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

NCT ID: NCT05162365

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-06

Study Completion Date

2022-11-18

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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IBI314

a cocktail of two SARS-CoV-2 S protein IgG1 antibodies, IBI314-A and IBI314-B, in a 1:1 \[w/w\] ratio

Group Type EXPERIMENTAL

IBI314

Intervention Type BIOLOGICAL

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo, intravenously, once, on Day 1

Interventions

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IBI314

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

Intervention Type BIOLOGICAL

Placebo

Placebo, intravenously, once, on Day 1

Intervention Type OTHER

Eligibility Criteria

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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.

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sobh

Anaheim, California, United States

Site Status

Long Beach Clinical Trials, LLC

Long Beach, California, United States

Site Status

Acclaim Clinical Research

San Diego, California, United States

Site Status

Herco Research Center, Inc.

Coral Gables, Florida, United States

Site Status

Midland Florida Clinical Research Center - Inf. Disease/Infectiology

DeLand, Florida, United States

Site Status

Palm Springs Research Institute

Hialeah, Florida, United States

Site Status

Sweet Hope Research Specialty, Inc

Hialeah, Florida, United States

Site Status

Prestige Clinical Research Center Inc

Miami, Florida, United States

Site Status

Cordova Research Institute, LLC

Miami, Florida, United States

Site Status

Clinical Trials of Florida, LLC

Miami, Florida, United States

Site Status

The Clinical Research Institute LLC

Miami Gardens, Florida, United States

Site Status

Pembroke Clinical Trials

Pembroke Pines, Florida, United States

Site Status

Luminous Clinical Research LLC - South Florida Urgent Care - Infectious Diseases

Pembroke Pines, Florida, United States

Site Status

Palm Beach Research Center

West Palm Beach, Florida, United States

Site Status

Florida Pulmonary Research Institute, LLC

Winter Park, Florida, United States

Site Status

Excel Clinical Research - Internal Medicine

Las Vegas, Nevada, United States

Site Status

Temple University Health System - Temple Lung Center

Philadelphia, Pennsylvania, United States

Site Status

Zenos Clinical Research

Dallas, Texas, United States

Site Status

Epic Clinical Research

Lewisville, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CIBI314A201

Identifier Type: -

Identifier Source: org_study_id