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

December 12, 2023 updated by: Innovent Biologics (Suzhou) Co. Ltd.
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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
248

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of treatment related AEs
Time Frame: 29 days after the last participant is randomized
Any AEs and SAEs occurring during the study
29 days after the last participant is randomized
Virologic efficacy Evaluation
Time Frame: 7 days after the last participant is randomized
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
maximum concentration (Cmax)
Time Frame: 29 days after the last participant is randomized
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)
Time Frame: 29 days after the last participant is randomized
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)
Time Frame: 29 days after the last participant is randomized

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)
Time Frame: 29 days after the last participant is randomized

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)
Time Frame: 29 days after the last participant is randomized
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
Time Frame: 29 days after the last participant is randomized
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
Time Frame: 29 days after the last participant is randomized
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)
Time Frame: 29 days after the last participant is randomized
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
Time Frame: 29 days after the last participant is randomized
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
Time Frame: 29 days after the last participant is randomized
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
Time Frame: 29 days after the last participant is randomized
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
Time Frame: 29 days after the last participant is randomized
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
Time Frame: 29 days after the last participant is randomized
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.
Time Frame: 29 days after the last participant is randomized
This is a virologic efficacy outcome measure.
29 days after the last participant is randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 29, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 18, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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