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Study to Select the Dose and Evaluate Safety and Efficacy of Monoclonal Antibody in Adult With Recently Diagnosed Asymptomatic to Moderately Severe COVID-19.

NCT04952805 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2022-02-03

No results posted yet for this study

Summary

MAD0004J08, the experimental drug, is a potent neutralizing IgG1 monoclonal antibody (mAb) targeting the spike protein of SARS-CoV-2. MAD0004J08 blocks viral attachment and entry into human cells and neutralizes the virus. Because of its high affinity and potency, MAD0004J08 may accelerate clearance of the virus and prevent clinical deterioration of COVID-19 patients, especially when administered shortly after infection, and prevent SARS-CoV-2 infection in uninfected subjects. Because of its high potency, MAD0004J08 is expected to be effective at low doses (mg range) and thus will be administered by intramuscular (IM) injection, as opposed to the intravenous bolus required by high dose mAbs.

The goals of this Phase II-III seamless adaptive clinical trial are:

Stage-1 (Phase II)

1. Select one dose level for progression to Stage-2 Stage-1 + Stage-2 (Phase III)
2. Provide confirmatory evidence of safety and efficacy for regulatory approval.

Conditions

  • Covid19

Interventions

DRUG

MAD0004J08

MAD0004J08 is a human monoclonal Antibody (mAb), 2.5 mL 2R vial available in two dose: 100 mg and 400 mg. The pharmaceutical form is solution for intramuscular injection.

OTHER

Placebo

Placebo matching to MAD0004J08, 2.5 mL 2R vial. The pharmaceutical form is solution for intramuscular injection.

Sponsors & Collaborators

  • Toscana Life Sciences Sviluppo s.r.l.

    lead INDUSTRY

Principal Investigators

  • Simone Lanini · IRCCS INMI Lazzaro Spallanzani - Istituto nazionale Malattie Infettive

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-06
Primary Completion
2022-03-31
Completion
2022-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04952805 on ClinicalTrials.gov