

Switzerland

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

Severe disease at enrollment

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

6: Severe disease at enrollment

Total sample size
Last imported at : Feb. 13, 2023, 8:44 a.m.
Source : ClinicalTrials.gov

132

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

time to clinical improvement

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

None

Phase
Last imported at : May 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Phase 2

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

[{"arm_notes": "", "treatment_id": 154, "treatment_name": "Aviptadil", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]