CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

Diagnostic test for SARS-Cov2 for patients and health staffWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug644 Control-EDI Wiki 1.00
drug1242 Intervention-EDI and health coaching Wiki 1.00

Correlated MeSH Terms (4)

Name (Synonyms) Correlation
D051436 Renal Insufficiency, Chronic NIH 0.58
D007674 Kidney Diseases NIH 0.45
D002908 Chronic Disease NIH 0.32
D006973 Hypertension NIH 0.28

Correlated HPO Terms (3)

Name (Synonyms) Correlation
HP:0012622 Chronic kidney disease HPO 0.58
HP:0000077 Abnormality of the kidney HPO 0.45
HP:0000822 Hypertension HPO 0.28

There is one clinical trial.

Clinical Trials

1 Patients and Health Staff of Cancer Centres During the Covid-19 Pandemic: Constitution of a Biological Collection Linked to a Prospective, Multicenter Cohort Study

The Covid-19 has, in a few weeks, made the world tremble: the number of deaths (mainly elderly and / or co-morbid) continues to increase, the confinement causes the collapsing of the economy and the decline of relationships inter-human. The data are too fragmented and the disease too recent to know its repercussions on the 3 million French people who have or have had cancer. The investigators would like, in 3 populations: * patients in treatment, * or in follow-up and * health personnel, to constitute a large prospective and longitudinal database of data: i / serological: humoral response, test performance, monitoring of serum immunoglobulin levels , reinfection threshold,…; ii / clinical: incidence, severity, mortality and their favorable factors impact of cancer treatment on Covid-19 infection and modification of the quality of oncological care in the context. In parallel, on a more limited sample of establishments, it will be : * appreciate the economic and functional repercussions, * will try to find out about the infection modalities in patients and health personnel and * will appreciate the levels of anxiety and depression to which health staff are subject.

NCT04421625 COVID-19 Diagnostic Test: Diagnostic test for SARS-Cov2 for patients and health staff

Primary Outcomes

Description: The clinical basis will done through a Covid 19 clinical signs follow-up questionnaire.

Measure: Establishment of a clinical basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.

Time: 12 months

Description: The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M0. The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire.

Measure: Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.

Time: 15 days

Description: The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M3. The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire.

Measure: Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.

Time: 3 months

Description: The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M6. The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire.

Measure: Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.

Time: 6 months

Description: The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M9. The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire.

Measure: Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.

Time: 9 months

Description: The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M12. The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire.

Measure: Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients.

Time: 12 months

Secondary Outcomes

Description: The evaluation will be done through the dosage of IgM and IgG anti-SARS-CoV2 at different time of measurement M0, M3, M6, M9 and M12 using a qualitive immunochomatographic test and quantitative ELISA test.

Measure: Dosage of IgM and IgG anti SARS-CoV2

Time: screening period, 3 months, 6 monthes, 9 months and 12 months

Description: The result obtained by the qualitative minute test for IgM will be compared to the quantitative ELISA test to know the specificity, sensitivity, positive predictive value, negative predictive value

Measure: Evaluate the diagnostic performance of the minute test for IgM

Time: 12 months

Description: The quantification of IgG level at M12 will be obtained by using the quantitative ELISA test for patients in cancer centres and health staff.

Measure: Evaluate the quantification of IgG in long term (M12) in the Cancer Centres populations

Time: 12 months

Description: The evaluation will be done on subjects who had previously developed IgG and have clinical signs of Covid-19. The signs will be confirmed by RT-PCR which detect the RNA of SARS-CoV2 using a nasal swab test.

Measure: Evaluate the frequency of reinfections among the persons who have developed IgG

Time: 12 months

Description: The evaluation is based on whether or not a reinfection occurs during follow-up and it will be done by the concentration of IgG anti-SARS-CoV2 using the quantitative ELISA test.

Measure: Evaluate the threshold of protective IgG among the subjects who have developed IgG

Time: 12 months

Description: The evaluation will be done by analysing the anti-SARS-CoV2 antibodies according to the FCGR2A and FCGR3A genotypes using RT-PCR

Measure: Evaluate the influence of polymorphisms of receptor of IgG Fc-gamma low-affinity (FcδIIA, FcδIIIa) on the humoral immune response

Time: 12 months

Description: The evaluation will be done by knowing the number of Covid-19-realated death, severe infections (oxygen therapy needed), moderate infections, prolonged symptomatic infections and asymptomatic infections reported to all subjects with a positive serology and/or a positive RT-PCR test.

Measure: Evaluate the severity of Covid-19 infection (invisible, visible, prolonged, severe and fatal) by age group

Time: 12 months

Description: The evaluation will be done by knowing the number of subjects who have a recurrence of clinical symptoms and/or positive SARS-CoV2 RT-PCR and/or a positive IgM serology (by the quantitative ELISA test or the qualitative minute test)

Measure: Evaluate the frequency of reinfection by Covid-19 (recurrence of evocative clinical symptoms and positive viral PCR or positive IgM serology) during follow-up

Time: 12 months

Description: The evaluation will be done on subjects who have a seropositivity and/or a positive SARS-CoV2 RT-PCR and/or a positive IgM serology (by the ELISA test or the minute test). The factors that are significantly associated to severe forms or mortality are : current or recent cancer treatment (Immunotherapy, chemotherapy based on the frequency of grade 3/4 neutropenia and/or lymphopenia), radiation therapy, surgery), concomitant treatment, comorbidities, type of cancer and stage, cancer-related medical history, biological markers

Measure: Evaluate the risk factors (clinical and therapeutic) to develop severe forms of Covid-19 infection in patients

Time: 12 months

Description: The evaluation will be done by using the PMSI (Program of medicalisation of information systems). This program allows describing the medical activity in health establishment. It is divided in 4 domains: MCO (Medicine, Surgery, Obstetric and Odontology), Follow-up care and rehabilitation, psychiatry, and home care

Measure: Evaluate the changes in health care practice

Time: 12 months

Description: The evaluation will be done by identifying the monetary value of resources mobilized more or less according to the observed changes at the level of modifications in patient treatment scheme (e.g. chemotherapy, radiotherapy and surgery), teleconsultations, and diagnostic of new cancers

Measure: Evaluate the resources associated with organizational changes

Time: 12 months

Description: The evaluation will be done by knowing the number of health staff sick leave. The information will be obtained with the human resources data and work medicine.

Measure: Evaluate the allocated resources

Time: 12 months

Description: The incidence will be obtained by counting the number of subjects infected by SARS-CoV2 (patients and health staff) every four months

Measure: Evaluate the incidence of Covid-19 infections

Time: 12 months

Description: The evaluation will be done by doing percentages (qualitative factors) / Average or median (quantitative variables) using the Constances cohort for the general population

Measure: Evaluate the distribution of risk factors for contamination in patients and in the general population

Time: 12 months

Description: The evaluation will be done before the screening, 3, 6, 9 and 12 months after the screening through the STAI state (State-Trait Anxiety Inventory) questionnaire with 20 items. It evaluates the felling of apprehension, tension, nervousness, anxiety. It is composed of 20 questions. Each answer is noted form 1 to 4. A high score (more than 48 for men and 55 for women) represents a high level of anxiety.

Measure: Evaluate the anxiety state over time

Time: screening period, 3 months, 6 monthes, 9 months and 12 months

Description: The Depression is evaluated before the screening, 3, 6, 9 and 12 months after the screening through the HADS (Hospital Anxiety and Depression Scale) questionnaire with 14 items. Each answer is coded from 0 to 3.The global score variates from 0 to 42. A high score (from 15 to 42) represents the existence of an anxio-depressive syndrome.

Measure: Evaluate the depression over time

Time: screening period, 3 months, 6 monthes, 9 months and 12 months

Description: The post-traumatic development is evaluated with the PTGI (post-Traumatic Growth Inventory) with 21 items. Each answer is noted from 0 to 5. A high score represents a change to a very great degree. It evaluates the positive changes perceives such as relating to others, news possibilities, personal strength, spiritual change and appreciation life

Measure: Evaluate the post-traumatic developments

Time: 12 months

Description: The evaluation will be done by analysing the number of time the health care of the patient has been changed using the medical file of the patient.

Measure: Evaluate the change in health care change frequency

Time: 12 months

Description: The evaluation will be done by analysing the medical file of the patient and calculate the number of patients for which the health care has been changed.

Measure: Evaluate the number of patients concerned by health care changes

Time: 12 months

Description: The rate of morbidity will be obtained by calculating the number of new cases of disease occurring during the study with the help of the medical file of each patient.

Measure: Evaluate the rate of morbidity

Time: 12 months

Description: The rate of mortality will be obtained by calculating the ratio of actual deaths to expected deaths.

Measure: Evaluate the rate of mortality

Time: 12 months

No related HPO nodes (Using clinical trials)