COVID-19 trials registries data warehouse

http://en.irct.ir/trial/59902

Ali Eshaghi

a.Eshahghi@rvsri.ac.ir

2021-11-29

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

Having Iranian citizenship; Age 18 years and older; Having history of full vaccination with Sinopharm vaccine (two doses) 75 to 195 days from the last vaccination; Signing an 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); Any current or new diagnosis of acute or chronic illness requiring continuous ongoing medical care; Severe cardiovascular disease; Breastfeeding; History of receiving any vaccine within 14 days before receiving the booster dose; History of diseases resulting in immunosuppression (suspected and definite); History of long-term use of immunosuppressive drugs, including history of long-term use of systemic corticosteroids (equivalent to 10 mg or more daily prednisolone) with the exception of topical steroids (more than 14 consecutive days) within the past 4 months; History of uncontrolled serious psychiatric illnesses; History of chronic neurological diseases (including seizures and epilepsy)؛ Acute febrile illness at the time of booster vaccine injection; Splenectomy for any reason; Close contact with a confirmed COVID-19 case within two weeks before the booster dose; Continued 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 is allowed as prophylaxis; Recent diagnosis or treatment of cancers except basal cell carcinoma and In-situ cervical cancer; Received blood and/or any blood products and/or immunoglobulins within three months preceding the booster dose; History of blood disorders (dyscrasia, coagulopathy, platelet deficiency or disorder, or deficiency of blood clotting factors); Current substance or alcohol abuse; Pregnancy based on the participant's statement and the time of the first day of the last menstrual period and negative pregnancy test (baby check) on the day of vaccination; History of COVID -19 based on laboratory or clinical evidence after primary vaccination; Chronic unstable diseases in the last 4 weeks, including hospitalization due to surgery, deterioration of one organ function, the need to add new drugs or serious dose adjustments to existing drugs.

2

Razi Vaccine and Serum Research Institute

18

100

Iran

Healthy volunteers

N/A

500

Neutralizing antibody activity

Not reported

[{"arm_notes": "one booster dose, previously vaccinated with Sinopharm", "treatment_id": 1066, "treatment_name": "Razi cov pars", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "one booster dose, previously vaccinated with Sinopharm", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]