NCT04261517

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

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

February 6, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

February 6, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2020

Completed
Last Updated

April 13, 2020

Status Verified

April 1, 2020

Enrollment Period

19 days

First QC Date

February 6, 2020

Last Update Submit

April 9, 2020

Conditions

Pneumonia, PneumocystisCoronavirusCOVID-19

Keywords

PneumoniaCOVID-19hydroxychloroquine

Outcome Measures

Primary Outcomes (4)

  • 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

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

    7 days after randomization

  • The mortality rate of subjects at weeks 2

    14 days after randomization

Secondary Outcomes (2)

  • 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

Study Arms (2)

Hydroxychloroquine and conventional treatments

EXPERIMENTAL

After randomization, subjects take hydroxychloroquine 400mg per day for 5 days, also take conventional treatments.

Drug: Hydroxychloroquine

Conventional treatments

NO INTERVENTION

After randomization, subjects take conventional treatments without hydroxychloroquine.

Interventions

HydroxychloroquineDRUG

Subjects take hydroxychloroquine 400 mg per day for 5 days, also take conventional treatments

Hydroxychloroquine and conventional treatments

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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;
  • Participants aged over 18;
  • Written the informed consent.

You may not qualify if:

  • Hypersensitivity to chloroquine or hydroxychloroquine;
  • Women during pregnancy;
  • Severe heart, lung, kidney, brain, blood diseases or other important systemic diseases;
  • Participants with retinal disease, hearing loss;
  • Participants with severe neurological and mental illness;
  • 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

Location

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Location

Related Publications (1)

  • Chen J, Liu D, Liu L, Liu P, Xu Q, Xia L, Ling Y, Huang D, Song S, Zhang D, Qian Z, Li T, Shen Y, Lu H. [A pilot study of hydroxychloroquine in treatment of patients with moderate COVID-19]. Zhejiang Da Xue Xue Bao Yi Xue Ban. 2020 May 25;49(2):215-219. doi: 10.3785/j.issn.1008-9292.2020.03.03. Chinese.

    PMID: 32391667DERIVED

Related Links

MeSH Terms

Conditions

Pneumonia, PneumocystisCoronavirus InfectionsCOVID-19Pneumonia

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

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

February 6, 2020

First Posted

February 7, 2020

Study Start

February 6, 2020

Primary Completion

February 25, 2020

Study Completion

February 25, 2020

Last Updated

April 13, 2020

Record last verified: 2020-04

Locations

CN(2)