Trial · Interventional

CompletedPhase 2Registry data

A Clinical Study Evaluating Inhaled Aviptadil on COVID-19

Short name HOPE

NCTNCT04844580Other idK-AY001-HOPE

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 80 participants (actual)
Sponsor: Centurion Pharma · Industry
Design: Randomized · Double masking
Countries: 1 country
Turkey (Türkiye)
Start: 10 Mar 2021
Primary completion: 7 Jun 2022
Completion: 22 Nov 2022
First posted: 14 Apr 2021
Last update posted: 5 Jun 2023
Conditions: Covid19

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202120222023

Ph 2
HOPE
NCT04844580
10 Mar 2021 to 22 Nov 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Inhaled AviptadilDrug
PlaceboDrug

Arms2

Placebo comparator
Standard Treatment + Placebo
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.
Experimental
Standard Treatment + Inhaled Aviptadil
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Clinical improvement
Time frame · 6 months
Registry description
Being discharged within 30 days of starting treatment, no need for oxygen support

Secondary outcomes(17)

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

7 results

Inhaled Aviptadil Is a New Hope for Recovery of Lung Damage due to COVID-19.

Esendagli et al. 2025Medical principles and practice : international journal of the Kuwait University, Health Science Centrecited by 7

PMID 39870064PMC11936437DOI 10.1159/000543773PUB-39870064

Free to read · publisher termsCC BY-NC7 results

Read at source See results (7)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 70 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

PepBank is a research reference. Talk to a doctor before you use any peptide.