Trial intelligence / Profile preview

Lopinavir/Ritonavir and Arbidol in Novel Coronavirus Infection

NCT04252885Phase 4

Key facts

Status
Completed
Start
Jan 2020
Primary completion
Apr 2020
Countries
1
Sponsor
Guangzhou Eighth People's Hospital
Modality
Small Molecules
Conditions
coronavirus disease 2019 (COVID-19)
01

Overview

Phase 4, randomised, open-label trial of lopinavir + ritonavir and umifenovir in coronavirus disease 2019 (COVID-19) (3 arms), sponsored by Guangzhou Eighth People's Hospital. Primary endpoint: Rate of virus inhibition at Day 21. Started Jan 2020; status: completed.

02

Design

3 arms
Study design
RandomizedOpen-label
  • Group A-Standard treatment+lopinavir/ritonavir

    Standard treatment + lopinavir (200mg) and ritonavir (50mg) (oral, q12h, 2 tablets each, 7-14 days)

  • Group B-Standard treatment+arbidol

    Standard treatment + arbidol (100mg) (oral, tid, 200mg each time, 7-14 days)

  • Group C-Standard treatment

    Standard treatment only

03

Who it enrols

Adults aged 18-80 with confirmed novel coronavirus infection, adequate renal and hepatic function, and no severe underlying diseases or interacting medications.

04

Endpoints

Primary

  • Rate of virus inhibition

Secondary

  • Disease prorogation-temperature

  • Disease prorogation-respiratory function 1

  • Disease prorogation-respiratory function 2

  • Disease prorogation-respiratory function 3

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