A Safety, Tolerability, and Efficacy Study of IBI314 in Ambulatory Patients With COVID-19

COVID-19 Clinical Trial

Official title:

A Safety, Tolerability, and Efficacy Study of IBI314 in Ambulatory Patients With COVID-19

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05162365
• Other study ID #: CIBI314A201
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: January 6, 2022
• Est. completion date: November 18, 2022

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 248
• Est. completion date: November 18, 2022
• Est. primary completion date: June 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Main Inclusion Criteria:

1. 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.

2. 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.

3. Male or female patients =18 years of age at the time of signing informed consent.

4. Agree to use an adequate method of contraception throughout the study period and for 90 days after the dose of study drug is administered.

5. Women of childbearing potential (WOCBP) must have a negative urinary pregnancy test at screening.

Main Exclusion Criteria:

1. 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.

2. 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.

3. Have evidence of multi-organ dysfunction/failure.

4. Systolic blood pressure <90 mmHg, diastolic blood pressure <60 mmHg, or requiring vasopressors.

5. 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).

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• IBI314
Low/medium/high dose, intravenously, once, on Day 1

Other:
• Placebo
Placebo, intravenously, once, on Day 1

Locations

Country	Name	City	State
United States	Sobh	Anaheim	California
United States	Herco Research Center, Inc.	Coral Gables	Florida
United States	Zenos Clinical Research	Dallas	Texas
United States	Midland Florida Clinical Research Center - Inf. Disease/Infectiology	DeLand	Florida
United States	Palm Springs Research Institute	Hialeah	Florida
United States	Sweet Hope Research Specialty, Inc	Hialeah	Florida
United States	Excel Clinical Research - Internal Medicine	Las Vegas	Nevada
United States	Epic Clinical Research	Lewisville	Texas
United States	Long Beach Clinical Trials, LLC	Long Beach	California
United States	Clinical Trials of Florida, LLC	Miami	Florida
United States	Cordova Research Institute, LLC	Miami	Florida
United States	Prestige Clinical Research Center Inc	Miami	Florida
United States	The Clinical Research Institute LLC	Miami Gardens	Florida
United States	Luminous Clinical Research LLC - South Florida Urgent Care - Infectious Diseases	Pembroke Pines	Florida
United States	Pembroke Clinical Trials	Pembroke Pines	Florida
United States	Temple University Health System - Temple Lung Center	Philadelphia	Pennsylvania
United States	Acclaim Clinical Research	San Diego	California
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Florida Pulmonary Research Institute, LLC	Winter Park	Florida

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

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.; 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.	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.; 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.	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	Proportion of patients with at least one COVID-19 related medically attended visits by Day 29	This is a clinical efficacy outcome measure.	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 admitted to a hospital and emergency room visit due to COVID-19 by Day 29	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.	29 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.	29 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.	29 days after the last participant is randomized