Efficacy and Safety of Jaktinib in Patients With COVID-19 Pneumonia.

NCT ID: NCT05672888

Last Updated: 2023-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2024-05-31

Brief Summary

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This was a randomized, double-blind, placebo-controlled parallel study.

Detailed Description

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Conditions

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COVID-19 Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Jaktinib

Jaktinib 100mg BID

Group Type EXPERIMENTAL

Jaktinib

Intervention Type DRUG

100mg of Jaktinib (given as two 50mg tablets) administered orally Twice daily(BID) with best available treatment.

Placebo

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (given as two placebo tablets) administered orally BID with best available treatment.

Interventions

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Jaktinib

100mg of Jaktinib (given as two 50mg tablets) administered orally Twice daily(BID) with best available treatment.

Intervention Type DRUG

Placebo

Placebo (given as two placebo tablets) administered orally BID with best available treatment.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 years of age, male or female;
* History of COVID-19 infection within 1 week;
* Subjects with HRCT consistent with viral pneumonia (Judged by investigator) and meeting any of the following criteria: With fever, respiratory symptoms; Shortness of breath present,RR ≥30 breaths/min.
* Clear consciousness, Capable and voluntary informed consent.

Exclusion Criteria

* Unable to take tablets orally Or suspected hypersensitivity to Jaktinib, drugs of the same class, or their excipients, Patients with severe gastrointestinal dysfunction affecting drug absorption;
* Any person meeting criteria for critical pneumonia;
* Patients considered unsuitable for this trial by the investigator.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jianya Zhou

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Zhejiang University

Locations

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The First Affiliated Hospital of College of Medicine Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Jianya Zhou

Role: CONTACT

0571-87235114

Facility Contacts

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Jianya Zhou

Role: primary

Other Identifiers

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ZGJAK-IIT-002

Identifier Type: -

Identifier Source: org_study_id

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