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COVID-19Phase 3NCT05722691

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

A Phase 3 study testing Double-Stranded RNA sodium salt in people with COVID-19, run by Promomed, LLC at 10 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
COVID-19
What is being tested?
Double-Stranded RNA sodium salt
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
800 participants
Where
10 sitesRussia
Study dates
9 Jun 2022to 17 Jan 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Russia10 sites

  • Regional Budgetary Healthcare Institution Ivanovo Clinical Hospital

    Ivanovo

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

    Kirov

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

    Moscow

  • Professorskaya Klinika LLC

    Perm

  • Avrora MedFort LLC

    Saint Petersburg

  • Eco-Safety R&D Centre LLC

    Saint Petersburg

  • OrCli Hospital LLC

    Saint Petersburg

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

    Saransk

  • 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

  • Regional State Budgetary Healthcare Institution Clinical Hospital No. 1

    Smolensk

Other trials in Russia

About this study

Official title: Double-Blind, Placebo-Controlled Multicentre Clinical Study for Efficacy and Safety Assessment of the Drug RADAMIN®VIRO for COVID-19 Postexposure Prophylaxis

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

Read the 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

Conditions
COVID-19
Being tested
Double-Stranded RNA sodium salt, Placebo
Keywords
SARS-CoV-2, RADAMIN®VIRO, Double-stranded RNA sodium salt
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Double-Stranded RNA sodium saltDrug

    Also called RADAMIN®VIRO

    Once intramuscular injection 5 mg (1 vial)

  • PlaceboDrug

    Once intramuscular injection (1 vial)

Study groups in NCT05722691
Study groupRoleWhat they receive
Double-stranded RNA sodium saltExperimentalArm 1 (n=400) received the study drug RADAMIN®VIRO once intramuscularly, 5 mg (1 vial).
Receives: Drug: Double-Stranded RNA sodium salt
PlaceboPlacebo comparatorArm 2 (n = 400) received 1 vial of placebo once intramuscularly
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From baseline to Visit 3 (days 10-11)

Secondary outcomes (10)

  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

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

  2. 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

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

  3. 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

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

  4. Time to COVID-19 infection

    Days to COVID-19 infection

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

  5. Symptoms typical of COVID-19

    The severity of symptoms typical of COVID-19

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

  6. Duration of symptoms typical of COVID-19

    Duration of symptoms (days) typical of COVID-19

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

  7. COVID-19 severity evaluation

    COVID-19 severity evaluation

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

  8. Hospitalisation due to COVID-19

    The number of subjects who needed hospitalisation due to COVID-19

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

  9. Total adverse events (AEs) stratified by severity and incidence

    Number of AEs stratified by severity and incidence

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

  10. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2023
  2. Study start9 Jun 2022
  3. Primary completion22 Nov 2022
  4. Study completion17 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05722691
Sponsor's protocol ID
RAD-012022
Status last verified
Feb 2023
First submitted
9 Feb 2023
Last updated
16 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Double-Stranded RNA sodium salt in people with COVID-19, run by Promomed, LLC at 10 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed COVID-19 and presence of at least 1 symptom typical of COVID-19 (time frame: From baseline to Visit 3 (days 10-11)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05722691.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.

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