Status:
COMPLETED
A Clinical Study Evaluating Inhaled Aviptadil on COVID-19
Lead Sponsor:
Centurion Pharma
Conditions:
Covid19
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This study is a multicenter, prospective, placebo-controlled, comparative, randomized, double-blind local phase II clinical trial. Duration of study is 18 months. In the study, patients will be random...
Eligibility Criteria
Inclusion
- 18 years and older women or men, under 70 years old
- 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)
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04844580
Start Date
March 10 2021
End Date
November 22 2022
Last Update
June 5 2023
Active Locations (9)
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1
Başkent University School of Medicine
Ankara, Turkey (Türkiye)
2
Hacettepe University School of Medicine
Ankara, Turkey (Türkiye)
3
Dicle Üniversitesi Tıp Fakültesi Hastanesi
Diyarbakır, Turkey (Türkiye)
4
Başakşehir Çam ve Sakura Şehir Hastanesi
Istanbul, Turkey (Türkiye)