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A Clinical Study Evaluating Inhaled Aviptadil on COVID-19 (HOPE)

Primary Purpose

Covid19

Status
Completed
Phase
Phase 2
Locations
Turkey
Study Type
Interventional
Intervention
Inhaled Aviptadil
Placebo
Sponsored by
Centurion Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Aviptadil, Inhaled, COVID-19, Pandemic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Başkent University School of Medicine
  • Hacettepe University School of Medicine
  • Dicle Üniversitesi Tıp Fakültesi Hastanesi
  • Başakşehir Çam ve Sakura Şehir Hastanesi
  • Health Sciences University Yedikule Training and Research Hospital
  • Prof. Dr. Feriha Öz Acil Durum Hastanesi
  • Prof. Dr. Murat Dilmener Acil Durum Hastanesi
  • Kocaeli Üniversitesi Tıp Fakültesi Hastanesi
  • Karadeniz Teknik Üniversitesi Tıp Fakültesi Hastanesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Standard Treatment + Placebo

Standard Treatment + Inhaled Aviptadil

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to discharge of patients
The rate of patients entering intensive care
Patients' rate of needing mechanical ventilation
Change in SpO2 (measured by pulse oximetry)
Normalization in body temperature
Dyspnea Scale (Modified Borg Dyspnea Scale (MBS)
6-minute walking test
The time it takes for patients to improvement of their symptoms (cough, shortness of breath)
The time it takes for the PCR to become negative
Sequelae and recovery rates in control thorax computed tomography at the end of month 1 and 6 months
Need for re-hospitalization
Normalization in laboratory results of blood parameters (PT, aPTT, D-dimer, Ferritin, Lymphocyte Count, CRP)
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)
Mortality rate
Normalization in Blood Pressure
Normalization in Respiration Rate/Minute
Normalization in SpO2

Full Information

First Posted
March 25, 2021
Last Updated
June 2, 2023
Sponsor
Centurion Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT04844580
Brief Title
A Clinical Study Evaluating Inhaled Aviptadil on COVID-19
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
June 7, 2022 (Actual)
Study Completion Date
November 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centurion Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Aviptadil, Inhaled, COVID-19, Pandemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Treatment + Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Standard Treatment + Inhaled Aviptadil
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Inhaled Aviptadil
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Aviptadil Placebo will be used for this arm.
Primary Outcome Measure Information:
Title
Clinical improvement
Description
Being discharged within 30 days of starting treatment, no need for oxygen support
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Time to discharge of patients
Time Frame
6 months
Title
The rate of patients entering intensive care
Time Frame
6 months
Title
Patients' rate of needing mechanical ventilation
Time Frame
6 months
Title
Change in SpO2 (measured by pulse oximetry)
Time Frame
6 months
Title
Normalization in body temperature
Time Frame
14 days
Title
Dyspnea Scale (Modified Borg Dyspnea Scale (MBS)
Time Frame
6 months
Title
6-minute walking test
Time Frame
28 days
Title
The time it takes for patients to improvement of their symptoms (cough, shortness of breath)
Time Frame
6 months
Title
The time it takes for the PCR to become negative
Time Frame
14 days
Title
Sequelae and recovery rates in control thorax computed tomography at the end of month 1 and 6 months
Time Frame
6 months
Title
Need for re-hospitalization
Time Frame
6 months
Title
Normalization in laboratory results of blood parameters (PT, aPTT, D-dimer, Ferritin, Lymphocyte Count, CRP)
Time Frame
28 days
Title
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
Title
Mortality rate
Time Frame
6 months
Title
Normalization in Blood Pressure
Time Frame
14 days
Title
Normalization in Respiration Rate/Minute
Time Frame
14 days
Title
Normalization in SpO2
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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: 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
Facility Information:
Facility Name
Başkent University School of Medicine
City
Ankara
Country
Turkey
Facility Name
Hacettepe University School of Medicine
City
Ankara
Country
Turkey
Facility Name
Dicle Üniversitesi Tıp Fakültesi Hastanesi
City
Diyarbakır
Country
Turkey
Facility Name
Başakşehir Çam ve Sakura Şehir Hastanesi
City
Istanbul
Country
Turkey
Facility Name
Health Sciences University Yedikule Training and Research Hospital
City
Istanbul
Country
Turkey
Facility Name
Prof. Dr. Feriha Öz Acil Durum Hastanesi
City
Istanbul
Country
Turkey
Facility Name
Prof. Dr. Murat Dilmener Acil Durum Hastanesi
City
Istanbul
Country
Turkey
Facility Name
Kocaeli Üniversitesi Tıp Fakültesi Hastanesi
City
Kocaeli
Country
Turkey
Facility Name
Karadeniz Teknik Üniversitesi Tıp Fakültesi Hastanesi
City
Trabzon
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Clinical Study Evaluating Inhaled Aviptadil on COVID-19

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