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

NCT05648799 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2024-07-22

No results posted yet for this study

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

Interventions

DRUG

GP30341 capsules 200 mg

orall take of capsules twice a day

DRUG

Standard therapy

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

Sponsors & Collaborators

  • Geropharm

    lead INDUSTRY

Principal Investigators

  • Sergey Noskov, MD, Pr. · Yaroslavl State Institution of Healthcare "Clinical Hospital No. 3" II stage

  • Elizaveta Antonova · St. Petersburg State Institution of Health Care "City Polyclinic No. 112"

  • Vladimir Rafalsky, MD, Pr. · Clinical Research Center of Kaliningrad State Healthcare Institution "Central City Clinical Hospital"

  • Lubov Shpagina, MD · Novosibirsk State Medical University, Ministry of Health of the Russian Federation

  • Viktor Filimonov, MD, Pr. · Ryazan State Medical University Ministry of Health of the Russian Federation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-17
Primary Completion
2022-05-11
Completion
2022-07-20

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05648799 on ClinicalTrials.gov