NCT04252274

Brief Summary

The study aims to evaluate the efficacy and safety of darunavir and cobistastat in the treatment of COVID-19 pneumonia

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

January 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 13, 2020

Status Verified

April 1, 2020

Enrollment Period

7 months

First QC Date

January 29, 2020

Last Update Submit

April 9, 2020

Conditions

Pneumonia, PneumocystisCoronavirus

Keywords

PneumoniaCOVID-19DarunavirCobicistat

Outcome Measures

Primary Outcomes (1)

  • The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7

    7 days after randomization

Secondary Outcomes (5)

  • The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3

    3 days after randomization

  • The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5

    5 days after randomization

  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    14 days after randomization

  • The critical illness rate of subjects at weeks 2

    14 days after randomization

  • The mortality rate of subjects at weeks 2

    14 days after randomization

Study Arms (2)

Darunavir, Cobicistat and conventional treatments

EXPERIMENTAL

After randomization, subjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments.

Drug: Darunavir and Cobicistat

Conventional treatments

NO INTERVENTION

After randomization, subjects take conventional treatments without darunavir and cobicistat.

Interventions

Darunavir and CobicistatDRUG

Subjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments

Darunavir, Cobicistat and conventional treatments

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The participants were diagnosed as COVID-19 pneumonia, according to the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 4 or update version) made by National Health Commission of the People's Republic of China.
  • Written the informed consent

You may not qualify if:

  • Hypersensitivity to darunavir, cobicistat, or any excipients
  • Patients with severe liver injury (Child-Pugh Class C)
  • Concomitant medications that are highly dependent on CYP3A clearance, and the elevated plasma concentrations are associated with serious or life-threatening events.
  • Subjects were considered to be unable to complete the study, or not suitable for the study by researchers
  • Exit criteria:
  • Subjects asked to withdraw the study
  • Subject will benefit if withdraw according to researchers' suggestions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201508, China

RECRUITING

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (1)

  • Chen J, Xia L, Liu L, Xu Q, Ling Y, Huang D, Huang W, Song S, Xu S, Shen Y, Lu H. Antiviral Activity and Safety of Darunavir/Cobicistat for the Treatment of COVID-19. Open Forum Infect Dis. 2020 Jun 21;7(7):ofaa241. doi: 10.1093/ofid/ofaa241. eCollection 2020 Jul.

    PMID: 32671131DERIVED

MeSH Terms

Conditions

Pneumonia, PneumocystisCoronavirus InfectionsPneumoniaCOVID-19

Interventions

cobicistat mixture with darunavir

Condition Hierarchy (Ancestors)

Lung Diseases, FungalMycosesBacterial Infections and MycosesInfectionsPneumocystis InfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesPneumonia, Viral

Central Study Contacts

Hongzhou Lu, Ph.D

CONTACT

+86-021-37990333luhongzhou@fudan.edu.cn

Hongzhou Lu, PI

CONTACT

+86-021-37990333luhongzhou@fudan.edu.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 29, 2020

First Posted

February 5, 2020

Study Start

January 30, 2020

Primary Completion

August 31, 2020

Study Completion

December 31, 2020

Last Updated

April 13, 2020

Record last verified: 2020-04

Locations

CN(2)