Ignite Creation Date:
2024-05-06 @ 4:20 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04952805
Status:
UNKNOWN
Last Update Posted:
2022-02-03
First Post:
2021-07-01
Brief Title:
Study to Select the Dose and Evaluate Safety and Efficacy of Monoclonal Antibody in Adult With Recently Diagnosed Asymptomatic to Moderately Severe COVID-19
Sponsor:
Toscana Life Sciences Sviluppo srl
Organization:
Toscana Life Sciences Sviluppo srl
Study Overview
Official Title:
Randomized Placebo-controlled Double-blind Multicenter Seamless Adaptive Phase II-III Clinical Trial to Select the Dose and Evaluate Safety and Efficacy of MAD0004J08 Monoclonal Antibody in Adult Patients With Recently Diagnosed Asymptomatic to Moderately Severe COVID-19
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
This clinical trial is designed as a randomized stratified placebo-controlled doubleblind multicenter seamless adaptive study The target study population is adult patients 18 years of age with recently diagnosed 3 days from 1st positive swab taken asymptomatic to moderately severe COVID-19 at baseline Patients with comorbidities will be allowed in the study assuming all inclusion and exclusion criteria are met Participants will not require hospitalization at baseline
The trial is designed in two stages
Stage I participants will be randomized 111 ratio to one of the one of the following three study cohorts
MAD0004J08 400 mg single dose
MAD0004J08 100 mg single dose
Placebo single dose The collected data will be analysed following a pre-planned interim analysis plan Based on the results of this analysis the Data Monitoring Committee DMC will recommend whether the study should advance to Stage-2 and if so will recommend selection of one of the two MAD0004J08 treatments for Stage-2 Alternatively the DMC will recommend stopping the study Final decisions will be made by an unblinded sub-group of the Steering Committee SC including senior Sponsor representatives based on summary results
Stage-2 participants will be randomized 11 ratio to one of two treatments
MAD0004J08 dose level selected in Stage-1 single dose
Placebo single dose Twelve 12 study visits and 2 telephone calls are scheduled for each participant over approximately 168 days Additional ad-hoc visits may be necessary to confirm eradication of SARS-CoV-2 from the upper respiratory tract URT following the 1st negative swab
At Visit 1 baseline all participants will undergo testing for serum IgA and IgG vs the spike S protein and IgG vs nucleocapsid N protein participants testing negative to all three antibodies at baseline are referred to as seronegative participants testing positive to any of the three antibodies at baseline are referred to as seropositive Due to the need to minimize time between diagnosis and intervention screening procedures baseline procedures randomization and administration of study treatment will occur on day 1
Visits from Day 3 to Day 21 Visits 2 to 9 will be conducted by study staff at the participants home unless the participant is hospitalized Visits from Day 28 to Day 168 Visits 10 to 12 will be conducted at the study center Participants requiring hospitalization during the study period are to be hospitalized at the study center where Visit 1 was conducted
At each scheduled visit nasopharyngeal swabs will be carried out Additional swabs may be taken ad hoc to confirm eradication after the 1st negative swab
Safety and efficacy endpoints will be analyzed as appropriate in two target populations all randomized participants ALL and seronegative randomized participants SEROneg and three time-windows baseline Visit 1 to end of Stage-1 or dropout interim analysis baseline Visit 1 to end of Stage-2 or dropout primary analysis and baseline Visit 1 to end of study Visit 12 or dropout final analysis
The trial is designed in two stages
Stage I participants will be randomized 111 ratio to one of the one of the following three study cohorts
MAD0004J08 400 mg single dose
MAD0004J08 100 mg single dose
Placebo single dose The collected data will be analysed following a pre-planned interim analysis plan Based on the results of this analysis the Data Monitoring Committee DMC will recommend whether the study should advance to Stage-2 and if so will recommend selection of one of the two MAD0004J08 treatments for Stage-2 Alternatively the DMC will recommend stopping the study Final decisions will be made by an unblinded sub-group of the Steering Committee SC including senior Sponsor representatives based on summary results
Stage-2 participants will be randomized 11 ratio to one of two treatments
MAD0004J08 dose level selected in Stage-1 single dose
Placebo single dose Twelve 12 study visits and 2 telephone calls are scheduled for each participant over approximately 168 days Additional ad-hoc visits may be necessary to confirm eradication of SARS-CoV-2 from the upper respiratory tract URT following the 1st negative swab
At Visit 1 baseline all participants will undergo testing for serum IgA and IgG vs the spike S protein and IgG vs nucleocapsid N protein participants testing negative to all three antibodies at baseline are referred to as seronegative participants testing positive to any of the three antibodies at baseline are referred to as seropositive Due to the need to minimize time between diagnosis and intervention screening procedures baseline procedures randomization and administration of study treatment will occur on day 1
Visits from Day 3 to Day 21 Visits 2 to 9 will be conducted by study staff at the participants home unless the participant is hospitalized Visits from Day 28 to Day 168 Visits 10 to 12 will be conducted at the study center Participants requiring hospitalization during the study period are to be hospitalized at the study center where Visit 1 was conducted
At each scheduled visit nasopharyngeal swabs will be carried out Additional swabs may be taken ad hoc to confirm eradication after the 1st negative swab
Safety and efficacy endpoints will be analyzed as appropriate in two target populations all randomized participants ALL and seronegative randomized participants SEROneg and three time-windows baseline Visit 1 to end of Stage-1 or dropout interim analysis baseline Visit 1 to end of Stage-2 or dropout primary analysis and baseline Visit 1 to end of study Visit 12 or dropout final analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None