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COVID-19Phase 1/2NCT05172141

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

A Phase 1/2 study testing IBI314(low dose), IBI314(high dose) and IBI314(medium dose) in people with COVID-19, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

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 Phase 1/2 study evaluating the safety, tolerability and efficacy of IBI314. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
IBI314(low dose), IBI314(high dose) and IBI314(medium dose)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
222 participants
Where
1 siteChina
Study dates
31 Dec 2021to 31 Jan 2023
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
  • Healthy volunteers accepted
  • Adult, Older adult

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 locations and contacts

1 site in 1 country.

China1 site

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510260

Other trials in China

About this study

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

Read the 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.

Conditions
COVID-19
Being tested
IBI314(low dose), IBI314(high dose), IBI314(medium dose), 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.

  • IBI314(low dose)Biological

    intravenously, once, on Day 1

  • IBI314(high dose)Biological

    intravenously, once, on Day 1

  • IBI314(medium dose)Biological

    intravenously, once, on Day 1

  • PlaceboOther

    intravenously, once, on Day 1

Study groups in NCT05172141
Study groupRoleWhat they receive
IBI314ExperimentalLow/medium/high dose, intravenously, once, on Day 1
Receives: Biological: IBI314(low dose); Biological: IBI314(high dose); Biological: IBI314(medium dose)
PlaceboPlacebo comparatorPlacebo, intravenously, once, on Day 1
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 (15)

  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.

    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.

    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. 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

  8. 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

  9. 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

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

    This is a virologic efficacy outcome measure.

    Measured: 7, 11, 22 days after the last participant is randomized

  11. 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: 11 days after the last participant is randomized

  12. 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: 22 days after the last participant is randomized

  13. Proportion of patients demonstrating symptoms alleviation on D3, 7, 15, 22, 29

    This is a clinical efficacy outcome measure.

    Measured: 3, 7, 15, 22, 29 days after the last participant is randomized

  14. Proportion of patients who become severe COVID-19 by Day 29

    This is a clinical efficacy outcome measure.

    Measured: 29 days after the last participant is randomized

  15. Proportion of patients requiring mechanical ventilation by day 29

    This is a clinical 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 posted29 Dec 2021
  2. Study start31 Dec 2021
  3. Primary completion31 Aug 2022
  4. Study completion31 Jan 2023

Why it stopped: Due to the company's development strategy adjustment, Innovant Biologics decided not to continue this study after consultation with investigators.

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
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
222 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05172141
Sponsor's protocol ID
CIBI314B201
Status last verified
Feb 2023
First submitted
24 Dec 2021
Last updated
1 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IBI314(low dose), IBI314(high dose) and IBI314(medium dose) in people with COVID-19, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

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 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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: Due to the company's development strategy adjustment, Innovant Biologics decided not to continue this study after consultation with investigators.). 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 NCT05172141.

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 1 Mar 2023.

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