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NCT04844580·Phase 2·INTERVENTIONAL

A Clinical Study Evaluating Inhaled Aviptadil on COVID-19

Status

Completed

Phase

Phase 2

Enrollment

80

Locations

9

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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

Treatment arms and agents.

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.

DRUG

Placebo

Aviptadil Placebo will be used for this arm.

Timeline

From registration to results.

  1. First posted

    Apr 14, 2021

  2. Study start

    Mar 10, 2021

  3. Primary completion

    Jun 7, 2022

  4. Study completion

    Nov 22, 2022

  5. Results posted

    Not reported

  6. Registry updated

    Jun 5, 2023

Outcomes

What the study measures.

Primary outcomes

Clinical improvement

Time frame · 6 months

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

Secondary outcomes

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
70 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

9 registered sites.

Turkey (Türkiye). Showing up to 24 locations stored in the fast local snapshot.

Başkent University School of Medicine

Ankara, Turkey (Türkiye)

Hacettepe University School of Medicine

Ankara, Turkey (Türkiye)

Dicle Üniversitesi Tıp Fakültesi Hastanesi

Diyarbakır, Turkey (Türkiye)

Başakşehir Çam ve Sakura Şehir Hastanesi

Istanbul, Turkey (Türkiye)

Health Sciences University Yedikule Training and Research Hospital

Istanbul, Turkey (Türkiye)

Prof. Dr. Feriha Öz Acil Durum Hastanesi

Istanbul, Turkey (Türkiye)

Prof. Dr. Murat Dilmener Acil Durum Hastanesi

Istanbul, Turkey (Türkiye)

Kocaeli Üniversitesi Tıp Fakültesi Hastanesi

Kocaeli, Turkey (Türkiye)

Karadeniz Teknik Üniversitesi Tıp Fakültesi Hastanesi

Trabzon, Turkey (Türkiye)

Related trials

More studies on Aviptadil.

Related PeptideStat pages

Put the record in context.

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