Clinical trial
A Comparative Randomized Clinical Study on Covid-19 Positive Hospitalized Patients Supplemented With NASAFYTOL
Aliases
CHOPIN
Name
CHOPIN
Description
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.
Trial arms
Arm 1
arm_1
Sample size
3
Intervention
Dosage information
Melphalan 3mg/kg (max 220mg), IPI 1mg/kg, NIVO 1mg/kg
Dosage schedule
M-PHP: 6 weekly, IPI+NIVO: 3 weekly
Population
Adult, Confirmed measurable hepatic metastases, WHO PS 0-1
Arm 2
arm_2
Sample size
4
Intervention
Dosage information
Melphalan 3mg/kg (max 220mg), IPI 1mg/kg, NIVO 3mg/kg
Dosage schedule
M-PHP: 6 weekly, IPI+NIVO: 3 weekly
Population
Adult, Confirmed measurable hepatic metastases, WHO PS 0-1
Trial start
2021-02-17
Estimated PCD
2021-10-29
Trial end
2022-03-31
Status
Completed
Treatment
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.
Arms:
standard treatment + NASAFYTOL®
FULTIUM® -D3 800
Vitamin D , FULTIUM® - D3 800 is a blue soft capsule that contains 800 UI (20 µg) of D3 vitamin (cholecalciferol).
Arms:
standard treatment + FULTIUM® - D3 800
Strandard of care treatment
Strandard of care treatment for Covid-19 infection
Arms:
standard treatment + FULTIUM® - D3 800, standard treatment + NASAFYTOL®
Size
51
Primary endpoint
Improvement of the patient's clinical condition based on the WHO ordinal outcomes score
day 14
Improvement of the patient's clinical condition based on the WHO ordinal outcomes score
day 14
Duration of hospitalization
day 14
In-hospital mortality
day 14
Temperature (fever)
day 14
Temperature (fever)
day 14
Need of oxygen therapy
day 14
Tolerance as defined by the Incidence of Adverse Events (AE)
day 14
Tolerance as defined by the incident of Serious Adverse Events (SAE)
day 14
Compliance using the pill count
day 14
Blood test
day 14
Blood test
day 14
Blood test
day 14
Eligibility criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 51, 'type': 'ACTUAL'}}
Updated at
2022-10-13
1 organization
1 product
1 indication
Product
Standard of care treatmentIndication
COVID-19Organization
Tilman