COVID-19 trials registries data warehouse

https://www.thaiclinicaltrials.org/show/TCTR20210720007

Suvimol Niyomnaitham

suvimol.niy@mahidol.edu

2021-07-20

Recruiting

RCT

Randomized

Sequential assignment

Open label

single-center

Prevention

1. Males or females at least 18 years of age (inclusive) 2. Have not received COVID-19 vaccine or received 1st dose of COVID-19 vaccine (Inactivated vaccine or AstraZeneca) within 4 weeks 3. Can understand Thai language through speaking, reading and writing 4. Able to communicate through electronic tools such as Google form or line. 5. Capable of attending all study visits according to the study schedule 6. Capable of informed consent and provision of written informed consent before any study procedures

1. Have history of severe drug or vaccine allergy (anaphylaxis) 2. Have detected COVID-19 infection 3. Have history of COVID-19 high risk contact 4. Have received blood transfusion, plasma, blood product, blood components, immunoglobulins, antiviral or antibodies within the last 90 days 5. Have history of cigarettes smoking, alcohol drinking and history of drug abuse 6. Be pregnant 7. Have unstable disease or could not control the symptom 8. Have history of immunodeficiency or use immunosuppressant or steroid drugs 9. Have any unusual symptoms or medical history that considered unable to participate in the study

9

Faculty of Medicine Siriraj Hospital

18

100

Thailand

Healthy volunteers

N/A

270

Adverse events 7 days after Vaccination and upto 12 weeks after 2nd dose or 2 weeks after 3rd dose amount of adverse events

Phase 2

[{"arm_notes": "Inactivated vaccine/AstraZeneca/mRNA (full dose)", "treatment_id": 2423, "treatment_name": "Chadox1 ncov-19+inactivated covid-19 vaccine+mrna vaccine", "treatment_type": "Non replicating viral vector+inactivated virus+rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Inactivated vaccine/AstraZeneca/mRNA (Half dose)", "treatment_id": 2423, "treatment_name": "Chadox1 ncov-19+inactivated covid-19 vaccine+mrna vaccine", "treatment_type": "Non replicating viral vector+inactivated virus+rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "AstraZeneca/Inactivated vaccine/mRNA (full dose)", "treatment_id": 2423, "treatment_name": "Chadox1 ncov-19+inactivated covid-19 vaccine+mrna vaccine", "treatment_type": "Non replicating viral vector+inactivated virus+rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "AstraZeneca/Inactivated vaccine/mRNA (full dose)", "treatment_id": 2423, "treatment_name": "Chadox1 ncov-19+inactivated covid-19 vaccine+mrna vaccine", "treatment_type": "Non replicating viral vector+inactivated virus+rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "mRNA/Inactivated vaccine", "treatment_id": 2424, "treatment_name": "Inactivated covid-19 vaccine+mrna vaccine", "treatment_type": "Inactivated virus+rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "\nmRNA/AstraZeneca", "treatment_id": 2425, "treatment_name": "Chadox1 ncov-19+mrna vaccine", "treatment_type": "Non replicating viral vector+rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "\nAstraZeneca/mRNA", "treatment_id": 2425, "treatment_name": "Chadox1 ncov-19+mrna vaccine", "treatment_type": "Non replicating viral vector+rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "\nInactivated vaccine/mRNA", "treatment_id": 2424, "treatment_name": "Inactivated covid-19 vaccine+mrna vaccine", "treatment_type": "Inactivated virus+rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "\nmRNA/mRNA", "treatment_id": 831, "treatment_name": "Mrna vaccine", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]