Coronavirus InfectionNCT04844658
Covid-19, Hospitalized, PatIents, Nasafytol
A study testing NASAFYTOL®, FULTIUM® -D3 800 and Strandard of care treatment in people with Coronavirus Infection, run by Tilman S.A. at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infection
- What is being tested?
- NASAFYTOL®, FULTIUM® -D3 800 and Strandard of care treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Feb 2021to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult ≥ 18 years of age at the time of inclusion in the study;
- Recently hospitalized patients in whom SARS CoV-2 infection has been laboratory confirmed by RT-PCR or other commercial or public health test on any sample.
- Severity of 3-4-5 according to the WHO 7-point ordinal scale (3: hospitalized, no oxygen therapy; 4: hospitalized, oxygen by mask or nasal prongs; 5:non-invasive ventilation or high-flow oxygen);
- Subject (or authorized legal representative) who can provide oral or written informed consent before beginning any study procedure;
- Understand and agree to abide by the study procedures.
Who cannot join
- Contra-indication to NASAFYTOL® or constituents (incl. Vit D): hypersensitivity or allergy to product components;
- Swallowing disorder or inability to take oral caps;
- Presence of comorbidities that imply a poor prognosis (according to clinical judgment);
- Pregnancy or breastfeeding women; If patient is a female of childbearing potential, patient must use an effective means of birth control (oral, intravaginal or transdermal oestrogen-progestogen combined hormonal contraceptives or intrauterine devices or sexual abstinence);
- Serious or active bacterial infections or documented sepsis by pathogens other than SARS-CoV-2;
- Patients participating in clinical trials of other products; Patients presenting acute impairment of renal function or nephrolithiasis; ALT/AST> 5 times the normal limit, or Neutropenia (Absolute neutrophil count < 500/uL), or Thrombocytopenia (Platelets < 50,000/uL).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Randomized Clinical Study on Covid-19 Positive Hospitalized Patients Supplemented With NASAFYTOL
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.
Read the 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:
- 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
- Duration (days) of hospitalization
- In-hospital mortality
- 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)
- Need of oxygen therapy
- Tolerance as defined by the Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
- Compliance using the pill count
- 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:
- Blood tests between inclusion and end of trial
- Radiological response - Thoracic CT scan or Chest XR
- 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)
- Time until negative RT-PCR
- Conditions
- Coronavirus Infection
- Being tested
- NASAFYTOL®, FULTIUM® -D3 800, Strandard of care treatment
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NASAFYTOL®Dietary supplement
Dietary supplement presented as green soft gel capsules of 1008 mg, containing a bioactive mixture of turmeric extract or curcumin, natural quercetin from Sophora japonica L. and vitamin D3.
FULTIUM® -D3 800Dietary supplement
Vitamin D , FULTIUM® - D3 800 is a blue soft capsule that contains 800 UI (20 µg) of D3 vitamin (cholecalciferol).
Strandard of care treatmentDrug
Strandard of care treatment for Covid-19 infection
| Study group | Role | What they receive |
|---|---|---|
| standard treatment + NASAFYTOL® | Experimental | Minimum 25 patients will receive NASAFYTOL® as a supportive supplementation to standard treatment of hospitalized patients infected with COVID-19.
For each patient, 8 capsules of NASAFYTOL® taken orally per day (4 capsules in the morning and 4 capsules in the evening before meal ,with a full glass of water. ) in support of the standard COVID-19 treatment in force in the hospital from the day after the randomization (day1) and during the period of hospitalization and maximum for 14 days Receives: Dietary Supplement: NASAFYTOL®; Drug: Strandard of care treatment |
| standard treatment + FULTIUM® - D3 800 | Active comparator | Minimum 25 patients will receive vitamin D , FULTIUM® - D3 800 as a supportive supplementation to standard treatment of hospitalized patients infected with COVID-19.
For each patient,1 capsule of Vitamin D taken orally per day (1 capsule in the morning) in support of the standard COVID-19 treatment in force in the hospital from the day after the randomization (day1) and for the duration of the hospitalization and maximum for 14 days Receives: Dietary Supplement: FULTIUM® -D3 800; Drug: Strandard of care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of the patient's clinical condition based on the WHO ordinal outcomes score
Time to a 1-point decrease on the ordinal scale. The ordinal scale reflects a range score 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".
Measured: day 14
Improvement of the patient's clinical condition based on the WHO ordinal outcomes score
Ordinal score at 14 days (or at hospital leave if <14 days) post randomization. The ordinal scale reflects a range score 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".
Measured: day 14
Duration of hospitalization
Number of days hospitalization
Measured: day 14
In-hospital mortality
Number of deads
Measured: day 14
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)
Measured: day 14
Temperature (fever)
Proportion of participants with normalization at day 14 (or at hospital leave if <14 days)
Measured: day 14
Need of oxygen therapy
Proportion of participants with oxygen therapy
Measured: day 14
Tolerance as defined by the Incidence of Adverse Events (AE)
Numbers of Adverse Events
Measured: day 14
Tolerance as defined by the incident of Serious Adverse Events (SAE)
Numbers of Serious Adverse Events
Measured: day 14
Compliance using the pill count
Numbers of Pill count taken by the patient
Measured: day 14
Blood test
C-reactive proteins : Time to halving of (or achieve normal ) CRP levels compared to peak value during trial
Measured: day 14
Blood test
Hematological values (included Lymphocyte Count) and others routine laboratory parameters (LDH, albumin, etc.): Time to normalization
Measured: day 14
Blood test
Vitamin D serum concentration: comparison of concentration between inclusion and end of trial and between the 2 arms.
Measured: day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start17 Feb 2021
- Primary completion29 Oct 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tilman S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Artialis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844658
- Sponsor's protocol ID
- CHOPIN
- Status last verified
- Oct 2022
- First submitted
- 12 Apr 2021
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gerain J, Uebelhoer M, Costes B, Herman J, Pietri S, Donneau AF, Monseur J, Henrotin Y. NASAFYTOL(R) supplementation in adults hospitalized with COVID-19 infection: results from an exploratory open-label randomized controlled trial. Front Nutr. 2023 Jun 22;10:1137407. doi: 10.3389/fnut.2023.1137407. eCollection 2023.
PubMed 37426178
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Randomized Clinical Study on Covid-19 Positive Hospitalized Patients Supplemented With NASAFYTOL
- ClinicalTrials.gov ID
- NCT04844658
- Acronym / sponsor ID
- CHOPIN
- Conditions
- Coronavirus Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Tilman S.A.Industry (pharma, biotech, devices)
- Collaborators
- Artialis
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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
- Duration (days) of hospitalization
- In-hospital mortality
- 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)
- Need of oxygen therapy
- Tolerance as defined by the Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
- Compliance using the pill count
- 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:
- Blood tests between inclusion and end of trial
- Radiological response - Thoracic CT scan or Chest XR
- 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)
- Time until negative RT-PCR
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard treatment + NASAFYTOL® | Experimental | Dietary Supplement: NASAFYTOL®, Drug: Strandard of care treatmentMinimum 25 patients will receive NASAFYTOL® as a supportive supplementation to standard treatment of hospitalized patients infected with COVID-19. For each patient, 8 capsules of NASAFYTOL® taken orally per day (4 capsules in the morning and 4 capsules in the evening before meal ,with a full glass of water. ) in support of the standard COVID-19 treatment in force in the hospital from the day after the randomization (day1) and during the period of hospitalization and maximum for 14 days |
| standard treatment + FULTIUM® - D3 800 | Active comparator | Dietary Supplement: FULTIUM® -D3 800, Drug: Strandard of care treatmentMinimum 25 patients will receive vitamin D , FULTIUM® - D3 800 as a supportive supplementation to standard treatment of hospitalized patients infected with COVID-19. For each patient,1 capsule of Vitamin D taken orally per day (1 capsule in the morning) in support of the standard COVID-19 treatment in force in the hospital from the day after the randomization (day1) and for the duration of the hospitalization and maximum for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult ≥ 18 years of age at the time of inclusion in the study;
- Recently hospitalized patients in whom SARS CoV-2 infection has been laboratory confirmed by RT-PCR or other commercial or public health test on any sample.
- Severity of 3-4-5 according to the WHO 7-point ordinal scale (3: hospitalized, no oxygen therapy; 4: hospitalized, oxygen by mask or nasal prongs; 5:non-invasive ventilation or high-flow oxygen);
- Subject (or authorized legal representative) who can provide oral or written informed consent before beginning any study procedure;
- Understand and agree to abide by the study procedures.
Key exclusion criteria (6 listed)
- Contra-indication to NASAFYTOL® or constituents (incl. Vit D): hypersensitivity or allergy to product components;
- Swallowing disorder or inability to take oral caps;
- Presence of comorbidities that imply a poor prognosis (according to clinical judgment);
- Pregnancy or breastfeeding women; If patient is a female of childbearing potential, patient must use an effective means of birth control (oral, intravaginal or transdermal oestrogen-progestogen combined hormonal contraceptives or intrauterine devices or sexual abstinence);
- Serious or active bacterial infections or documented sepsis by pathogens other than SARS-CoV-2;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NASAFYTOL®Dietary supplement presented as green soft gel capsules of 1008 mg, containing a bioactive mixture of turmeric extract or curcumin, natural quercetin from Sophora japonica L. and vitamin D3. | Dietary supplement | standard treatment + NASAFYTOL® |
| FULTIUM® -D3 800Vitamin D , FULTIUM® - D3 800 is a blue soft capsule that contains 800 UI (20 µg) of D3 vitamin (cholecalciferol). | Dietary supplement | standard treatment + FULTIUM® - D3 800 |
| Strandard of care treatmentStrandard of care treatment for Covid-19 infection | Drug | standard treatment + FULTIUM® - D3 800, standard treatment + NASAFYTOL® |
Primary outcome
Improvement of the patient's clinical condition based on the WHO ordinal outcomes score
Time frame: day 14
Time to a 1-point decrease on the ordinal scale. The ordinal scale reflects a range score 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".
Improvement of the patient's clinical condition based on the WHO ordinal outcomes score
Time frame: day 14
Ordinal score at 14 days (or at hospital leave if <14 days) post randomization. The ordinal scale reflects a range score 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".
Duration of hospitalization
Time frame: day 14
Number of days hospitalization
In-hospital mortality
Time frame: day 14
Number of deads
Temperature (fever)
Time frame: day 14
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)
Temperature (fever)
Time frame: day 14
Proportion of participants with normalization at day 14 (or at hospital leave if <14 days)
Need of oxygen therapy
Time frame: day 14
Proportion of participants with oxygen therapy
Tolerance as defined by the Incidence of Adverse Events (AE)
Time frame: day 14
Numbers of Adverse Events
Tolerance as defined by the incident of Serious Adverse Events (SAE)
Time frame: day 14
Numbers of Serious Adverse Events
Compliance using the pill count
Time frame: day 14
Numbers of Pill count taken by the patient
Blood test
Time frame: day 14
C-reactive proteins : Time to halving of (or achieve normal ) CRP levels compared to peak value during trial
Blood test
Time frame: day 14
Hematological values (included Lymphocyte Count) and others routine laboratory parameters (LDH, albumin, etc.): Time to normalization
Blood test
Time frame: day 14
Vitamin D serum concentration: comparison of concentration between inclusion and end of trial and between the 2 arms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Derived from this study: PubMed 37426178Gerain J, Uebelhoer M, Costes B, Herman J, Pietri S, Donneau AF, Monseur J, Henrotin Y. NASAFYTOL(R) supplementation in adults hospitalized with COVID-19 infection: results from an exploratory open-label randomized controlled trial. Front Nutr. 2023 Jun 22;10:1137407. doi: 10.3389/fnut.2023.1137407. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NASAFYTOL®, FULTIUM® -D3 800 and Strandard of care treatment in people with Coronavirus Infection, run by Tilman S.A. at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of the patient's clinical condition based on the WHO ordinal outcomes score (time frame: day 14). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04844658, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.