A Safety, Tolerability, and Efficacy Study of IBI314 in Patients With Mild to Moderate COVID-19
- Conditions
- COVID-19
- Interventions
- Biological: IBI314(low dose)Other: PlaceboBiological: IBI314(high dose)Biological: IBI314(medium dose)
- Registration Number
- NCT05172141
- Lead Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Brief Summary
This is a Phase 1/2 study evaluating the safety, tolerability and efficacy of IBI314.
- Detailed 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 222
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
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IBI314 IBI314(low dose) Low/medium/high dose, intravenously, once, on Day 1 IBI314 IBI314(medium dose) Low/medium/high dose, intravenously, once, on Day 1 Placebo Placebo Placebo, intravenously, once, on Day 1 IBI314 IBI314(high dose) Low/medium/high dose, intravenously, once, on Day 1
- Primary Outcome Measures
Name Time Method Number of treatment related AEs 29 days after the last participant is randomized Any AEs and SAEs occurring during the study
Virologic efficacy Evaluation 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
- Secondary Outcome Measures
Name Time Method maximum concentration (Cmax) 29 days after the last participant is randomized PK parameters to be evaluated for IBI314 including maximum concentration (Cmax) will be determined when appropriate.
volume of distribution (V) 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.
area under the concentration-time curve (AUC) 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.
half-life (t1/2) 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.
Change from baseline in viral shedding on Day 7, 11, 22 7, 11, 22 days after the last participant is randomized This is a virologic efficacy outcome measure.
Time-weighted average change in viral shedding from baseline through D22 as measured by RT-qPCR in NP swab samples. 22 days after the last participant is randomized This is a virologic efficacy outcome measure.
Time to alleviation of symptoms (going to mild or absent) 29 days after the last participant is randomized This is a clinical efficacy outcome measure.
Proportion of patients who become severe COVID-19 by Day 29 29 days after the last participant is randomized This is a clinical efficacy outcome measure.
Proportion of patients with all-cause mortality by Day 29 29 days after the last participant is randomized This is a clinical efficacy outcome measure.
clearance (CL) 29 days after the last participant is randomized PK parameters to be evaluated for IBI314 including clearance (CL) will be determined when appropriate.
The incidence of anti-IBI314 antibody (ADA) and neutralizing antibody (NAb) in serum before and after study drug administration 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).
Time to negative RT-qPCR in NP swab samples with no subsequent positive RT-qPCR 29 days after the last participant is randomized This is a virologic efficacy outcome measure.
Time-weighted average change in viral shedding from baseline through D11 as measured by RT-qPCR in NP swab samples 11 days after the last participant is randomized This is a virologic efficacy outcome measure.
Proportion of patients demonstrating symptoms alleviation on D3, 7, 15, 22, 29 3, 7, 15, 22, 29 days after the last participant is randomized This is a clinical efficacy outcome measure.
Proportion of patients requiring mechanical ventilation by day 29 29 days after the last participant is randomized This is a clinical efficacy outcome measure.
Trial Locations
- Locations (1)
The Second Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China