COVID-19 trials registries data warehouse

http://en.irct.ir/trial/61472

Abbas Basiri

research@unrc.ir

2022-02-02

Completed

nonRCT

Non-randomized

Single group assignment

Open label

single-center

Prevention

Men and women older than 18 Patients with history of kidney transplantation who vaccinated with two doses Sinopharm vaccine after transplantation Women who are not pregnant or breast-feeding People who have been transplanted for more than 6 months

Subjects with active infection with signs of SARS-COV-2 at screening visit History of covid-19 based on a previous positive PCR Treatment of active Cytomegalovirus (CMV) infection History of receiving rituximab during the past 6 months History of receiving IVIg during the past 6 months Subjects who have a history of severe allergic reactions (e.g. anaphylaxis) to the study vaccine or any components of the vaccine or any other drugs Subjects who have received any other investigational product within 30 days prior to the screening visit or intend to participate in other clinical studies during this trial History of transplant rejection during the past 30 days Subjects with special circumstances who, may increase the risk of participating in the study or interfering with the evaluation of the primary endpoints of the study according to researcher's opinion

1

Shahid Beheshti university of medical sciences Urology and Nephrology Research Center

18

100

Iran

High risk patients

N/A

100

Evaluation of seroconversion of antibody against spike protein Evaluation of seroconversion of neutralizing antibodies

Not reported

[{"arm_notes": "25 \u00b5g;1;IM", "treatment_id": 335, "treatment_name": "Covax-19", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]