Acute Respiratory Distress Syndrome due to SARS-CoV-2. COVID-19, virus identified
Conditions
Interventions
Intervention 1: Intervention group1: Participants in this group will receive two doses (IM) of RAZI recombinant spike protein vaccine 21 days apart followed by a nasal spray 51 days after the first do
Sponsors
Razi Vaccine and Serum Research Institute
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 18 years of age or older; Having access to internet and smart phone; No current COVID-19; No pregnancy; No plan to have children in the next 6 months and willing to use at least one effective method of contraception; Signed informed consent form.
Exclusion criteria
Exclusion criteria: Any current or new diagnosis of acute or chronic illness requiring continuous ongoing medical care Breastfeeding; History of receiving any COVID -19 vaccine; Received blood and/or any blood products and/or immunoglobulins within three months preceding the screening day; Long-term use of immunosuppressive drugs or systemic corticosteroids within the past 4 months; History of allergic diseases such as angioedema or anaphylactic reactions to any drug, vaccine or food; Recent diagnosis or treatment of cancers except basal cell carcinoma and In-situ cervical cancer History of uncontrolled serious psychiatric illnesses; History of blood disorders (dyscrasia, coagulopathy, platelet deficiency or disorder, or deficiency of blood clotting factors); History of chronic neurological diseases (including seizures and epilepsy); Current substance or alcohol abuse; Splenectomy for any reason; Close contact with a confirmed COVID-19 case within two weeks before the first vaccine dose; History of diagnosis or treatment for HIV; Chronic unstable diseases in the last 4 weeks, including hospitalization due to surgery, deterioration of one organ function, the need to add new drugs or serious dose adjustments to existing drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of any symptomatic confirmed COVID-19 disease: Number and percentage of confirmed COVID-19 disease two weeks after second vaccine dose. Timepoint: Any time between the 14 days after second vaccine dose and the end of study. Method of measurement: Diagnosis of COVID-19 disease will be based on Iran's Ministry of Health's guideline and a positive PCR test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of confirmed moderate or severe illness or death due to COVID-19: Number and percentage of moderate, severe illness or death due to COVID-19. Timepoint: Any time, two weeks after the second dose until the end of study. Method of measurement: PCR test and Clinical evaluations. Severity of Covid-19 will be classified according to NIH criteria.;Occurrence of confirmed severe illness or death due to COVID-19: Number and percentage of severe illness or death due to COVID-19. Timepoint: Any time, two weeks after the second dose until the end of study. Method of measurement: PCR test and Clinical evaluations. Severity of Covid-19 will be classified according to NIH criteria.;Abnormal vital signs and anaphylactic reactions up to 30 minutes after vaccination: number and percentages of participants who develop abnormal vital signs within half an 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 systemic hypersensitivity with at least two of the following signs and symptoms: erythema, pruritus, urticaria and angioedema, bronchospasm, laryngeal edema, dizziness, hypotension, nausea, shortness of breath, wheezing, arrhythmia, cyanosis, vomiting, diarrhea, abdominal pain. Timepoint: Immediately and up to half an hours after vaccination. Method of measurement: Clinical examination.;Local adverse events within the first week post-vaccination: including pain, tenderness, erythema or redness, swelling and stiffness that will be assessed based on the severity score, duration and peak intensity. Timepoint: Daily assessment up to six days following 1st and 2nd vaccine dose. Method of measurement: They will be assessed through e-Diary card. This card is provided in the mobile application.;Systemic adverse events within the first week post-vaccination: including nausea and vomiting, diarrhea, headache, fatigue, muscle pain that w | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Hossein Fallah Mehrabadi
Razi Vaccine and Serum Research Institute
Outcome results
None listed