A Clinical Study Evaluating Inhaled Aviptadil on COVID-19

Covid19 Clinical Trial

— HOPE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04844580
• Other study ID #: K-AY001-HOPE
• Status: Completed
• Phase: Phase 2
• Start date: March 10, 2021
• Est. completion date: November 22, 2022

Study information

• Verified date: June 2023
• Source: Centurion Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 22, 2022
• Est. primary completion date: June 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Inhaled Aviptadil
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.
• Placebo
Aviptadil Placebo will be used for this arm.

Locations

Country	Name	City	State
Turkey	Baskent University School of Medicine	Ankara
Turkey	Hacettepe University School of Medicine	Ankara
Turkey	Dicle Üniversitesi Tip Fakültesi Hastanesi	Diyarbakir
Turkey	Basaksehir Çam ve Sakura Sehir Hastanesi	Istanbul
Turkey	Health Sciences University Yedikule Training and Research Hospital	Istanbul
Turkey	Prof. Dr. Feriha Öz Acil Durum Hastanesi	Istanbul
Turkey	Prof. Dr. Murat Dilmener Acil Durum Hastanesi	Istanbul
Turkey	Kocaeli Üniversitesi Tip Fakültesi Hastanesi	Kocaeli
Turkey	Karadeniz Teknik Üniversitesi Tip Fakültesi Hastanesi	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Centurion Pharma

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical improvement	Being discharged within 30 days of starting treatment, no need for oxygen support	6 months
Secondary	Time to discharge of patients		6 months
Secondary	The rate of patients entering intensive care		6 months
Secondary	Patients' rate of needing mechanical ventilation		6 months
Secondary	Change in SpO2 (measured by pulse oximetry)		6 months
Secondary	Normalization in body temperature		14 days
Secondary	Dyspnea Scale (Modified Borg Dyspnea Scale (MBS)		6 months
Secondary	6-minute walking test		28 days
Secondary	The time it takes for patients to improvement of their symptoms (cough, shortness of breath)		6 months
Secondary	The time it takes for the PCR to become negative		14 days
Secondary	Sequelae and recovery rates in control thorax computed tomography at the end of month 1 and 6 months		6 months
Secondary	Need for re-hospitalization		6 months
Secondary	Normalization in laboratory results of blood parameters (PT, aPTT, D-dimer, Ferritin, Lymphocyte Count, CRP)		28 days
Secondary	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)		28 days
Secondary	Mortality rate		6 months
Secondary	Normalization in Blood Pressure		14 days
Secondary	Normalization in Respiration Rate/Minute		14 days
Secondary	Normalization in SpO2		14 days