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PharmacokineticsNCT05648799

Pharmacokinetics, Safety and Efficacy Study of GP30341 (GEROPHARM, Russia)

A study testing GP30341 capsules 200 mg and Standard therapy in people with Pharmacokinetics and Safety Issues, run by Geropharm at 5 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

Pharmacokinetics, safety and efficacy study of GP30341, 200 mg capsules (GEROPHARM LLC, Russia) in healthy volunteers and patients with novel coronavirus infection 2019 (COVID-19) with a high risk of adverse outcome Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pharmacokinetics, Safety Issues, Efficacy
What is being tested?
GP30341 capsules 200 mg and Standard therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
246 participants
Where
5 sitesRussia
Study dates
17 Mar 2022to 20 Jul 2022
Phase
Interventional
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Signed informed consent to participate in the study.
  • Males with a verified diagnosis "healthy" according to the data of standard clinical, laboratory and instrumental examination methods.
  • Age 18-45 years old inclusive.
  • Body mass index 18.5 - 30 kg/m2.
  • Agree to use an adequate method of contraception (double barrier method) during the entire period of participation in the study and for 3 weeks after its completion.
  • Consent to all restrictions imposed during the study.
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  • Citizenship of the Russian Federation.
  • Signed informed consent to participate in the study.
  • Male and female patients aged ≥18 years at the time of providing informed consent.
  • Laboratory confirmation of COVID-19 infection ≤5 days prior to randomization1, defined as a positive RT-PCR test for SARS-CoV-2 RNA and/or a positive antigen test for SARS-CoV-2 in a nasal swab.
  • Clinical onset of COVID-19 infection (as ≥1 symptom consistent with COVID-19) ≤5 days prior to randomization.
  • Presence of ≥1 symptom consistent with COVID-19 at time of randomization3.
  • Mild to moderate COVID-19 infection with ≥1 risk factor for adverse outcome.
  • WHO (World Health Organization) Clinical Progression Scale score ≥3 at screening 6.
  • Consent and ability to take oral medications.
  • Agree to use reliable contraceptive measures throughout the study and for 3 weeks after - Negative pregnancy test in women capable of childbearing.
  • Consent and ability to comply with the Protocol's procedures, prohibitions and restrictions.

Who cannot join

  • Burdened allergic history, drug intolerance.
  • Hypersensitivity to heparin, molnupiravir and any of the excipients of the study drug.
  • Any acute and chronic diseases, incl. but not limited to:
  • diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract (including diseases of the colon), liver, kidneys, blood;
  • positive test results for hepatitis C (antibodies) or hepatitis B (surface antigen), HIV (antibodies to HIV-1/2), syphilis (antibodies to Treponema pallidum).
  • Deviations from normal values of heart rate (60-89), SBP (90-130 mm Hg), DBP (60-89 mm Hg), NPV (12-20), body temperature (35.7 - 37.0 °C).
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  • ECG Deviations, according to a specialist, during screening.
  • laboratory tests results deviations from the normal values.
  • Hard-to-reach veins of the upper extremities, vein thrombosis, thrombophlebitis in a family history of close relatives, "compromised" veins due to frequent previous venipunctures.
  • Surgical interventions on the gastrointestinal tract (with the exception of appendectomy) in history.
  • Acute infectious diseases less than 4 weeks prior to screening.
  • Presence of at least one of the epidemic signs:
  • return from overseas travel 14 days prior to screening and no test results for SARS-CoV-2 RNA or SARS-CoV-2 antigen;
  • close contact in the last 14 days prior to screening with a person under observation for COVID-19 who subsequently fell ill;
  • close contact in the past 14 days prior to screening with individuals who have laboratory-confirmed case of COVID-19;
  • Occupational contacts in the past 14 days prior to screening with individuals who have a suspected or confirmed case of COVID-I9.
  • Regular intake of any medications, including vitamins, herbal preparations, and dietary supplements, less than 2 weeks before screening.
  • Significant blood loss (more than 450 ml of blood or plasma) within 3 months prior to screening, due to, including, but not limited to, blood donation, blood loss during advanced surgery or trauma.
  • Drinking alcohol in quantities exceeding 10 units per week (on average) (1 unit of alcohol is equivalent to 500 ml of beer, 200 ml of dry wine or 50 ml of strong alcoholic drinks) or anamnestic information about alcoholism, drug addiction, abuse of strong drugs.
  • Positive test results for alcohol, drug use and the use of strong drugs.
  • Nicotine addiction (regular tobacco use, including smoking of all types of electronic cigarettes, hookahs, snuff, etc. less than 6 months prior to screening).
  • Participation in a clinical trial of any drugs (including experimental drugs) or experimental medical devices for 3 months or 5 half-lives prior to Screening, whichever is longer.
  • Dehydration due to diarrhea, vomiting, or other cause within the last 24 hours prior to screening.
  • Any diet (eg vegetarian, fasting, etc.) or lifestyle (including night work and extreme physical activity such as heavy lifting) that may interfere with the study.
  • Taking drugs that have a pronounced effect on hemodynamics, liver function, etc. (barbiturates, omeprazole, cimetidine, etc.) less than 30 days before screening.
  • Mental diseases, history of epilepsy, seizures.
  • Volunteers who are obviously or likely, in the opinion of the investigator, unable to understand and evaluate the information on this study as part of the informed consent process, in particular regarding expected risks and possible discomfort.
  • Stage2:
  • Hypersensitivity or intolerance reactions to any of the components of the test drug or the proposed standard therapy drugs according to the anamnesis.
  • Vaccination to prevent COVID-19 within 6 months prior to screening or planning vaccination during the study period.
  • Vaccination with any vaccine within 4 weeks prior to screening.
  • Use of drugs from the list of prohibited therapy (section 5.3.3 of the Study Protocol) in the anamnesis or their planned use during the study period.
  • Past infection with COVID-19 within 6 months prior to screening.
  • Current hospitalization or, in the opinion of the Investigator, expected hospitalization within 48 hours after randomization.
  • Dysfunction of organs that affect the absorption and metabolism of the test drug, which include, but are not limited to the following:
  • diseases of the gastrointestinal tract, which, in the opinion of the researcher, may interfere with the absorption of the contents of the capsules;
  • Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 or 5 chronic kidney disease;
  • Signs of significant uncontrolled comorbidity, such as disorders of the nervous, respiratory, cardiovascular, kidney, liver, endocrine, or gastrointestinal tract, that persist at the time of screening and, in the opinion of the Investigator, significantly increase the risk of adverse outcome and preclude participation patient in the study.
  • Acute pancreatitis or exacerbation of chronic pancreatitis ≤3 months prior to randomization.
  • Severe immunodeficiency states, which include, but are not limited to, the following:
  • HIV infection, syphilis;
  • chemotherapy within 5 weeks prior to screening;
  • absolute number of neutrophils in blood <500/mm3;
  • history of hematopoietic stem cell transplantation.
  • Signs of severe or extremely severe COVID-19 infection at the time of screening and randomization.
  • Heart rate less than 50 beats per minute at rest at screening.
  • Platelet count <100,000/µl or platelet transfusion within 5 days prior to randomization12.
  • Pregnancy or lactation in women.
  • Alcoholism or alcohol consumption in excess of:
  • for men: 14 units per week (on average);
  • for women: 7 units per week (on average).
  • Addiction and/or substance abuse.
  • Participation in other clinical trials within 28 days prior to screening, or planned participation during the period of this study.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Russia5 sites

  • Kaliningrad State Healthcare Institution "Central City Clinical Hospital"

    Kaliningrad, 236005

  • Novosibirsk Federal State Medical University

    Novosibirsk, 630007

  • Federal Ryazan State Medical University named after Academician I.P. Pavlov

    Ryazan, 390026

  • St. Petersburg State Health Institution "City Polyclinic No. 112"

    Saint Petersburg, 195427

  • Yaroslavl Region "Clinical Hospital No. 3", ,, Mayakovskogo st., 61

    Yaroslavl, 150007

Other trials in Russia

About this study

Official title: Multicenter Open Two-stage Study of Pharmacokinetics, Safety and Efficacy of GP30341, 200 mg Capsules (GEROPHARM LLC, Russia) in Healthy Volunteers and Outpatients With Novel Coronavirus Infection 2019 With a High Risk of Adverse Outcome

Pharmacokinetics, safety and efficacy study of GP30341, 200 mg capsules (GEROPHARM LLC, Russia) in healthy volunteers and patients with novel coronavirus infection 2019 (COVID-19) with a high risk of adverse outcome

Read the detailed description

Multicenter open two-stage study of pharmacokinetics, safety and efficacy of GP30341, 200 mg capsules (GEROPHARM LLC, Russia) involving healthy volunteers and patients with novel coronavirus infection 2019 (COVID-19) with a high risk of adverse outcome.

I stage: An open non-comparative study of pharmacokinetics and safety of GP30341 studied at different dosing regimens with an escalation of the daily dose in healthy volunteers.

II stage: Open randomized study efficacy and safety of GP30341, 200 mg capsules with active control - comparison with standard therapy - in patients with COVID-19 infection with a high risk of adverse outcome.

Being tested
GP30341 capsules 200 mg, Standard therapy
Keywords
Molnupiravir, COVID-19, 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.

  • GP30341 capsules 200 mgDrug

    Also called molnupiravir

    orall take of capsules twice a day

  • Standard therapyDrug

    Also called COVID-19 therapy

    Standard medicines for treatment of a new coronavirus infection 2019 (COVID-19).

Study groups in NCT05648799
Study groupRoleWhat they receive
GP30341 capsules 200 mgExperimental4 capsules containing 200 mg of molnupiravir p.o. twice a day during 5 days (daily dose 1600 mg) in combination with Standard therapy in accordance with the current version of the guidelines for the prevention, diagnosis and treatment of a new coronavirus infection 2019 (COVID-19).
Receives: Drug: GP30341 capsules 200 mg
Standart therapyActive comparatorStandard therapy in accordance with the current version of the guidelines for the prevention, diagnosis and treatment of a new coronavirus infection 2019 (COVID-19).
Receives: Drug: Standard therapy

What is being measured

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

  1. AUC0-t

    Total area under the curve "concentration of the active metabolite of the active substance - time" in the time interval from 0 (the moment of taking the drug) to the collection of the last blood sample with the determined concentration of the active substance at the time point t.

    Measured: cohort N1 -10 minutes, 10, 20, 30, 45 mintes, 1 hour, 1hour 15 minutes, 1.5, 2, 2.5, 4, 5, 6, 8, 10, 12, 24 hours; Cohort N2 -10 minutes, 30 minutes, 1 hour, 2, 12, 12.5, 13, 14, 24, 36 hours

  2. Cmax

    maximum concentration of the active metabolite of the active substance in the blood plasma of volunteers during the observation period.

    Measured: cohort N1 - 10 minutes, 10, 20, 30, 45 minutes, 1hour, 1hour 15 minutes, 1.5 hour, 2, 2.5, 4, 5, 6, 8, 10, 12, 24 hours; Cohort N2 -10 minutes, 30 minutes, 1hour, 2, 12, 12.5, 13, 14, 24, 36 hours

  3. tmax

    time to reach the maximum concentration (Cmax) of the active metabolite of the active substance in the blood plasma of volunteers.

    Measured: cohort N1 -10 minutes, 10, 20, 30, 45 minutes, 1hour, 1hour 15 minutes, 1.5hour, 2, 2.5, 4, 5, 6, 8, 10, 12, 24 hours; Cohort N2 -10 minutes, 30 minutes, 1hour, 2, 12, 12.5, 13, 14, 24, 36 hours

  4. t1/2

    half-life of the active metabolite of the active substance.

    Measured: 0-24 hours

  5. λz

    rate constant of elimination of the active metabolite of the active substance.

    Measured: cohort N1 -10 minutes, 10, 20, 30, 45 mintes, 1 hour, 1hour 15 minutes, 1.5, 2, 2.5, 4, 5, 6, 8, 10, 12, 24 hours; Cohort N2 -10 minutes, 30 minutes, 1 hour, 2, 12, 12.5, 13, 14, 24, 36 hours

  6. AUC0-∞

    total area under the curve "concentration of the active metabolite of the active substance - time" in the time interval from 0 (the moment of taking the drug) to infinity.

    Measured: cohort N1 -10 minutes, 10, 20, 30, 45 mintes, 1 hour, 1hour 15 minutes, 1.5, 2, 2.5, 4, 5, 6, 8, 10, 12, 24 hours; Cohort N2 -10 minutes, 30 minutes, 1 hour, 2, 12, 12.5, 13, 14, 24, 36 hours

  7. Frequency of COVID-19 progression on Day 14

    Frequency of COVID-19 progression to a more severe severity compared to baseline on Day 14

    Measured: day 14 from randomization

Secondary outcomes (5)

  1. Proportion of patients hospitalized or dying within 28±2 days of randomization.

    Proportion of patients hospitalized or dying from any cause within 28±2 days of randomization.

    Measured: 0-30 days from randomization

  2. Proportion of patients with a score of more than 3 on the WHO Clinical Progression Scale on Day of end of therapy, Day 10 and Day 14.

    Proportion of patients with a score of more than 3 on the WHO (World Health Organization) Clinical Progression Scale on Day of end of therapy, Day 10 and Day 14.

    Measured: 0-14 days from randomization

  3. Time to clinical improvement in the form of a persistent reduction in the number of symptoms characteristic of COVID-19 infection by one or more within 28 ± 2 days from randomization.

    Time to clinical improvement in the form of a persistent reduction in the number of symptoms characteristic of COVID-19 infection by one or more within 28 ± 2 days from randomization.

    Measured: 0-30 days from randomization

  4. Time to clinical progression in the form of (whichever is sooner) a persistent increase in the number of symptoms characteristic of COVID-19 infection by one or more, hospitalization or death from any cause within 28±2 days from randomization.

    Time to clinical progression in the form of (whichever is sooner) a persistent increase in the number of symptoms characteristic of COVID-19 infection by one or more, hospitalization or death from any cause within 28±2 days from randomization.

    Measured: 0-30 days from randomization

  5. Proportion of patients with a positive nasal swab test for SARS-CoV-2 on Days 3, Day of end of therapy, 10, 14, 28±2 from randomization.

    roportion of patients with a positive nasal swab test for SARS-CoV-2 on Days 3, Day of end of therapy, 10, 14, 28±2 from randomization.

    Measured: 0-30 days from randomization

Timeline

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

  1. First posted13 Dec 2022
  2. Study start17 Mar 2022
  3. Primary completion11 May 2022
  4. Study completion20 Jul 2022

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
two-stage study: 1 stage - two-period escalating dose study involved two sequential cohorts of 6 healthy volunteers. 2 stage - randomized comparative study with hypothesis of superior efficacy in parallel groups.
Masking
None (open label)
Enrolment
246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05648799
Sponsor's protocol ID
GP30341-P4-31
Status last verified
Oct 2022
First submitted
7 Dec 2022
Last updated
22 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing GP30341 capsules 200 mg and Standard therapy in people with Pharmacokinetics and Safety Issues, run by Geropharm at 5 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 17 inclusion and 53 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 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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?

AUC0-t (time frame: cohort N1 -10 minutes, 10, 20, 30, 45 mintes, 1 hour, 1hour 15 minutes, 1.5, 2, 2.5, 4, 5, 6, 8, 10, 12, 24 hours; Cohort N2 -10 minutes, 30 minutes, 1 hour, 2, 12, 12.5, 13, 14, 24, 36 hours). The study lists 7 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 NCT05648799.

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 22 Jul 2024.

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