COVID-19 trials registries data warehouse

http://en.irct.ir/trial/59912

Ahmad Karimi Rahjerdi

Rahjerdi@strc.ac.ir

2021-11-29

Completed

RCT

Randomized

Parallel

Blind label

single-center

Prevention

Age more than18; Not having COVID 19 since the last dose of primary vaccination with Sinopharm; Fully vaccinated and within the 75 to 195 days post vaccination period; Signing the informed consent form; For females of childbearing age 18 to 49 years: use of at least one effective method of contraception (condom, oral contraceptive pills, intrauterine device, norplant capsule) and willing to continue up to two month after the booster dose.

History of allergy to drugs or vaccines (e.g urticaria and fever); Current acute or chronic symptomatic illness that requires ongoing medical or surgical care; History of severe cardiovascular disease; Lactation; History of receiving any vaccine during the 14 days period prior to the day of receiving booster dose; History of transfusion of any blood product or immunoglobulin within the 3 months period before receiving booster dose; History of diseases resulting in immunosuppression (suspected and definite); History of long-term use of immunosuppressive drugs or systemic corticosteroids in the last 4 months period leading up to the screening day; History of diagnosis or treatment for cancer (except basal cell carcinoma and Insitu cervical cancer); History of uncontrolled serious psychiatric illnesses; History of blood disorders (Blood Dyscrasias, coagulation disorders, platelet deficiency, etc); History of chronic neurological diseases (including seizure and epilepsy); Current drug/alcohol abuse (addiction); Acute febrile illness at the time of booster vaccine injection; Having splenectomy for any reason; Any close contact with a definitively infected person with COVID-19 within the two weeks period before the day of receiving the booster dose; Current use of anticoagulants such as coumarin and related anticoagulants (such as warfarin) or new oral anticoagulants / antiplatelet agents. Note: Less than 325 mg of aspirin per day as prophylaxis is allowed; Chronic unstable disease (last 4 weeks) at the discretion of the principal investigator; Pregnancy.

2

Organization of Defensive Innovation and Research

18

100

Iran

Healthy volunteers

N/A

400

Neutralizing antibody activity

Not reported

[{"arm_notes": "one booster dose IM, previously vaccinated with Sinopharm", "treatment_id": 1922, "treatment_name": "Inactivated sars-cov-2 vaccine fakhravac (mivac)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "one booster dose IM, previously vaccinated with Sinopharm", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]