AzTrials
AzTrials

COVID-19Phase 1NCT05208996

The siCoV/KK46 Drug Open-safety Study

A Phase 1 study testing siCoV/KK46 in people with COVID-19, run by National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia at 1 site in Russia.

Completed

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

Official record
Search all trials

Trial summary

This is an open-label, dose-escalation phase I study to assess the safety and tolerability of siCoV/KK46 in healthy volunteers. The purpose of this study is to determine the maximum daily dose of siCoV/KK46 as a single agent in adult healthy participants. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
siCoV/KK46
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteRussia
Study dates
22 Jan 2021to 26 Mar 2021
Phase
Phase 1
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 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy men aged 18 to 45 years
  • Able to give informed consent and attend all study visits
  • Blood pressure level: systolic blood pressure 100 to 139 mm Hg, diastolic blood pressure 60 to 89 mm Hg.
  • Heart rate from 60 to 90 beats per minute
  • Body mass index 18.5 -30. The body weight should be ≥ 55 kg;
  • Men must agree to use the reliable contraception while on study medication and for posttrial contraception for 30 days
  • Be able to understand and comply with protocol requirements

Who cannot join

  • A burdened allergic history.
  • Previous adverse reactions to the active substance and/or excipients included in the drug.
  • Chronic diseases of the cardiovascular, lymphatic, respiratory, nervous, endocrine, digestive, musculoskeletal, integumentary, immune systems, as well as the genitourinary apparatus and hematopoietic organs.
  • Weakness of the inspiratory muscles of respiration (according to spirometry result).
  • Acute infectious diseases symptoms in the last 4 weeks before screening.
  • Treatment with any medicine that have a pronounced effect on hemodynamics and affects the liver function (barbiturates, omeprazole, cimetidine, etc.) within 2 months prior to screening.
Show all 18Show fewer
  • Regular treatment with any medicine less than 2 weeks prior to screening and single treatment less than 7 days prior screening.
  • Donation of blood or plasma less than 3 months prior to screening.
  • Transfusion of blood and/or its components less than 3 months prior to screening.
  • Participation in other investigational drug or device clinical trials within 90 days prior to screening.
  • Drinking of more than 10 units of alcohol (1 unit of alcohol is equivalent to 330 mL of beer, 150 mL of wine or 40 mL of strong alcoholic drinks) per week within the last month prior to inclusion in the study and/or history of alcohol, drug or chemical abuse.
  • Smoking more than 10 cigarettes currently, or history of smoking this number of cigarettes within 6 months prior to screening.
  • Positive blood tests for HIV, hepatitis B and С, syphilis. Positive PCR test results for SARS-CoV-2(nasal swab).
  • Positive result on a urine drug screening test.
  • Positive test for ethanol vapor in exhaled air.
  • Planned hospitalization during the period of participation in the study, for any reason other than hospitalization specified by this protocol.
  • Inability or inability to follow the protocol, to perform the procedures prescribed by the protocol, to follow a diet, activity regime.
  • Any conditions that, according to the researcher's, may be a contraindication to the participation in the study.

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • NRC Institute of Immunology FMBA

    Moscow, 115478

Other trials in Russia

About this study

Official title: An Open-safety Study of the siCoV/KK46 Drug Administered Via an Inhaled Route in Healthy Volunteers

This is an open-label, dose-escalation phase I study to assess the safety and tolerability of siCoV/KK46 in healthy volunteers. The purpose of this study is to determine the maximum daily dose of siCoV/KK46 as a single agent in adult healthy participants. Based on preclinical data from this institution, the investigators hypothesize that SARS-CoV-2 inhibition with siCoV/KK46 could potentially reduce pulmonary inflammation, thereby improving COVID-19 patient outcomes.

Read the detailed description

This is an open-label, dose-escalation phase I study to assess the safety and tolerability of single and multiple doses of siCoV/KK46 in healthy male volunteers.

This study include 3 cohorts received 3.7 mg, 11.1 mg, 22.2 mg of the siCoV/KK46, respectively, via inhalation route.

All subjects will undergo scheduled safety and tolerability assessments while in the clinical unit and as outpatients to the end of the follow-up period.

Conditions
COVID-19
Being tested
siCoV/KK46
Keywords
COVID-19, siRNA, SARS-CoV-2
Medical subject headings
COVID-19

What participants receive

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

  • siCoV/KK46Drug

    The modified phase I "3 + 1+1" study design was used in dose escalation from low dose to high dose to determine the maximum daily dose. Sequential assignment of Patient cohorts to one of three dose levels of inhaled siCoV/KK46: 3.7 mg, 11.1 mg, 22.2 mg.

Study groups in NCT05208996
Study groupRoleWhat they receive
siCoV/KK46ExperimentalDrug contains anti-SARS-CoV-2 siRNAs/KK-46 (peptide dendrimer) complexes for inhalation use
Receives: Drug: siCoV/KK46

What is being measured

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

  1. This is an open-label, dose-escalation phase I study to assess the safety and tolerability of siCoV/KK46 in healthy volunteers

    Adverse Events

    Measured: Within 72 hours after single treatment with siCoV/KK46

  2. Vital Signs

    Blood pressure in mm Hg

    Measured: Within 72 hours after single treatment with siCoV/KK46

  3. Body Temperature control

    Taking an Axillary Temperature

    Measured: Within 72 hours after single treatment with siCoV/KK46

  4. Heart rate

    Heart Rate in beats per minute

    Measured: Within 72 hours after single treatment with siCoV/KK46

  5. Clinical Chemistry to asses Potassium level

    Measurement of Potassium level in blood

    Measured: Within 72 hours after single treatment with siCoV/KK46

  6. Clinical Chemistry to asses Sodium level

    Measurement of Sodium level in blood

    Measured: Within 72 hours after single treatment with siCoV/KK46

  7. Clinical Chemistry to asses Chloride level

    Measurement of Chloride level in blood

    Measured: Within 72 hours after single treatment with siCoV/KK46

  8. Clinical Chemistry to asses Bicarbonate level

    Measurement of Bicarbonate level in blood

    Measured: Within 72 hours after single treatment with siCoV/KK46

  9. Clinical Chemistry to asses Calcium level

    Measurement of Calcium level in blood

    Measured: Within 72 hours after single treatment with siCoV/KK46

  10. Clinical Chemistry to asses Phosphate level

    Measurement of Phosphate level in blood

    Measured: Within 72 hours after single treatment with siCoV/KK46

  11. Clinical Chemistry to asses Creatine phosphokinase level

    Measurement of Creatine phosphokinase level in blood

    Measured: Within 72 hours after single treatment with siCoV/KK46

  12. Clinical Chemistry to asses Blood urea nitrogen level

    Measurement of Blood urea nitrogen level

    Measured: Within 72 hours after single treatment with siCoV/KK46

  13. Clinical Chemistry to asses Albumin level

    Measurement of Albumin level in blood

    Measured: Within 72 hours after single treatment with siCoV/KK46

  14. Clinical Chemistry to asses Protein level

    Measurement of Protein level in blood

    Measured: Within 72 hours after single treatment with siCoV/KK46

  15. Clinical Chemistry to asses Aspartate transaminase level

    Measurement of Aspartate transaminase level in blood

    Measured: Within 72 hours after single treatment with siCoV/KK46

  16. Clinical Chemistry to asses Alanine transaminase level

    Measurement of Alanine transaminase level in blood

    Measured: Within 72 hours after single treatment with siCoV/KK46

  17. Clinical Chemistry to asses Alkaline phosphatase level

    Measurement of Alkaline phosphatase level in blood

    Measured: Within 72 hours after single treatment with siCoV/KK46

  18. Clinical Chemistry to asses Bilirubin level

    Measurement of Bilirubin level in blood

    Measured: Within 72 hours after single treatment with siCoV/KK46

  19. Blood Glucose Test

    Measurement of Glucose level

    Measured: Within 72 hours after single treatment with siCoV/KK46

  20. Haematology blood test

    Qualitative and quantitative composition of the cellular components of the blood

    Measured: Within 72 hours after single treatment with siCoV/KK46

  21. Urinalysis

    Physical, chemical, and microscopic examination of urine

    Measured: Within 72 hours after single treatment with siCoV/KK46

  22. 12-Lead Electrocardiogram

    Measurement of Heart rate; PR, QRS, RR, QT and QTc intervals from digital recordings

    Measured: Within 72 hours after single treatment with siCoV/KK46

Timeline

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

  1. First posted26 Jan 2022
  2. Study start22 Jan 2021
  3. Primary completion26 Mar 2021
  4. Study completion26 Mar 2021

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
This is a dose-escalation trial, all participants will receive single or multiple treatment with siCoV/KK46 via an inhaled route. Participants enrolled in this trial may receive one of the following doses: Cohort 1: 3.7 mg; Cohort 2: 11.1 mg; Cohort 3: 22.2 mg
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05208996
Sponsor's protocol ID
SiCoV/KK46-2020
Status last verified
Jan 2022
First submitted
30 Nov 2021
Last updated
26 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing siCoV/KK46 in people with COVID-19, run by National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia at 1 site 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 7 inclusion and 18 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 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

This is an open-label, dose-escalation phase I study to assess the safety and tolerability of siCoV/KK46 in healthy volunteers (time frame: Within 72 hours after single treatment with siCoV/KK46). The study lists 22 primary outcomes in all. 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 NCT05208996.

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 26 Jan 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in