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A Safety, Tolerability, and Efficacy Study of IBI314 in Patients With Mild to Moderate COVID-19

Primary Purpose

COVID-19

Status

Terminated

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

IBI314(low dose)

IBI314(high dose)

IBI314(medium dose)

Placebo

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

The Second Affiliated Hospital of Guangzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IBI314

Placebo

Arm Description

Low/medium/high dose, intravenously, once, on Day 1

Placebo, intravenously, once, on Day 1

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.

clearance (CL)

PK parameters to be evaluated for IBI314 including clearance (CL) will be determined when appropriate.

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).

Time to alleviation of symptoms (going to mild or absent)

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.

Proportion of patients demonstrating symptoms alleviation on D3, 7, 15, 22, 29

This is a clinical efficacy outcome measure.

Proportion of patients who become severe COVID-19 by Day 29

This is a clinical efficacy outcome measure.

Proportion of patients requiring mechanical ventilation by day 29

This is a clinical efficacy outcome measure.

Full Information

NCT ID

NCT05172141

First Posted

December 24, 2021

Last Updated

February 27, 2023

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05172141

Brief Title

A Safety, Tolerability, and Efficacy Study of IBI314 in Patients With Mild to Moderate COVID-19

Official Title

A Safety, Tolerability, and Efficacy Study of IBI314 in Patients With Mild to Moderate COVID-19

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Terminated

Why Stopped

Due to the company's development strategy adjustment, Innovant Biologics decided not to continue this study after consultation with investigators.

Study Start Date

December 31, 2021 (Actual)

Primary Completion Date

August 31, 2022 (Actual)

Study Completion Date

January 31, 2023 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a Phase 1/2 study evaluating the safety, tolerability and efficacy of IBI314.

Detailed Description

Phase 1 is a randomized, double-blind, placebo-controlled, single ascending dose study in up to 24 health volunteers. This phase of the study is designed to assess the safety, tolerability and PK of IBI314 administered as a single IV infusion. Phase 2 is a randomized, double-blind, placebo-controlled expansion study in approximately 198 mild to moderate adult patients with COVID-19. This phase of the study is designed to assess the efficacy, safety, PK and PD of IBI314.

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

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Masking participant and Investigator

Allocation

Randomized

Enrollment

222 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IBI314

Arm Type

Experimental

Arm Description

Low/medium/high dose, intravenously, once, on Day 1

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo, intravenously, once, on Day 1

Intervention Type

Biological

Intervention Name(s)

IBI314(low dose)

Intervention Description

intravenously, once, on Day 1

Intervention Type

Biological

Intervention Name(s)

IBI314(high dose)

Intervention Description

intravenously, once, on Day 1

Intervention Type

Biological

Intervention Name(s)

IBI314(medium dose)

Intervention Description

intravenously, once, on Day 1

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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 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.

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

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 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

7, 11, 22 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

11 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

22 days after the last participant is randomized

Title

Proportion of patients demonstrating symptoms alleviation on D3, 7, 15, 22, 29

Description

This is a clinical efficacy outcome measure.

Time Frame

3, 7, 15, 22, 29 days after the last participant is randomized

Title

Proportion of patients who become severe 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 requiring mechanical ventilation by day 29

Description

This is a clinical 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

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 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).

Facility Information:

Facility Name

The Second Affiliated Hospital of Guangzhou Medical University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510260

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Safety, Tolerability, and Efficacy Study of IBI314 in Patients With Mild to Moderate COVID-19

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