Low-doses Melphalan Inhalation in Patients With COVID-19 (CoronavIrus Disease 2019) Pneumonia

• Status: Recruiting
• Trial end date: 2020-10-30
• Target enrollment: 0
• Participant gender: All

Summary

This single-center, prospective, open-label, comparator study, blind for central accessor evaluates the efficacy, safety of inhalations of low-doses of melphalan in patients with pneumonia with confirmed or suspected COVID-19. All patients will receive 0,1 mg of melphalan in 7-10 daily inhalations 1 time per day.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal State Budgetary Institution, Pulmonology Scientific Research Institute
• Collaborators: Medsi Clinic #1, Moscow; Moscow State University of Medicine and Dentistry
• Treatments: Melphalan

Criteria

Inclusion Criteria:

1. Age ≥18 years

2. A patient must have confirmed the diagnosis of bi-lateral moderate / severe pneumonia ( viral or viral-bacterial with confirmed of suspected COVID-19).

3. Presence new infiltrates or increase already available infiltrates of pulmonary infiltrates on lung CT within 48 hours before baseline.

4. A patient has as minimum one of the following symptoms:

fever >38 degrees Celsius, cough, dyspnea, SaO2 (arterial oxygen saturation) <95% (with room air)

Exclusion Criteria:

1. Informed consent is withdrawn by the patient.

2. The patient doesn't follow the instructions of the research staff regarding the requirements of the research protocol.

3. Unable to contact the patient.

4. The researcher believes that participation in the study is not in the interests of the patient and / or further participation in the study is unsafe for the patient's health.

5. There is a violation of the criteria for inclusion and / or non-inclusion in the study.

6. The patient has developed an adverse event, which, according to the researcher, makes further participation in the study unsafe for the patient.

7. The licensing authority or ethics committee, for any reason, decides to discontinue the entire study or close this research center.

8. A female patient becomes pregnant, is planning a pregnancy, or is breastfeeding while participating in this study.