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:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-24 @ 5:17 PM
NCT ID:
NCT04932850
Eligibility Criteria:
Inclusion Criteria:
1. Informed consent: Signed written informed consent before inclusion in the study
2. Full comprehension: Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study
3. Sex and age: Healthy men and women, 18 - 55 years old, inclusive
4. Negative SARS-CoV-2 serology test at screening (negative anti-S and anti-N)
5. Negative SARS-CoV-2 qRT-PCR in the 72 h before treatment (test on day -3 or -2 or -1 with result before treatment)
6. Body Mass Index: 18.5-30 kg/m2, inclusive, at screening
7. Vital signs: Systolic blood pressure 90-139 mmHg, diastolic blood pressure 60-90 mmHg, heart rate 50-100 bpm, measured after 5 min at rest in the supine position
8. ECG: Electrocardiogram without clinically significant abnormalities at screening
9. Contraception and fertility: Women of child-bearing potential must be using at least one of the following reliable methods of contraception and confirm to use adequate contraception during the study:
1. Hormonal oral or implantable or transdermal, or injectable contraceptives for at least 2 months before the screening visit;
2. A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit
3. A male sexual partner who agrees to use a male condom with spermicide
4. A sterile sexual partner
5. A same sex partner Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all women, urine pregnancy test result must be negative at screening and day 1
Exclusion Criteria:
1. Physical findings: Clinically significant abnormal physical findings which could interfere with the objectives of the study
2. Allergy: Ascertained or presumptive hypersensitivity to the active principle and/or ingredients of the investigational products; history of anaphylaxis to drugs or allergic reactions likely to be exacerbated by any component of the investigational products in the Investigator's opinion
3. Concomitant medications: Medications, including over the counter (OTC) medications and herbal remedies, for 2 weeks before screening and immunoglobulin or blood products for 6 months before screening (except contraceptives or a single use of paracetamol, aspirin, or combination OTC products containing paracetamol with an antihistamine, or OTC non-steroidal anti-inflammatory drugs (NSAIDs) at a dose equal or lower than that recommended on the package; vitamins and nutritional supplements, if regularly taken before the study, are also allowed)
4. Monoclonal Antibodies (mAb): Previous intake of a mAb within 6 months, or 5 antibody half-life, whichever is longer, before study start
5. Transient acute illness: Acute (time-limited) illness, including fever above 37.5°C on the day before or on the day of the planned treatment; subjects excluded for transient acute illness may be dosed if illness resolves within the screening period or may be rescreened once
6. Diseases: Significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, psychiatric or neurological diseases that may interfere with the aim of the study or increase subjects risks; history of malignancy in the last 5 years
7. SARS CoV-2 or COVID-19:
1. Participants with any confirmed current or previous COVID-19 infection at screening, or at day -1 or day 1
2. Participant with clinical signs or symptoms consistent with COVID-19, e.g. fever, dry cough, dyspnoea, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4 weeks before/at screening or at day -1 or day 1
3. Any prior intake of investigational or licenced vaccine indicated for the prevention of SARS CoV-2 or COVID-19 or expected intake during follow-up period
4. Has been reported as a case (confirmed or probable) of COVID-19 from the regional health system
8. Immunodeficiency due to illness, including HIV infection (positivity to anti-HIV-Ab), or due to drugs, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent within 6 months before screening.
9. Infections: History of active infection with hepatitis B or C or positive test result for anti-HCV-Ab or HBsAg or anti-HBc-Ab at screening; history of infection with SARS or MERS
10. Laboratory analyses: Abnormal laboratory values that in the opinion of the Investigator are clinically significant
11. Investigative drug studies: Participation in the evaluation of any investigational product for 6 months before this study
12. Blood donation: blood donations for 3 months before the study, during the study and in the 3 months after the end of the study
13. Drug test: positive drug test at screening or day -1
14. Drug, alcohol: history of drug or alcohol abuse within 6 months before screening
15. Pregnancy (women only): positive or missing pregnancy test at screening or day 1; pregnant or lactating women
16. Other: Any condition that might compromise study subject's safety or interfere with the study evaluations or interpretation of subject's safety or study results
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04932850
Study Brief:
Protocol Section:
NCT04932850