SARS-CoV2 treatment. MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations MedDRA version: 23.1 Level: PT Classification code 10084460 Term: COVID-19 treatment System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: MAD0004J08
Product Code: [MBHX0120]
Pharmaceutical Form: Solution for injection/infusion
Current Sponsor code: MAD0004J08
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
Toscana Life Sciences Sviluppo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent taken before any study procedure from any patient capable of giving consent, or, when the patient is incapable of doing so, by his or her legal/authorized representative. 2. Age = 18 years. 3. First nasopharyngeal swab testing positive for SARS-CoV-2 by RT-PCR taken no more than 3 days before randomization (Visit 1). Results of “rapid” semiquantitative tests are not acceptable. 4. Asymptomatic to moderately symptomatic outpatients with no need for immediate hospitalization: grade 1, or grade 2 or grade 3 of Clinical Severity Scale. 5. No childbearing potential (post-menopause, surgically-induced, or pharmacologicallyinduced sterility) or, if of childbearing potential, negative urinary pregnancy test (women) and commitment to use at least 2 forms of contraception for at least 168 days from administration of study drug (men and women). 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 600 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 206
Exclusion criteria
Exclusion criteria: 1. Severe or critical COVID-19: grade 4 or grade 5 of clinical severity scale. 2. Current hospitalization and/or hospitalization or emergency room visit in the past 14 days. 3. Need for immediate hospitalization for any reason in the investigator’s opinion. 4. Severe liver disease as determined by values of ALT and/or AST >5x upper limit of normal (ULN) and/or history of liver cirrhosis. 5. Severe renal disease as determined by estimated creatinine clearance (CcCl) 2 mg/dL (>176.8 µmol/L) or ongoing renal dialysis. 6. Absolute neutrophil count (ANC) < 1000/µL. 7. Demyelinating and connective tissue disease. 8. Active tuberculosis or suspected active bacterial, fungal, viral, or other infection (besides COVID-19). 9. Any condition that in the Investigator’s opinion may be negatively affected by the study treatments and/or study procedures. 10. Any condition, including psychiatric disorders, alcohol, or substance abuse, which in the Investigator’s opinion may interfere with completion of the study procedures. 11. Any condition with life expectancy <6 months in the Investigator’s opinion. 12. Ongoing or planned pregnancy. 13. Ongoing breast feeding. 14. History of life-threatening event in the 1 month before Visit 1. 15. History of surgery in the 1 month before Visit 1. 16. History of treatment with blood components in the 6 months before Visit 1. 17. History of cancer treated with chemotherapy in the 6 months before Visit 1. 18. History of solid organ transplant at any time before Visit 1. 19. History of severe and/or serious allergic reaction to monoclonal antibodies or any component of MAD0004J08, including anaphylaxis at any time before Visit 1. 20. Treatment with an investigational drug or vaccine within 5 half-lives or 30 days (whichever is longer) of randomization. 21. Treatment at any time with monoclonal antibodies bamlanivimab, bamlanivimab + etesevimab combination, and casiribimab + imdevimab combination . Receipt of an approved vaccine vs. COVID-19 is NOT an exclusion criterion, i.e. is compatible with enrolment in the study if all inclusion and exclusion criteria are met.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety: - To assess the safety and tolerability of MAD0004J08 as determined by severe and serious adverse events. Efficacy: - To demonstrate that MAD0004J08 shortens the time to clearance of SARS-CoV-2 from the URT.;Secondary Objective: Safety: - To assess the overall safety and tolerability, local reactogenicity, and production of anti-drug antibodies of MAD0004J08. Efficacy: - To demonstrate that MAD0004J08 reduces the proportion of participants who experience one of the clinically outcomes that are part of the composite endpoint. - To assess the impact of MAD0004J08 on SARS-CoV-2 virus in the URT and on the clinical course of COVID-19.;Primary end point(s): Safety: - Proportion of participants with severe (Grade 3) unsolicited AEs and/or serious unsolicited AEs (SAEs). Efficacy: - Time to SARS-CoV-2 clearance in the URT.;Timepoint(s) of evaluation of this end point: Safety and efficacy endpoints will be analyzed as appropriate in two target populations and three time windows: - Primary populations: 1) all randomized participants (ALL), and 2) seronegative randomized participants (SEROneg). - Time windows (defined at an individual participant level): 1) baseline (Visit 1) to end of Stage-1 or dropout (interim analysis), 2) baseline (Visit 1) to end of Stage-2 or dropout (primary analysis), 3) baseline (Visit 1) to end of study (Visit 12) or dropout (final analysis). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety: - Proportion of participants with unsolicited AEs, including clinically relevant laboratory and ECG abnormalities, and with solicited local AEs at the injection site; proportion of tested participants who develop ADA (ADA testing limited to the first 60 randomized participants). Efficacy: - Proportion of patients experiencing at least one of the following events: peripheral capillary oxygen saturation (SpO2) < 94%, newly established or increased dose home oxygen therapy, hospitalization, death (clinical composite endpoint); - Viral clearance and viral load in the URT and SpO2% by visit, COVID-19 clinical symptoms, newly established or increased dose home oxygen therapy, proportion of patients requiring hospitalization, hospital oxygen therapy, admission to intensive care unit (ICU) and deaths; duration of hospital and ICU stay and of oxygen therapy.;Timepoint(s) of evaluation of this end point: Safety and efficacy endpoints will be analyzed as appropriate in two target populations and three time windows: - Primary populations: 1) all randomized participants (ALL), and 2) seronegative randomized participants (SEROneg). - Time windows (defined at an individual participant level): 1) baseline (Visit 1) to end of Stage-1 or dropout (interim analysis), 2) baseline (Visit 1) to end of Stage-2 or dropout (primary analysis), 3) baseline (Visit 1) to end of study (Visit 12) or dropout (final analysis). | — |
Countries
Italy
Contacts
Public ContactSarah Nosari
Toscana Life Sciences e Sviluppo S.r.l.
Outcome results
None listed