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

COVID-19 Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05672888
• Other study ID #: ZGJAK-IIT-002
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 2023
• Est. completion date: May 2024

Study information

• Verified date: January 2023
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Jianya Zhou
• Phone: 0571-87235114
• Email: zhoujianya[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Pneumonia

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of College of Medicine Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Mortality	Proportion of patients with all-cause mortality at Day 28	Day 1 to Day 28