- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05172141
A Safety, Tolerability, and Efficacy Study of IBI314 in Patients With Mild to Moderate COVID-19
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Lei Qian, Doctor
- Phone Number: 02131837215
- Email: lei.qian@innoventbio.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510260
- The Second Affiliated Hospital of Guangzhou Medical University
-
Contact:
- Lika Ye, Master
- Phone Number: 020-34152377
- Email: yelika@163.com
-
Contact:
- Zhihong Xie, Master
- Phone Number: 020-39195896
- Email: xzh0302@126.com
-
Principal Investigator:
- Jianxing He, Doctor
-
Principal Investigator:
- Yunhui Zhang, Doctor
-
Principal Investigator:
- Keji Shan, Master
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Main Inclusion Criteria:
First onset of COVID-19 symptoms <7 days at randomization, symptoms such as fever and/or chills, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea.
Have a positive SARS-CoV-2 Reverse Transcription-Polymerase Chain Reaction (RT-PCR) test using an appropriate sample such as nasopharyngeal (NP), nasal, oropharyngeal, or saliva within 72 hours prior to randomization. A historical record of a positive result from a test conducted ≤72 hours prior to randomization is acceptable.
Male or female patients ≥18 years of age at the time of signing informed consent.
Agree to use an adequate method of contraception throughout the study period and for 6 months after the dose of study drug is administered.
Women of childbearing potential (WOCBP) must have a negative urinary pregnancy test at screening.
Main Exclusion Criteria:
Have oxygen saturation (SpO2) ≤93 % on room air at sea level or a ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) <300, respiratory rate ≥30 per minute, heart rate ≥125 per minute.
Have evidence of multi-organ dysfunction/failure. Systolic blood pressure <90 mmHg, diastolic blood pressure <60 mmHg, or requiring vasopressors.
Require or anticipated impending need for endotracheal intubation, mechanical ventilation, oxygen delivered by high-flow nasal cannula noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IBI314
Low/medium/high dose, intravenously, once, on Day 1
|
intravenously, once, on Day 1
intravenously, once, on Day 1
intravenously, once, on Day 1
|
Placebo Comparator: Placebo
Placebo, intravenously, once, on Day 1
|
intravenously, once, on Day 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of treatment related AEs
Time Frame: 29 days after the last participant is randomized
|
Any AEs and SAEs occurring during the study
|
29 days after the last participant is randomized
|
Virologic efficacy Evaluation
Time Frame: 7 days after the last participant is randomized
|
Time-weighted average change in viral shedding from baseline through Day 7 as measured by RT-qPCR in NP swab samples
|
7 days after the last participant is randomized
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
maximum concentration (Cmax)
Time Frame: 29 days after the last participant is randomized
|
PK parameters to be evaluated for IBI314 including maximum concentration (Cmax) will be determined when appropriate.
|
29 days after the last participant is randomized
|
area under the concentration-time curve (AUC)
Time Frame: 29 days after the last participant is randomized
|
PK parameters to be evaluated for IBI314 including area under the concentration-time curve (AUC) will be determined when appropriate.
|
29 days after the last participant is randomized
|
volume of distribution (V)
Time Frame: 29 days after the last participant is randomized
|
PK parameters to be evaluated for IBI314 including volume of distribution (V) will be determined when appropriate.
|
29 days after the last participant is randomized
|
The incidence of anti-IBI314 antibody (ADA) and neutralizing antibody (NAb) in serum before and after study drug administration
Time Frame: 29 days after the last participant is randomized
|
Each patient will be tested for anti-drug (IBI314) antibody (ADA), and ADA-positive serum samples will continue to be tested for neutralizing antibodies (NAb).
|
29 days after the last participant is randomized
|
Time to alleviation of symptoms (going to mild or absent)
Time Frame: 29 days after the last participant is randomized
|
This is a clinical efficacy outcome measure.
|
29 days after the last participant is randomized
|
Proportion of patients with all-cause mortality by Day 29
Time Frame: 29 days after the last participant is randomized
|
This is a clinical efficacy outcome measure.
|
29 days after the last participant is randomized
|
Time to negative RT-qPCR in NP swab samples with no subsequent positive RT-qPCR
Time Frame: 29 days after the last participant is randomized
|
This is a virologic efficacy outcome measure.
|
29 days after the last participant is randomized
|
half-life (t1/2)
Time Frame: 29 days after the last participant is randomized
|
PK parameters to be evaluated for IBI314 including half-life (t1/2) will be determined when appropriate.
|
29 days after the last participant is randomized
|
clearance (CL)
Time Frame: 29 days after the last participant is randomized
|
PK parameters to be evaluated for IBI314 including clearance (CL) will be determined when appropriate.
|
29 days after the last participant is randomized
|
Change from baseline in viral shedding on Day 7, 11, 22
Time Frame: 7, 11, 22 days after the last participant is randomized
|
This is a virologic efficacy outcome measure.
|
7, 11, 22 days after the last participant is randomized
|
Time-weighted average change in viral shedding from baseline through D11 as measured by RT-qPCR in NP swab samples
Time Frame: 11 days after the last participant is randomized
|
This is a virologic efficacy outcome measure.
|
11 days after the last participant is randomized
|
Time-weighted average change in viral shedding from baseline through D22 as measured by RT-qPCR in NP swab samples.
Time Frame: 22 days after the last participant is randomized
|
This is a virologic efficacy outcome measure.
|
22 days after the last participant is randomized
|
Proportion of patients demonstrating symptoms alleviation on D3, 7, 15, 22, 29
Time Frame: 3, 7, 15, 22, 29 days after the last participant is randomized
|
This is a clinical efficacy outcome measure.
|
3, 7, 15, 22, 29 days after the last participant is randomized
|
Proportion of patients who become severe COVID-19 by Day 29
Time Frame: 29 days after the last participant is randomized
|
This is a clinical efficacy outcome measure.
|
29 days after the last participant is randomized
|
Proportion of patients requiring mechanical ventilation by day 29
Time Frame: 29 days after the last participant is randomized
|
This is a clinical efficacy outcome measure.
|
29 days after the last participant is randomized
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIBI314B201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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