Clinical trial NCT04844580: A Clinical Study Evaluating Inhaled Aviptadil on COVID-19
Official title: A Comparative, Multicenter, Placebo-Controlled, Double-Blind Phase II Clinical Trial Evaluating the Efficacy, Safety and Tolerability of Inhaled Aviptadil in Patients 18 Years and Older With COVID-19 Pulmonary Involvement - HOPE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Covid19
Keywords: Aviptadil
Inhaled
COVID-19
Pandemic
Lead sponsor: Centurion Pharma
Sponsor class: INDUSTRY
First posted: 2021-04-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Exclusion Criteria:

1. Intensive care admission
2. The need for mechanical ventilation
3. 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).
4. COVID-19 disease with no indication for hospitalization
5. Participants in another clinical trial
6. Pregnancy or lactation
7. Solid organ or stem cell transplantation story
8. Patients with collagen tissue disease
9. Use of immunosuppressive therapy
10. Procalcitonin ≥2 (baseline visit)
11. Under 18 years old
12. Those who had myocardial infarction in the last 3 months
13. 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.
14. Those who, in the opinion of the investigator, cannot continue the treatment protocol regularly or cannot cooperate
15. Presence of malignancy
16. Patients with neurological diseases

Primary outcomes:
measure: Clinical improvement
timeFrame: 6 months
Secondary outcomes:
measure: Time to discharge of patients
timeFrame: 6 months
measure: The rate of patients entering intensive care
timeFrame: 6 months
measure: Patients' rate of needing mechanical ventilation
timeFrame: 6 months
measure: Change in SpO2 (measured by pulse oximetry)
timeFrame: 6 months
measure: Normalization in body temperature
timeFrame: 14 days
measure: Dyspnea Scale (Modified Borg Dyspnea Scale (MBS)
timeFrame: 6 months
measure: 6-minute walking test
timeFrame: 28 days
measure: The time it takes for patients to improvement of their symptoms (cough, shortness of breath)
timeFrame: 6 months
measure: The time it takes for the PCR to become negative
timeFrame: 14 days
measure: Sequelae and recovery rates in control thorax computed tomography at the end of month 1 and 6 months
timeFrame: 6 months
measure: Need for re-hospitalization
timeFrame: 6 months
measure: Normalization in laboratory results of blood parameters (PT, aPTT, D-dimer, Ferritin, Lymphocyte Count, CRP)
timeFrame: 28 days
measure: 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)
timeFrame: 28 days
measure: Mortality rate
timeFrame: 6 months
measure: Normalization in Blood Pressure
timeFrame: 14 days
measure: Normalization in Respiration Rate/Minute
timeFrame: 14 days
measure: Normalization in SpO2
timeFrame: 14 days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Başkent University School of Medicine
city: Ankara
country: Turkey
facility: Hacettepe University School of Medicine
city: Diyarbakır
country: Turkey
facility: Dicle Üniversitesi Tıp Fakültesi Hastanesi
city: Istanbul
country: Turkey
facility: Başakşehir Çam ve Sakura Şehir Hastanesi
city: Istanbul
country: Turkey
facility: Health Sciences University Yedikule Training and Research Hospital
city: Istanbul
country: Turkey
facility: Prof. Dr. Feriha Öz Acil Durum Hastanesi
city: Istanbul
country: Turkey
facility: Prof. Dr. Murat Dilmener Acil Durum Hastanesi
city: Kocaeli
country: Turkey
facility: Kocaeli Üniversitesi Tıp Fakültesi Hastanesi
city: Trabzon
country: Turkey
facility: Karadeniz Teknik Üniversitesi Tıp Fakültesi Hastanesi
Study officials:
References: