Coronaviruses Disease COVID-19
Conditions
Interventions
Measles Rubella
Normal Saline
Astra Zeneca
Sponsors
Noguchi Memorial Institute for Medical Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Volunteers without clinical evidence of COVID-19 infection aged 18 years and older. 2. Participants who are at high risk of SARS-CoV-2 infection, defined as adults whose locations or circumstances put them at appreciable risk of exposure to SARS-CoV-2 and COVID-19. 3. Must have a mobile phone and access to the Internet for data collection purposes. 4. Participants who are willing and able to provide informed consent via an electronic consent process.
Exclusion criteria
Exclusion criteria: 1. Weight outside range 50 kg – 120 kg (110 lbs – 265 lbs). 2. Self-reported or laboratory confirmed previous or current diagnosis of SARS-CoV-2. 3. Self-reported current acute respiratory infection. 4. Concurrent and/or recent use of the investigational product, a product considered to be equivalent to the investigational product, or any other product that is likely to interfere with the investigational products in this trial or the interpretation of trial data . 5. Self-reported known allergies to any of the IMPs and excipients of the IMPs and placebo. 6. Self-reported presence or history of the conditions listed in the appendices. 7. Self-reported current use of medication with known to interact with any of the medications listed in the appendices. 8. Inability or unwillingness to be followed up for the trial period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptomatic COVID-19: Clinical diagnosis of COVID-19 with laboratory confirmation (i.e. based on viral PCR), and symptoms of COVID-19 (cough, shortness of breath or difficulty breathing, fever, chills, muscle pain, sore throat, new loss of taste or smell, nausea, vomiting, or diarrhea) by day 60 from commencement of trial intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome of special interest is: Severity of COVID-19 over the study period 1.Primary endpoint, but instead of the 60-day time-window, over the course of the first 30 days of treatment; 2.Symptomatic COVID-19 (with subsequent virological confirmation) during the 5-month study period; 3.Incident COVID-19 during the 60-day study period, which includes asymptomatic infections identified by serology samples taken at the time-point of study exit. ;To observe whether prior exposure to the MR vaccine can boost the immune response obtained from the specific COVID-19 AstraZeneca Vaccine | — |
Countries
Ghana
Contacts
Public ContactSusan Adu Amankwah
Co Principal investigator
Outcome results
None listed