Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT04844658
Status:
COMPLETED
Last Update Posted:
2022-10-13
First Post:
2021-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Covid-19, Hospitalized, PatIents, Nasafytol
Sponsor:
Tilman S.A.
Organization:
Study Overview
Official Title:
A Comparative Randomized Clinical Study on Covid-19 Positive Hospitalized Patients Supplemented With NASAFYTOL
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate the effect and safety of NASAFYTOL® on COVID-19 positive hospitalized patients as a supportive supplementation to standard-of-care in improving clinical parameters safely during hospital admission (maximum 14 days).
The study is a standard-of-care comparative, open, parallel two-arms and randomized trial in 50 adult patients positive to COVID-19 infection and hospitalized. It will be monocentric but may be extended to several investigation sites (multicentric) depending on the evolution of the epidemic within the hospitals.
The study is a standard-of-care comparative, open, parallel two-arms and randomized trial in 50 adult patients positive to COVID-19 infection and hospitalized. It will be monocentric but may be extended to several investigation sites (multicentric) depending on the evolution of the epidemic within the hospitals.
Detailed Description:
50 patients (25 per arm) infected with COVID-19 and hospitalized (depending on the progress of the pandemic and therefore the presence of COVID-19 patients, this number could reach 100 (50 per arm)). The first ten sentinel patients will be monitored at the safety level before enrolling the rest of the participants.
The effect and safety of NASAFYTOL® will be evaluated using the following outcome measures:
1. Improvement of clinical condition of the patient defined by the COVID-19 WHO ordinal Outcomes score. This scale reflects a range from uninfected to dead, where 0 is "no clinical or virological evidence of infection", 1 is "no limitation of activities", 2 is "limitation of activities", 3 is "hospitalized, no oxygen therapy", 4 is "oxygen by mask or nasal prongs", 5 is "non-invasive ventilation or high-flow oxygen", 6 is "intubation and mechanical ventilation", 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".
* Time to a 1-point decrease
* Score at 14 days (or at hospital leave if \<14 days) post randomization
2. Duration (days) of hospitalization
3. In-hospital mortality
4. Temperature (fever):
* Time to resolution of fever for at least 48 hours without antipyretics for 48 hours - Defined as ≤36.6°C (axilla), ≤37.2°C (oral) or ≤37.8°C (rectal or tympanic)
* Proportion of participants with normalization at day 14 (or at hospital leave if \<14 days)
5. Need of oxygen therapy
6. Tolerance as defined by the Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
7. Compliance using the pill count
8. Blood test:
* C-reactive proteins : Time to halving of (or achieve normal ) CRP levels compared to peak value during trial
* Hematological values (included Lymphocyte Count) and others routine laboratory parameters (LDH, albumin, etc.): Time to normalization
* Vitamin D serum concentration: comparison of concentration between inclusion and end of trial and between the 2 arms.
Optional outcome measures will be perform if data is available from routine practice:
9. Blood tests between inclusion and end of trial
10. Radiological response - Thoracic CT scan or Chest XR
11. Oxygenation PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio) :
* Time to improvement (TBD) in oxygenation for at least 48 hours
* Proportion of participants with normalization at day 14 (or at hospital leave if \<14 days)
12. Time until negative RT-PCR
The effect and safety of NASAFYTOL® will be evaluated using the following outcome measures:
1. Improvement of clinical condition of the patient defined by the COVID-19 WHO ordinal Outcomes score. This scale reflects a range from uninfected to dead, where 0 is "no clinical or virological evidence of infection", 1 is "no limitation of activities", 2 is "limitation of activities", 3 is "hospitalized, no oxygen therapy", 4 is "oxygen by mask or nasal prongs", 5 is "non-invasive ventilation or high-flow oxygen", 6 is "intubation and mechanical ventilation", 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".
* Time to a 1-point decrease
* Score at 14 days (or at hospital leave if \<14 days) post randomization
2. Duration (days) of hospitalization
3. In-hospital mortality
4. Temperature (fever):
* Time to resolution of fever for at least 48 hours without antipyretics for 48 hours - Defined as ≤36.6°C (axilla), ≤37.2°C (oral) or ≤37.8°C (rectal or tympanic)
* Proportion of participants with normalization at day 14 (or at hospital leave if \<14 days)
5. Need of oxygen therapy
6. Tolerance as defined by the Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
7. Compliance using the pill count
8. Blood test:
* C-reactive proteins : Time to halving of (or achieve normal ) CRP levels compared to peak value during trial
* Hematological values (included Lymphocyte Count) and others routine laboratory parameters (LDH, albumin, etc.): Time to normalization
* Vitamin D serum concentration: comparison of concentration between inclusion and end of trial and between the 2 arms.
Optional outcome measures will be perform if data is available from routine practice:
9. Blood tests between inclusion and end of trial
10. Radiological response - Thoracic CT scan or Chest XR
11. Oxygenation PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio) :
* Time to improvement (TBD) in oxygenation for at least 48 hours
* Proportion of participants with normalization at day 14 (or at hospital leave if \<14 days)
12. Time until negative RT-PCR
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: