Status:
UNKNOWN
Low-doses Melphalan Inhalation in Patients With COVID-19 (CoronavIrus Disease 2019) Pneumonia
Lead Sponsor:
Federal State Budgetary Institution, Pulmonology Scientific Research Institute
Collaborating Sponsors:
Medsi Clinic #1, Moscow
Moscow State University of Medicine and Dentistry
Conditions:
COVID-19
Viral Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 confir...
Detailed Description
It was previously shown that in ultra-low (more than 100 times lower than conventional therapeutic) doses inhalations of alkylating drug (melphalan) are effective in severe steroid-resistant bronchial...
Eligibility Criteria
Inclusion
- Age ≥18 years
- A patient must have confirmed the diagnosis of bi-lateral moderate / severe pneumonia ( viral or viral-bacterial with confirmed of suspected COVID-19).
- Presence new infiltrates or increase already available infiltrates of pulmonary infiltrates on lung CT within 48 hours before baseline.
- 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
- Informed consent is withdrawn by the patient.
- The patient doesn't follow the instructions of the research staff regarding the requirements of the research protocol.
- Unable to contact the patient.
- 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.
- There is a violation of the criteria for inclusion and / or non-inclusion in the study.
- The patient has developed an adverse event, which, according to the researcher, makes further participation in the study unsafe for the patient.
- The licensing authority or ethics committee, for any reason, decides to discontinue the entire study or close this research center.
- A female patient becomes pregnant, is planning a pregnancy, or is breastfeeding while participating in this study.
Key Trial Info
Start Date :
April 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04380376
Start Date
April 30 2020
End Date
October 30 2020
Last Update
May 12 2020
Active Locations (2)
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1
Kirill Zykov
Moscow, Russia, 115682
2
Clinical hospital
Moscow, Russia, 125430