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

NCT05648799 | Completed DMC

• 1 other identifier: GP30341-P4-31
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 5

Brief 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

Conditions

Pharmacokinetics; Safety Issues; Efficacy

Keywords

Molnupiravir; COVID-19; SARS-CoV-2

Outcome Measures

Primary Outcomes (7)

• 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.

  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

• Cmax

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

  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

• tmax

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

  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

• t1/2

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

  0-24 hours

• λz

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

  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

• 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.

  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

• Frequency of COVID-19 progression on Day 14

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

  day 14 from randomization

Secondary Outcomes (5)

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

  0-30 days from randomization

• 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.

  0-14 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.

  0-30 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.

  0-30 days from randomization

• 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.

  0-30 days from randomization

Other Outcomes (3)

• Percentage of volunteers with AEs associated with the test drug.

  0-30 days from randomization

• Proportion of CTCAE Grade 5.0 or greater adverse events associated with the test product.

  0-30 days from randomization

• Proportion of cases of early termination of participation in the study due to the development of adverse events.

  0-30 days from randomization

Study Arms (2)

GP30341 capsules 200 mg

EXPERIMENTAL

4 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).

Drug: GP30341 capsules 200 mg

Standart therapy

ACTIVE COMPARATOR

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).

Drug: Standard therapy

Interventions

GP30341 capsules 200 mg DRUG

orall take of capsules twice a day

Also known as: molnupiravir

GP30341 capsules 200 mg

Standard therapy DRUG

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

Also known as: COVID-19 therapy

Standart therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Citizenship of the Russian Federation.

You may not qualify if:

• 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).
• 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;

Sponsors & Collaborators

• Geropharm: lead

Study Sites (5)

Kaliningrad State Healthcare Institution "Central City Clinical Hospital"

Kaliningrad, 236005, Russia

Location

Novosibirsk Federal State Medical University

Novosibirsk, 630007, Russia

Location

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

Ryazan, 390026, Russia

Location

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

Saint Petersburg, 195427, Russia

Location

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

Yaroslavl, 150007, Russia

Location

MeSH Terms

Conditions

COVID-19

Interventions

molnupiravir; Standard of Care

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sergey Noskov, MD, Pr.

  Yaroslavl State Institution of Healthcare "Clinical Hospital No. 3" II stage

  PRINCIPAL INVESTIGATOR

• Elizaveta Antonova

  St. Petersburg State Institution of Health Care "City Polyclinic No. 112"

  PRINCIPAL INVESTIGATOR

• Vladimir Rafalsky, MD, Pr.

  Clinical Research Center of Kaliningrad State Healthcare Institution "Central City Clinical Hospital"

  PRINCIPAL INVESTIGATOR

• Lubov Shpagina, MD

  Novosibirsk State Medical University, Ministry of Health of the Russian Federation

  PRINCIPAL INVESTIGATOR

• Viktor Filimonov, MD, Pr.

  Ryazan State Medical University Ministry of Health of the Russian Federation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study was conducted as open to the Participant and the Investigator. However, collected blood samples were blinded to an analytical laboratory specialist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 13, 2022
• Study Start: March 17, 2022
• Primary Completion: May 11, 2022
• Study Completion: July 20, 2022
• Last Updated: July 22, 2024

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (5)