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Trial record 1 of 1 for:    NCT04844580
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A Clinical Study Evaluating Inhaled Aviptadil on COVID-19 (HOPE)

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ClinicalTrials.gov Identifier: NCT04844580
Recruitment Status : Recruiting
First Posted : April 14, 2021
Last Update Posted : April 27, 2021
Sponsor:
Collaborator:
Klinar CRO
Information provided by (Responsible Party):
Centurion Pharma

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.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Inhaled Aviptadil Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator)
Masking Description: Double-blind
Primary Purpose: Treatment
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
Actual Study Start Date : March 10, 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
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.
Drug: Placebo
Aviptadil Placebo will be used for this arm.

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.
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.




Primary Outcome Measures :
  1. Clinical improvement [ Time Frame: 6 months ]
    Being discharged within 30 days of starting treatment, no need for oxygen support


Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04844580


Locations
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Turkey
Başkent University School of Medicine Recruiting
Ankara, Turkey
Contact: Erdem Ozdemir    +90 212 275 0708 (1300)    Erdem Özdemir <ErdemOzdemir@centurion.com.tr>   
Principal Investigator: Dorina Rama Esendaglı         
Hacettepe University School of Medicine Recruiting
Ankara, Turkey
Contact: Erdem Özdemir    +90 212 275 0708 (1300)    Erdem Özdemir <ErdemOzdemir@centurion.com.tr>   
Principal Investigator: Çağkan İnkaya         
Health Sciences University Yedikule Training and Research Hospital Recruiting
Istanbul, Turkey
Contact: Erdem Özdemir    +90 212 275 0708 (1300)    Erdem Özdemir <ErdemOzdemir@centurion.com.tr>   
Principal Investigator: Erdoğan Çetinkaya         
Sponsors and Collaborators
Centurion Pharma
Klinar CRO
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Responsible Party: Centurion Pharma
ClinicalTrials.gov Identifier: NCT04844580    
Other Study ID Numbers: K-AY001-HOPE
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centurion Pharma:
Aviptadil
Inhaled
COVID-19
Pandemic
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes