MERCAPTAMINE for COVID-19 (SARS-CoV-2 infection) | COVID-19 pneumonia

Inclusion criteria

• {"criterion_text":"- Age ≥18 years\n- Infertility condition (postmenopausal, surgically induced infertility e.g., vasectomy with documented azoospermia for men or tubal closure for women) or in potentially fertile subjects, negative urinary pregnancy test (women), and consent to adhere to the following contraception requirements from 2 weeks prior to enrollment to 18 weeks after experimental drug administration (men and women)\n- Positive nasopharyngeal swab for SARS-CoV-2 (antigenic or molecular test)\n- Onset of COVID-19 symptoms related ≤10 days\n- Clinical signs and symptoms of COVID-19 pneumonia\n- Imaging examination (X-ray/echo/TAC) of the chest compatible with COVID-19 pneumonia not requiring high oxygen flows\n- Low-flow respiratory support with Venturi mask or goggles with a pO2/FiO2 ratio (index derived from the ratio of PaO2 detected by blood gas analysis, to the fraction of oxygen, FiO2 administered) > 200mmHg\n- Body Weight ≥50 kg\n- Ability to provide informed consent\n- Ability to adhere to follow-up visits"}

Exclusion criteria

• {"criterion_text":"- Age <18 years\n- pO2/FiO2 ratio ≤ 200 mmHg\n- Need for oxygen at high flows (CPAP/NIV/VM/ECMO)\n- Use of antiretroviral drugs\n- Hemoglobin concentration less than 10 g/dl\n- Elevation of creatinine kinase at baseline more than three times the upper limit of normal\n- 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 more than twice the upper limit of normal, platelet count <100,000/mm3, white blood cell (WBC) <2500 (mcL)\n- Pregnancy or breastfeeding\n- Silico-tuberculosis\n- Seropositivity for HIV, HCV, HBV (HBsAg positivity)\n- Liver failure (Child A-C), renal failure (creatinine clearance < 50 ml/min), heart failure (NYHA IV), active stage neoplasms (those who have had cycles of chemotherapy including biologic drugs and/or radiation therapy in the past 6 months), ongoing neurological/psychiatric pathology (e.g., depression, psychotic crisis, suicide attempt)\n- Gastric/duodenal ulcer undergoing treatment\n- Systemic lupus erythematosus (autoimmune disease)\n- Hypersensitivity to cysteamine or penicillin\n- Drug/alcohol abuse\n- Inability to understand and sign informed consent\n- Presence of any physical or psychological condition that, in the opinion of the principal investigator, makes participation in the study not recommended"}

Primary endpoints

• {"endpoint_text":"- Percentage of patients with treatment-related AEs of grade ≥3 within 28 days and 90 days after the start of therapy\n- Percentage of patients with AEs (of any grade and those with serious conditions) of any grade and regardless of causality within 28 days and 90 days after the start of therapy","definition_or_measurement_approach":"AEs graded by severity (grade ≥3 for first endpoint); time windows specified: assessments within 28 days and 90 days after therapy start. Causality considered for second endpoint (regardless of causality)."}

Secondary endpoints

• {"endpoint_text":"- Percentage of patients who decide to discontinue therapy before day 10 or discharge\n- Difference between number of tablets taken and expected number of cysteamine tablets\n- Pharmacokinetic curve of cysteamine at day 7±1 (blood draws at 0, 1, 2 and 3 hours after drug administration)\n- Cytokines and blood biomarkers at baseline and days 3, 7±1 (or hospital discharge if before day 10), 28±3.\n- Modulation of gene expression induced by cysteamine therapy at day 7±1 compared with baseline\n- Number of days required for SARS-COV-2 swab negativization.\n- Clinical status expressed by the 11 items of the WHO Clinical Progression Scale at day 7, 10 and 28.\n- Number of days to hospital discharge","definition_or_measurement_approach":"Includes adherence/discontinuation up to day 10 or discharge; tablet counts vs expected; PK sampling at day 7±1 with blood draws at 0,1,2,3 hours; cytokine/biomarker sampling at specified days; gene expression comparison baseline vs day 7±1; virological clearance measured as days to swab negativization; WHO Clinical Progression Scale assessed at days 7, 10, 28; hospital length of stay measured in days."}

Italy

Earliest CTIS Part Ii Submission Date

01-08-2024

Latest Decision Or Authorization Date

21-10-2024

Processing Time Days

81

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

National Institute For Infectious Diseases Lazzaro Spallanzani

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy