A Clinical Study Evaluating Inhaled Aviptadil on COVID-19 (HOPE)
Covid19
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Aviptadil, Inhaled, COVID-19, Pandemic
Eligibility 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:
- 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
Sites / Locations
- Başkent University School of Medicine
- Hacettepe University School of Medicine
- Dicle Üniversitesi Tıp Fakültesi Hastanesi
- Başakşehir Çam ve Sakura Şehir Hastanesi
- Health Sciences University Yedikule Training and Research Hospital
- Prof. Dr. Feriha Öz Acil Durum Hastanesi
- Prof. Dr. Murat Dilmener Acil Durum Hastanesi
- Kocaeli Üniversitesi Tıp Fakültesi Hastanesi
- Karadeniz Teknik Üniversitesi Tıp Fakültesi Hastanesi
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Standard Treatment + Placebo
Standard Treatment + Inhaled Aviptadil
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.
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.