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NCT Number: NCT04844580

A Clinical Study Evaluating Inhaled Aviptadil on COVID-19

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Başkent University School of Medicine, Ankara, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

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.

Placebo

Drug

Aviptadil Placebo will be used for this arm.

Primary outcomes

  1. Clinical improvement

    Time frame: 6 months

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

Secondary outcomes

  1. Time to discharge of patients

    Time frame: 6 months

  2. The rate of patients entering intensive care

    Time frame: 6 months

  3. Patients' rate of needing mechanical ventilation

    Time frame: 6 months

  4. Change in SpO2 (measured by pulse oximetry)

    Time frame: 6 months

  5. Normalization in body temperature

    Time frame: 14 days

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

    Time frame: 6 months

  7. 6-minute walking test

    Time frame: 28 days

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

    Time frame: 6 months

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

    Time frame: 14 days

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

    Time frame: 6 months

  11. Need for re-hospitalization

    Time frame: 6 months

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

    Time frame: 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)

    Time frame: 28 days

  14. Mortality rate

    Time frame: 6 months

  15. Normalization in Blood Pressure

    Time frame: 14 days

  16. Normalization in Respiration Rate/Minute

    Time frame: 14 days

  17. Normalization in SpO2

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Centurion Pharma

Industry

Registry information

Official study 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

Acronym: HOPE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 14, 2021
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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