COVID-19 trials registries data warehouse

http://en.irct.ir/trial/54881

Mohammadreza Hosseinpour

mr.hosseinpour@shifapharmed.com

2021-03-13

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

Aged 18 to 75 years Being able to fully understand the study processes and understand the explanations of the facilitators correctly Being able to fully understand the study processes and understand the explanations of the facilitators correctly Being able to understand the contents of the informed consent form and sign it before entering the study Allowing the researchers to access medical records and test results if hospitalized due to suspected, or confirmed COVID-19 Using effective methods of contraception during the study at least two months after the second dose of vaccine Volunteers who agree not to donate blood, blood products, or bone marrow from the start of the vaccine until 21 days after receiving the last dose of the vaccine

Confirmed, suspected, or asymptomatic COVID-19 detected by PCR at baseline History of contact with a person with SARS-CoV-2 infection (positive PCR test) during the last 14 days History of SARS-CoV-2 infection (Only in immunogenicity subsample Fever or at least two of these symptoms: Dry cough, severe fatigue, nasal congestion, runny nose, sore throat, myalgia, diarrhea, dyspnea, and shortness of breath during the 14 days prior to vaccination History of severe allergic reaction to vaccination or allergic reactions to Inactivated vaccine components Known case of tuberculosis, hepatitis B or hepatitis C History of coagulopathy History of splenectomy Uncontrolled hypertension, uncontrolled diabetes, uncontrolled chronic cardiac, renal, neurologic, or severe pulmonary disease Acute diseases or an exacerbation of a chronic disease in the last 7 days Any malignancy, immunodeficiency, HIV, lymphoma, leukemia, or other autoimmune diseases Receiving immunomodulators or immunosuppressors at least 14 days in the past 3 months or planning to use in the next year Receiving live vaccine in one month or other vaccines in 14 days before inoculation History of drug or alcohol abuse in the last 12 months caused medical, familial or occupational problems Receiving immunoglobulins or blood products in 3 months before inoculation or planning to use in the next year Receiving any other investigational drug in 6 months before inoculation Having a plan to participate in a drug trial during the study period Planning to receive any vaccination in on month after inoculation History of severe mental disorders affecting the participation in the study Pregnant or lactating women or those who intend to become pregnant during the study period History of travel abroad in the last 14 days Any other condition that makes a person inappropriate for participation based on the investigator opinion

2

Shifa Pharmed Industrial Co.

18

75

Iran

Healthy volunteers

N/A

20000

Vaccine efficacy of Shifa-pharmed inactivated SARS-COV-2 vaccine Neutralizing antibody (phase 2) Anti SARS-COV-2 antibody titer (IgG, IgM) (Geometric mean titer) (phase 2) Severe COVID-19 cases

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "5 \u03bcg;2;days0-28;IM", "treatment_id": 90, "treatment_name": "Antigen protein", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]