AzTrials
AzTrials

Covid19Phase 2HOPENCT04844580

A Clinical Study Evaluating Inhaled Aviptadil on COVID-19

A Phase 2 study testing Inhaled Aviptadil in people with Covid19, run by Centurion Pharma at 9 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Covid19
What is being tested?
Inhaled Aviptadil
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
9 sitesTurkey (Türkiye)
Study dates
10 Mar 2021to 22 Nov 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Turkey (Türkiye)9 sites

  • Başkent University School of Medicine

    Ankara

  • Hacettepe University School of Medicine

    Ankara

  • Dicle Üniversitesi Tıp Fakültesi Hastanesi

    Diyarbakır

  • Başakşehir Çam ve Sakura Şehir Hastanesi

    Istanbul

  • Health Sciences University Yedikule Training and Research Hospital

    Istanbul

  • Prof. Dr. Feriha Öz Acil Durum Hastanesi

    Istanbul

  • Prof. Dr. Murat Dilmener Acil Durum Hastanesi

    Istanbul

  • Kocaeli Üniversitesi Tıp Fakültesi Hastanesi

    Kocaeli

  • Karadeniz Teknik Üniversitesi Tıp Fakültesi Hastanesi

    Trabzon

Other trials in Turkey (Türkiye)

About this study

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

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
Being tested
Inhaled Aviptadil, Placebo
Keywords
Aviptadil, Inhaled, COVID-19, Pandemic
Medical subject headings
COVID-19, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inhaled AviptadilDrug

    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.

  • PlaceboDrug

    Aviptadil Placebo will be used for this arm.

Study groups in NCT04844580
Study groupRoleWhat they receive
Standard Treatment + PlaceboPlacebo comparatorStandard 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.
Receives: Drug: Placebo
Standard Treatment + Inhaled AviptadilExperimentalIn 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.
Receives: Drug: Inhaled Aviptadil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical improvement

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

    Measured: 6 months

Secondary outcomes (17)

  1. Time to discharge of patients

    Measured: 6 months

  2. The rate of patients entering intensive care

    Measured: 6 months

  3. Patients' rate of needing mechanical ventilation

    Measured: 6 months

  4. Change in SpO2 (measured by pulse oximetry)

    Measured: 6 months

  5. Normalization in body temperature

    Measured: 14 days

  6. Dyspnea Scale (Modified Borg Dyspnea Scale (MBS)

    Measured: 6 months

  7. 6-minute walking test

    Measured: 28 days

  8. The time it takes for patients to improvement of their symptoms (cough, shortness of breath)

    Measured: 6 months

  9. The time it takes for the PCR to become negative

    Measured: 14 days

  10. Sequelae and recovery rates in control thorax computed tomography at the end of month 1 and 6 months

    Measured: 6 months

  11. Need for re-hospitalization

    Measured: 6 months

  12. Normalization in laboratory results of blood parameters (PT, aPTT, D-dimer, Ferritin, Lymphocyte Count, CRP)

    Measured: 28 days

  13. 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)

    Measured: 28 days

  14. Mortality rate

    Measured: 6 months

  15. Normalization in Blood Pressure

    Measured: 14 days

  16. Normalization in Respiration Rate/Minute

    Measured: 14 days

  17. Normalization in SpO2

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2021
  2. Study start10 Mar 2021
  3. Primary completion7 Jun 2022
  4. Study completion22 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Double blind
Who is masked
Participant, Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04844580
Sponsor's protocol ID
K-AY001-HOPE
Acronym
HOPE
Status last verified
Jun 2023
First submitted
25 Mar 2021
Last updated
5 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Esendagli D, Sari N, Akhan S, Arslan S, Dogan Ontas IA, Yilmaz G, Aksoy F, Kant A, Yasar KK, Unlu EC, Akilli IK, Celen MK, Mermutluoglu C, Dayan S, Kara E, Durhan G, Unal S, Demirkol B, Arafat L, Cetinkaya E, Cortuk M, Durmus Kocak N, Parmaksiz ET, Inkaya AC. Inhaled Aviptadil Is a New Hope for Recovery of Lung Damage due to COVID-19. Med Princ Pract. 2025;34(2):191-200. doi: 10.1159/000543773. Epub 2025 Jan 27.

    PubMed 39870064

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Inhaled Aviptadil in people with Covid19, run by Centurion Pharma at 9 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical improvement (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04844580, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
HOPE Clinical Trial NCT04844580 | AzTrials