COVID-19 trials registries data warehouse

http://en.irct.ir/trial/57980

Ahmad Karimi Rahjerdi

Rahjerdi@strc.ac.ir

2021-08-29

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

Age > 18; Having Iranian citizenship; Internet and smart mobile access (him/herself or one of him/his family); Living in and around the city where the trial takes place; No current COVID-19 disease; No pregnancy; Using safe methods of contraception; Signing the informed consent form.

Current acute or chronic symptomatic illness that requires ongoing medical or surgical care; Acute febrile illness; Lactation; History of receiving COVID19 vaccine; History of transfusion of any blood product or immunoglobulin within the 3 months before the study; History of long-term use (14 successive days) of immunosuppressive drugs or systemic corticosteroids in the last 4 months leading up to the study; History of diagnosis or treatment for HIV; History of allergic diseases such as angioedema or anaphylactic reactions following the use of drugs, vaccines or food; 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); 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 as prophylaxis is allowed.; Current drug or alcohol abuse (addiction); Close contact with a definite case of COVID-19 up to two weeks prior to the day of receiving the first dose; Chronic diseases that are not listed as exclusion criteria but are considered unstable within the last 4 weeks.

2

Organization of Defensive Innovation and Research

18

100

Iran

Healthy volunteers

N/A

41128

Occurrence of confirmed symptomatic Covid-19 disease two weeks after the second vaccine dose

Phase 3

[{"arm_notes": "Two doses FAKHRAVAC (MIVAC) vaccine at 21 days", "treatment_id": 1922, "treatment_name": "Inactivated sars-cov-2 vaccine fakhravac (mivac)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Two doses of Sinopharm vaccine at 21 days", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]