Covid-19 infection MedDRA version: 23.1 Level: LLT Classification code 10084401 Term: COVID-19 respiratory infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Cystagon
Product Name: Cystagon
Product Code: [-]
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: MERCAPTAMINA
CAS Number: 156-57-0
Current Sponsor code: -
Other descriptive name:
Sponsors
ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age >=18 years • Positive nasopharyngeal swab for SARS-CoV-2 (antigen or molecular test) • COVID-19 symptoms onset = 200 • Weight >= 50 kg • Ability to provide informed consent • Ability to adhere to control visits • Infertility condition (post-menopause, surgically induced sterility eg vasectomy with documented azoospermia for men or tubal closure for women) or in subjects of childbearing potential, negative urine pregnancy test (women), and consent to comply with following contraception requirements from 2 weeks prior to enrollment to 18 weeks after study drug administration (men and women): -Use of condom for male subjects or one of the following contraceptive methods by the partner: -Combined hormonal contraceptives associated with ovulation inhibitors (oral, intravaginal, transdermal) -Hormonal progestin contraceptives associated with an ovulation inhibitor (oral, injectable, implantable) -Intrauterine devices -Bilateral tubal ligation -sexual abstinence (hetero) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: Exclusion criteria • Age <18 years • pO2 / FiO2 ratio = < 200 mmHg • Need for high flow oxygen (CPAP / NIV / VM / ECMO) • Use of antiretroviral drugs • Hemoglobin concentration below 10 g / dl • Elevation of creatinine kinase at baseline more than three times the normal upper limit • Abnormal laboratory values at baseline (baseline alanine aminotransferase (ALT) concentration more than three times the upper limit of normal, serum creatinine concentration more than twice the upper limit of normal, serum total bilirubin level greater than twice the upper limit than normal, platelet count <100,000 / mm3, white blood cells (WBC) <2500 (mcL) • Pregnancy or breastfeeding • Silico-tuberculosis • Scheduled or current use of cyclosporine, tacrolimus, erythromycin or colchicine • Seropositivity for HIV, HCV, HBV (HBsAg positivity) • Hepatic insufficiency (Child A-C), Renal insufficiency (creatinine clearance <50 ml / min), heart failure (NYHA III-IV), decompensated diabetes mellitus, neoplasms, current neurological / psychiatric pathology (eg depression, psychotic crisis, suicide attempt), chronic inflammatory bowel disease or gastric / duodenal ulcer under treatment, autoimmune diseases • Hypersensitivity to cysteamine or penicillin • Drug / alcohol abuse • Inability to understand and sign informed consent Presence of any physical or psychological condition which, according to the study responsible, makes participation in the study not recommended
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study evaluate the safety of cysteamine in hospitalized patients with COVID-19 pneumonia not requiring high oxygen flows, previously vaccinated with anti-COVID-19 vaccines or not vaccinated by recording serious and non-serious adverse events. Therapeutic adherence and tolerability of the cysteamine administered orally in two different dosage regimens, 1050 mg / day and 1950 mg / day will be evaluated. Any adverse events may be correlated with blood levels of cysteamine;Secondary Objective: The study perform an immunological characterization of the activity of cysteamine on the antibody and cellular response of patients treated using specific laboratory assays. Pharmacokinetics of cysteamine. The pharmacokinetics (PK) of cysteamine after taking Cystagon® are characterized by rapid absorption (highest C in short t) and a short half-life. The dosage of cysteamine will be done on day 6 using samples taken before the administration of the drug, and after 1 and 2 hours after the administration of the drug. The High-Performance Liquid Chromatography-UltraViolet (HPLC-UV) System will be used. Exploratory objectives: To investigate the potential efficacy of administering two different cysteamine dosing regimens, 1050 mg / day and 1950 mg / day, in addition to standard of care, in hospitalized patients with COVID-19 pneumonia not requiring high oxygen flows;Primary end point(s): • Percentage of patients with treatment-related AEs of grade =3 within 28 days and 90 days from the start of therapy • Percentage of patients with AE (all and those in serious conditions) of any degree and regardless of causality within 28 days and 90 days from the start of therapy • Percentage of patients who decide to stop therapy before day 10 or discharge • Difference between number of tablets taken and expected number of cysteamine tablets • Pharmacokinetic curve of cysteamine at day 6;Timepoint(s) of evaluation of this end point: • within 28 days and 90 days from the start of | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints • Cytokines and blood biomarkers at baseline and on days 3, 7, 10 (or discharge if before day 10), 28. Exploratory endpoints • Number of days required for the SARS-COV-2 buffer to become negative. • Clinical status expressed by the 11 points of the WHO Clinical Progression Scale on days 7, 10 and 28. • Number of days until discharge from the hospital • Percentage of patients requiring high flow oxygen therapy within day 10 • Percentage of patients transferred to the ICU or who died within day 28;Timepoint(s) of evaluation of this end point: Secondary endpoints • on days 3, 7, 10 (or discharge if before day 10), 28. Exploratory endpoints • Number of days required for the SARS-COV-2 buffer to become negative. • by the 11 points of the WHO Clinical Progression Scale on days 7, 10 and 28. • Number of days until discharge from the hospital • within day 10 • within day 28 | — |
Countries
Italy
Contacts
Public ContactUOSD Ricerca Traslazionale
Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani
Outcome results
None listed