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 randomized in a ratio of 1: 1 into two arms, standard medical therapy + placebo versus standard medical therapy + inhaled Aviptadil arms. Randomization will be carried out by the block randomization method. In the event that patients need intensive care in the study, the patients will be taken into intensive care unit and excluded from the study and their treatment will be continued in the intensive care unit as deemed appropriate by the physician and it is foreseen that inhaled Aviptadil will be used for a period of minimum 7 and maximum 14 days. Aviptadil will be discontinued in patients who do not heal after 14 days. This study includes 8 visits, consisting of a total of 7 physical visits and 1 phone follow-up visit. The study period will be 6 months for each patient. Patient recruitment is planned to take 12 months. Study centers will be asked to use investigational products for their patients who sign the informed consent form for 12 months. The study population will consist of patients 18 years of age and older with COVID-19 pulmonary involvement and hospitalized patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Aviptadil is the synthetic analogue of the Vasoactive Intestinal Peptide (VIP), a biologically active 28 amino acid natural peptide that is endogenously synthesized in humans. It is one of the signaling molecules of the neuroendocrine immune network and has vasodilator, anti-proliferative, anti-inflammatory and immunomodulatory properties.
Aviptadil Placebo will be used for this arm.
Başkent University School of Medicine
Ankara, Turkey (Türkiye)
Hacettepe University School of Medicine
Ankara, Turkey (Türkiye)
Dicle Üniversitesi Tıp Fakültesi Hastanesi
Diyarbakır, Turkey (Türkiye)
Başakşehir Çam ve Sakura Şehir Hastanesi
Istanbul, Turkey (Türkiye)
Health Sciences University Yedikule Training and Research Hospital
Istanbul, Turkey (Türkiye)
Prof. Dr. Feriha Öz Acil Durum Hastanesi
Istanbul, Turkey (Türkiye)
Prof. Dr. Murat Dilmener Acil Durum Hastanesi
Istanbul, Turkey (Türkiye)
Kocaeli Üniversitesi Tıp Fakültesi Hastanesi
Kocaeli, Turkey (Türkiye)
Karadeniz Teknik Üniversitesi Tıp Fakültesi Hastanesi
Trabzon, Turkey (Türkiye)
Clinical improvement
Being discharged within 30 days of starting treatment, no need for oxygen support
Time frame: 6 months
Time to discharge of patients
Time frame: 6 months
The rate of patients entering intensive care
Time frame: 6 months
Patients' rate of needing mechanical ventilation
Time frame: 6 months
Change in SpO2 (measured by pulse oximetry)
Time frame: 6 months
Normalization in body temperature
Time frame: 14 days
Dyspnea Scale (Modified Borg Dyspnea Scale (MBS)
Time frame: 6 months
6-minute walking test
Time frame: 28 days
The time it takes for patients to improvement of their symptoms (cough, shortness of breath)
Time frame: 6 months
The time it takes for the PCR to become negative
Time frame: 14 days
Sequelae and recovery rates in control thorax computed tomography at the end of month 1 and 6 months
Time frame: 6 months
Need for re-hospitalization
Time frame: 6 months
Normalization in laboratory results of blood parameters (PT, aPTT, D-dimer, Ferritin, Lymphocyte Count, CRP)
Time frame: 28 days
Normalization in laboratory results of biochemistry parameters (Glucose, ALT, AST, LDH, Total Bilirubin, Total Protein, Albumin, Alkaline Phosphatase, GGT, Sodium, Potassium, Calcium, Phosphor, CPK, Magnesium, eGFR, BUN, Uric Acid, Creatinine Clearance)
Time frame: 28 days
Mortality rate
Time frame: 6 months
Normalization in Blood Pressure
Time frame: 14 days
Normalization in Respiration Rate/Minute
Time frame: 14 days
Normalization in SpO2
Time frame: 14 days
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