COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05526183

Ekmel Olcay, MD

ekmelolcay@gmail.com

2022-09-02

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: i-1 healthy volunteers of both sexes aged 18-59 years i-2 able to give signed informed consent, i-3 will be able to comply with the study protocol for approximately 6 months (depending on the group), i-4 hiv, hepatitis b and c tests are negative, i-5 body temperature below 37.2oc i-6 covid-19 igg and igm antibodies negative and no history of symptomatic disease, i-7 those who have not previously received any covid-19 vaccines i-8 negative qpcr sars-cov-2 result in nasopharynx or sputum samples, i-9 body mass index between 18-35 kg/m2, i-10 abnormal finding in complete blood count, alanine aminotransferase (alt), aspartate aminotransferase (ast), total bilirubin, urea, creatinine and fasting blood sugar between the normal reference values or detected in any laboratory parameter is grade 1 according to the opinion of the investigator* volunteers not older (>grade 1) i-11 good general health (history and physical examination within 14 days prior to enrollment in the study), i-12 if female, healthy volunteers who are not pregnant or who can use appropriate contraception within 30 days before vaccine injection and within 6 months after vaccination will be included in the study. i-13 male volunteers who can use appropriate contraception within 6 months after vaccine injection will be included in the study.

e-1. subjects with a history of seizures, encephalopathy or psychosis, e-2. subjects who have a known allergy to any vaccine or are allergic to any component of the vaccine to be administered, e-3. pregnant or lactating women, women who have a positive pregnancy test or plan to become pregnant within the next 6 months. e-4. subjects whose body temperature is above 37.2oc at the time of vaccination or who have signs of active infection, e-5. subjects with a positive history of sars (sars-cov-1) (based on voluntary declaration), e-6.subjects with severe cardiovascular disease (arrhythmia, conduction block, myocardial infarction, uncontrolled hypertension), e-7. subjects with serious chronic diseases (asthma, diabetes, thyroid diseases, etc.), e-8. subjects with congenital or acquired angioedema, e-9. subjects with a diagnosis of immunodeficiency, e-10. subjects with a diagnosis of bleeding diathesis, e-11. subjects who take immunosuppressive treatment, those who take anti-allergic treatment, those who take cytotoxic treatment, those who take inhaled corticosteroids (except for allergic rhinitis or topical steroid ointments), e-12. subjects who received blood and blood product transfusion in the last 4 months, e-13. subjects who participated in any vaccine study or took experimental drugs within 1 month before starting the study, e-14. subjects who received any live vaccines in the 1 month prior to the study e-15. subjects who received inactivated vaccine within 14 days of starting the study e-16. subjects receiving active tuberculosis treatment, e-17. subjects with a personal or family history of thrombosis and thromboembolism, persons prone to thrombosis e-18. according to the researcher's evaluation, those who have any condition (medical, psychological, social, etc.) that may impair the volunteer's compliance with the study will be excluded from the study.

2

Ankara City Hospital Bilkent

18

59

Turkey

Healthy volunteers

N/A

36

Incidence of Adverse Events

None

Phase 1

[{"arm_notes": "Low dose", "treatment_id": 2600, "treatment_name": "Covachgmix", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "High dose", "treatment_id": 2600, "treatment_name": "Covachgmix", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]