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

NCT05722691 | Completed Phase 3

• 1 other identifier: RAD-012022
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 10

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

Conditions

COVID-19

Keywords

SARS-CoV-2; RADAMIN®VIRO; Double-stranded RNA sodium salt

Outcome Measures

Primary Outcomes (1)

• 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

  From baseline to Visit 3 (days 10-11)

Secondary Outcomes (10)

• Confirmed COVID-19 and presence of at least 1 symptom typical of COVID-19

  From baseline to Visit 2 (days 3-4), 4 (days 21 ± 1), 5 (days 28 ± 1)

• Сonfirmed COVID-19 and absence of symptoms typical for COVID-19

  From baseline to Visit 2 (days 3-4), 3 (days 10-11)

• Сonfirmed COVID-19 and absence of symptoms typical for COVID-19

  From baseline to Visit 2 (days 3-4), 3 (days 10-11), 4 (days 21 ± 1), 5 (days 28 ± 1)

• Time to COVID-19 infection

  From baseline to Visit 5 (study completion, day 28±1)

• Symptoms typical of COVID-19

  From baseline to Visit 2 (days 3-4), 3 (days 10-11), 4 (days 21 ± 1), 5 (days 28 ± 1)

Study Arms (2)

Double-stranded RNA sodium salt

EXPERIMENTAL

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

Drug: Double-Stranded RNA sodium salt

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Double-Stranded RNA sodium salt DRUG

Once intramuscular injection 5 mg (1 vial)

Also known as: RADAMIN®VIRO

Double-stranded RNA sodium salt

Placebo DRUG

Once intramuscular injection (1 vial)

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Promomed, LLC: lead

Study Sites (10)

Regional Budgetary Healthcare Institution Ivanovo Clinical Hospital

Ivanovo, Russia

Location

Federal State Budgetary Educational Institution of Higher Education Kirov State Medical University of Ministry of Health of the Russian Federation

Kirov, Russia

Location

State Budgetary Healthcare Institution of Moscow Municipal Clinical Hospital Named after S. I. Spasokukotsky of Moscow Healthcare Department

Moscow, Russia

Location

Professorskaya Klinika LLC

Perm, Russia

Location

Avrora MedFort LLC

Saint Petersburg, Russia

Location

Eco-Safety R&D Centre LLC

Saint Petersburg, Russia

Location

OrCli Hospital LLC

Saint Petersburg, Russia

Location

Federal State Budgetary Educational Institution of Higher Education N. P. Ogarev Mordovia State University

Saransk, Russia

Location

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

Smolensk, Russia

Location

Regional State Budgetary Healthcare Institution Clinical Hospital No. 1

Smolensk, Russia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 10, 2023
• Study Start: June 9, 2022
• Primary Completion: November 22, 2022
• Study Completion: January 17, 2023
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (10)