Observational trial evaluating the serologic status of household contacts of patients diagnosed with COVID-19

SARS-CoV-2 has now crossed the 1 million number of cases and tens of thousands of deaths. It´s R⁰ has been calculated between 2 and 5.7 solely based on clinical symptoms but it is estimated to likely be higher. Serologic evidence of infection has not been analyzed. A transverse, observational, and descriptive study involving household contacts of documented patients with COVID-19 infection: contacts will be invited to participate and a blood sample will be drawn: IgM and IgG qualitative and quantitative measurements will be performed. Demographic data regarding age, comorbidities, calculated time spent before and after the patients’ diagnosis, isolation practices etc.

Observational – Patient registry, cross-sectional cohort study

Biospecimen Retention:   Samples With DNA
Blood samples will be obtained by capillary puncture or venipuncture for rapid testing of antibodies against SARS-CoV-2 (IVD COVID-19 IgM/IgG test kit, Singclean).

Primary Outcome Measures  :

• Identify antibodies [ Time Frame: 1 day ]
• Identify the presence of IgM and IgG antibodies from intradomestic contacts of patients with PCR for detected SARS-CoV-2 .

Secondary Outcome Measures  :

• Determine antibody sensitivity [ Time Frame: 1 day ]
• Determine the sensitivity of IgM and IgG antibody detection by ELISA in direct eastern contacts of patients with PCR for detected SARS-CoV-2.
• IgM determination [ Time Frame: 1 day ]
• Determine the presence of IgM antibodies by ELISA in direct eastern contacts of patients with detected SARS-CoV-2 PCR.
• IgG determination [ Time Frame: 1 day ]
• Determine the presence of IgG antibodies by ELISA in direct eastern contacts of patients with detected SARS-CoV-2 PCR.

Clinical Trial.gov details

Enabling Technologies & Assays
Vulnerable Populations

May 2020 — Jun 2020

Mexico

Clinical Epidemiology of COVID-19 in Malaria Settings