COVID-19 Clinical Trial
— MICOVOfficial title:
Single-center, Prospective, Open-label, Comparator Study, Blind for Central Accessor to Access the Efficacy, Safety, and Tolerability of Inhalations of Low-doses of Melphalan in Patients With Pneumonia With Confirmed or Suspected COVID-19
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | October 30, 2020 |
Est. primary completion date | October 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 Informed consent is withdrawn by the patient. 2.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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Clinical hospital | Moscow | |
Russian Federation | Kirill Zykov | Moscow |
Lead Sponsor | Collaborator |
---|---|
Federal State Budgetary Institution, Pulmonology Scientific Research Institute | Medsi Clinic #1, Moscow, Moscow State University of Medicine and Dentistry |
Russian Federation,
Pukhal'skii AL, Shmarina GV, Zykov KA, Aleshkin VA. [Effect of steroid therapy on the clinical course of bronchial asthma]. Vestn Ross Akad Med Nauk. 2009;(6):3-9. Review. Russian. — View Citation
Pukhalsky A, Shmarina G, Alioshkin V, Sabelnikov A. Alkylating drugs applied in non-cytotoxic doses as a novel compounds targeting inflammatory signal pathway. Biochem Pharmacol. 2006 Nov 30;72(11):1432-8. Epub 2006 Mar 14. Review. — View Citation
Pukhalsky AL, Shmarina GV. Stimulatory and protective effects of alkylating agents applied in ultra-low concentrations. Pharmacology. 2001;62(3):129-32. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The changes of COVID Ordinal Outcomes Scale | The number of patients with the clinical improvement is defined as an improvement of two points (from the status at baseline) on an ordinal scale of clinical improvement on day 28 or discharge from hospital ( whatever occurs earlier) Death Hospitalized with Invasive mechanical ventilation plus additional organ support - ECMO / pressors / RRT Hospitalized with intubation and mechanical ventilation Hospitalized on non-invasive ventilation or high flow oxygen. Hospitalized on a mask or nasal prongs. Hospitalized no oxygen therapy. Ambulatory, with limitation of activities. Ambulatory, no limitation of activities. I. No clinical or virological evidence of infection. |
baseline vs Day 14, day 28 | |
Primary | Percentage of the patients with Clinical Recovery | Percentage of the patients with clinical recovery which is defined as a normalisation of fever, respiratory rate, and oxygen saturation, and improvement of cough, sustained for at least 72 hours, or live hospital discharge, whichever comes first. Normalization and improvement criteria: Fever - <37°C, Respiratory rate - =24/minute on room air, Oxygen saturation - >94% on room air, Cough - mild or absent on a patient reported scale of severe, moderate, mild, absent. |
baseline vs day 7, day 14, day 28 | |
Primary | The changes of the Borg's scale | The evaluation of changes in modified Borg dyspnea scale. From 0 to 10 units.A lower score means a better clinical result (0 is the absence of dyspnea, and 10 - is maximal dyspnea). Minimal clinically important difference is 1 unit. | Baseline vs day 7, day 14, day 28 | |
Secondary | CRP level | Change in C-reactive protein (CRP) level from baseline in mg/ml. A lower level of CRP means a better clinical result. | baseline, day 7, Day 14, Day 28 | |
Secondary | Lymphocyte count | Change in blood absolute lymphocyte count from baseline. A higher number of lymphocytes means a better clinical result. | baseline, day 7, Day 14, Day 28 | |
Secondary | D-dimer | Change in blood D-dimer level from baseline. A lower level of D-dimer means a better clinical result. | baseline, day 7, Day 14, Day 28 | |
Secondary | IL-6 | Change in peripheral blood IL-6 level from baseline. A lower level of IL-6 means a better clinical result. | baseline, day 7, Day 14, Day 28 | |
Secondary | Percentage of patients without artificial lung ventilation | Percentage of patients without artificial lung ventilation during the study. A lower percentage of patients means a better clinical result. | baseline, day 7, Day 14, Day 28 |
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