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

NCT05672888 | Unknown Phase 2

• 1 other identifier: ZGJAK-IIT-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19 Pneumonia

Keywords

Pneumonia; COVID-19 Infection

Outcome Measures

Primary Outcomes (1)

• Time to Recovery

  Recovery assessed by the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS). Time to reach NIAID-OS 1, 2, or 3 for the first time. NIAID-OS: 1 Not hospitalized, no limitations on activities. 2 Not hospitalized, limitation on activities and/or requiring home oxygen. 3 Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care.

  Day 1 to Day 28

Secondary Outcomes (2)

• Percentage of participants who require invasive mechanical ventilation due to disease progression at Day 3, 7, 1 4 or EOT

  Day 3, 7, 14 or EOT

• Mortality

  Day 1 to Day 28

Study Arms (2)

Jaktinib

EXPERIMENTAL

Jaktinib 100mg BID

Drug: Jaktinib

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

Jaktinib DRUG

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

Jaktinib

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital of College of Medicine Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Pneumonia; COVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Jianya Zhou

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianya Zhou

CONTACT

0571-87235114; zhoujianya@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 5, 2023
• Study Start: March 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: May 1, 2024
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)