Inhalation Low Dose Radionuclide Therapy in Treatment COVID-19

July 4, 2021 updated by: Andrey Kaprin, National Medical Research Radiological Centre of the Ministry of Health of Russia

Inhalation Low Dose Radionuclide Therapy in Comprehensive Treatment of COVID-19 Viral Pneumonia

Coronavirus disease (COVID-19) is a pandemic of unprecedented proportions with an exponential increase in incidence. Airway epithelium infection caused by coronavirus (SARS-CoV-2) triggers a cascade of difficult-to-control reactions, a so-called "cytokine storm". In contrast to the previously used method of external beam radiation therapy for patients at high risk of a cytokine storm, in present study a different dose delivery mechanism through inhalation of 99mTc-labeled carbon ultrafine aerosol obtained from a TechnegasPlus generator is used. By utilizing anthropometric phantoms the dosimetric characteristics of the applied technique and obtained the coefficients of the transition from the count rate over the area of interest to the activity contained in this area (in kBq) were studied. By observing a group of healthy volunteers after inhalation of 99mTc-labeled carbon ultrafine aerosol, the accumulated dose in the human lungs under internal irradiation of 99mTc was determined. A novel technique has been developed and the possibility of using inhaled low-dose radionuclide therapy in the complex treatment of patients with COVID-19 - associated pneumonia has been studied. As a result, a significant improvement of hematological parameters in the group of patients after inhalation of 99mTc-labeled carbon ultrafine aerosol as compared to the control group is expected.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 125284
        • P. Hertsen Moscow Oncology Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Positive SARS-Cov-2 polymerase chain reaction (PCR)
  2. CT confirmed pneumonia
  3. Men and non-pregnant women ≥ 18 y/o with early laboratory signs of cytokine storm
  4. Men and non-pregnant women <65 y/o and/or with early laboratory signs of cytokine storm
  5. Informed consent obtained for participation

Exclusion Criteria:

  1. Age ≤ 18
  2. Severe course of COVID-19
  3. Pregnant or breast-feeding females
  4. Severe concomitant pathology
  5. Previous and/or present treatment of oncology disease (e.g. immunotherapy)
  6. Autoimmune diseases, severe cardiac disease, bone marrow and/or visceral transplantation
  7. Surgical treatment and/or radiotherapy of chest pathology
  8. Treatment with specific antiviral and anticytokine agents a day before inhalation procedure
  9. Absence of informed consent obtained for participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Healthy volunteers
CT-scans for exclusion of pneumonia. Accumulated absorbed dose calculation of volunteers' lungs after inhalation of 99mTc-pertechnetate aerosol from commercial gas generator which was loaded by 833 MBq of 99mTc-pertechnetate.
Radiation: 99mTc-pertechnetate aerosol
99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol
Experimental: Patient with COVID-19 pneumonia
Inhalation of 99mTc-pertechnetate aerosol from commercial gas generator which was loaded by 4165 MBq of 99mTc-pertechnetate. CT scans a day before, 7 and 14 days after inhalation procedure. Blood tests a day before, 1, 3 and 7 days after inhalation procedure.
Drug: 99mTc-pertechnetate aerosol
99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol
No Intervention: Patient with COVID-19 pneumonia without intervention
Blood tests at 1, 3 and 7 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Count of White Blood Cells (WBC) After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.
Time Frame: Days 1, 3 and 7 after inhalation
Patients with COVID-19 viral pneumonia were observed for safety after administration of 99mTc-pertechnetate aerosol inhalation, and followed up at 1, 3, 7 days after inhalation. Patients did blood test to observe for abnormalities in clinical parameters and compare to baseline results as assessed by CTCAE v5.0. These tests were also performed in patients with COVID-19 viral pneumonia receiving standard treatment. The results were compared between the two groups.
Days 1, 3 and 7 after inhalation
Count of Red Blood Cells (RBC) After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.
Time Frame: Days 1, 3 and 7 after inhalation
Patients with COVID-19 viral pneumonia were observed for safety after administration of 99mTc-pertechnetate aerosol inhalation, and followed up at 1, 3, 7 days after inhalation. Patients did blood test to observe for abnormalities in clinical parameters and compare to baseline results as assessed by CTCAE v5.0. These tests were also performed in patients with COVID-19 viral pneumonia receiving standard treatment. The results were compared between the two groups.
Days 1, 3 and 7 after inhalation
Hemoglobin Count (Hb) After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.
Time Frame: Days 1, 3 and 7 after inhalation
Patients with COVID-19 viral pneumonia were observed for safety after administration of 99mTc-pertechnetate aerosol inhalation, and followed up at 1, 3, 7 days after inhalation. Patients did blood test to observe for abnormalities in clinical parameters and compare to baseline results as assessed by CTCAE v5.0. These tests were also performed in patients with COVID-19 viral pneumonia receiving standard treatment. The results were compared between the two groups.
Days 1, 3 and 7 after inhalation
Percentage of Neutrophils (N) After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.
Time Frame: Days 1, 3 and 7 after inhalation
Patients with COVID-19 viral pneumonia were observed for safety after administration of 99mTc-pertechnetate aerosol inhalation, and followed up at 1, 3, 7 days after inhalation. Patients did blood test to observe for abnormalities in clinical parameters and compare to baseline results as assessed by CTCAE v5.0. These tests were also performed in patients with COVID-19 viral pneumonia receiving standard treatment. The results were compared between the two groups.
Days 1, 3 and 7 after inhalation
Absolute Neutrophil Count (ANC) After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.
Time Frame: Days 1, 3 and 7 after inhalation
Patients with COVID-19 viral pneumonia were observed for safety after administration of 99mTc-pertechnetate aerosol inhalation, and followed up at 1, 3, 7 days after inhalation. Patients did blood test to observe for abnormalities in clinical parameters and compare to baseline results as assessed by CTCAE v5.0. These tests were also performed in patients with COVID-19 viral pneumonia receiving standard treatment. The results were compared between the two groups.
Days 1, 3 and 7 after inhalation
Absolute Lymphocyte Count (ALC) After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.
Time Frame: Days 1, 3 and 7 after inhalation
Patients with COVID-19 viral pneumonia were observed for safety after administration of 99mTc-pertechnetate aerosol inhalation, and followed up at 1, 3, 7 days after inhalation. Patients did blood test to observe for abnormalities in clinical parameters and compare to baseline results as assessed by CTCAE v5.0. These tests were also performed in patients with COVID-19 viral pneumonia receiving standard treatment. The results were compared between the two groups.
Days 1, 3 and 7 after inhalation
Level of Lactate in the Blood After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.
Time Frame: Days 1, 3 and 7 after inhalation
Patients with COVID-19 viral pneumonia were observed for safety after administration of 99mTc-pertechnetate aerosol inhalation, and followed up at 1, 3, 7 days after inhalation. Patients did blood test to observe for abnormalities in clinical parameters and compare to baseline results as assessed by CTCAE v5.0. These tests were also performed in patients with COVID-19 viral pneumonia receiving standard treatment. The results were compared between the two groups.
Days 1, 3 and 7 after inhalation
Level of D-dimer in Blood After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.
Time Frame: Days 1, 3 and 7 after inhalation
Patients with COVID-19 viral pneumonia were observed for safety after administration of 99mTc-pertechnetate aerosol inhalation, and followed up at 1, 3, 7 days after inhalation. Patients did blood test to observe for abnormalities in clinical parameters and compare to baseline results as assessed by CTCAE v5.0. These tests were also performed in patients with COVID-19 viral pneumonia receiving standard treatment. The results were compared between the two groups.
Days 1, 3 and 7 after inhalation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Level of CD4+ T-cells in Blood After 99mTc-pertechnetate Aerosol Inhalation for Evaluation of Cellular Immune Response After This Procedure in Patients With COVID-19 Viral Pneumonia
Time Frame: Days 1, 3 and 7 after inhalation
Patients with COVID-19 viral pneumonia were observed for safety after administration of 99mTc-pertechnetate aerosol inhalation, and followed up at 1, 3, 7 days after inhalation. Patients did blood test to observe for abnormalities in clinical parameters and compare to baseline results as assessed by CTCAE v5.0. These tests were also performed in patients with COVID-19 viral pneumonia receiving standard treatment. The results were compared between the two groups.
Days 1, 3 and 7 after inhalation
Level of NK-cells in Blood After 99mTc-pertechnetate Aerosol Inhalation for Evaluation of Cellular Immune Response After This Procedure in Patients With COVID-19 Viral Pneumonia
Time Frame: Days 1, 3 and 7 after inhalation
Patients with COVID-19 viral pneumonia were observed for safety after administration of 99mTc-pertechnetate aerosol inhalation, and followed up at 1, 3, 7 days after inhalation. Patients did blood test to observe for abnormalities in clinical parameters and compare to baseline results as assessed by CTCAE v5.0. These tests were also performed in patients with COVID-19 viral pneumonia receiving standard treatment. The results were compared between the two groups.
Days 1, 3 and 7 after inhalation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Medical Research Radiological Centre of the Ministry of Health of Russia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 10, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RNT COVID-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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