Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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. Have been admitted to a hospital prior to randomization, or is hospitalized (inpatient) at randomization due to COVID-19. 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 Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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
Placebo Comparator
Placebo
  • Other: Placebo
    Placebo, intravenously, once, on Day 1

Recruiting Locations

Epic Clinical Research
Lewisville, Texas 75057
Contact:
Heather Myers
469-361-8007
hmyers@epicclinicalresearch.com

More Details

NCT ID
NCT05162365
Status
Recruiting
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.

Study Contact

Winnie Leung
86 21 31837200
winnie.leung@innoventbio.com

Detailed Description

Phase 1 is a randomized, double-blind, placebo-controlled, single ascending dose study in up to 48 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 192 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.