COVID-19 trials registries data warehouse

https://slctr.lk/trials/slctr-2022-008

Ms. Wajeha Najeeb

wajehaamc@gmail.com

2022-04-05

Recruiting

RCT

Randomized

Parallel

Blind label

unclear

Prevention

- Adults 18 years of age or older - Men and women - Healthy or with stable chronic medical conditions specifically including asthma, stable HIV, hepatitis B virus, or hepatitis C virus infection, will be eligible for participation in the trial while all rest comorbidities will be an exclusion. - Must have history of 2 times homologous vaccine intervention of BBIBP-CorV vaccine.

- People with known comorbidities (Diabetes, hypertension, heart diseases, chronic respiratory diseases like bronchiectasis, COPD etc) except those mentioned above in inclusion. - People who will have not received homologous vaccine two doses of BBIBP-CorV vaccine or those whose previous medical record of last 2 doses will be missing . - Difference between homologous vaccine and heterologous vaccine if less than 6 months - Pregnancy - History of flu or cough at that time - Medical history of COVID-19 at time of trial - On immunosuppressive therapy - Diagnosed with an immunocompromising condition

2

Public Sector Medical College; Rawalpindi

18

100

Pakistan

Healthy volunteers

N/A

448

Number of participants with anaphylactic reactions ( 3 to 4 hour post vaccine) [3 to 4 hour post vaccine]Number of participants with feverNumber of participants with myalgia Number of participants with pain and redness at injection siteNumber of participants feeling cold Number of participants with dizziness Number of participants with paresthesia in arm Number of participants with lightheadedness (participants of point 2 to 8 will report back if they experience any of these symptoms or need any health service) [ 2- Participants of point 2 to 8 will report back if they experience any of these symptoms or need any health service) within first 7 days of giving vaccine]Number of participants with no reaction experienced or observed at all (after 7 days) they will all report back after 7 days to tell [No reaction experienced or observed at all after 7 days of vaccination ]Number of participants with dyspnea (till 3 to 4 hour) [ Till 3 to 4 hours post vaccination ]Number of participants with tachycardia (24 hours ) [ Till 24 hours post ]

Phase 4

[{"arm_notes": "homologous first booster dose", "treatment_id": 26, "treatment_name": "Ad5-ncov", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "homologous first booster dose", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]