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Report for D007153: Immunologic Deficiency Syndromes NIH
(Synonyms: Immunologic Defi, Immunologic Deficienc, Immunologic Deficiency Syn, Immunologic Deficiency Syndrome, Immunologic Deficiency Syndromes)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (13)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug109 | ATV Wiki | 0.41 |
| drug1274 | Human Coach first, then Virtual Assistant Wiki | 0.41 |
| drug4 | 0.12% Chlorhexidine oral/nasal rinse Wiki | 0.41 |
| drug3071 | Virtual Assistant first, then Human Coach Wiki | 0.41 |
| drug590 | CUVITRU Wiki | 0.41 |
| drug6 | 0.5% Povidone/Iodine oral/nasal rinse Wiki | 0.41 |
| drug695 | Cobicistat Wiki | 0.41 |
| drug362 | BR Wiki | 0.41 |
| drug822 | DRV Wiki | 0.41 |
| drug2545 | Saline oral/nasal rinse Wiki | 0.41 |
| drug2540 | Saline Wiki | 0.15 |
| drug752 | Convalescent Plasma Wiki | 0.08 |
| drug2311 | Questionnaire Wiki | 0.08 |
Correlated MeSH Terms (8)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D000163 | Acquired Immunodeficiency Syndrome NIH | 0.24 |
| D015658 | HIV Infections NIH | 0.13 |
| D000077062 | Burnout, Psychological NIH | 0.12 |
| D004194 | Disease NIH | 0.07 |
| D003141 | Communicable Diseases NIH | 0.03 |
| D007239 | Infection NIH | 0.02 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.02 |
| D018352 | Coronavirus Infections NIH | 0.02 |
There are 6 clinical trials
Clinical Trials
1 A Phase 2/3, Multicenter, Open-label, Multicohort Study Evaluating Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected, Virologically Suppressed Pediatric Participants
Cohort 1: The primary objectives are: - To evaluate the steady-state pharmacokinetics (PK) of Atazanavir (ATV) and Darunavir (DRV) and confirm the dose of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) in HIV-1 infected, virologically suppressed adolescent participants weighing ≥ 25 kg (12 to < 18 years of age) - To evaluate the safety and tolerability of ATV/co or DRV/co through 24 weeks in HIV-1 infected, virologically suppressed adolescent participants weighing ≥ 25 kg (12 to < 18 years of age) Cohort 2: The primary objectives are: - To evaluate the steady-state PK of ATV and DRV and confirm the dose of ATV/co or DRV/co in HIV-1 infected, virologically suppressed pediatric participants weighing ≥ 25 to < 35 kg (6 to < 12 years of age) - To evaluate the steady-state PK of tenofovir alafenamide (TAF) and confirm the dose of emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, virologically suppressed pediatric participants weighing ≥ 25 to < 35 kg (6 to < 12 years of age) - To evaluate the safety and tolerability of ATV/co, DRV/co, and F/TAF through 24 weeks in HIV-1 infected, virologically suppressed pediatric participants weighing ≥ 25 to < 35 kg (6 to < 12 years of age) Cohort 3: The primary objectives are: - To evaluate the steady-state PK of ATV and DRV and confirm the dose of ATV/co or DRV/co in HIV-1 infected, virologically suppressed pediatric participants weighing ≥ 14 to < 25 kg (≥ 3 years of age) - To evaluate the steady-state PK of TAF and confirm the dose of F/TAF in HIV-1 infected, virologically suppressed pediatric participants weighing ≥ 14 to < 25 kg (≥ 3 years of age) - To evaluate the safety and tolerability of ATV/co, DRV/co, and F/TAF through 24 weeks in HIV-1 infected, virologically suppressed pediatric participants weighing ≥ 14 to < 25 kg (≥ 3 years of age)
NCT02016924 Acquired Immune Deficiency Syndrome (AIDS) HIV Infections Drug: ATV Drug: DRV Drug: Cobicistat Drug: BR MeSH:HIV Infections Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes
HPO:Immunodeficiency
Primary Outcomes
Description: AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Measure: Pharmacokinetic (PK) Parameter: AUCtau of ATV and DRV Time: Predose, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10
Description: AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Measure: Pharmacokinetic (PK) Parameter: AUCtau of ATV, DRV, and TAF for Cohorts 2 and 3 Time: Predose 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Week 2 or Week 4
Measure: Percentage of Participants Experiencing Treatment Emergent Adverse Events (AEs) and Treatment Emergent Laboratory Abnormalities Through Week 24 Time: First dose date and up to 24 weeks plus 30 days
Secondary Outcomes
Description: Ctau is defined as the observed drug concentration at the end of the dosing interval.
Measure: PK Parameter: Ctau of ATV, DRV, and COBI for Cohort 1 Time: Intensive PK samples at Predose, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10. Trough PK samples at Day 1 prior to adminstering COBI and at Weeks 12, 24, and 48 (Part A), or at Weeks 4, 12, 24, 32, and 48 (Part B).
Description: Cmax is defined as the maximum observed concentration of drug.
Measure: PK Parameter: Cmax of ATV, DRV, and COBI for Cohort 1 Time: Intensive PK samples at Predose, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10. Trough PK samples at Day 1 prior to adminstering COBI and at Weeks 12, 24, and 48 (Part A), or at Weeks 4, 12, 24, 32, and 48 (Part B).
Description: CL/F is defined as the apparent oral clearance following administration of the drug.
Measure: PK Parameter: CL/F of ATV, DRV, and COBI for Cohort 1 Time: Intensive PK samples at Predose, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10. Trough PK samples at Day 1 prior to adminstering COBI and at Weeks 12, 24, and 48 (Part A), or at Weeks 4, 12, 24, 32, and 48 (Part B).
Description: Vz/F is defined as the apparent volume of distribution of the drug.
Measure: PK Parameter: Vz/F of COBI for Cohort 1 Time: Intensive PK samples at Predose, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10. Trough PK samples at Day 1 prior to adminstering COBI and at Weeks 12, 24, and 48 (Part A), or at Weeks 4, 12, 24, 32, and 48 (Part B).
Description: Ctau is defined as the observed drug concentration at the end of the dosing interval.
Measure: PK Parameter: Ctau of ATV, DRV, COBI, FTC, and TFV for Cohorts 2 and 3 Time: Intensive PK samples at Predose 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Week 2 or Week 4. Trough PK samples at Weeks 8, 24, and 36, and timed PK samples (15 minutes to 3 hours post-dose) at Weeks 12, 16, and 48
Description: Cmax is defined as the maximum observed concentration of drug.
Measure: PK Parameter: Cmax of ATV, DRV, COBI, TAF, FTC and TFV for Cohorts 2 and 3 Time: Intensive PK samples at Predose 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Week 2 or Week 4. Trough PK samples at Weeks 8, 24, and 36, and timed PK samples (15 minutes to 3 hours post-dose) at Weeks 12, 16, and 48
Description: CL/F is defined as the apparent oral clearance following administration of the drug.
Measure: PK Parameter: CL/F of ATV, DRV, and TAF for Cohorts 2 and 3 Time: Intensive PK samples at Predose 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Week 2 or Week 4. Trough PK samples at Weeks 8, 24, and 36, and timed PK samples (15 minutes to 3 hours post-dose) at Weeks 12, 16, and 48
Description: Vz/F is defined as the apparent volume of distribution of the drug.
Measure: PK Parameter: Vz/F of COBI and TAF for Cohorts 2 and 3 Time: Intensive PK samples at Predose 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Week 2 or Week 4. Trough PK samples at Weeks 8, 24, and 36, and timed PK samples (15 minutes to 3 hours post-dose) at Weeks 12, 16, and 48
Measure: The incidence of treatment-emergent AEs and treatment-emergent laboratory abnormalities through Week 48 Time: Up to 48 weeks plus 30 days
Measure: The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 and as defined by the US FDA-defined snapshot algorithm Time: Week 24
Measure: The change from baseline in CD4+ cell counts Time: Week 24
Measure: The change from baseline in CD4+ cell counts Time: Week 48
Measure: The change from baseline in CD4+ percentages Time: Week 24
Measure: The change from baseline in CD4+ percentages Time: Week 48
Measure: Acceptability of COBI and F/TAF as Measured by Palatability Time: Day 1, and at Weeks 4 (Day 10 for Cohort 1 Part A), 24 and 48.
2 24-APR-2020: Real-world CANadian CUvitru Non-Interventional Study in Subjects Transitioning From Subcutaneous Immunoglobulin (CANCUN)
Primary Outcomes
Description: AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Measure: Pharmacokinetic (PK) Parameter: AUCtau of ATV and DRV Time: Predose, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10Description: AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Measure: Pharmacokinetic (PK) Parameter: AUCtau of ATV, DRV, and TAF for Cohorts 2 and 3 Time: Predose 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Week 2 or Week 4Measure: Percentage of Participants Experiencing Treatment Emergent Adverse Events (AEs) and Treatment Emergent Laboratory Abnormalities Through Week 24 Time: First dose date and up to 24 weeks plus 30 days
Secondary Outcomes
Description: Ctau is defined as the observed drug concentration at the end of the dosing interval.
Measure: PK Parameter: Ctau of ATV, DRV, and COBI for Cohort 1 Time: Intensive PK samples at Predose, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10. Trough PK samples at Day 1 prior to adminstering COBI and at Weeks 12, 24, and 48 (Part A), or at Weeks 4, 12, 24, 32, and 48 (Part B).Description: Cmax is defined as the maximum observed concentration of drug.
Measure: PK Parameter: Cmax of ATV, DRV, and COBI for Cohort 1 Time: Intensive PK samples at Predose, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10. Trough PK samples at Day 1 prior to adminstering COBI and at Weeks 12, 24, and 48 (Part A), or at Weeks 4, 12, 24, 32, and 48 (Part B).Description: CL/F is defined as the apparent oral clearance following administration of the drug.
Measure: PK Parameter: CL/F of ATV, DRV, and COBI for Cohort 1 Time: Intensive PK samples at Predose, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10. Trough PK samples at Day 1 prior to adminstering COBI and at Weeks 12, 24, and 48 (Part A), or at Weeks 4, 12, 24, 32, and 48 (Part B).Description: Vz/F is defined as the apparent volume of distribution of the drug.
Measure: PK Parameter: Vz/F of COBI for Cohort 1 Time: Intensive PK samples at Predose, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10. Trough PK samples at Day 1 prior to adminstering COBI and at Weeks 12, 24, and 48 (Part A), or at Weeks 4, 12, 24, 32, and 48 (Part B).Description: Ctau is defined as the observed drug concentration at the end of the dosing interval.
Measure: PK Parameter: Ctau of ATV, DRV, COBI, FTC, and TFV for Cohorts 2 and 3 Time: Intensive PK samples at Predose 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Week 2 or Week 4. Trough PK samples at Weeks 8, 24, and 36, and timed PK samples (15 minutes to 3 hours post-dose) at Weeks 12, 16, and 48Description: Cmax is defined as the maximum observed concentration of drug.
Measure: PK Parameter: Cmax of ATV, DRV, COBI, TAF, FTC and TFV for Cohorts 2 and 3 Time: Intensive PK samples at Predose 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Week 2 or Week 4. Trough PK samples at Weeks 8, 24, and 36, and timed PK samples (15 minutes to 3 hours post-dose) at Weeks 12, 16, and 48Description: CL/F is defined as the apparent oral clearance following administration of the drug.
Measure: PK Parameter: CL/F of ATV, DRV, and TAF for Cohorts 2 and 3 Time: Intensive PK samples at Predose 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Week 2 or Week 4. Trough PK samples at Weeks 8, 24, and 36, and timed PK samples (15 minutes to 3 hours post-dose) at Weeks 12, 16, and 48Description: Vz/F is defined as the apparent volume of distribution of the drug.
Measure: PK Parameter: Vz/F of COBI and TAF for Cohorts 2 and 3 Time: Intensive PK samples at Predose 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Week 2 or Week 4. Trough PK samples at Weeks 8, 24, and 36, and timed PK samples (15 minutes to 3 hours post-dose) at Weeks 12, 16, and 48Measure: The incidence of treatment-emergent AEs and treatment-emergent laboratory abnormalities through Week 48 Time: Up to 48 weeks plus 30 days
Measure: The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 and as defined by the US FDA-defined snapshot algorithm Time: Week 24
Measure: The change from baseline in CD4+ cell counts Time: Week 24
Measure: The change from baseline in CD4+ cell counts Time: Week 48
Measure: The change from baseline in CD4+ percentages Time: Week 24
Measure: The change from baseline in CD4+ percentages Time: Week 48
Measure: Acceptability of COBI and F/TAF as Measured by Palatability Time: Day 1, and at Weeks 4 (Day 10 for Cohort 1 Part A), 24 and 48.
This study will provide insights on the infusion parameters, dosing, and experience of participants transitioning to CUVITRU in a real-world setting.
NCT03716700 Primary Immunodeficiency Diseases (PID) Biological: CUVITRU MeSH:Immunologic Deficiency Syndromes
HPO:Immunodeficiency
Primary Outcomes
Description: Median infusion volume per site
Measure: Infusion parameter 1: Cohort 1-Start of data collection Time: Baseline
Description: Median infusion volume per site
Measure: Infusion parameter 1: Cohort 1- Month 3 Time: Month 3
Description: Median infusion volume per site
Measure: Infusion parameter 1: Cohort 1- Month 6 Time: Month 6
Description: Median infusion volume per site
Measure: Infusion parameter 1: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-up
Description: Median infusion volume per site
Measure: Infusion parameter 1: Cohort 2- Start of data collection Time: Baseline
Description: Median infusion volume per site
Measure: Infusion parameter 1: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-up
Description: Median infusion volume per infusion
Measure: Infusion parameter 1.1: Cohort 1- Start of data collection Time: Baseline
Description: Median infusion volume per infusion
Measure: Infusion parameter 1.1: Cohort 1- Month 3 Time: Month 3
Description: Median infusion volume per infusion
Measure: Infusion parameter 1.1: Cohort 1- Month 6 Time: Month 6
Description: Median infusion volume per infusion
Measure: Infusion parameter 1.1: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-up
Description: Median infusion volume per infusion
Measure: Infusion parameter 1.1: Cohort 2- Start of data collection Time: Baseline
Description: Median infusion volume per infusion
Measure: Infusion parameter 1.1: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-up
Description: Median number of infusion sites
Measure: Infusion parameter 2: Cohort 1- Start of data collection Time: Baseline
Description: Median number of infusion sites
Measure: Infusion parameter 2: Cohort 1- Month 3 Time: Month 3
Description: Median number of infusion sites
Measure: Infusion parameter 2: Cohort 1- Month 6 Time: Month 6
Description: Median number of infusion sites
Measure: Infusion parameter 2: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-up
Description: Median number of infusion sites
Measure: Infusion parameter 2: Cohort 2- Start of data collection Time: Baseline
Description: Median number of infusion sites
Measure: Infusion parameter 2: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-up
Description: Median infusion duration
Measure: Infusion parameter 3: Cohort 1- Start of data collection Time: Baseline
Description: Median infusion duration
Measure: Infusion parameter 3: Cohort 1- Month 3 Time: Month 3
Description: Median infusion duration
Measure: Infusion parameter 3: Cohort 1- Month 6 Time: Month 6
Description: Median infusion duration
Measure: Infusion parameter 3: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-up
Description: Median infusion duration
Measure: Infusion parameter 3: Cohort 2- Start of data collection Time: Baseline
Description: Median infusion duration
Measure: Infusion parameter 3: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-up
Description: Median number of infusions to reach participant's maximum infusion volume
Measure: Infusion parameter 3.1: Cohort 1- Month 3 Follow-up Time: Month 3
Description: Median number of infusions to reach participant's maximum infusion volume
Measure: Infusion parameter 3.1: Cohort 1- Month 6 Follow-up Time: Month 6
Description: Median number of infusions to reach participant's maximum infusion volume
Measure: Infusion parameter 3.1: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-up
Description: Median number of infusions to reach participant's maximum infusion volume
Measure: Infusion parameter 3.1: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-up
Description: Median number of infusions per month per participant
Measure: Infusion parameter 3.2: Cohort 1- Start of data collection Time: Baseline
Description: Median number of infusions per month per participant
Measure: Infusion parameter 3.2: Cohort 1- Month 3 Time: Month 3
Description: Median number of infusions per month per participant
Measure: Infusion parameter 3.2: Cohort 1- Month 6 Time: Month 6
Description: Median number of infusions per month per participant
Measure: Infusion parameter 3.2: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-up
Description: Median number of infusions per month per participant
Measure: Infusion parameter 3.2: Cohort 2- Start of data collection Time: Baseline
Description: Median number of infusions per month per participant
Measure: Infusion parameter 3.2: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-up
Description: Median number of infusions to reach final dose interval per participant
Measure: Infusion parameter 3.3: Cohort 1- Start of data collection Time: Baseline
Description: Median number of infusions to reach final dose interval per participant
Measure: Infusion parameter 3.3: Cohort 1- Month 3 Time: Month 3
Description: Median number of infusions to reach final dose interval per participant
Measure: Infusion parameter 3.3: Cohort 1- Month 6 Time: Month 6
Description: Median number of infusions to reach final dose interval per participant
Measure: Infusion parameter 3.3: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-up
Description: Median number of infusions to reach final dose interval per participant
Measure: Infusion parameter 3.3: Cohort 2- Start of data collection Time: Baseline
Description: Median number of infusions to reach final dose interval per participant
Measure: Infusion parameter 3.3: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-up
Secondary Outcomes
Description: Median maximal infusion rate per site
Measure: Infusion parameter 4.1: Cohort 1- Start of data collection Time: Baseline
Description: Median maximal infusion rate per site
Measure: Infusion parameter 4.1: Cohort 1- Month 3 Time: Month 3
Description: Median maximal infusion rate per site
Measure: Infusion parameter 4.1: Cohort 1- Month 6 Time: Month 6
Description: Median maximal infusion rate per site
Measure: Infusion parameter 4.1: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-up
Description: Median maximal infusion rate per site
Measure: Infusion parameter 4.1: Cohort 2- Start of data collection Time: Baseline
Description: Median maximal infusion rate per site
Measure: Infusion parameter 4.1: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-up
Description: Number of infusions that are discontinued, slowed, or interrupted
Measure: Infusion parameter 4.2: Cohort 1- Start of data collection Time: Baseline
Description: Number of infusions that are discontinued, slowed, or interrupted
Measure: Infusion parameter 4.2: Cohort 1- Month 3 Time: Month 3
Description: Number of infusions that are discontinued, slowed, or interrupted
Measure: Infusion parameter 4.2: Cohort 1- Month 6 Time: Month 6
Description: Number of infusions that are discontinued, slowed, or interrupted
Measure: Infusion parameter 4.2: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-up
Description: Number of infusions that are discontinued, slowed, or interrupted
Measure: Infusion parameter 4.2: Cohort 2- Start of data collection Time: Baseline
Description: Number of infusions that are discontinued, slowed, or interrupted
Measure: Infusion parameter 4.2: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-up
Description: Median number of infusions to reach participant's maximum infusion rate
Measure: Infusion parameter 4.3: Cohort 1- Month 3 Time: Month 3
Description: Median number of infusions to reach participant's maximum infusion rate
Measure: Infusion parameter 4.3: Cohort 1- Month 6 Time: Month 6
Description: Median number of infusions to reach participant's maximum infusion rate
Measure: Infusion parameter 4.3: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-up
Description: Median number of infusions to reach participant's maximum infusion rate
Measure: Infusion parameter 4.3: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-up
Description: Mean dose
Measure: Infusion parameter 5.1: Cohort 1- Start of data collection Time: Baseline
Description: Mean dose
Measure: Infusion parameter 5.1: Cohort 1- Month 3 Time: Month 3
Description: Mean dose
Measure: Infusion parameter 5.1: Cohort 1- Month 6 Time: Month 6
Description: Mean dose
Measure: Infusion parameter 5.1: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-up
Description: Mean dose
Measure: Infusion parameter 5.1: Cohort 2- Start of data collection Time: Baseline
Description: Mean dose
Measure: Infusion parameter 5.1: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-up
Description: Mean dosing interval
Measure: Infusion parameter 5.2: Cohort 1- Start of data collection Time: Baseline
Description: Mean dosing interval
Measure: Infusion parameter 5.2: Cohort 1- Month 3 Time: Month 3
Description: Mean dosing interval
Measure: Infusion parameter 5.2: Cohort 1- Month 6 Time: Month 6
Description: Mean dosing interval
Measure: Infusion parameter 5.2: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-up
Description: Mean dosing interval
Measure: Infusion parameter 5.2: Cohort 2- Start of data collection Time: Baseline
Description: Mean dosing interval
Measure: Infusion parameter 5.2: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-up
Description: Mean number of dose adjustments
Measure: Infusion parameter 5.3: Cohort 1- Start of data collection Time: Baseline
Description: Mean number of dose adjustments
Measure: Infusion parameter 5.3: Cohort 1- Month 3 Time: Month 3
Description: Mean number of dose adjustments
Measure: Infusion parameter 5.3: Cohort 1- Month 6 Time: Month 6
Description: Mean number of dose adjustments
Measure: Infusion parameter 5.3: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-up
Description: Mean number of dose adjustments
Measure: Infusion parameter 5.3: Cohort 2- Start of data collection Time: Baseline
Description: Mean number of dose adjustments
Measure: Infusion parameter 5.3: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-up
Description: TSQM-9 is a 9-item, validated, self-administered instrument used to assess participant's satisfaction with medication. The three domains assessed are effectiveness, convenience, and global satisfaction
Measure: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9): Cohort 1 Time: 12 Month final follow-up
Description: TSQM-9 is a 9-item, validated, self-administered instrument used to assess participant's satisfaction with medication. The three domains assessed are effectiveness, convenience, and global satisfaction
Measure: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9): Cohort 2 Time: 12 Month final follow-up
Description: The LQI is a self-administered questionnaire developed specifically for participants/legal guardians involved in IVIG treatments. It consists of 15-items, divided into four domains: treatment interferences (6 items), therapy-related problems (4 items), therapy setting (3 items), and treatment costs (2 items). Items are rated on a 7-point Likert-type scale ranging from 1: "Extremely bad" to 7: "Extremely good". Total scores range from 15 to 105, with higher scores indicating the highest possible satisfaction with factors such as independence, therapy convenience, social/school/work activities, and health and travel costs
Measure: Life Quality Index (LSI): Cohort 1 Time: 12 Month final follow-up
Description: The LQI is a self-administered questionnaire developed specifically for participants/legal guardians involved in IVIG treatments. It consists of 15-items, divided into four domains: treatment interferences (6 items), therapy-related problems (4 items), therapy setting (3 items), and treatment costs (2 items). Items are rated on a 7-point Likert-type scale ranging from 1: "Extremely bad" to 7: "Extremely good". Total scores range from 15 to 105, with higher scores indicating the highest possible satisfaction with factors such as independence, therapy convenience, social/school/work activities, and health and travel costs
Measure: Life Quality Index (LSI): Cohort 2 Time: 12 Month final follow-up
Description: The TPQ is a self-administered questionnaire developed to assess participants' preference towards the administration of new subcutaneous immunoglobulin G (SCIG) therapy. There are 4-items on the questionnaire, which investigate a participant's preference on the clinic/hospital/home setting of receiving the immunoglobulin therapy, the participant's rating on the frequency and method of administration, and the participant's preference to continue receiving the SCIG treatment.
Measure: Treatment Preference Questionnaire: Cohort 1 Time: 12 Month final follow-up
Description: The TPQ is a self-administered questionnaire developed to assess participants' preference towards the administration of new subcutaneous immunoglobulin G (SCIG) therapy. There are 4-items on the questionnaire, which investigate a participant's preference on the clinic/hospital/home setting of receiving the immunoglobulin therapy, the participant's rating on the frequency and method of administration, and the participant's preference to continue receiving the SCIG treatment.
Measure: Treatment Preference Questionnaire: Cohort 2 Time: 12 Month final follow-up
3 Coronavirus Outcomes Registries in Immunocompromised Individuals Australia (CORIA): a Multisite Registry and Optional Biorepository in People With COVID-19 and Selected Conditions Affecting Immune Function
Primary Outcomes
Description: Median infusion volume per site
Measure: Infusion parameter 1: Cohort 1-Start of data collection Time: BaselineDescription: Median infusion volume per site
Measure: Infusion parameter 1: Cohort 1- Month 3 Time: Month 3Description: Median infusion volume per site
Measure: Infusion parameter 1: Cohort 1- Month 6 Time: Month 6Description: Median infusion volume per site
Measure: Infusion parameter 1: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median infusion volume per site
Measure: Infusion parameter 1: Cohort 2- Start of data collection Time: BaselineDescription: Median infusion volume per site
Measure: Infusion parameter 1: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median infusion volume per infusion
Measure: Infusion parameter 1.1: Cohort 1- Start of data collection Time: BaselineDescription: Median infusion volume per infusion
Measure: Infusion parameter 1.1: Cohort 1- Month 3 Time: Month 3Description: Median infusion volume per infusion
Measure: Infusion parameter 1.1: Cohort 1- Month 6 Time: Month 6Description: Median infusion volume per infusion
Measure: Infusion parameter 1.1: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median infusion volume per infusion
Measure: Infusion parameter 1.1: Cohort 2- Start of data collection Time: BaselineDescription: Median infusion volume per infusion
Measure: Infusion parameter 1.1: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median number of infusion sites
Measure: Infusion parameter 2: Cohort 1- Start of data collection Time: BaselineDescription: Median number of infusion sites
Measure: Infusion parameter 2: Cohort 1- Month 3 Time: Month 3Description: Median number of infusion sites
Measure: Infusion parameter 2: Cohort 1- Month 6 Time: Month 6Description: Median number of infusion sites
Measure: Infusion parameter 2: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median number of infusion sites
Measure: Infusion parameter 2: Cohort 2- Start of data collection Time: BaselineDescription: Median number of infusion sites
Measure: Infusion parameter 2: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median infusion duration
Measure: Infusion parameter 3: Cohort 1- Start of data collection Time: BaselineDescription: Median infusion duration
Measure: Infusion parameter 3: Cohort 1- Month 3 Time: Month 3Description: Median infusion duration
Measure: Infusion parameter 3: Cohort 1- Month 6 Time: Month 6Description: Median infusion duration
Measure: Infusion parameter 3: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median infusion duration
Measure: Infusion parameter 3: Cohort 2- Start of data collection Time: BaselineDescription: Median infusion duration
Measure: Infusion parameter 3: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median number of infusions to reach participant's maximum infusion volume
Measure: Infusion parameter 3.1: Cohort 1- Month 3 Follow-up Time: Month 3Description: Median number of infusions to reach participant's maximum infusion volume
Measure: Infusion parameter 3.1: Cohort 1- Month 6 Follow-up Time: Month 6Description: Median number of infusions to reach participant's maximum infusion volume
Measure: Infusion parameter 3.1: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median number of infusions to reach participant's maximum infusion volume
Measure: Infusion parameter 3.1: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median number of infusions per month per participant
Measure: Infusion parameter 3.2: Cohort 1- Start of data collection Time: BaselineDescription: Median number of infusions per month per participant
Measure: Infusion parameter 3.2: Cohort 1- Month 3 Time: Month 3Description: Median number of infusions per month per participant
Measure: Infusion parameter 3.2: Cohort 1- Month 6 Time: Month 6Description: Median number of infusions per month per participant
Measure: Infusion parameter 3.2: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median number of infusions per month per participant
Measure: Infusion parameter 3.2: Cohort 2- Start of data collection Time: BaselineDescription: Median number of infusions per month per participant
Measure: Infusion parameter 3.2: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median number of infusions to reach final dose interval per participant
Measure: Infusion parameter 3.3: Cohort 1- Start of data collection Time: BaselineDescription: Median number of infusions to reach final dose interval per participant
Measure: Infusion parameter 3.3: Cohort 1- Month 3 Time: Month 3Description: Median number of infusions to reach final dose interval per participant
Measure: Infusion parameter 3.3: Cohort 1- Month 6 Time: Month 6Description: Median number of infusions to reach final dose interval per participant
Measure: Infusion parameter 3.3: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median number of infusions to reach final dose interval per participant
Measure: Infusion parameter 3.3: Cohort 2- Start of data collection Time: BaselineDescription: Median number of infusions to reach final dose interval per participant
Measure: Infusion parameter 3.3: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-upSecondary Outcomes
Description: Median maximal infusion rate per site
Measure: Infusion parameter 4.1: Cohort 1- Start of data collection Time: BaselineDescription: Median maximal infusion rate per site
Measure: Infusion parameter 4.1: Cohort 1- Month 3 Time: Month 3Description: Median maximal infusion rate per site
Measure: Infusion parameter 4.1: Cohort 1- Month 6 Time: Month 6Description: Median maximal infusion rate per site
Measure: Infusion parameter 4.1: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median maximal infusion rate per site
Measure: Infusion parameter 4.1: Cohort 2- Start of data collection Time: BaselineDescription: Median maximal infusion rate per site
Measure: Infusion parameter 4.1: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-upDescription: Number of infusions that are discontinued, slowed, or interrupted
Measure: Infusion parameter 4.2: Cohort 1- Start of data collection Time: BaselineDescription: Number of infusions that are discontinued, slowed, or interrupted
Measure: Infusion parameter 4.2: Cohort 1- Month 3 Time: Month 3Description: Number of infusions that are discontinued, slowed, or interrupted
Measure: Infusion parameter 4.2: Cohort 1- Month 6 Time: Month 6Description: Number of infusions that are discontinued, slowed, or interrupted
Measure: Infusion parameter 4.2: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-upDescription: Number of infusions that are discontinued, slowed, or interrupted
Measure: Infusion parameter 4.2: Cohort 2- Start of data collection Time: BaselineDescription: Number of infusions that are discontinued, slowed, or interrupted
Measure: Infusion parameter 4.2: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median number of infusions to reach participant's maximum infusion rate
Measure: Infusion parameter 4.3: Cohort 1- Month 3 Time: Month 3Description: Median number of infusions to reach participant's maximum infusion rate
Measure: Infusion parameter 4.3: Cohort 1- Month 6 Time: Month 6Description: Median number of infusions to reach participant's maximum infusion rate
Measure: Infusion parameter 4.3: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median number of infusions to reach participant's maximum infusion rate
Measure: Infusion parameter 4.3: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-upDescription: Mean dose
Measure: Infusion parameter 5.1: Cohort 1- Start of data collection Time: BaselineDescription: Mean dose
Measure: Infusion parameter 5.1: Cohort 1- Month 3 Time: Month 3Description: Mean dose
Measure: Infusion parameter 5.1: Cohort 1- Month 6 Time: Month 6Description: Mean dose
Measure: Infusion parameter 5.1: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-upDescription: Mean dose
Measure: Infusion parameter 5.1: Cohort 2- Start of data collection Time: BaselineDescription: Mean dose
Measure: Infusion parameter 5.1: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-upDescription: Mean dosing interval
Measure: Infusion parameter 5.2: Cohort 1- Start of data collection Time: BaselineDescription: Mean dosing interval
Measure: Infusion parameter 5.2: Cohort 1- Month 3 Time: Month 3Description: Mean dosing interval
Measure: Infusion parameter 5.2: Cohort 1- Month 6 Time: Month 6Description: Mean dosing interval
Measure: Infusion parameter 5.2: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-upDescription: Mean dosing interval
Measure: Infusion parameter 5.2: Cohort 2- Start of data collection Time: BaselineDescription: Mean dosing interval
Measure: Infusion parameter 5.2: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-upDescription: Mean number of dose adjustments
Measure: Infusion parameter 5.3: Cohort 1- Start of data collection Time: BaselineDescription: Mean number of dose adjustments
Measure: Infusion parameter 5.3: Cohort 1- Month 3 Time: Month 3Description: Mean number of dose adjustments
Measure: Infusion parameter 5.3: Cohort 1- Month 6 Time: Month 6Description: Mean number of dose adjustments
Measure: Infusion parameter 5.3: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-upDescription: Mean number of dose adjustments
Measure: Infusion parameter 5.3: Cohort 2- Start of data collection Time: BaselineDescription: Mean number of dose adjustments
Measure: Infusion parameter 5.3: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-upDescription: TSQM-9 is a 9-item, validated, self-administered instrument used to assess participant's satisfaction with medication. The three domains assessed are effectiveness, convenience, and global satisfaction
Measure: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9): Cohort 1 Time: 12 Month final follow-upDescription: TSQM-9 is a 9-item, validated, self-administered instrument used to assess participant's satisfaction with medication. The three domains assessed are effectiveness, convenience, and global satisfaction
Measure: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9): Cohort 2 Time: 12 Month final follow-upDescription: The LQI is a self-administered questionnaire developed specifically for participants/legal guardians involved in IVIG treatments. It consists of 15-items, divided into four domains: treatment interferences (6 items), therapy-related problems (4 items), therapy setting (3 items), and treatment costs (2 items). Items are rated on a 7-point Likert-type scale ranging from 1: "Extremely bad" to 7: "Extremely good". Total scores range from 15 to 105, with higher scores indicating the highest possible satisfaction with factors such as independence, therapy convenience, social/school/work activities, and health and travel costs
Measure: Life Quality Index (LSI): Cohort 1 Time: 12 Month final follow-upDescription: The LQI is a self-administered questionnaire developed specifically for participants/legal guardians involved in IVIG treatments. It consists of 15-items, divided into four domains: treatment interferences (6 items), therapy-related problems (4 items), therapy setting (3 items), and treatment costs (2 items). Items are rated on a 7-point Likert-type scale ranging from 1: "Extremely bad" to 7: "Extremely good". Total scores range from 15 to 105, with higher scores indicating the highest possible satisfaction with factors such as independence, therapy convenience, social/school/work activities, and health and travel costs
Measure: Life Quality Index (LSI): Cohort 2 Time: 12 Month final follow-upDescription: The TPQ is a self-administered questionnaire developed to assess participants' preference towards the administration of new subcutaneous immunoglobulin G (SCIG) therapy. There are 4-items on the questionnaire, which investigate a participant's preference on the clinic/hospital/home setting of receiving the immunoglobulin therapy, the participant's rating on the frequency and method of administration, and the participant's preference to continue receiving the SCIG treatment.
Measure: Treatment Preference Questionnaire: Cohort 1 Time: 12 Month final follow-upDescription: The TPQ is a self-administered questionnaire developed to assess participants' preference towards the administration of new subcutaneous immunoglobulin G (SCIG) therapy. There are 4-items on the questionnaire, which investigate a participant's preference on the clinic/hospital/home setting of receiving the immunoglobulin therapy, the participant's rating on the frequency and method of administration, and the participant's preference to continue receiving the SCIG treatment.
Measure: Treatment Preference Questionnaire: Cohort 2 Time: 12 Month final follow-upCORIA is an observational cohort study of immunosuppressed populations who test positive for COVID-19. This includes people living with HIV, cancer, acquired immunodeficiency associated with other immunosuppressive therapy, primary immunodeficiency and recipients of a solid organ transplant. Participants will have routine clinical data collected with optional baseline collection and storage of a blood sample for storage . The study will be conducted in up to 30 sites within Australia.
NCT04354818 HIV-1-infection Cancer Primary Immune Deficiency Disorder Immunosuppression Disorders COVID-19 MeSH:Immunologic Deficiency Syndromes Disease
HPO:Immunodeficiency
Primary Outcomes
Measure: percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died Time: Day 28
Secondary Outcomes
Measure: percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died Time: 3 months
4 Coronavirus Infection in Primary or Secondary Immunosuppressed Children and Adults.
Primary Outcomes
Measure: percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died Time: Day 28Secondary Outcomes
Measure: percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died Time: 3 monthsA weekly questionnaire is sent to patients and parents of patients who are vulnerable for infections. Possible symptoms of COVID19 are asked for and use of healthcare services and testing for COVID19. Weekly reports are being send to the national institutions to update advice given to this group.
NCT04382508 Immune Suppression Immune Deficiency Infection COVID Children, Adult Other: Questionnaire MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Immunologic Deficiency Syndromes
HPO:Immunodeficiency
Primary Outcomes
Description: To describe frequency of cough, fever, diarrhoea, shortness of breath, sore throat, blocked nose, red eyes, headache, joint pain, muscle pain, fatigue, chills, nausea, vomiting, diarrhoea over a year
Measure: To describe COVID19 infection in children/adults who are vulnerable for infection in an outpatients setting Time: 1 year
Secondary Outcomes
Description: Patient/parent reported positive tests for COVID19
Measure: Number of children/adults tested positive for COVID19 Time: 1 year
Description: Patient/parent reported admissions in hospital because of COVID19
Measure: Number of children/adults admitted in hospital because of COVID19 Time: 1 year
Description: Patient/parent reported effect of COVID19 on daily activities
Measure: To assess the impact of COVID19 infection on the daily activities of immunosuppressed adults and children Time: 1 year
5 Multi-Center Prospective Cohort Study: Impact of Burnout on Cardiovascular and Immune Biomarkers Among Frontline Healthcare Professionals During Covid-19 Pandemic in Abu Dhabi Emirate
Primary Outcomes
Description: To describe frequency of cough, fever, diarrhoea, shortness of breath, sore throat, blocked nose, red eyes, headache, joint pain, muscle pain, fatigue, chills, nausea, vomiting, diarrhoea over a year
Measure: To describe COVID19 infection in children/adults who are vulnerable for infection in an outpatients setting Time: 1 yearSecondary Outcomes
Description: Patient/parent reported positive tests for COVID19
Measure: Number of children/adults tested positive for COVID19 Time: 1 yearDescription: Patient/parent reported admissions in hospital because of COVID19
Measure: Number of children/adults admitted in hospital because of COVID19 Time: 1 yearDescription: Patient/parent reported effect of COVID19 on daily activities
Measure: To assess the impact of COVID19 infection on the daily activities of immunosuppressed adults and children Time: 1 yearThe main objective of our project is to investigate the evolution of psychosocial, cardiovascular and immune markers in healthcare with different levels of exposure to the COVID-19 pandemic.
NCT04422418 Cardiovascular Risk Factor Burnout Immune Deficiency MeSH:Immunologic Deficiency Syndromes Burnout, Psychological
HPO:Immunodeficiency
Primary Outcomes
Description: Burnout - through self-reported stress and burnout thoughts, beliefs, emotions, behavior related to Covid-19 using Maslach Burnout Inventory. Maslach Burnout Inventory - is a 22-item survey that covers 3 areas: Emotional Exhaustion (EE), Depersonalization (DP), and low sense of Personal Accomplishment (PA). Each subscale includes multiple questions with frequency rating choices of Never, A few times a year or less, Once a month or less, A few times a month, Once a week, A few times a week, or Every day.
Measure: Change from Baseline Burnout at 2-3 months and 6 months Time: baseline, 2-3 months, 6 months
Description: Data is collected through wearable monitoring technology. Cardiovascular risk through monitoring of heart rate variability (HRV) markers. Changes of heart rate variability (HRV) reflecting cardiac autonomic dysfunction are associated with greater risks for cardiac morbidity and mortality.
Measure: Change from Baseline Cardiovascular Risk Cardiovascular Risk Through Heart Rate Variability Markers at 2-3 months and 6 months Time: baseline, 2-3 months, 6 months
Description: Data is collected through wearable monitoring technology. Actigraphy data is collected in 1 min epochs using the zero-crossing modes.
Measure: Change from Baseline Through Actigraphy at 2-3 months and 6 months Time: baseline, 2-3 months, 6 months
Description: Data is collected through wearable monitoring technology. Sleep efficiency is defined as the proportion of the estimated sleep periods spent asleep. Sleep latency is the length of time taken to fall asleep, calculated as the time between 'lights off' to the first period of 3 min of consecutive epochs scored as sleep.
Measure: Change from Baseline Through Sleep Quality at 2-3 months and 6 months Time: baseline, 2-3 months, 6 months
Description: Cardiovascular risk through Fuster-BEWAT score. The Fuster-BEWAT score will be analyzed as a continuous variable with total score ranging from 0 to 15 points. Additionally, each component will be categorized as ideal (3) or nonideal (0 to 2), and participants will be classified as having poor, intermediate, or ideal cardiovascular health based on the total number of ideal components (0 to 1 = poor, 2 to 3 = intermediate, 4 to 5 = ideal) (Fernández-Alvira et al., 2017).
Measure: Change from Baseline Cardiovascular Risk Through Fuster-BEWAT score at 2-3 months and 6 months Time: baseline, 2-3 months, 6 months
Description: Classification of the immune function will be screened.
Measure: Change from Baseline Immune Dysfunction at 2-3 months and 6 months Time: baseline, 2-3 months, 6 months
Secondary Outcomes
Description: Submaximal field test and maximal oxygen consumption (VO2, mL/kg/min).
Measure: Change from Baseline Cardio-Respiratory Fitness at 2-3 months and 6 months Time: baseline, 2-3 months, 6 months
6 Worldwide COVID-19 in Children and Adult Patients With Primary ImmunoDeficiencies (PID) Survey
Primary Outcomes
Description: Burnout - through self-reported stress and burnout thoughts, beliefs, emotions, behavior related to Covid-19 using Maslach Burnout Inventory. Maslach Burnout Inventory - is a 22-item survey that covers 3 areas: Emotional Exhaustion (EE), Depersonalization (DP), and low sense of Personal Accomplishment (PA). Each subscale includes multiple questions with frequency rating choices of Never, A few times a year or less, Once a month or less, A few times a month, Once a week, A few times a week, or Every day.
Measure: Change from Baseline Burnout at 2-3 months and 6 months Time: baseline, 2-3 months, 6 monthsDescription: Data is collected through wearable monitoring technology. Cardiovascular risk through monitoring of heart rate variability (HRV) markers. Changes of heart rate variability (HRV) reflecting cardiac autonomic dysfunction are associated with greater risks for cardiac morbidity and mortality.
Measure: Change from Baseline Cardiovascular Risk Cardiovascular Risk Through Heart Rate Variability Markers at 2-3 months and 6 months Time: baseline, 2-3 months, 6 monthsDescription: Data is collected through wearable monitoring technology. Actigraphy data is collected in 1 min epochs using the zero-crossing modes.
Measure: Change from Baseline Through Actigraphy at 2-3 months and 6 months Time: baseline, 2-3 months, 6 monthsDescription: Data is collected through wearable monitoring technology. Sleep efficiency is defined as the proportion of the estimated sleep periods spent asleep. Sleep latency is the length of time taken to fall asleep, calculated as the time between 'lights off' to the first period of 3 min of consecutive epochs scored as sleep.
Measure: Change from Baseline Through Sleep Quality at 2-3 months and 6 months Time: baseline, 2-3 months, 6 monthsDescription: Cardiovascular risk through Fuster-BEWAT score. The Fuster-BEWAT score will be analyzed as a continuous variable with total score ranging from 0 to 15 points. Additionally, each component will be categorized as ideal (3) or nonideal (0 to 2), and participants will be classified as having poor, intermediate, or ideal cardiovascular health based on the total number of ideal components (0 to 1 = poor, 2 to 3 = intermediate, 4 to 5 = ideal) (Fernández-Alvira et al., 2017).
Measure: Change from Baseline Cardiovascular Risk Through Fuster-BEWAT score at 2-3 months and 6 months Time: baseline, 2-3 months, 6 monthsDescription: Classification of the immune function will be screened.
Measure: Change from Baseline Immune Dysfunction at 2-3 months and 6 months Time: baseline, 2-3 months, 6 monthsSecondary Outcomes
Description: Submaximal field test and maximal oxygen consumption (VO2, mL/kg/min).
Measure: Change from Baseline Cardio-Respiratory Fitness at 2-3 months and 6 months Time: baseline, 2-3 months, 6 monthsWith the emergence of SARS-CoV-2 and the COVID-19 pandemic, there is an urgent need to understand the impact of infection on immunodeficient individuals. Whilst co-morbidities (such as diabetes, cancer, arterial hypertension, heart disease...) have been documented in people infected with SARS-CoV-2, there is currently no information on the consequences and outcomes for individuals with primary immunodeficiencies (PID). Following the 1st phase of the survey (launched by Isabelle Meyts (ESID), Nizar Mahlaoui (CEREDIH & IPOPI) and Kate Sullivan with Stuart Tangye (IUIS), that gave an idea of the number of affected PID patients and the impact of SARS-CoV-2 and directly focusing on obtaining this top level of information), we are launching the 2nd phase: "COPID19". COPID19 survey is a secured online GDPR compliant platform based in Paris (Imagine Institute). It has been approved by the Paris-Necker-Enfants malades IRB and Ethics Committee. However, this retrospective survey is designed for global distribution. Data can be entered by a health care professional (mostly clinicians) through a personal login and password. Each documenting person will have access to his/her own patients' data. COPID19 require a greater level of information than the 1st phase. The eCRF will be open to evolutions depending on progresses in our knowledge of this pandemic.
NCT04459689 Primary Immune Deficiency COVID MeSH:Immunologic Deficiency Syndromes
HPO:Immunodeficiency
Primary Outcomes
Measure: Survival of patients with PID affected by COVID-19 Time: Baseline
Measure: Rate of admission to ICU of patients with PID affected by COVID-19 Time: Baseline
Measure: Rate of oxygen therapy of patients with PID affected by COVID-19 Time: Baseline
Secondary Outcomes
Measure: Sequelae of patients with PID affected by COVID-19 Time: Baseline
HPO Nodes
HP:0002721: Immunodeficiency
Genes 268
PIK3CA CCDC47 CTBP1 ATRX NHEJ1 BLNK CHD1 CD81 NOP10 IKBKB CD79A TNFRSF13C CD19 AICDA LIG4 CD19 IRF2BP2 LAMTOR2 IFNGR1 UNC119 IGHM TTC7A CD81 PNP SPATA5 RAG2 PKP1 WRAP53 ADA2 TTC37 FGFRL1 CLCA4 TERT RAG1 HYOU1 LAT TYK2 LRBA TTC7A NFE2L2 CD19 DCTN4 RREB1 CD40LG FRAS1 IKBKG TNFRSF13B CFTR RAG1 IRAK4 MAN2B1 CTLA4 JAK3 SHANK3 AGL IL21 ICOS PRKDC TNFRSF13C XRCC4 LIG4 CARD9 BSCL2 TBCE CTPS1 IL7R ANTXR2 MAN2B1 HELLS IL21R MALT1 CD3G LAMTOR2 AP3D1 CD40 ARVCF MBTPS2 ACP5 PTPRC NFKB2 TFRC MS4A1 MAPK1 MTHFD1 LYST ADA POLE RAG2 XIAP SDHC DNMT3B UNG BCL11B DOCK2 ORAI1 RTEL1 IL12RB1 TLR3 FOS AK2 IL2RG TRAF3 CTLA4 DCLRE1C SIN3A SLC46A1 LRRC8A AGPAT2 TINF2 DCLRE1C IRF7 GP1BB TGFB1 UFD1 PPARG LETM1 CAVIN1 ADA ICOS SP110 CD247 IL2RG IRAK4 RAC2 ICOS MMUT TICAM1 KLLN PIK3R1 WIPF1 NFKB1 RBCK1 CORO1A IRF8 STAT1 XRCC4 MEIS2 EPG5 RTEL1 ZBTB24 IKZF1 NSD2 XIAP EXTL3 NCF1 STIM1 FOXN1 MS4A1 GATA2 COG6 CRKL ISG15 COMT RAG1 NPM1 ATM WAS HBB RNF168 RMRP SKIV2L CDCA7 JMJD1C STAT1 CHD1 FOXN1 PRPS1 RAB27A CDC42 UROS BCL10 SKIV2L DKC1 TNFRSF13C DNMT3B FCGR3A HIRA DKC1 ACTB BCR TNFRSF4 ZBTB24 CDH23 SH2D1A CPLX1 CYBA PGM3 CDC42 SEC23B STK4 TBX1 CD3E CD79B CHD7 POLE ACD IGLL1 TERC IFNGR2 TNFRSF13B CD28 UNC93B1 STX1A EPG5 AKT1 TBK1 SMARCAL1 TERT CR2 IRF8 RMRP IL2RG IL12B IL2RB NFKB1 NCF2 RAG2 WHCR PARN RTEL1 SIK3 SDHB LMNB2 PIK3CD CARD11 FCN3 CAV1 TBX1 TCF3 CYBB PIK3R1 CR2 USF3 PTEN MYC TNFSF12 AK2 MAGT1 CR2 IL2RA LCK RNF168 CD3D NHP2 IKBKG SEC24C PARN NFKB2 IL7R TNFSF12 BTK LYST CUL4B USB1 BUB1B PRKCD CTC1 SPATA5 DKC1 STAT1 GATA1 TINF2 USP8 RAG1 PGM3 TNFRSF1B SDHD MYD88 Protein Mutations 37
A71V C282Y E138A F53L G190S G48V G73S I167V I47V I50L I50V I54L I54M I76V I82A I84V K20M L100I L10F L24I L33F L76V L89V L90M M184V M36I M46I N88S Q151M T74P V11I V179D V179F V32I V82A Y181I Y181V SNP 0
Primary Outcomes
Measure: Survival of patients with PID affected by COVID-19 Time: BaselineMeasure: Rate of admission to ICU of patients with PID affected by COVID-19 Time: Baseline
Measure: Rate of oxygen therapy of patients with PID affected by COVID-19 Time: Baseline