Evaluating the Immune Response for COVID-19
COVIDIMMUNE
Evaluation of the Immune Response in Symptomatic and Asymptomatic Patients' Diagnosed Witih COVID-19
1 other identifier
observational
214
1 country
1
Brief Summary
The 2019-20 coronavirus disease, caused by COVID-19, is an ongoing pandemic. The measures in which public health officials quarantine confirmed and isolate symptomatic cases in order to reduce the spread COVID-19 is the common practice used in most countries. However, a significant question remains in regards to the asymptomatically infected individuals, which may propagate the virus and impede infection control. The other question to consider is whether these asymptomatic carriers develop an immune response or continue viral shedding. The purpose of the current study is the evaluate the immune response, i.e developing anti-SARS-CoV-2 antibodies in the asymptomatic cases, in a household study design. We plan to evaluate over 1000 patients with positive COVID-19 results and their households.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2020
CompletedFirst Posted
Study publicly available on registry
April 16, 2020
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2022
CompletedApril 21, 2026
April 1, 2026
1.8 years
April 13, 2020
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Proportion of symptomatic patients with immune response (IgM/IgG/IgA)
The percentage of symptomatic patients who developed either IgM/IgG/IgA response within 100 days from COVID-19 Infection
100 days
Proportion of Asymptomatic patients with immune response (IgM/IgG/IgA)
The percentage of Asymptomatic patients who developed either IgM/IgG/IgA response within 100 days from COVID-19 Infection
100 days
Secondary Outcomes (6)
Time to IgM
Evaluated within a 100 days followup
Time to IgG
Evaluated within a 100 days followup
Time to IgA
Evaluated within a 100 days followup
Serology kits inter-observer agreement
Evaluated within a 100 days followup
Proportion of symptomatic patients with immune response (IgM/IgG/IgA)- long term
1 year
- +1 more secondary outcomes
Study Arms (2)
Symptomatic
COVID-19 RT-PCR positive patients with reported symptoms
Asymptomatic
COVID-19 RT-PCR positive patients without presenting any symptoms
Interventions
Nasoropharyngeal swabs for COVID-19 RT-PCR - initial screening/retest +every 10 days in 100 days followup period
Blood samples for COVID-19 serology - initial screening/retest +every 10 days in 100 days followup period Each sample will be examined by 4-6 serology kits.
Symptoms questionnaire which will be filled by participant on initial screening/retest visit + every 10 days in 100 days followup period
Eligibility Criteria
Patients who were found positive in a clinical RT-PCR diagnostic test in the Shamir Medical Center and their households. Following a positive COVID-19 RT-PCR result in the Shamir medical center lab, the subject will be contacted by telephone and will be offered to participate in the study. Upon consent, medical staff will arrive to the subject's house and further explain the details of the study and ask for an informed consent of the subject and any of the households over 18 years old.
You may qualify if:
- Positive COVID-19 RT-PCR to the subject or his/her household.
- Over 18 years old
- Ability to sign an informed consent
You may not qualify if:
- Inability to sign an informed consent
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assaf-Harofeh Medical Center
Ramla, 70300, Israel
Related Publications (4)
Wu JT, Leung K, Leung GM. Nowcasting and forecasting the potential domestic and international spread of the 2019-nCoV outbreak originating in Wuhan, China: a modelling study. Lancet. 2020 Feb 29;395(10225):689-697. doi: 10.1016/S0140-6736(20)30260-9. Epub 2020 Jan 31.
PMID: 32014114BACKGROUNDBai Y, Yao L, Wei T, Tian F, Jin DY, Chen L, Wang M. Presumed Asymptomatic Carrier Transmission of COVID-19. JAMA. 2020 Apr 14;323(14):1406-1407. doi: 10.1001/jama.2020.2565.
PMID: 32083643BACKGROUNDMizumoto K, Kagaya K, Zarebski A, Chowell G. Estimating the asymptomatic proportion of coronavirus disease 2019 (COVID-19) cases on board the Diamond Princess cruise ship, Yokohama, Japan, 2020. Euro Surveill. 2020 Mar;25(10):2000180. doi: 10.2807/1560-7917.ES.2020.25.10.2000180.
PMID: 32183930BACKGROUNDZhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, Wang X, Yuan J, Li T, Li J, Qian S, Hong C, Wang F, Liu Y, Wang Z, He Q, Li Z, He B, Zhang T, Fu Y, Ge S, Liu L, Zhang J, Xia N, Zhang Z. Antibody Responses to SARS-CoV-2 in Patients With Novel Coronavirus Disease 2019. Clin Infect Dis. 2020 Nov 19;71(16):2027-2034. doi: 10.1093/cid/ciaa344.
PMID: 32221519BACKGROUND
Related Links
Biospecimen
Nasoropharyngeal swabs Blood samples for serology: IgM, IgG, IgA
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shai Efrati, MD
Head of Research and Development Unit
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Research and Development Unit, Shamir Medical Center
Study Record Dates
First Submitted
April 13, 2020
First Posted
April 16, 2020
Study Start
May 1, 2020
Primary Completion
February 2, 2022
Study Completion
February 2, 2022
Last Updated
April 21, 2026
Record last verified: 2026-04