COVID-19 trials registries data warehouse

https://www.thaiclinicaltrials.org/show/TCTR20210720005

Suvimol Niyomnaitham

suvimol.niy@mahidol.ac.th

2021-07-20

Recruiting

nonRCT

Non-randomized

Sequential assignment

Open label

multi-center

Prevention

1. Males or females at least 18 years of age (inclusive) 2. Had a history of SARS-CoV-2-positive by RT-PCR from airway specimens at screening day (10+/-4 weeks or 20+/-4 weeks after detection) 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 received blood transfusion, plasma, blood product, blood components, immunoglobulins, antiviral or antibodies within the last 90 days 3. Have history of cigarettes smoking, alcohol drinking and history of drug abuse 4. Be pregnant 5. Have history of any vaccination within 14 days before screening visit 6. Had received more than one COVID-19 vaccination before diagnosis of COVID-19 infection 7.Had received any COVID-19 vaccination after Yes diagnosis of COVID-19 infection 8. Have unstable disease or could not control the symptom 9.Have history of immunodeficiency or use immunosuppressant or steroid drugs? 10. Have any unusual symptoms or medical history that considered unable to participate in the study

6

Faculty of Medicine Siriraj Hospital

18

100

Thailand

Close contacts to covid patients

N/A

180

Adverse events 4 weeks amount of adverse events

Phase 2

[{"arm_notes": "after 20+/-4 weeks COVID-19 diagnosis", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "after 20+/-4 weeks COVID-19 diagnosis", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "after 20+/-4 weeks COVID-19 diagnosis", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "after 10+/-4 weeks COVID-19 diagnosis", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "after 10+/-4 weeks COVID-19 diagnosis", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "after 10+/-4 weeks COVID-19 diagnosis", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]