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Evaluating the Immune Response for COVID-19 (COVIDIMMUNE)

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ClinicalTrials.gov Identifier: NCT04348422
Recruitment Status : Recruiting
First Posted : April 16, 2020
Last Update Posted : February 15, 2021
Sponsor:
Information provided by (Responsible Party):
Prof. Shay Efrati, Assaf-Harofeh Medical Center

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.


Condition or disease Intervention/treatment
COVID-19 Diagnostic Test: COVID-19 RT-PCR Diagnostic Test: COVID-19 Serology Other: Symptoms questionnare

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Immune Response in Symptomatic and Asymptomatic Patients' Diagnosed Witih COVID-19
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 31, 2021

Group/Cohort Intervention/treatment
Symptomatic
COVID-19 RT-PCR positive patients with reported symptoms
Diagnostic Test: COVID-19 RT-PCR
Nasoropharyngeal swabs for COVID-19 RT-PCR - initial screening/retest +every 10 days in 100 days followup period

Diagnostic Test: COVID-19 Serology
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.

Other: Symptoms questionnare
Symptoms questionnaire which will be filled by participant on initial screening/retest visit + every 10 days in 100 days followup period

Asymptomatic
COVID-19 RT-PCR positive patients without presenting any symptoms
Diagnostic Test: COVID-19 RT-PCR
Nasoropharyngeal swabs for COVID-19 RT-PCR - initial screening/retest +every 10 days in 100 days followup period

Diagnostic Test: COVID-19 Serology
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.

Other: Symptoms questionnare
Symptoms questionnaire which will be filled by participant on initial screening/retest visit + every 10 days in 100 days followup period




Primary Outcome Measures :
  1. Proportion of symptomatic patients with immune response (IgM/IgG/IgA) [ Time Frame: 100 days ]
    The percentage of symptomatic patients who developed either IgM/IgG/IgA response within 100 days from COVID-19 Infection

  2. Proportion of Asymptomatic patients with immune response (IgM/IgG/IgA) [ Time Frame: 100 days ]
    The percentage of Asymptomatic patients who developed either IgM/IgG/IgA response within 100 days from COVID-19 Infection


Secondary Outcome Measures :
  1. Time to IgM [ Time Frame: Evaluated within a 100 days followup ]
    the mean time patients devleoped IgM

  2. Time to IgG [ Time Frame: Evaluated within a 100 days followup ]
    the mean time patients devleoped IgG

  3. Time to IgA [ Time Frame: Evaluated within a 100 days followup ]
    the mean time patients devleoped IgG

  4. Serology kits inter-observer agreement [ Time Frame: Evaluated within a 100 days followup ]
    Cohen's kappa coefficient calculated between the different serology kits used for evaluation

  5. Proportion of symptomatic patients with immune response (IgM/IgG/IgA)- long term [ Time Frame: 1 year ]
    The percentage of symptomatic patients who developed either IgM/IgG/IgA response within 1-1.3 years from COVID-19 Infection

  6. Proportion of Asymptomatic patients with immune response (IgM/IgG/IgA) -long term [ Time Frame: 1 year ]
    The percentage of symptomatic patients who developed either IgM/IgG/IgA response within 1-1.3 years from COVID-19 Infection


Biospecimen Retention:   Samples Without DNA
Nasoropharyngeal swabs Blood samples for serology: IgM, IgG, IgA


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • Positive COVID-19 RT-PCR to the subject or his/her household.
  • Over 18 years old
  • Ability to sign an informed consent

Exclusion Criteria:

  • Inability to sign an informed consent
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04348422


Contacts
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Contact: Shai Efrati, MD 972549212866 efratishai@outlook.com
Contact: Amir Hadanny, MD 972544707381 amir.had@gmail.com

Locations
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Israel
Assaf-Harofeh Medical Center Recruiting
Ramla, Israel, 70300
Contact: Shai Efrati, MD    97289779395    hbo@asaf.health.gov.il   
Contact: Amir Hadanny, MD    97289779395    hbo@asaf.health.gov.il   
Sub-Investigator: Amir Hadanny, MD         
Principal Investigator: Shai Efrati, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
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Principal Investigator: Shai Efrati, MD Head of Research and Development Unit
Additional Information:
Publications:
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Responsible Party: Prof. Shay Efrati, Head of Research and Development Unit, Shamir Medical Center, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT04348422    
Other Study ID Numbers: 105-20-ASF
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Anonymous data may be shared upon request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No