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

Phase 2

Not yet recruiting

• Conditions: COVID-19 Pneumonia
• Interventions: Drug: Jaktinib; Drug: Placebo

• Registration Number: NCT05672888
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-04
• Study First Submitted QC: 2023-01-04
• Study First Posted: 2023-01-05
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-01-17
• Study Start: 2023-03
• Primary Completion: 2024-01
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Jaktinib	Jaktinib	Jaktinib 100mg BID
Placebo	Placebo	placebo

Primary Outcome Measures

Name	Time	Method
Time to Recovery	Day 1 to Day 28	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.

Secondary Outcome Measures

Name	Time	Method
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	Proportion of patients with all-cause mortality at Day 28

Trial Locations

Locations (1)

The First Affiliated Hospital of College of Medicine Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China