Clinical trial NCT05172141: A Safety, Tolerability, and Efficacy Study of IBI314 in Patients With Mild to Moderate COVID-19
Official title: A Safety, Tolerability, and Efficacy Study of IBI314 in Patients With Mild to Moderate COVID-19
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: COVID-19
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2021-12-29
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Number of treatment related AEs
timeFrame: 29 days after the last participant is randomized
measure: Virologic efficacy Evaluation
timeFrame: 7 days after the last participant is randomized
Secondary outcomes:
measure: maximum concentration (Cmax)
timeFrame: 29 days after the last participant is randomized
measure: area under the concentration-time curve (AUC)
timeFrame: 29 days after the last participant is randomized
measure: half-life (t1/2)
timeFrame: 29 days after the last participant is randomized
measure: clearance (CL)
timeFrame: 29 days after the last participant is randomized
measure: volume of distribution (V)
timeFrame: 29 days after the last participant is randomized
measure: The incidence of anti-IBI314 antibody (ADA) and neutralizing antibody (NAb) in serum before and after study drug administration
timeFrame: 29 days after the last participant is randomized
measure: Time to alleviation of symptoms (going to mild or absent)
timeFrame: 29 days after the last participant is randomized
measure: Proportion of patients with all-cause mortality by Day 29
timeFrame: 29 days after the last participant is randomized
measure: Time to negative RT-qPCR in NP swab samples with no subsequent positive RT-qPCR
timeFrame: 29 days after the last participant is randomized
measure: Change from baseline in viral shedding on Day 7, 11, 22
timeFrame: 7, 11, 22 days after the last participant is randomized
measure: Time-weighted average change in viral shedding from baseline through D11 as measured by RT-qPCR in NP swab samples
timeFrame: 11 days after the last participant is randomized
measure: Time-weighted average change in viral shedding from baseline through D22 as measured by RT-qPCR in NP swab samples.
timeFrame: 22 days after the last participant is randomized
measure: Proportion of patients demonstrating symptoms alleviation on D3, 7, 15, 22, 29
timeFrame: 3, 7, 15, 22, 29 days after the last participant is randomized
measure: Proportion of patients who become severe COVID-19 by Day 29
timeFrame: 29 days after the last participant is randomized
measure: Proportion of patients requiring mechanical ventilation by day 29
timeFrame: 29 days after the last participant is randomized
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References: