COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04844580

Erdem Ozdemir

ErdemOzdemir@centurion.com.tr

2021-04-14

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: 1.18 years and older women or men, under 70 years old 2.patients with positive sars-cov-2 real time pcr result and an appearance in line with covid-19 pneumonia on thorax ct 3. need for oxygen support or spo2 <94 in room air 4. patients who can use a nebulizer (with assistance when necessary) 5.patients who are willing and capable (mentally and physically) who can sign a written informed consent form, to participate in all aspects of the study, to participate in the planned visits and to comply with the terms of the protocol.

intensive care admission the need for mechanical ventilation patients with previously known organ (kidney, heart and liver) failure * to be determined as previously known heart failure (ef <30), previously known liver failure (child-pugh c) and previously known renal failure (cr.clerance <30). covid-19 disease with no indication for hospitalization participants in another clinical trial pregnancy or lactation solid organ or stem cell transplantation story patients with collagen tissue disease use of immunosuppressive therapy procalcitonin ≥2 (baseline visit) under 18 years old those who had myocardial infarction in the last 3 months those who do not have the capacity to understand the possible results, scope and nature of the study due to legal insufficiency and / or other reasons. those who, in the opinion of the investigator, cannot continue the treatment protocol regularly or cannot cooperate presence of malignancy patients with neurological diseases

2

Centurion Pharma

18

70

Turkey

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

80

Clinical improvement

None

Phase 2

[{"arm_notes": "Inhaled", "treatment_id": 155, "treatment_name": "Aviptadil (vasoactive intestinal peptide)", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]