Inhalation Low Dose Radionuclide Therapy in Treatment COVID-19

NCT ID: NCT04724538

Last Updated: 2021-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2021-03-15

Brief Summary

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.

Conditions

Covid19; Pneumonia, Viral

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

99mTc-pertechnetate aerosol

Intervention Type: RADIATION

99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol

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.

Group Type: EXPERIMENTAL

99mTc-pertechnetate aerosol

Intervention Type: DRUG

99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol

Patient with COVID-19 pneumonia without intervention

Blood tests at 1, 3 and 7 days.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

99mTc-pertechnetate aerosol

99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol

Intervention Type: RADIATION

99mTc-pertechnetate aerosol

99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Medical Research Radiological Centre of the Ministry of Health of Russia

OTHER

Sponsor Role: lead

Responsible Party

Andrey Kaprin

general director of the National Medical Research Radiological Centre of the Ministry of Health of Russia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

P. Hertsen Moscow Oncology Research Institute

Moscow, , Russia

Countries

Russia

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

RNT COVID-19

Identifier Type: -

Identifier Source: org_study_id