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Virus Therapy

IBI314 for COVID-19

Phase 1 & 2
Waitlist Available
Research Sponsored by Innovent Biologics (Suzhou) Co. Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days after the last participant is randomized
Awards & highlights

Study 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.

Eligible Conditions
  • COVID-19
  • Coronavirus

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days after the last participant is randomized
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days after the last participant is randomized for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of treatment related AEs
Virologic efficacy Evaluation
Secondary outcome measures
Change from baseline in viral shedding on Day 7, 11, 22
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
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: IBI314Experimental Treatment1 Intervention
a cocktail of two SARS-CoV-2 S protein IgG1 antibodies, IBI314-A and IBI314-B, in a 1:1 [w/w] ratio
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Innovent Biologics (Suzhou) Co. Ltd.Lead Sponsor
167 Previous Clinical Trials
25,529 Total Patients Enrolled
1 Trials studying COVID-19
222 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Safety, Tolerability, and Efficacy Study of IBI314 in Ambulatory Patients With COVID-19
2022. "A Safety, Tolerability, and Efficacy Study of IBI314 in Ambulatory Patients With COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05162365.
~76 spots leftby Apr 2025
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