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

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.

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Biological: IBI314; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 248
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92806
      • Sobh
    • Long Beach, California, United States, 90806
      • Long Beach Clinical Trials, LLC
    • San Diego, California, United States, 92120
      • Acclaim Clinical Research
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Herco Research Center, Inc.
    • DeLand, Florida, United States, 32720
      • Midland Florida Clinical Research Center - Inf. Disease/Infectiology
    • Hialeah, Florida, United States, 33012
      • Palm Springs Research Institute
    • Hialeah, Florida, United States, 33016
      • Sweet Hope Research Specialty, Inc
    • Miami, Florida, United States, 33186
      • Clinical Trials of Florida, LLC
    • Miami, Florida, United States, 33155
      • Cordova Research Institute, LLC
    • Miami, Florida, United States, 33133
      • Prestige Clinical Research Center Inc
    • Miami Gardens, Florida, United States, 33169
      • The Clinical Research Institute LLC
    • Pembroke Pines, Florida, United States, 33028
      • Pembroke Clinical Trials
    • Pembroke Pines, Florida, United States, 33029-2818
      • Luminous Clinical Research LLC - South Florida Urgent Care - Infectious Diseases
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Center
    • Winter Park, Florida, United States, 32789
      • Florida Pulmonary Research Institute, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Excel Clinical Research - Internal Medicine
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140-5103
      • Temple University Health System - Temple Lung Center
  • Texas
    • Dallas, Texas, United States, 75230
      • Zenos Clinical Research
    • Lewisville, Texas, United States, 75057
      • Epic Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo, intravenously, once, on Day 1
Experimental: IBI314; a cocktail of two SARS-CoV-2 S protein IgG1 antibodies, IBI314-A and IBI314-B, in a 1:1 [w/w] ratio	Biological: IBI314; Low/medium/high dose, intravenously, once, on Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of treatment related AEs	Any AEs and SAEs occurring during the study	29 days after the last participant is randomized
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2022
• Primary Completion (Actual): June 29, 2022
• Study Completion (Actual): November 18, 2022

Study Registration Dates

• First Submitted: December 12, 2021
• First Submitted That Met QC Criteria: December 16, 2021
• First Posted (Actual): December 17, 2021

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CIBI314A201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No