COVID-19 trials registries data warehouse

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=15890

Glenda Gray

glenda.gray@mrc.ac.za

2021-05-20

Recruiting

RCT

Randomized

Crossover

Blind label

multi-center

Prevention

1.Age = 18 years if volunteer self-reports pregnant OR HIV-positive, OR age = 40 years with = 1 co-morbidity known to be associated with severe COVID-19, for example: • Hypertension • Type 2 diabetes mellitus • Obesity (body mass index [BMI] of 30 kg/m2 or higher but < 40 kg/m2) • Severe Obesity (BMI = 40 kg/m2) • Heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies • Chronic kidney disease • COPD (chronic obstructive pulmonary disease) • Cancer • Non-HIV immunocompromised state (weakened immune system) or solid organ transplant • Pregnancy • Sickle cell disease • Smoking 2.Willingness to be followed and remain in the catchment area for the planned duration of the study. 3.Ability and willingness to provide informed consent. 4.Willingness to discuss HIV infection risks and willing to receive HIV testing, risk reduction counseling, and appropriate referrals to minimize HIV acquisition, if volunteer is pregnant 5.Assessment of understanding: volunteer demonstrates understanding of this study, completes a questionnaire prior to first vaccination with demonstration of understanding of all questionnaire items answered incorrectly. 6.Willing to defer SARS-CoV-2 vaccination until the crossover visit (anticipated at approximately Month 3.5). 7.Agrees not to enroll in another study of an investigational research agent until the end of the study. Enrollment in studies of investigational research agents for the treatment of COVID-19 is allowed for participants who develop COVID-19 disease.

1.Acutely ill 72 hours prior to or at screening. Volunteers meeting this criterion may be rescheduled within the relevant window periods. Participants with minor illnesses can be enrolled at the discretion of the investigator. 2.History of angioedema or anaphylaxis 3.Self-reported previous COVID-19 diagnosis Vaccines and other Injections 4.Prior administration of a SARS-CoV-2 vaccine. 5.Live attenuated vaccines received within 30 days before first vaccination or scheduled within 14/28 days after injection (eg, measles, mumps, and rubella [MMR], oral polio vaccine [OPV], varicella, yellow fever, live attenuated influenza vaccine). 6.Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B). Blood products, systemic immunoglobulins, or monoclonal antibodies (including against SARS-CoV-2) received within 90 days before vaccination

1

SOUTH AFRICAN MEDICAL RESEARCH COUNCIL SAMRC

18

65

Botswana;Kenya;Malawi;South Africa;Swaziland;Uganda;Zambia;Zimbabwe

High risk patients

N/A

14000

Primary Objective 1 and 2 To assess vaccine efficacy against virologically-confirmed symptomatic COVID-19 and severe COVID-19 in people at risk for severe COVID-19.Primary Objective 3 To assess safety and tolerability of COVID-19 mRNA vaccine in adults who are at risk of severe COVID-19

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "Immediate vaccination;2;Months 0-1", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]