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Study for Efficacy and Safety Assessment of the Drug RADAMIN®VIRO for COVID-19 Postexposure Prophylaxis

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Double-Stranded RNA sodium salt
Placebo
Sponsored by
Promomed, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring SARS-CoV-2, RADAMIN®VIRO, Double-stranded RNA sodium salt

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female subjects aged 18 to 80 inclusive (subjects) as of the time of signing the Subject Information Sheet (SIS) Informed Consent Form. A subject resides with a person with confirmed COVID-19 who meets both of the following criteria: The first positive result for SARS-CoV-2 RNA laboratory test with nucleic acid amplification techniques (NAAT) or SARS-CoV-2 antigen with immunochromatographic assay, obtained up to 72 hours prior to randomisation of a subject participating in the study. At least one of the symptoms typical of COVID-19 is observed, with symptoms onset no more than 5 days prior to the randomisation of the subject participating in the study. Negative result for antigen of SARS-CoV-2 with immunochromatographic assay. No symptoms typical of COVID-19 observed. A subject is expected to continue to reside with a person with confirmed COVID-19 during the entire clinical study period; hospitalisation of a person with officially confirmed COVID-19 is not needed at the time of study subject's randomisation. Subject's consent to use reliable contraception methods during the entire study and for 3 weeks after the end of the study. Reliable contraception methods are: sexual abstinence, the use of a condom combined with a spermicidal agent. Female subjects incapable of bearing children (history: hysterectomy, tubal ligation, infertility, menopause for more than 2 years), as well as male subjects with infertility or a history of vasectomy may participate in the study. Availability of SIS Informed Consent Form signed and dated by a patient. Availability of Informed Consent Form for collection of information on COVID-19 signed and dated by a person with confirmed COVID-19. Exclusion Criteria: Hypersensitivity to the study drug components, procaine. Contraindications to intramuscular injections. Contact with 2 or more persons with confirmed COVID-19 within a month prior to screening or residing with 2 or more people with officially confirmed COVID-19 at the time of screening. Joint residence with more than 10 people. Laboratory-confirmed case of COVID-19 within 6 months prior to randomisation. Vaccination against COVID-19 within less than 4 weeks prior to screening. Use or necessity to use unauthorised pharmaceuticals at the time of screening. Use of immunostimulatory, immunomodulatory, or immunosuppressive medications within 3 months prior to screening. Subjects undergoing renal replacement therapy or with a history of severe renal insufficiency (estimated glomerular filtration rate (GFR) < 30 ml/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, within 6 months prior to screening). Primary biliary cirrhosis class C according to the Child - Pugh classification or a history of chronic or active hepatitis B or C. Positive test result for HIV, syphilis, hepatitis B and/or C at the time of screening. Chronic cardiac failure, Functional Class 3 III-IV according to the New York Heart Association (NYHA) Functional Classification. A history of malignant tumours, except for subjects with disease being not observed within the last 5 years, subjects with completely cured basal cell skin cancer, or completely cured carcinoma in situ. Alcohol, pharmacological and/or drug dependence (history and/or at the time of screening). Schizophrenia, schizoaffective disorder, bipolar disorder, or other psychiatric disorder (history or suspected) at the time of screening. Any history data that may complicate, in the opinion of the investigator, interpretation of the study results or create additional risk for the subject due to his/her participation in the study. Unwillingness or inability of a subject to comply with the Protocol procedures (in the opinion of the investigator). Pregnant or lactating women, or women planning a pregnancy. Participation in another clinical study within 3 months prior to enrolment in the present study. Other conditions that prevent the subject from inclusion in the study.

Sites / Locations

  • Regional Budgetary Healthcare Institution Ivanovo Clinical Hospital
  • Federal State Budgetary Educational Institution of Higher Education Kirov State Medical University of Ministry of Health of the Russian Federation
  • State Budgetary Healthcare Institution of Moscow Municipal Clinical Hospital Named after S. I. Spasokukotsky of Moscow Healthcare Department
  • Professorskaya Klinika LLC
  • Avrora MedFort LLC
  • Eco-Safety R&D Centre LLC
  • OrCli Hospital LLC
  • Federal State Budgetary Educational Institution of Higher Education N. P. Ogarev Mordovia State University
  • Federal State Budgetary Educational Institution of Higher Education Smolensk State Medical University of Ministry of Health of the Russian Federation Principal Investigator Kozlov Roman Sergeevich
  • Regional State Budgetary Healthcare Institution Clinical Hospital No. 1

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Double-stranded RNA sodium salt

Placebo

Arm Description

Arm 1 (n=400) received the study drug RADAMIN®VIRO once intramuscularly, 5 mg (1 vial).

Arm 2 (n = 400) received 1 vial of placebo once intramuscularly

Outcomes

Primary Outcome Measures

Confirmed COVID-19 and presence of at least 1 symptom typical of COVID-19
The number of subjects with confirmed COVID-19 and presence of at least 1 symptom typical of COVID-19

Secondary Outcome Measures

Confirmed COVID-19 and presence of at least 1 symptom typical of COVID-19
The number of subjects with confirmed COVID-19 and presence of at least 1 symptom typical of COVID-19
Сonfirmed COVID-19 and absence of symptoms typical for COVID-19
The number of subjects with confirmed COVID-19 and absence of symptoms typical for COVID-19
Сonfirmed COVID-19 and absence of symptoms typical for COVID-19
The number of subjects with confirmed COVID-19 and absence or presence of symptoms typical of COVID-19
Time to COVID-19 infection
Days to COVID-19 infection
Symptoms typical of COVID-19
The severity of symptoms typical of COVID-19
Duration of symptoms typical of COVID-19
Duration of symptoms (days) typical of COVID-19
COVID-19 severity evaluation
COVID-19 severity evaluation
Hospitalisation due to COVID-19
The number of subjects who needed hospitalisation due to COVID-19
Total adverse events (AEs) stratified by severity and incidence
Number of AEs stratified by severity and incidence
Incidence of serious adverse events (SAEs), including those due to the use of the study drug/placebo.
Number of SAEs including those due to the use of the study drug/placebo.

Full Information

First Posted
February 9, 2023
Last Updated
February 14, 2023
Sponsor
Promomed, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05722691
Brief Title
Study for Efficacy and Safety Assessment of the Drug RADAMIN®VIRO for COVID-19 Postexposure Prophylaxis
Official Title
Double-Blind, Placebo-Controlled Multicentre Clinical Study for Efficacy and Safety Assessment of the Drug RADAMIN®VIRO for COVID-19 Postexposure Prophylaxis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 9, 2022 (Actual)
Primary Completion Date
November 22, 2022 (Actual)
Study Completion Date
January 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Promomed, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is Double-Blind, Placebo-Controlled Multicentre Clinical Phase III Study conducted in 10 medical facilities. The objective of the study is to evaluate efficacy and safety of the drug Drug RADAMIN®VIRO, Lyophilisate for Preparation of Solution for Intramuscular and Subcutaneous Administration for COVID-19 Postexposure Prophylaxis
Detailed Description
Upon signing the informed consent form and screening, 800 eligible subjects resides with a person with confirmed COVID-19 were randomized at a 1:1 ratio to receive either RADAMIN®VIRO once intramuscularly 5 mg (1 vial) or 1 vial of placebo once intramuscularly

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
SARS-CoV-2, RADAMIN®VIRO, Double-stranded RNA sodium salt

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Double-stranded RNA sodium salt
Arm Type
Experimental
Arm Description
Arm 1 (n=400) received the study drug RADAMIN®VIRO once intramuscularly, 5 mg (1 vial).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Arm 2 (n = 400) received 1 vial of placebo once intramuscularly
Intervention Type
Drug
Intervention Name(s)
Double-Stranded RNA sodium salt
Other Intervention Name(s)
RADAMIN®VIRO
Intervention Description
Once intramuscular injection 5 mg (1 vial)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once intramuscular injection (1 vial)
Primary Outcome Measure Information:
Title
Confirmed COVID-19 and presence of at least 1 symptom typical of COVID-19
Description
The number of subjects with confirmed COVID-19 and presence of at least 1 symptom typical of COVID-19
Time Frame
From baseline to Visit 3 (days 10-11)
Secondary Outcome Measure Information:
Title
Confirmed COVID-19 and presence of at least 1 symptom typical of COVID-19
Description
The number of subjects with confirmed COVID-19 and presence of at least 1 symptom typical of COVID-19
Time Frame
From baseline to Visit 2 (days 3-4), 4 (days 21 ± 1), 5 (days 28 ± 1)
Title
Сonfirmed COVID-19 and absence of symptoms typical for COVID-19
Description
The number of subjects with confirmed COVID-19 and absence of symptoms typical for COVID-19
Time Frame
From baseline to Visit 2 (days 3-4), 3 (days 10-11)
Title
Сonfirmed COVID-19 and absence of symptoms typical for COVID-19
Description
The number of subjects with confirmed COVID-19 and absence or presence of symptoms typical of COVID-19
Time Frame
From baseline to Visit 2 (days 3-4), 3 (days 10-11), 4 (days 21 ± 1), 5 (days 28 ± 1)
Title
Time to COVID-19 infection
Description
Days to COVID-19 infection
Time Frame
From baseline to Visit 5 (study completion, day 28±1)
Title
Symptoms typical of COVID-19
Description
The severity of symptoms typical of COVID-19
Time Frame
From baseline to Visit 2 (days 3-4), 3 (days 10-11), 4 (days 21 ± 1), 5 (days 28 ± 1)
Title
Duration of symptoms typical of COVID-19
Description
Duration of symptoms (days) typical of COVID-19
Time Frame
From baseline to Visit 5 (study completion, day 28±1)
Title
COVID-19 severity evaluation
Description
COVID-19 severity evaluation
Time Frame
From baseline to Visit 2 (days 3-4), 3 (days 10-11), 4 (days 21 ± 1), 5 (days 28 ± 1)
Title
Hospitalisation due to COVID-19
Description
The number of subjects who needed hospitalisation due to COVID-19
Time Frame
From baseline to Visit 5 (study completion, day 28±1)
Title
Total adverse events (AEs) stratified by severity and incidence
Description
Number of AEs stratified by severity and incidence
Time Frame
From baseline to Visit 5 (study completion, day 28±1)
Title
Incidence of serious adverse events (SAEs), including those due to the use of the study drug/placebo.
Description
Number of SAEs including those due to the use of the study drug/placebo.
Time Frame
From baseline to Visit 5 (study completion, day 28±1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female subjects aged 18 to 80 inclusive (subjects) as of the time of signing the Subject Information Sheet (SIS) Informed Consent Form. A subject resides with a person with confirmed COVID-19 who meets both of the following criteria: The first positive result for SARS-CoV-2 RNA laboratory test with nucleic acid amplification techniques (NAAT) or SARS-CoV-2 antigen with immunochromatographic assay, obtained up to 72 hours prior to randomisation of a subject participating in the study. At least one of the symptoms typical of COVID-19 is observed, with symptoms onset no more than 5 days prior to the randomisation of the subject participating in the study. Negative result for antigen of SARS-CoV-2 with immunochromatographic assay. No symptoms typical of COVID-19 observed. A subject is expected to continue to reside with a person with confirmed COVID-19 during the entire clinical study period; hospitalisation of a person with officially confirmed COVID-19 is not needed at the time of study subject's randomisation. Subject's consent to use reliable contraception methods during the entire study and for 3 weeks after the end of the study. Reliable contraception methods are: sexual abstinence, the use of a condom combined with a spermicidal agent. Female subjects incapable of bearing children (history: hysterectomy, tubal ligation, infertility, menopause for more than 2 years), as well as male subjects with infertility or a history of vasectomy may participate in the study. Availability of SIS Informed Consent Form signed and dated by a patient. Availability of Informed Consent Form for collection of information on COVID-19 signed and dated by a person with confirmed COVID-19. Exclusion Criteria: Hypersensitivity to the study drug components, procaine. Contraindications to intramuscular injections. Contact with 2 or more persons with confirmed COVID-19 within a month prior to screening or residing with 2 or more people with officially confirmed COVID-19 at the time of screening. Joint residence with more than 10 people. Laboratory-confirmed case of COVID-19 within 6 months prior to randomisation. Vaccination against COVID-19 within less than 4 weeks prior to screening. Use or necessity to use unauthorised pharmaceuticals at the time of screening. Use of immunostimulatory, immunomodulatory, or immunosuppressive medications within 3 months prior to screening. Subjects undergoing renal replacement therapy or with a history of severe renal insufficiency (estimated glomerular filtration rate (GFR) < 30 ml/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, within 6 months prior to screening). Primary biliary cirrhosis class C according to the Child - Pugh classification or a history of chronic or active hepatitis B or C. Positive test result for HIV, syphilis, hepatitis B and/or C at the time of screening. Chronic cardiac failure, Functional Class 3 III-IV according to the New York Heart Association (NYHA) Functional Classification. A history of malignant tumours, except for subjects with disease being not observed within the last 5 years, subjects with completely cured basal cell skin cancer, or completely cured carcinoma in situ. Alcohol, pharmacological and/or drug dependence (history and/or at the time of screening). Schizophrenia, schizoaffective disorder, bipolar disorder, or other psychiatric disorder (history or suspected) at the time of screening. Any history data that may complicate, in the opinion of the investigator, interpretation of the study results or create additional risk for the subject due to his/her participation in the study. Unwillingness or inability of a subject to comply with the Protocol procedures (in the opinion of the investigator). Pregnant or lactating women, or women planning a pregnancy. Participation in another clinical study within 3 months prior to enrolment in the present study. Other conditions that prevent the subject from inclusion in the study.
Facility Information:
Facility Name
Regional Budgetary Healthcare Institution Ivanovo Clinical Hospital
City
Ivanovo
Country
Russian Federation
Facility Name
Federal State Budgetary Educational Institution of Higher Education Kirov State Medical University of Ministry of Health of the Russian Federation
City
Kirov
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of Moscow Municipal Clinical Hospital Named after S. I. Spasokukotsky of Moscow Healthcare Department
City
Moscow
Country
Russian Federation
Facility Name
Professorskaya Klinika LLC
City
Perm
Country
Russian Federation
Facility Name
Avrora MedFort LLC
City
Saint Petersburg
Country
Russian Federation
Facility Name
Eco-Safety R&D Centre LLC
City
Saint Petersburg
Country
Russian Federation
Facility Name
OrCli Hospital LLC
City
Saint Petersburg
Country
Russian Federation
Facility Name
Federal State Budgetary Educational Institution of Higher Education N. P. Ogarev Mordovia State University
City
Saransk
Country
Russian Federation
Facility Name
Federal State Budgetary Educational Institution of Higher Education Smolensk State Medical University of Ministry of Health of the Russian Federation Principal Investigator Kozlov Roman Sergeevich
City
Smolensk
Country
Russian Federation
Facility Name
Regional State Budgetary Healthcare Institution Clinical Hospital No. 1
City
Smolensk
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

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Study for Efficacy and Safety Assessment of the Drug RADAMIN®VIRO for COVID-19 Postexposure Prophylaxis

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