COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04952805

Simone Lanini

Pierpaola Borgonovo, info.studiclinici@opis.it (PI email not reported)

2021-07-07

Not recruiting

RCT

Randomized

Adaptive

Blind label

multi-center

Treatment

inclusion criteria: - 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. - age ≥18 years. at least 30% of participants will be ≥ 65 years old. - 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. - asymptomatic to moderately symptomatic outpatients with no need for immediate hospitalization: grade 1, or grade 2 or grade 3 of clinical severity scale. - no childbearing potential (post-menopause, surgically-induced, or pharmacologically-induced 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).

- severe or critical covid-19: grade 4 or grade 5 of clinical severity scale. - current hospitalization and/or hospitalization or emergency room visit in the past 14 days. - need for immediate hospitalization for any reason in the investigator's opinion. - severe liver disease as determined by values of alt and/or ast >5x upper limit of normal (uln) and/or history of liver cirrhosis. - severe renal disease as determined by estimated creatinine clearance (cccl) <30 ml/min or serum creatinine >2 mg/dl (>176.8 μmol/l) or ongoing renal dialysis. - absolute neutrophil count (anc) < 1000/μl. - demyelinating and connective tissue disease. - active tuberculosis or suspected active bacterial, fungal, viral, or other infection (besides covid- 19). - any condition that in the investigator's opinion may be negatively affected by the study treatments and/or study procedures. - any condition, including psychiatric disorders, alcohol, or substance abuse, which in the investigator's opinion may interfere with completion of the study procedures. - any condition with life expectancy <6 months in the investigator's opinion. - ongoing or planned pregnancy. - ongoing breast feeding. - history of life-threatening event in the 1 month before visit 1. - history of surgery in the 1 month before visit 1. - history of treatment with blood components in the 6 months before visit 1. - history of cancer treated with chemotherapy in the 6 months before visit 1. - history of solid organ transplant at any time before visit 1. - history of severe and/or serious allergic reaction to monoclonal antibodies or any component of mad0004j08, including anaphylaxis at any time before visit 1. - treatment with an investigational drug or vaccine within 5 half-lives or 30 days (whichever is longer) of randomization. - treatment at any time with monoclonal antibodies bamlanivimab, bamlanivimab + etesevimab combination, and casiribimab + imdevimab combination.

3

Toscana Life Sciences Sviluppo s.r.l.

18

100

Italy

Mild disease at enrollment

1: Mild disease at enrollment

800

Severe (Grade 3) unsolicited AEs and/or serious unsolicited AEs (SAEs).;Time to SARS-CoV-2 clearance in the URT.

None

Phase 2/Phase 3

[{"arm_notes": "400 mg (stage 2 includes only 2 arms.Therefore, number of participants might differ)", "treatment_id": 763, "treatment_name": "Mad0004j08", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "100 mg (stage 2 includes only 2 arms.Therefore, number of participants might differ)", "treatment_id": 763, "treatment_name": "Mad0004j08", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]