COVID-19 trials registries data warehouse

http://en.irct.ir/trial/52975

Ali Eshaghi

a.Eshahghi@rvsri.ac.ir

2021-01-21

Completed

RCT

Randomized

Parallel

Blind label

single-center

Prevention

Having Iranian citizenship; Diploma or higher degree; Adults aged 18 - 55 years; Body mass index 17 to 35 kg/m2; Having good health based on clinical and laboratory criteria; Having sublingual temperature less than or equal to 37.2 ° C in the morning based on mercury thermometer; Negative IgG and IgM antibody titers for COVID-19 S antigen; Negative RT-PCR test for COVID-19; Negative IgG ELISA for HIV; Having heart rate between 60 and 100; Signed the informed consent form; The participant agrees to reduce the risk of developing of COVID-19; For females of childbearing age 18 to 49 years: not being pregnant based on the first day of the last menstrual period; For females of childbearing age 18 to 49 years: negative pregnancy test based on bHCG on the day of screening and the day of vaccination; For females of childbearing age 18 to 49 years: use at least one effective method of contraception (condoms, oral contraceptive pills, intrauterine device, Norplant capsule) and willing to continue using it up to three month after last vaccine dose; Unwillingness to have children and use effective methods of contraception up to three months after completion of vaccination (all participants). Confirmation by a psychiatrist that the participant's mental health and capacity allows him/her to make a decision regarding his/her participation in the trial.

Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care on the day of vaccination; Working in an occupation with a high risk of exposure to COVID-19 including medical staff, occupations with close contact with the client; Breastfeeding; Receipt any vaccine during the 30 days before the screening day; Received blood and/or any blood products and/or immunoglobulins within three months preceding the screening day; Any confirmed or suspected immunodeficient state; History of long-term use of immunosuppressive medication (defined as more than 14 continuous days) in the last 4 months leading up to screening day; Long-term use (defined as more than 14 continuous days) of systemic corticosteroids (equivalent to 10 mg or more daily prednisolone) within the past 4 months, except topical steroids; History of allergic diseases such as angioedema or anaphylactic reactions; History of any allergy to the drug or vaccine (defined as any clinical signs or symptom of itching at the injection site, urticaria in the body after injection, excessive redness at the injection site); History of autoimmune diseases (other than controlled autoimmune thyroid disease, stable celiac disease, mild psoriasis, vitiligo that does not require corticosteroid or immunosuppressive therapy); History of chemotherapy in the last 5 years; History of cancer in the last 5 years; History of serious psychiatric illnesses; History of blood disorders (dyscrasia, coagulopathy, platelet deficiency or disorder, deficiency of blood factors); Suffering from chronic obstructive pulmonary disease such as asthma and COPD that diagnosed by a specialist and is/was under medication; Suffering from ischemic heart disease that is/was under medication by a specialist , history of cardiac interventions; Suffering from hypertension that is/was under medication by a specialist ; Suffering from diabetes that is/was under medication by a specialist ; History of chronic neurological diseases (including seizures and epilepsy); Any history of substance or alcohol abuse within the last 2 years; Any abnormality in the hematology or biochemical laboratory tests based on FDA toxicity score (grade >1) on the screening day; History of confirmed COVID-19; Acute febrile illness at the time of vaccination; History of acetaminophen allergy; Acute or chronic hepatitis B and C; Receiving prophylactic drug against tuberculosis; History of syncope with blood transfusion or blood observation; Splenectomy for any reason; Any close contact with a confirmed COVID-19 case within two weeks before the first dose of vaccine; History of SARS or MERS; Participate in any clinical trials (research) study other than this study.

4

Razi Vaccine and Serum Research Institute

18

55

Iran

Healthy volunteers

N/A

153

Abnormal vital signs and anaphylactic reactions before and immediately after vaccination: number and percentages of participants who develop abnormal vital signs within three hours of receiving the vaccine at each doses will be recorded. Abnormal vital signs include temperature, respiratory rate, heart rate, systolic and diastolic blood pressure. Anaphylaxis is defined as an immediate systemic hypersensitivity simultaneously involving two systems. Anaphylactic reactions include: erythema, pruritus, urticaria and angioedema, bronchospasm, laryngeal edema, dizziness, hypotension, nausea, shortness of breath, wheezing, arrhythmia, cyanosis, vomiting, diarrhea, abdominal pain and will be checked up to three hours after each vaccination. The number and percentage of ocal adverse events within the first week post-vaccination (including pain, tenderness, erythema / redness, swelling and stiffness, itching) that will be assessed based on the severity score, duration and peak intensity. The number and percentage of systemic adverse event within the first week post-vaccination (including nausea and vomiting, diarrhea, headache, fatigue, muscle pain) that will be assessed based on the severity score, duration and peak intensity. The number and percentage of people who shows abnormal laboratory findings, including biochemistry, hematology, and urine tests. These tests include: Hemoglobin, WBC, Lymphocytes cell, Neutrophils, Eosinophils, Platelets, ESR, CRP, LDH, Sodium, Potassium, HbA1c, BUN, Creatinine, Calcium, Alkaline phosphatase, ALT, AST, Bilirubin (total), Uric Acid, U/A, Urine protein, Urine glucose, Urine RBC

Phase 1

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "5 \u03bcg\u2044200\u03bcl ", "treatment_id": 1066, "treatment_name": "Razi cov pars", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "10 \u03bcg\u2044200\u03bcl", "treatment_id": 1066, "treatment_name": "Razi cov pars", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "20 \u03bcg\u2044200\u03bcl", "treatment_id": 1066, "treatment_name": "Razi cov pars", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]