Back to resultsA Safety, Tolerability, and Efficacy Study of IBI314 in Ambulatory Patients With COVID-19
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IBI314
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
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 90 days 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 been admitted to a hospital prior to randomization, or is hospitalized (inpatient) at randomization due to COVID-19.
- 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 and mechanical ventilation, oxygen delivered by high-flow nasal cannula noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO).
Sites / Locations
- Sobh
- Long Beach Clinical Trials, LLC
- Acclaim Clinical Research
- Herco Research Center, Inc.
- Midland Florida Clinical Research Center - Inf. Disease/Infectiology
- Palm Springs Research Institute
- Sweet Hope Research Specialty, Inc
- The Clinical Research Institute LLC
- Prestige Clinical Research Center Inc
- Cordova Research Institute, LLC
- Clinical Trials of Florida, LLC
- Pembroke Clinical Trials
- Luminous Clinical Research LLC - South Florida Urgent Care - Infectious Diseases
- Palm Beach Research Center
- Florida Pulmonary Research Institute, LLC
- Excel Clinical Research - Internal Medicine
- Temple University Health System - Temple Lung Center
- Zenos Clinical Research
- Epic Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
IBI314
Placebo
Arm Description
a cocktail of two SARS-CoV-2 S protein IgG1 antibodies, IBI314-A and IBI314-B, in a 1:1 [w/w] ratio
Outcomes
Primary Outcome Measures
Number of treatment related AEs
Any AEs and SAEs occurring during the study
Virologic efficacy Evaluation
Time-weighted average change in viral shedding from baseline through Day 7 as measured by RT-qPCR in NP swab samples.
Secondary Outcome Measures
maximum concentration (Cmax)
PK parameters to be evaluated for IBI314 including maximum concentration (Cmax) will be determined when appropriate.
area under the concentration-time curve (AUC)
PK parameters to be evaluated for IBI314 including area under the concentration-time curve (AUC) will be determined when appropriate.
half-life (t1/2)
PK parameters to be evaluated for IBI314 including half-life (t1/2) will be determined when appropriate.
Time to alleviation of symptoms (going to mild or absent);
Proportion of patients admitted to a hospital and emergency room visit due to COVID-19 by Day 29;
Proportion of patients with all-cause mortality by Day 29.
clearance (CL)
PK parameters to be evaluated for IBI314 including clearance (CL) will be determined when appropriate.
Change from baseline in viral shedding on Day 7, 11, 22;
Time-weighted average change in viral shedding from baseline through D11 as measured by RT-qPCR in NP swab samples;
Time-weighted average change in viral shedding from baseline through D22 as measured by RT-qPCR in NP swab samples.
volume of distribution (V)
PK parameters to be evaluated for IBI314 including volume of distribution (V) will be determined when appropriate.
The incidence of anti-IBI314 antibody (ADA) and neutralizing antibody (NAb) in serum before and after study drug administration
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).
Proportion of patients with at least one COVID-19 related medically attended visits by Day 29
This is a clinical efficacy outcome measure.
Time to alleviation of symptoms (going to mild or absent)
This is a clinical efficacy outcome measure.
Proportion of patients admitted to a hospital and emergency room visit due to COVID-19 by Day 29
This is a clinical efficacy outcome measure.
Proportion of patients with all-cause mortality by Day 29
This is a clinical efficacy outcome measure.
Time to negative RT-qPCR in NP swab samples with no subsequent positive RT-qPCR
This is a virologic efficacy outcome measure.
Change from baseline in viral shedding on Day 7, 11, 22
This is a virologic efficacy outcome measure.
Time-weighted average change in viral shedding from baseline through D11 as measured by RT-qPCR in NP swab samples
This is a virologic efficacy outcome measure.
Time-weighted average change in viral shedding from baseline through D22 as measured by RT-qPCR in NP swab samples.
This is a virologic efficacy outcome measure.
Full Information
NCT ID
NCT05162365
First Posted
December 12, 2021
Last Updated
November 28, 2022
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05162365
Brief Title
A Safety, Tolerability, and Efficacy Study of IBI314 in Ambulatory Patients With COVID-19
Official Title
A Safety, Tolerability, and Efficacy Study of IBI314 in Ambulatory Patients With COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 6, 2022 (Actual)
Primary Completion Date
June 29, 2022 (Actual)
Study Completion Date
November 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a dose-finding, inferentially seamless Phase 1/2 study evaluating the safety, tolerability and efficacy of IBI314 in Ambulatory Patients with COVID-19.
Detailed Description
Phase 1 is a randomized, double-blind, placebo-controlled, single ascending dose study in up to 32 ambulatory adult patients with COVID-19. This phase of the study is designed to assess the safety, tolerability, PK, and PD of IBI314 administered as a single IV infusion. Phase 2 is a randomized, double-blind, placebo-controlled expansion study in approximately 208 ambulatory adult patients with COVID-19. This phase of the study is designed to assess the efficacy and safety of IBI314, administered by single IV infusion at dose levels that meet none of the termination criteria for dose escalation in Phase 1 of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
248 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IBI314
Arm Type
Experimental
Arm Description
a cocktail of two SARS-CoV-2 S protein IgG1 antibodies, IBI314-A and IBI314-B, in a 1:1 [w/w] ratio
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
IBI314
Intervention Description
Low/medium/high dose, intravenously, once, on Day 1
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo, intravenously, once, on Day 1
Primary Outcome Measure Information:
Title
Number of treatment related AEs
Description
Any AEs and SAEs occurring during the study
Time Frame
29 days after the last participant is randomized
Title
Virologic efficacy Evaluation
Description
Time-weighted average change in viral shedding from baseline through Day 7 as measured by RT-qPCR in NP swab samples.
Time Frame
7 days after the last participant is randomized
Secondary Outcome Measure Information:
Title
maximum concentration (Cmax)
Description
PK parameters to be evaluated for IBI314 including maximum concentration (Cmax) will be determined when appropriate.
Time Frame
29 days after the last participant is randomized
Title
area under the concentration-time curve (AUC)
Description
PK parameters to be evaluated for IBI314 including area under the concentration-time curve (AUC) will be determined when appropriate.
Time Frame
29 days after the last participant is randomized
Title
half-life (t1/2)
Description
PK parameters to be evaluated for IBI314 including half-life (t1/2) will be determined when appropriate.
Time to alleviation of symptoms (going to mild or absent);
Proportion of patients admitted to a hospital and emergency room visit due to COVID-19 by Day 29;
Proportion of patients with all-cause mortality by Day 29.
Time Frame
29 days after the last participant is randomized
Title
clearance (CL)
Description
PK parameters to be evaluated for IBI314 including clearance (CL) will be determined when appropriate.
Change from baseline in viral shedding on Day 7, 11, 22;
Time-weighted average change in viral shedding from baseline through D11 as measured by RT-qPCR in NP swab samples;
Time-weighted average change in viral shedding from baseline through D22 as measured by RT-qPCR in NP swab samples.
Time Frame
29 days after the last participant is randomized
Title
volume of distribution (V)
Description
PK parameters to be evaluated for IBI314 including volume of distribution (V) will be determined when appropriate.
Time Frame
29 days after the last participant is randomized
Title
The incidence of anti-IBI314 antibody (ADA) and neutralizing antibody (NAb) in serum before and after study drug administration
Description
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).
Time Frame
29 days after the last participant is randomized
Title
Proportion of patients with at least one COVID-19 related medically attended visits by Day 29
Description
This is a clinical efficacy outcome measure.
Time Frame
29 days after the last participant is randomized
Title
Time to alleviation of symptoms (going to mild or absent)
Description
This is a clinical efficacy outcome measure.
Time Frame
29 days after the last participant is randomized
Title
Proportion of patients admitted to a hospital and emergency room visit due to COVID-19 by Day 29
Description
This is a clinical efficacy outcome measure.
Time Frame
29 days after the last participant is randomized
Title
Proportion of patients with all-cause mortality by Day 29
Description
This is a clinical efficacy outcome measure.
Time Frame
29 days after the last participant is randomized
Title
Time to negative RT-qPCR in NP swab samples with no subsequent positive RT-qPCR
Description
This is a virologic efficacy outcome measure.
Time Frame
29 days after the last participant is randomized
Title
Change from baseline in viral shedding on Day 7, 11, 22
Description
This is a virologic efficacy outcome measure.
Time Frame
29 days after the last participant is randomized
Title
Time-weighted average change in viral shedding from baseline through D11 as measured by RT-qPCR in NP swab samples
Description
This is a virologic efficacy outcome measure.
Time Frame
29 days after the last participant is randomized
Title
Time-weighted average change in viral shedding from baseline through D22 as measured by RT-qPCR in NP swab samples.
Description
This is a virologic efficacy outcome measure.
Time Frame
29 days after the last participant is randomized
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 90 days 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:
according to protocol v3.0, Note: Patients with mild-to-moderate disease who are placed in a facility where required by local guidelines can be enrolled.
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 and mechanical ventilation, oxygen delivered by high-flow nasal cannula noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO).
Facility Information:
Facility Name
Sobh
City
Anaheim
State/Province
California
ZIP/Postal Code
92806
Country
United States
Facility Name
Long Beach Clinical Trials, LLC
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Acclaim Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Herco Research Center, Inc.
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Midland Florida Clinical Research Center - Inf. Disease/Infectiology
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Palm Springs Research Institute
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Sweet Hope Research Specialty, Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
The Clinical Research Institute LLC
City
Miami Gardens
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Prestige Clinical Research Center Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Cordova Research Institute, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Clinical Trials of Florida, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Pembroke Clinical Trials
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Luminous Clinical Research LLC - South Florida Urgent Care - Infectious Diseases
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33029-2818
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Florida Pulmonary Research Institute, LLC
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Excel Clinical Research - Internal Medicine
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Temple University Health System - Temple Lung Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140-5103
Country
United States
Facility Name
Zenos Clinical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Epic Clinical Research
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75057
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Safety, Tolerability, and Efficacy Study of IBI314 in Ambulatory Patients With COVID-19
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