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COVID-19Phase 1/2NCT05162365

A Safety, Tolerability, and Efficacy Study of IBI314 in Ambulatory Patients With COVID-19

A Phase 1/2 study testing IBI314 in people with COVID-19, run by Innovent Biologics (Suzhou) Co. Ltd. at 19 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
IBI314
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
248 participants
Where
19 sitesUnited States
Study dates
6 Jan 2022to 18 Nov 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • Sobh

    Anaheim, California, 92806

  • Herco Research Center, Inc.

    Coral Gables, Florida, 33134

  • Zenos Clinical Research

    Dallas, Texas, 75230

  • Midland Florida Clinical Research Center - Inf. Disease/Infectiology

    DeLand, Florida, 32720

  • Palm Springs Research Institute

    Hialeah, Florida, 33012

  • Sweet Hope Research Specialty, Inc

    Hialeah, Florida, 33016

  • Excel Clinical Research - Internal Medicine

    Las Vegas, Nevada, 89109

  • Epic Clinical Research

    Lewisville, Texas, 75057

  • Long Beach Clinical Trials, LLC

    Long Beach, California, 90806

  • Prestige Clinical Research Center Inc

    Miami, Florida, 33133

  • Cordova Research Institute, LLC

    Miami, Florida, 33155

  • Clinical Trials of Florida, LLC

    Miami, Florida, 33186

  • The Clinical Research Institute LLC

    Miami Gardens, Florida, 33169

  • Pembroke Clinical Trials

    Pembroke Pines, Florida, 33028

  • Luminous Clinical Research LLC - South Florida Urgent Care - Infectious Diseases

    Pembroke Pines, Florida, 33029-2818

  • Temple University Health System - Temple Lung Center

    Philadelphia, Pennsylvania, 19140-5103

  • Acclaim Clinical Research

    San Diego, California, 92120

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Florida Pulmonary Research Institute, LLC

    Winter Park, Florida, 32789

Other trials in United States

About this study

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.

Read the 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.

Conditions
COVID-19
Being tested
IBI314, Placebo
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IBI314Biological

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

  • PlaceboOther

    Placebo, intravenously, once, on Day 1

Study groups in NCT05162365
Study groupRoleWhat they receive
IBI314Experimentala cocktail of two SARS-CoV-2 S protein IgG1 antibodies, IBI314-A and IBI314-B, in a 1:1 [w/w] ratio
Receives: Biological: IBI314
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of treatment related AEs

    Any AEs and SAEs occurring during the study

    Measured: 29 days after the last participant is randomized

  2. Virologic efficacy Evaluation

    Time-weighted average change in viral shedding from baseline through Day 7 as measured by RT-qPCR in NP swab samples.

    Measured: 7 days after the last participant is randomized

Secondary outcomes (14)

  1. maximum concentration (Cmax)

    PK parameters to be evaluated for IBI314 including maximum concentration (Cmax) will be determined when appropriate.

    Measured: 29 days after the last participant is randomized

  2. area under the concentration-time curve (AUC)

    PK parameters to be evaluated for IBI314 including area under the concentration-time curve (AUC) will be determined when appropriate.

    Measured: 29 days after the last participant is randomized

  3. half-life (t1/2)

    PK parameters to be evaluated for IBI314 including half-life (t1/2) will be determined when appropriate.

    • Time to alleviation of symptoms (going to mild or absent);
    • Proportion of patients admitted to a hospital and emergency room visit due to COVID-19 by Day 29;
    • Proportion of patients with all-cause mortality by Day 29.

    Measured: 29 days after the last participant is randomized

  4. clearance (CL)

    PK parameters to be evaluated for IBI314 including clearance (CL) will be determined when appropriate.

    • Change from baseline in viral shedding on Day 7, 11, 22;
    • Time-weighted average change in viral shedding from baseline through D11 as measured by RT-qPCR in NP swab samples;
    • Time-weighted average change in viral shedding from baseline through D22 as measured by RT-qPCR in NP swab samples.

    Measured: 29 days after the last participant is randomized

  5. volume of distribution (V)

    PK parameters to be evaluated for IBI314 including volume of distribution (V) will be determined when appropriate.

    Measured: 29 days after the last participant is randomized

  6. The incidence of anti-IBI314 antibody (ADA) and neutralizing antibody (NAb) in serum before and after study drug administration

    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).

    Measured: 29 days after the last participant is randomized

  7. Proportion of patients with at least one COVID-19 related medically attended visits by Day 29

    This is a clinical efficacy outcome measure.

    Measured: 29 days after the last participant is randomized

  8. Time to alleviation of symptoms (going to mild or absent)

    This is a clinical efficacy outcome measure.

    Measured: 29 days after the last participant is randomized

  9. Proportion of patients admitted to a hospital and emergency room visit due to COVID-19 by Day 29

    This is a clinical efficacy outcome measure.

    Measured: 29 days after the last participant is randomized

  10. Proportion of patients with all-cause mortality by Day 29

    This is a clinical efficacy outcome measure.

    Measured: 29 days after the last participant is randomized

  11. Time to negative RT-qPCR in NP swab samples with no subsequent positive RT-qPCR

    This is a virologic efficacy outcome measure.

    Measured: 29 days after the last participant is randomized

  12. Change from baseline in viral shedding on Day 7, 11, 22

    This is a virologic efficacy outcome measure.

    Measured: 29 days after the last participant is randomized

  13. Time-weighted average change in viral shedding from baseline through D11 as measured by RT-qPCR in NP swab samples

    This is a virologic efficacy outcome measure.

    Measured: 29 days after the last participant is randomized

  14. Time-weighted average change in viral shedding from baseline through D22 as measured by RT-qPCR in NP swab samples.

    This is a virologic efficacy outcome measure.

    Measured: 29 days after the last participant is randomized

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2021
  2. Study start6 Jan 2022
  3. Primary completion29 Jun 2022
  4. Study completion18 Nov 2022

Why it stopped: The company decision that terminated the further develop of the molecule and had notified FDA about the termination as well.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05162365
Sponsor's protocol ID
CIBI314A201
Status last verified
Dec 2023
First submitted
12 Dec 2021
Last updated
18 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Huang Y, Lin Z, Guo X, Zhang F, Wang Y, Zhang Z, Chen J, Liu L, Zhu M, Li Y, Ni M, Zhen Z, Wu Z, Ling X, Zhou S, Xi Y, Yu Y, Liang W, Zhao J, Li L, He J, Sang L. Development of broadly neutralizing antibodies against Omicron variants from existing neutralizing antibodies in clinical trials. Virol J. 2025 Nov 4;22(1):358. doi: 10.1186/s12985-025-02964-8.

    PubMed 41188882

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IBI314 in people with COVID-19, run by Innovent Biologics (Suzhou) Co. Ltd. at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The company decision that terminated the further develop of the molecule and had notified FDA about the termination as well.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of treatment related AEs (time frame: 29 days after the last participant is randomized). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05162365, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.

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