COVID-19 trials registries data warehouse

http://en.irct.ir/trial/62022

Hasan Jalili

hjalili@ut.ac.ir

2022-02-26

Completed

nonRCT

Non-randomized

Parallel

Open label

multi-center

Prevention

Aged over 18 years old In the volunteer’s vaccination history, the interval between the first and second dose is between 4 to 8 weeks and at least 3 months and at most 5 months have passed since the injection of the second dose of the volunteer's vaccination. The volunteer must be able and willing to cooperate with the researchers throughout the study period. The volunteer must be able to fully understand the executive processes of the study and to understand the explanations of the facilitators correctly. The volunteer would be able to understand the contents of the informed consent form and sign the informed consent before recruitment. Access to the medical records and test results if hospitalised for any reason including due to the suspected or confirmed COVID-19 should be allowed. The volunteer has been in a medically stable condition for the past three months (he/she has not been hospitalized, his / her chronic illness has not recurred). His / her chronic illness medication instructions have not changed due to lack of control over clinical symptoms, etc.)

Confirmed, suspected, or asymptomatic COVID-19 case Candidate with a history of SARS-CoV-2 infection (documented rtPCR) after receiving the second dose of COVID-19 vaccine. During the period of home quarantine due to Covid-19 (suspicion of exposure or suspicious symptoms). In the 14 days prior to vaccination: fever or presence of at least two symptoms from Dry cough, severe fatigue, nasal congestion, runny nose, sore throat, myalgia, diarrhoea, dyspnea, and shortness of breath History of severe allergic reaction, urticaria or allergic reactions to COVID-19 Inactivated vaccine ingredients (allergic to Aluminium). Personal or family history of seizure, epilepsy, encephalopathy or psychiatric disorders Presence of congenital malformations or any genetic disorder Presence of any malignancy Known case of immunodeficiency, HIV, lymphoma, leukemia, or other autoimmune diseases. Receiving immunosuppressive drugs or corticosteroids in the last 6 months Splenectomy or history of any organ removal History of coagulation disorders History of hereditary and acquired angioedema over the past year Receiving Anti-TB treatment Positive HBsAg/ Positive HCV antibody Receiving immunomodulators or immunosuppressors at least for14 days in the past 3 months Receiving live vaccine in one month or other vaccines in 14 days before inoculation Receiving immunoglobulins or blood products in 3 months before inoculation History of severe mental disorders affecting the participation in the study Women with a positive pregnancy test (Beta HCG in a blood sample) or breastfeeding or those who intend to become pregnant during the study period. Any other circumstances are other than the above-mentioned ones that the researcher deems inappropriate for a person participating in a clinical trial. These cases are recorded as the reason for not entering.

3

SHIFAPHARMED Industrial Group Co

18

100

Iran

Healthy volunteers

N/A

210

Total IgG titers against Wuhan and Omicron variants (with GMT, GMI) The neutralization capacity of booster doses against Wuhan and Omicron variants

Phase 3

[{"arm_notes": "3rd injection", "treatment_id": 2050, "treatment_name": "Coviran barekat", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Omicron strain, both with a history of receiving two doses of CovIran Barkat", "treatment_id": 2050, "treatment_name": "Coviran barekat", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Omicron strain, with a history of receiving two doses of Sinopharm", "treatment_id": 2050, "treatment_name": "Coviran barekat", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]