A Study of Jacktinib Hydrochloride Tablets in the Treatment of Severe Novel Coronavirus Pneumonia

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05688839

Collaborator

(none)

Enrollment

Location

Arms

1.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A randomized, double-blind, placebo parallel control study and is expected to enroll 20-60 eligible patients with severe novel coronavirus pneumonia.

Condition or Disease	Intervention/Treatment	Phase
Novel COVID-19-Infected Pneumonia	Drug: Jaktinib hydrochloride tablets	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Second Study to Assess the Efficacy and Safety of Jacktinib Hydrochloride Tablets in the Treatment of Severe Novel Coronavirus Pneumonia

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Jaktinib 100mg BID Jaktinib hydrochloride tablets, 2 x 50mg dosage, BID	Drug: Jaktinib hydrochloride tablets 2 doses per day, each containing two 50mg Jaktinib or placebo tablets
Placebo Comparator: Placebo 2 x Placebo tablets, BID	Drug: Jaktinib hydrochloride tablets 2 doses per day, each containing two 50mg Jaktinib or placebo tablets

Arm

Intervention/Treatment

Experimental: Jaktinib 100mg BID

Jaktinib hydrochloride tablets, 2 x 50mg dosage, BID

Drug: Jaktinib hydrochloride tablets

2 doses per day, each containing two 50mg Jaktinib or placebo tablets

Placebo Comparator: Placebo

2 x Placebo tablets, BID

Drug: Jaktinib hydrochloride tablets

2 doses per day, each containing two 50mg Jaktinib or placebo tablets

Outcome Measures

Primary Outcome Measures

Efficacy of Jaktinib [28 days after randomization]
The proportion of subjects with disease progression or all-cause mortality
Efficacy of Jaktinib [14 days after randomization]
The proportion of subjects with disease progression or all-cause mortality
Efficacy of Jaktinib [28 days after randomization]
The proportion of subjects whose (National Institute of Allergy and Infectious Disease Ordinal Scale (NIAID-OS) score improved by ≥ 2 points from the baseline
Efficacy of Jaktinib [28 days after randomization]
The change value of NIAID-OS score compared with the baseline
Efficacy of Jaktinib [Up to 28 days after randomization]
Time interval from randomization to clinical improvement (defined as NIAID-OS 1-3 points)
Efficacy of Jaktinib [Up to 28 days after randomization]
Time interval from randomization to discharge
Efficacy of Jaktinib [28 days after randomization]
The proportion of subjects receiving mechanical ventilation due to disease progression at 3, 7, and 14 days after randomization until the end of treatment (EOT)
Efficacy of Jaktinib [28 days after randomization]
The proportion of subjects whose chest High-Resolution CT (HRCT) showed significant absorption of pulmonary inflammation (definition of significant absorption: the lung inflammatory lesions were reduced by more than 50%) at 7, 14 days after treatment until EOT

Secondary Outcome Measures

Safety of Jaktinib [Up to 2 months after randomization]
Incidence rate of adverse events and serious adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Aged ≥18 years old, regardless of gender;
There is a history of novel coronavirus antigen- or nucleic acid-positive infection within 1-2 weeks;
HRCT is consistent with the manifestation of viral pneumonia (judged by the investigator)
Those who voluntarily sign informed consent.

Exclusion Criteria:

Those who cannot take orally, or are suspected to be allergic to jackitinib hydrochloride, similar drugs, or their excipients, or have severe gastrointestinal dysfunction that affects drug absorption;
Critical pneumonia patients with other organ failure requiring ICU monitoring and treatment;
Those who have received the following treatments within the specified time window before randomization:

They have received Janus kinase (JAK) inhibitor, interleukin 6 (IL-6) inhibitor, IL-1 inhibitor, tumor necrosis factor (TNF) inhibitor, T cell or B cell depletion agent, interferon and other immunosuppressive drugs within the first two weeks of randomization, except glucocorticoid;
Systematically used CYP 3A4 potent inhibitor or potent inducer in the first five drug half-lives at random;

Immune deficiency;
Those who have received the novel coronavirus vaccine within 1 week before randomization;
Prior to randomization, there were the following active and uncontrolled infections: tuberculosis, HIV, syphilis, mycoplasma, chlamydia, parasites, and viral infections other than SARS CoV-2 that required systemic anti-infection treatment;
Renal diseases requiring dialysis treatment;
Pregnant and lactating women;
Any other subjects that were considered unsuitable by the investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Changsha Taihe Hospital	Changsha	Hunan	China

Sponsors and Collaborators

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Investigators

Principal Investigator: RongHu Li, Changsha Taihe Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

ClinicalTrials.gov Identifier:

NCT05688839

Other Study ID Numbers:

ZGJAK-IIT-005

First Posted:

Jan 18, 2023

Last Update Posted:

Jan 18, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pneumonia

Study Results

No Results Posted as of Jan 18, 2023