Clinical trial NCT05162365: A Safety, Tolerability, and Efficacy Study of IBI314 in Ambulatory Patients With COVID-19
Official title: A Safety, Tolerability, and Efficacy Study of IBI314 in Ambulatory Patients With 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: 2021-12-17
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Main 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. 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).

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: Proportion of patients with at least one COVID-19 related medically attended visits by Day 29
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 admitted to a hospital and emergency room visit due to COVID-19 by Day 29
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: 29 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: 29 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: 29 days after the last participant is randomized
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Sobh
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials, LLC
state: California
city: San Diego
country: United States
facility: Acclaim Clinical Research
state: California
city: Coral Gables
country: United States
facility: Herco Research Center, Inc.
state: Florida
city: DeLand
country: United States
facility: Midland Florida Clinical Research Center - Inf. Disease/Infectiology
state: Florida
city: Hialeah
country: United States
facility: Palm Springs Research Institute
state: Florida
city: Hialeah
country: United States
facility: Sweet Hope Research Specialty, Inc
state: Florida
city: Miami Gardens
country: United States
facility: The Clinical Research Institute LLC
state: Florida
city: Miami
country: United States
facility: Prestige Clinical Research Center Inc
state: Florida
city: Miami
country: United States
facility: Cordova Research Institute, LLC
state: Florida
city: Miami
country: United States
facility: Clinical Trials of Florida, LLC
state: Florida
city: Pembroke Pines
country: United States
facility: Pembroke Clinical Trials
state: Florida
city: Pembroke Pines
country: United States
facility: Luminous Clinical Research LLC - South Florida Urgent Care - Infectious Diseases
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Winter Park
country: United States
facility: Florida Pulmonary Research Institute, LLC
state: Florida
city: Las Vegas
country: United States
facility: Excel Clinical Research - Internal Medicine
state: Nevada
city: Philadelphia
country: United States
facility: Temple University Health System - Temple Lung Center
state: Pennsylvania
city: Dallas
country: United States
facility: Zenos Clinical Research
state: Texas
city: Lewisville
country: United States
facility: Epic Clinical Research
state: Texas
Study officials:
References: