COVID-19 trials registries data warehouse

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=14507

Susan Adu Amankwah

sadu-amankwah@noguchi.ug.edu.gh

2020-11-21

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

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.

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

3

Noguchi Memorial Institute for Medical Research

18

65

Ghana

Health workers

N/A

150

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.

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 3

[{"arm_notes": "0,5ml;1;SC", "treatment_id": 774, "treatment_name": "Measles mumps rubella vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "0,5ml;1", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]