COVID-19. COVID-19, virus identified
Conditions
Sponsors
CinnaGen Company
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Men or women 50 > age = 18 Participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations and tests Healthy adults or adults with stable medical conditions Women eligible to participate in the study who are not pregnant or breastfeeding
Exclusion criteria
Exclusion criteria: Subjects with active infection with SARS-COV-2 signs at the screening visit Subjects with body temperature equal or more than 38 degrees centigrade, during 72 hours before screening visit or during the visit Subjects with any progressive or severe neurological disorder, including dementia, stroke, seizures, or a history of Guillain-Barre syndrome High-risk subjects who are prioritized for the national vaccination program, those are treated with immunosuppressive drugs or cytotoxic drugs, or systemic corticosteroids at doses = 10 mg daily of prednisolone or equivalent doses of other corticosteroids more than 14 days Pregnant women, or breastfeeding mothers, or women who plan to become pregnant during the study 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 Subjects who have been vaccinated with other vaccines against the SARS-CoV-2 virus Subjects who received other authorized vaccines within 28 days prior to the screening visit in this study or intend to receive any vaccines up to 14 days after the second vaccination Subjects who have any known bleeding disorder or may have problems with the intramuscular injection according to the researcher's opinion Subjects who have received or intend to receive any blood / plasma or immunoglobulin products 90 days prior to the screening visit 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 Subjects who have donated =450 ml of blood or blood products 28 days prior to the screening visit Subjects who are given the priority of vaccination within 2 months after participating in the study, according to the national immunization program Subjects with ESRD Subjects with dawn syndrome Subjects with BMI = 40 Subjects with cystic fibrosis, COPD, PAH Subjects with uncontrolled asthma Subjects with uncontrolled hypertension Subjects with uncontrolled diabetes Mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of COVID-19 incidence. Timepoint: 14 days after the second dose. Method of measurement: Participants must have at least two of the following systemic symptoms: fever (38 ° C), chills, myalgia, headache, sore throat, nausea, vomiting, diarrhea, nasal discharge, new olfactory disorder, "or" the participant must have experienced at least one of the following respiratory signs and symptoms: cough, shortness of breath, clinical or radiographic evidence of pneumonia "and" at least one positive PCR test for SARS-CoV-2.;Evaluation of severe COVID-19 incidence. Timepoint: 14 days after the second dose. Method of measurement: If the patient has any of the following symptoms, is classified as severe type of COVID-19: respiratory rate =30 per minute. Heart rate =125 per minute. Oxygen saturation =93% in ambient air. Respiratory failure or acute respiratory distress syndrome (ARDS) or (requires high-flow oxygen or non-invasive or mechanical ventilation or ECMO) Evidence of shock (systolic blood pressure <90 mm Hg, diastolic blood pressure <60 mm Hg) or the need for vasopressors). Acute renal, hepatic or neurological dysfunction. Hospitalization in the intensive care unit or death. | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of solicited adverse events. Timepoint: Up to 7 days after each dose. Method of measurement: Checkup, history checking and participants reports based on adverse event reporting system.;Occurrence of unsolicited adverse events. Timepoint: Up to 28 days after each dose. Method of measurement: Checkup, history checking and participants reports based on adverse event reporting system.;Occurrence of serious adverse events and suspected unexpected serious adverse events. Timepoint: within 6 months after the second dose. Method of measurement: Checkup, history checking and participants reports based on adverse event reporting system. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNassim Anjidani
Orchid Pharmed
Outcome results
None listed