A Safety, Tolerability, and Efficacy Study of IBI314 in Patients With Mild to Moderate COVID-19

Innovent Biologics

Status and phase: Terminated; Phase 2; Phase 1

Conditions: COVID-19

Treatments: Biological: IBI314(high dose); Biological: IBI314(medium dose); Biological: IBI314(low dose); Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05172141

CIBI314B201

Details and patient eligibility

About

This is a Phase 1/2 study evaluating the safety, tolerability and efficacy of IBI314.

Full description

Phase 1 is a randomized, double-blind, placebo-controlled, single ascending dose study in up to 24 health volunteers. This phase of the study is designed to assess the safety, tolerability and PK of IBI314 administered as a single IV infusion. Phase 2 is a randomized, double-blind, placebo-controlled expansion study in approximately 198 mild to moderate adult patients with COVID-19. This phase of the study is designed to assess the efficacy, safety, PK and PD of IBI314.

Enrollment: 222 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

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.

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.

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

Agree to use an adequate method of contraception throughout the study period and for 6 months after the dose of study drug is administered.

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

Main Exclusion Criteria:

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.

Have evidence of multi-organ dysfunction/failure. Systolic blood pressure <90 mmHg, diastolic blood pressure <60 mmHg, or requiring vasopressors.

Require or anticipated impending need for endotracheal intubation, mechanical ventilation, oxygen delivered by high-flow nasal cannula noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

222 participants in 2 patient groups, including a placebo group

IBI314

Experimental group

Description:

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

Treatment:

Biological: IBI314(medium dose)

Biological: IBI314(low dose)

Biological: IBI314(high dose)

Placebo

Placebo Comparator group

Description:

Placebo, intravenously, once, on Day 1

Treatment:

Other: Placebo