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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05172141
• Other study ID #: CIBI314B201
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: December 31, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 222
• Est. completion date: January 31, 2023
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• IBI314(low dose)
intravenously, once, on Day 1
• IBI314(high dose)
intravenously, once, on Day 1
• IBI314(medium dose)
intravenously, once, on Day 1

Other:
• Placebo
intravenously, once, on Day 1

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment related AEs	Any AEs and SAEs occurring during the study	29 days after the last participant is randomized
Primary	Virologic efficacy Evaluation	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	maximum concentration (Cmax)	PK parameters to be evaluated for IBI314 including maximum concentration (Cmax) will be determined when appropriate.	29 days after the last participant is randomized
Secondary	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.	29 days after the last participant is randomized
Secondary	half-life (t1/2)	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
Secondary	clearance (CL)	PK parameters to be evaluated for IBI314 including clearance (CL) will be determined when appropriate.	29 days after the last participant is randomized
Secondary	volume of distribution (V)	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
Secondary	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).	29 days after the last participant is randomized
Secondary	Time to alleviation of symptoms (going to mild or absent)	This is a clinical efficacy outcome measure.	29 days after the last participant is randomized
Secondary	Proportion of patients with all-cause mortality by Day 29	This is a clinical efficacy outcome measure.	29 days after the last participant is randomized
Secondary	Time to negative RT-qPCR in NP swab samples with no subsequent positive RT-qPCR	This is a virologic efficacy outcome measure.	29 days after the last participant is randomized
Secondary	Change from baseline in viral shedding on Day 7, 11, 22	This is a virologic efficacy outcome measure.	7, 11, 22 days after the last participant is randomized
Secondary	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.	11 days after the last participant is randomized
Secondary	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.	22 days after the last participant is randomized
Secondary	Proportion of patients demonstrating symptoms alleviation on D3, 7, 15, 22, 29	This is a clinical efficacy outcome measure.	3, 7, 15, 22, 29 days after the last participant is randomized
Secondary	Proportion of patients who become severe COVID-19 by Day 29	This is a clinical efficacy outcome measure.	29 days after the last participant is randomized
Secondary	Proportion of patients requiring mechanical ventilation by day 29	This is a clinical efficacy outcome measure.	29 days after the last participant is randomized