Efficacy of Monoclonal Neutralizing Antibody AZD 7442 (Tixagevimab-Cilgavimab for prevention of COVID-19 among cancer patients: Double blinded Randomized placebo Controlled Trial (ProvMAB Trial)

ABSTRACT

ConditionThe monoclonal antibody neutralizes the potency of AZD7442 can protect cancer patients to Coronarvirus 2019 infection
Coronavirus disease , Monoclonal Neutralizing Antibody AZD7442 (Tixagevimab- Cilgavimab),covid-19 vaccine ;Coronavirus disease , Monoclonal Neutralizing Antibody AZD7442 (Tixagevimab- Cilgavimab),covid-19 vaccine

InterventionInjection Monoclonal antibody,NSS injection;Experimental Drug,Placebo Comparator Drug;Monoclonal antibody,Placebo

Primary outcome:Symptomatic COVID infection 180 days percent

CriteriaInclusion criteria 1. Low-risk patients or high-risk groups aged 18 years and over.
2. Weight greater than or equal to 40 kg.
3. Patients with Hematologic malignancy, breast cancer, lung cancer and colon cancer. who are receiving cancer treatment or have been treated for cancer within 6 months from the date of study (by assessing survival for more than 6 months).
People who have received at least 3 doses of Covid-19 vaccine and received the latest dose of vaccine for more than 2 weeks and not more than 3 months.
5. Understand Thai language and be able to communicate with the researcher to assess side effects from treatment. Able to use communication technology equipment
6. Can be monitored
7. Consent and sign to participate in the research

Exclusion criteria 1. Pregnant or lactating women
2. Infected with Coronavirus 2019 within 3 months before participating in the research.
3. Has hepatic disease (child C) or end-stage renal disease (ESRD not on hemodialysis or not on hemodialysis at least twice a week).

4. Metastatic or terminal cancer (by assessing survival time less than 3 months)
5. Patients who are bedridden and unable to be treated are outpatients.
6. Previously received other neutralizing monoclonal antibody drugs within 60 days.
7. People who have had an allergic reaction to Tixagevimab/Cilgavimab.
8. People who have received the latest dose of Covid-19 vaccine for more than 3 months.