Respiratory Distress Syndrome due to SARS-CoV-2. COVID-19, virus identified
Conditions
Interventions
Intervention 1: Intervention group: Two doses of 10 micro gram vaccine injected in the deltoid muscle (IM) at 21 days interval. Intervention 2: Control group: Two doses of Sinopharm vaccine injected
Sponsors
Organization of Defensive Innovation and Research
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age > 18; Having Iranian citizenship; Internet and smart mobile access (him/herself or one of him/his family); Living in and around the city where the trial takes place; No current COVID-19 disease; No pregnancy; Using safe methods of contraception; Signing the informed consent form.
Exclusion criteria
Exclusion criteria: Current acute or chronic symptomatic illness that requires ongoing medical or surgical care; Acute febrile illness; Lactation; History of receiving COVID19 vaccine; History of transfusion of any blood product or immunoglobulin within the 3 months before the study; History of long-term use (14 successive days) of immunosuppressive drugs or systemic corticosteroids in the last 4 months leading up to the study; History of diagnosis or treatment for HIV; History of allergic diseases such as angioedema or anaphylactic reactions following the use of drugs, vaccines or food; History of diagnosis or treatment for cancer (except basal cell carcinoma and Insitu cervical cancer); History of uncontrolled serious psychiatric illnesses; History of blood disorders (Blood Dyscrasias, coagulation disorders, platelet deficiency, etc); Continued use of anticoagulants such as coumarin and related anticoagulants (such as warfarin) or new oral anticoagulants / antiplatelet agents. Note: Less than 325 mg of aspirin per day as prophylaxis is allowed.; Current drug or alcohol abuse (addiction); Close contact with a definite case of COVID-19 up to two weeks prior to the day of receiving the first dose; Chronic diseases that are not listed as exclusion criteria but are considered unstable within the last 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of confirmed symptomatic Covid-19 disease two weeks after the second vaccine dose. Timepoint: Two weeks after the second dose of the vaccine up to 6 months. Method of measurement: Clinical assessments and PCR test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of confirmed moderate, or severe illness or death due to Covid-19 infection two weeks after the second vaccine dose. Timepoint: Two weeks after the second vaccine dose up to 6 months. Method of measurement: Clinical assessments and PCR test.;Occurrence of confirmed severe cases or death due to Covid-19 infection two weeks after the second vaccine dose. Timepoint: Two weeks after the second vaccine dose up to 6 months. Method of measurement: Clinical assessments and PCR test.;Abnormal vital signs and anaphylactic reactions immediately after vaccination. Timepoint: In the first half an hour after each vaccine dose. Method of measurement: Temperature is measured using a digital thermometer. Respiratory rate will be counted by the research staff over one minute. Blood pressure and heart rate will be measured by a digital sphygmomanometer in a sitting position.;Local adverse events within the first week post-vaccination. Timepoint: For the first 6 days after each vaccine dose. Method of measurement: Record daily symptoms using a mobile phone application.;Systemic adverse event within the first week post-vaccination. Timepoint: For the first 6 days after each vaccine dose. Method of measurement: Record daily symptoms using a mobile phone application.;Serious Adverse Event/Reaction(SAEs) , Suspected Unexpected Serious Adverse Reaction (SUSARs), Medically Attended Adverse Events (MAAEs). Timepoint: Up to six months after the last dose of the vaccine. Method of measurement: adverse events will be assessed monthly up to 6 months. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohsen ForughiZadeh Moghadam
Malek Ashtar University
Outcome results
None listed