Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT05184218
Eligibility Criteria:
Healthy Volunteers
Inclusion Criteria:
* Is male or non-pregnant female adult ≥ 18 and ≤ 55 years of age
* Has a body mass index (BMI) \< 35 kg/m2.
* Is healthy as determined by medical history and physical examination
* Agrees to use contraception through 3 months after the last dose of IGM-6268
Exclusion Criteria:
* Receipt of any COVID-19 vaccine during this study and follow-up period
* Prior positive SARS-CoV2 test
* Hepatitis B virus (HBV), hepatitis C virus (HCV), or uncontrolled human immunodeficiency virus (HIV) infection
* Use of any nasally administered drug
Mild-Moderate COVID Patients
Inclusion Criteria:
* Is male or non-pregnant female adult ≥ 18 and ≤ 55 years of age
* Agrees to use contraception through 3 months after the last dose of IGM-6268
* Agrees to the collection of blood, urine, saliva, and nasopharyngeal samples, per protocol.
* Signs and symptoms of mild to moderate COVID-19 but not requiring hospitalization
* Has a laboratory-confirmed SARS-CoV-2 infection as determined by FDA-authorized antigen or NAAT diagnostic assay during the period of 72 hours prior to enrollment.
Exclusion Criteria:
* Receipt of any COVID-19 vaccine during this study and follow-up period
* Receipt of remdisivir, antiviral antibody treatment (plasma or Mabs), immosuppressive therapies, or cytokine-targeted anti-inflammatory drugs
* Concurrent use of drugs not approved for use in COVID-19 patients (e.g., ivermectin, chloroquine/hydroxychloroquine, budesonide).
* Co-morbidities including but not limited to hypertension, cardiovascular disease, diabetes (Type 1 or 2), chronic kidney disease, or asthma
* Subject is considered to be in their last few weeks of life prior to this acute illness
* Cancer within the last 5 years except stable prostate cancer and basal cell carcinoma
* Hepatitis B virus (HBV), hepatitis C virus (HCV), or uncontrolled human immunodeficiency virus (HIV) infection
* Influenza or confirmed or suspected pulmonary or systemic bacterial infection
* Receipt of any COVID-19 vaccine during this study and follow-up period
* Use of any nasally administered drug
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05184218
Study Brief:
Protocol Section:
NCT05184218