Covid19Phase 2/3NCT04952805
Study to Select the Dose and Evaluate Safety and Efficacy of Monoclonal Antibody in Adult With Recently Diagnosed Asymptomatic to Moderately Severe COVID-19.
A Phase 2/3 study testing MAD0004J08 in people with Covid19, run by Toscana Life Sciences Sviluppo s.r.l. at 14 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- MAD0004J08
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 14 sitesItaly
- Study dates
- 6 Jun 2021to 31 Aug 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Italy14 sites
Az. Ospedaliera San Giuseppe Moscati
Avellino, 83100
Azienda Ospedaliero-Universitaria Careggi di Firenze
Florence, 50134
A.O. Ospedali Riuniti di Foggia - Università degli Studi di Fog
Foggia
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan, 20122
Az. Ospedaliera dei Colli - P.O. "D. Cotugno"
Naples, 80131
Azienda Ospedaliero-Universitaria di Parma
Parma, 43126
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, 27100
Azienda USL Ospedale "Guglielmo da Saliceto"
Piacenza, 29121
A.O.U. Pisana - Ospedale di Cisanello
Pisa, 56124
IRCCS INMI Lazzaro Spallanzani - Istituto nazionale Malattie Infettive
Roma, RM, 00149
Policlinico Santa Maria alle Scotte - Università di Siena
Siena, 53100
Ospedale di Cattinara
Trieste, 34149
ASL di Vercelli - Ospedale Sant'Andrea
Vercelli, 13100
A.O.U. Integrata di Verona
Verona, 37134
About this study
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
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:
Read more
Stage-1 (Phase II)
- Select one dose level for progression to Stage-2 Stage-1 + Stage-2 (Phase III)
- Provide confirmatory evidence of safety and efficacy for regulatory approval.
Read the 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 (1:1:1 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 (1:1 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 visit(s) 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 participant's 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).
- Conditions
- Covid19
- Being tested
- MAD0004J08, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAD0004J08Drug
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.
PlaceboOther
Placebo matching to MAD0004J08, 2.5 mL 2R vial. The pharmaceutical form is solution for intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm _400 mg | Experimental | To all the patients enrolled is admistrated with single dose of MAD0004J08 400 mg. Receives: Drug: MAD0004J08 |
| Interventional Arm _100 mg | Experimental | To all the patients enrolled is admistrated with single dose of MAD0004J08 100 mg. Receives: Drug: MAD0004J08 |
| Placebo Arm | Placebo comparator | To all the patients enrolled is admistrated with single dose of placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe (Grade 3) unsolicited AEs and/or serious unsolicited AEs (SAEs).
Proportion of participants with severe (Grade 3) unsolicited AEs and/or serious unsolicited AEs (SAEs).
Measured: From admission to discharge - Assessed as day 0
Time to SARS-CoV-2 clearance in the URT.
Evaluation of the time required for the elimination of SARS-CoV-2 in the URT.
Measured: From baseline (visit 1) up to day 168 ± 7 (visit 12)
Secondary outcomes (17)
Unsolicited AEs, including clinically relevant laboratory and ECG abnormalities.
Proportion of participants with unsolicited AEs, including clinically relevant laboratory and ECG abnormalities.
Measured: From baseline (visit 1) up to day 168 ± 7 (visit 12)
Solicited local AEs at the injection site
Proportion of participants with solicited local AEs at the injection site. Will be considered: pain, swelling and redness at the injection site.
Measured: From baseline (visit 1) up to day 28 (Visit 10)
Number of participants who develop ADA.
Proportion of participants who develop ADA. The first 60 randomized participants will be tested for ADA.
Measured: At baseline (visit 1), at day 7 (visit 4), at day 28 (visit 10), at day 56 ± 7 (visit 11) and at day 168 ± 7 (visit 12)
SARS-CoV-2 clearance in the URT
Proportion of participants with SARS-CoV-2 clearance in the Upper Respiratory Tract (URT) at each visit.
Measured: At baseline (visit 1), at day 7 (visit 4), at day 28 (visit 10), at day 56 ± 7 (visit 11) and at day 168 ± 7 (visit 12)
SARS-CoV-2 viral load in nasopharyngeal swab
SARS-CoV-2 viral load (number of copies) in nasopharyngeal swab, as measured by RT-PCR at each visit.
Measured: From baseline (visit 1) up to day 168 ± 7 (visit 12)
SPO2% and lowest SpO2 % post baseline.
SPO2 % value at each visit and lower SpO2 % after baseline.
Measured: From baseline (visit 1) up to day 168 ± 7 (visit 12)
SpO2 % < 94%.
Proportion of participants with SpO2 % < 94%.
Measured: From baseline (visit 1) up to day 168 ± 7 (visit 12)
Participants with increased dose home oxygen therapy
Proportion of participants with newly established or increased dose home oxygen therapy increased home oxygen therapy (only applies to patients with underlying conditions other than COVID-19 requiring such therapy, e.g., COPD).
Measured: From baseline (visit 1) up to day 168 ± 7 (visit 12)
Area under the curve (AUC) of COVID-19 total symptom score (range: 0-24).
Assessment of COVID-19 total symptom score
Measured: From baseline (visit 1) up to day 168 ± 7 (visit 12)
Participants requiring hospitalization
Proportion of participants requiring hospitalization.
Measured: From event start (day 0) through event completion
Cumulative time of hospital stay in days.
Number of days the participant was hospitalised
Measured: From event start (day 0) through event completion
Hospitalized participants requiring supplemental oxygen therapy.
Proportion of hospitalized participants requiring supplemental oxygen therapy.
Measured: From event start (day 0) through event completion
Cumulative time of hospitalized oxygen therapy in days.
Number of days the hospitalized participant required oxygen therapy
Measured: From event start (day 0) through event completion
Participants admitted to intensive care unit (ICU).
Proportion of participants admitted to intensive care unit (ICU).
Measured: From event start (day 0) through event completion
Cumulative time of ICU stay in days.
Number of days the hospitalized participant stay in therapy intensive care unit
Measured: From event start (day 0) through event completion
All-cause mortality.
Analysis of all All-cause mortality.
Measured: From baseline (visit 1) to through study completion
MAD0004J08 serum concentration.
Evaluation of MAD0004J08 serum concetration
Measured: From baseline (visit 1) up to day 168 ± 7 (visit 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start6 Jun 2021
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toscana Life Sciences Sviluppo s.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Simone Lanini, Principal investigator, IRCCS INMI Lazzaro Spallanzani - Istituto nazionale Malattie Infettive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952805
- Sponsor's protocol ID
- A0001B
- Status last verified
- Feb 2022
- First submitted
- 1 Jul 2021
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04952805
- Acronym / sponsor ID
- A0001B
- Conditions
- Covid19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Toscana Life Sciences Sviluppo s.r.l.Industry (pharma, biotech, devices)
- Study start
- 6 Jun 2021 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
- Select one dose level for progression to Stage-2 Stage-1 + Stage-2 (Phase III)
- 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 (1:1:1 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 (1:1 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 visit(s) 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 participant's 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm _400 mg | Experimental | Drug: MAD0004J08To all the patients enrolled is admistrated with single dose of MAD0004J08 400 mg. |
| Interventional Arm _100 mg | Experimental | Drug: MAD0004J08To all the patients enrolled is admistrated with single dose of MAD0004J08 100 mg. |
| Placebo Arm | Placebo comparator | Other: PlaceboTo all the patients enrolled is admistrated with single dose of placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAD0004J08MAD0004J08 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. | Drug | Interventional Arm _100 mg, Interventional Arm _400 mg |
| PlaceboPlacebo matching to MAD0004J08, 2.5 mL 2R vial. The pharmaceutical form is solution for intramuscular injection. | Other | Placebo Arm |
Primary outcome
Severe (Grade 3) unsolicited AEs and/or serious unsolicited AEs (SAEs).
Time frame: From admission to discharge - Assessed as day 0
Proportion of participants with severe (Grade 3) unsolicited AEs and/or serious unsolicited AEs (SAEs).
Time to SARS-CoV-2 clearance in the URT.
Time frame: From baseline (visit 1) up to day 168 ± 7 (visit 12)
Evaluation of the time required for the elimination of SARS-CoV-2 in the URT.
17 secondary outcomes
Unsolicited AEs, including clinically relevant laboratory and ECG abnormalities.
Time frame: From baseline (visit 1) up to day 168 ± 7 (visit 12)
Solicited local AEs at the injection site
Time frame: From baseline (visit 1) up to day 28 (Visit 10)
Number of participants who develop ADA.
Time frame: At baseline (visit 1), at day 7 (visit 4), at day 28 (visit 10), at day 56 ± 7 (visit 11) and at day 168 ± 7 (visit 12)
SARS-CoV-2 clearance in the URT
Time frame: At baseline (visit 1), at day 7 (visit 4), at day 28 (visit 10), at day 56 ± 7 (visit 11) and at day 168 ± 7 (visit 12)
SARS-CoV-2 viral load in nasopharyngeal swab
Time frame: From baseline (visit 1) up to day 168 ± 7 (visit 12)
SPO2% and lowest SpO2 % post baseline.
Time frame: From baseline (visit 1) up to day 168 ± 7 (visit 12)
SpO2 % < 94%.
Time frame: From baseline (visit 1) up to day 168 ± 7 (visit 12)
Participants with increased dose home oxygen therapy
Time frame: From baseline (visit 1) up to day 168 ± 7 (visit 12)
Area under the curve (AUC) of COVID-19 total symptom score (range: 0-24).
Time frame: From baseline (visit 1) up to day 168 ± 7 (visit 12)
Participants requiring hospitalization
Time frame: From event start (day 0) through event completion
Cumulative time of hospital stay in days.
Time frame: From event start (day 0) through event completion
Hospitalized participants requiring supplemental oxygen therapy.
Time frame: From event start (day 0) through event completion
Cumulative time of hospitalized oxygen therapy in days.
Time frame: From event start (day 0) through event completion
Participants admitted to intensive care unit (ICU).
Time frame: From event start (day 0) through event completion
Cumulative time of ICU stay in days.
Time frame: From event start (day 0) through event completion
All-cause mortality.
Time frame: From baseline (visit 1) to through study completion
MAD0004J08 serum concentration.
Time frame: From baseline (visit 1) up to day 168 ± 7 (visit 12)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone Lanini principal investigator
IRCCS INMI Lazzaro Spallanzani - Istituto nazionale Malattie Infettive
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MAD0004J08 in people with Covid19, run by Toscana Life Sciences Sviluppo s.r.l. at 14 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe (Grade 3) unsolicited AEs and/or serious unsolicited AEs (SAEs). (time frame: From admission to discharge - Assessed as day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04952805, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.