A Clinical Study Evaluating Inhaled Aviptadil on COVID-19

NCT04844580 | Completed Phase 2

• 1 other identifier: K-AY001-HOPE
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 9

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.

Conditions

Covid19

Keywords

Aviptadil; Inhaled; COVID-19; Pandemic

Outcome Measures

Primary Outcomes (1)

• Clinical improvement

  Being discharged within 30 days of starting treatment, no need for oxygen support

  6 months

Secondary Outcomes (17)

• Time to discharge of patients

  6 months

• The rate of patients entering intensive care

  6 months

• Patients' rate of needing mechanical ventilation

  6 months

• Change in SpO2 (measured by pulse oximetry)

  6 months

• Normalization in body temperature

  14 days

Study Arms (2)

Standard Treatment + Placebo

PLACEBO COMPARATOR

Standard medical treatment, as deemed appropriate by physicians, is going to be according to the Turkish Republic COVID-19 (SARS-CoV-2 INFECTION) ADULT PATIENT TREATMENT GUIDELINES published by the Ministry of Health, General Directorate of Public Health. The management of all additional complications and / or symptoms that develop in patients will be managed in the same way as specified in these guidelines. If these guidelines are changed by the Turkish Republic Ministry of Health General Directorate of Public Health, a protocol amendment will be planned. The necessary changes within the scope of urgent security measures will be reflected in the standard treatment in accordance with the necessary regulations.

Drug: Placebo

Standard Treatment + Inhaled Aviptadil

EXPERIMENTAL

In addition to the standard medical treatment mentioned above, patients randomized to this arm will be given Inhaled Aviptadil 2 times a day, 30 minutes apart. Aviptadil treatment is aimed to be a minimum of 7 days and a maximum of 14 days. Aviptadil will be discontinued in patients who do not heal after 14 days. The dose of inhaled Aviptadil was determined by evaluating the results of the Phase 1 and Phase 2 studies.

Drug: Inhaled Aviptadil

Interventions

Inhaled Aviptadil DRUG

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.

Standard Treatment + Inhaled Aviptadil

Placebo DRUG

Aviptadil Placebo will be used for this arm.

Standard Treatment + Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \. Need for oxygen support or SpO2 \<94 in room air
• \. 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centurion Pharma: lead

Study Sites (9)

Başkent University School of Medicine

Ankara, Turkey (Türkiye)

Location

Hacettepe University School of Medicine

Ankara, Turkey (Türkiye)

Location

Dicle Üniversitesi Tıp Fakültesi Hastanesi

Diyarbakır, Turkey (Türkiye)

Location

Başakşehir Çam ve Sakura Şehir Hastanesi

Istanbul, Turkey (Türkiye)

Location

Health Sciences University Yedikule Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Prof. Dr. Feriha Öz Acil Durum Hastanesi

Istanbul, Turkey (Türkiye)

Location

Prof. Dr. Murat Dilmener Acil Durum Hastanesi

Istanbul, Turkey (Türkiye)

Location

Kocaeli Üniversitesi Tıp Fakültesi Hastanesi

Kocaeli, Turkey (Türkiye)

Location

Karadeniz Teknik Üniversitesi Tıp Fakültesi Hastanesi

Trabzon, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 14, 2021
• Study Start: March 10, 2021
• Primary Completion: June 7, 2022
• Study Completion: November 22, 2022
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (9)