COVID-19Phase 3MANTICONCT05205759

Non-inferiority Trial on Monoclonal Antibodies in COVID-19

A Phase 3 study testing Bamlanivimab Etesevimab, Sotrovimab and Casirivimab-Imdevimab in people with COVID-19, run by Azienda Ospedaliera Universitaria Integrata Verona at 20 sites in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 50 years and older
Conditions the study is for: COVID-19
What is being tested?: Bamlanivimab Etesevimab, Sotrovimab and Casirivimab-Imdevimab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 319 participants
Where: 20 sitesItaly
Study dates: 9 Dec 2021to 5 Apr 2022
Phase: Phase 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 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 50 years
Informed consent by the subject or legally authorized representative
Laboratory-confirmed SARS-CoV-2 infection, as determined by antigen or nucleic acid identification in any specimen, within 4 days of eligibility assessment
Peripheral oxygen saturation ≥ 94% on room air and not requiring supplemental oxygen
Onset of symptoms within 4 days of eligibility assessment. Onset time of symptoms is defined as the time when the patient experienced the presence of at least one of the following SARS-CoV-2 infection-associated symptoms for the first time [4]: cough, nasal congestion, sore throat, feeling hot or feverish, myalgia, fatigue, headache, anosmia/ageusia, nausea, vomiting, and/or diarrhoea

Who cannot join

Previously or currently hospitalized or requiring hospitalization
Respiratory distress with respiratory rate ≥ 25 breaths/min
Heart rate ≥ 125 beats per minute
Peripheral oxygen saturation ≤ 93% on room air at sea level
Known allergies to any of the components used in the formulation of the trial drugs
Hemodynamic instability requiring use of pressors within 24 hours of randomization

Show all 16Show fewer

Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that could potentially lead to hospitalization within 30 days
Any co-morbidity requiring surgery within 7 days or that is considered life-threatening within 90 days
History of positive SARS-CoV-2 test prior to 4 days of the eligibility assessment
Previous treatment with a SARS-CoV-2 specific monoclonal antibody
History of convalescent COVID-19 plasma treatment
Participation in a clinical study involving an investigational intervention within the last 30 days
Pregnancy or breast feeding
Investigator site personnel directly affiliated with this study
Sexually active women of childbearing potential or sexually active men who are unwilling to practice effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose
Inability to participate to the study follow-up

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

Italy20 sites

IRCCS Policlinico di S. Orsola
Bologna
PO SS Trinità di Cagliari
Cagliari
Azienda Ospedaliera Cannizzaro
Catania
Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele
Catania
PO Garibaldi Nesima
Catania
Azienda Socio-Sanitaria Territoriale di Cremona
Cremona
Ospedale S. Maria Annunziata
Florence
Covid Hospital Jesolo
Jesolo
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan
Azienda Ospedaliera dei Colli, presidio ospedaliero Cotugno
Naples
Azienda Ospedaliera di Padova
Padova
AOU Policlinico
Palermo
Azienda Ospedaliera S. Maria della Misericordia
Perugia
Università degli Studi di Pescara
Pescara
Fondazione Policlinico Universitario A. Gemelli
Roma
Ospedale San Paolo ASL 2 Savonese
Savona
AOU Città della Salute e Scienza, Presidio Molinette
Torino
Azienda Sanitaria Universitaria Giuliano-Isontina (ASUGI)
Trieste
Azienda Sanitaria Universitaria Friuli Centrale
Udine
Azienda Ospedaliera di Verona
Verona, 37134

Other trials in Italy

About this study

Official title: Adaptive, Randomized, Non-inferiority Trial to Evaluate the Efficacy of Monoclonal Antibodies in Outpatients With Mild or Moderate COVID-19

Currently, 3 anti-SARS-CoV-2 monoclonal antibody products have received Emergency Use Authorizations from the Italian Medicines Agency (AIFA) for the treatment of mild to moderate COVID-19 in non hospitalized patients with laboratory-confirmed SARS-CoV-2 infection who are at high risk for progressing to severe disease and/or hospitalization (bamlanivimab plus etesevimab, sotrovimab, and casirivimab plus imdevimab). Differently from casirivimab/imdevimab and sotrovimab, the European Medicines Agency (EMA) has never recommended authorising the combination bamlanivimab/etesevimab for treating COVID-19. Moreover, the evidence on sotrovimab relies on the interim analysis results of an ongoing randomised placebo-controlled clinical trial [1], unlike the combinations bamlanivimab/etesevimab and casirivimab/imdevimab, whose results of the randomised placebo-controlled trials were published after having completed the enrolment [2,3]. The study aims at assessing the non-inferiority of bamlanivimab plus etesevimab and sotrovimab vs. casirivimab plus imdevimab on COVID-19 progression in patients aged at least 50 years at an early stage of the disease. The progression of COVID-19 disease (hospitalization, need for supplementary oxygen therapy at home, death) within 14 days of randomisation is the composite outcome variable on which the calculation of the sample size is based. Based on available data regarding the reduction in the number of hospitalisations and medical visits with the use of casirivimab plus imdevimab at an early-stage of COVID-19, a disease progression of 5% has been estimated in the reference arm. 5% delta margin was considered clinically relevant, taking into account both the estimates of disease progression in the study population in absence of early treatment with monoclonal antibodies (20%, based on national data) and the efficacy of the reference standard. Therefore, 1260 participants will be randomly assigned in an equal ratio between the reference standard and each of the other two experimental arms (1:1:1). Randomization will be computer-generated in permuted blocks with a stratification based on site.

Read the detailed description

Sample size. The parameters for the sample size estimation were derived from the only double-blind, randomised, placebo-controlled trial assessing the clinical efficacy of casirivimab/imdevimab (reference standard) [3]. Hospitalisation related to COVID-19 or all-cause mortality in this study occurred in 7 of 736 patients in the casirivimab/imdevimab 1200-mg group (1.0%) and in 24 of 748 patients in the placebo group who underwent randomisation concurrently (3.2%) (relative risk reduction, 70.4%; P=0.002). Assuming a non-inferiority margin of 5%, 420 patients per group were needed to achieve 90% power with a 1-sided α level of .025, allowing for 5% dropout. A 5% non-inferiority margin was chosen as the maximal difference between treatments in COVID-19 progression that would be clinically acceptable by consultation with Infectious Diseases and clinical trial specialists involved in the protocol development.

Conditions: COVID-19
Being tested: Bamlanivimab Etesevimab, Sotrovimab, Casirivimab-Imdevimab
Keywords: Coronavirus Infections, Monoclonal antibodies, Bamlanivimab Etesevimab, Casirivimab Imdevimab, Sotrovimab
Medical subject headings: COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bamlanivimab EtesevimabDrug
Single intravenous infusion of bamlanivimab 700 mg and etesevimab 1400 mg, administered together [1 bamlanivimab vial (700 mg/20 mL) and 2 etesevimab vials (700 mg/20 mL)] in a 250-mL prefilled 0.9% Sodium Chloride infusion bag over one hour.
SotrovimabDrug
Single intravenous infusion of sotrovimab 500 mg (500 mg/8 mL), administered in 100 mL prefilled 0.9% sodium chloride injection infusion solution over 1/2 hour.
Casirivimab-ImdevimabDrug
Single intravenous infusion of casirivimab 600 mg + imdevimab 600 mg, administered together in 250 mL prefilled 0.9% sodium chloride injection infusion solution over one hour. Casirivimab and imdevimab are each supplied in individual single use vials. Casirivimab is available as 300 mg/2.5 mL (120 mg/mL) or 1332 mg/11.1 mL (120 mg/mL). Imdevimab is available as 300 mg/2.5 mL (120 mg/mL) or 1332 mg/11.1 mL (120 mg/mL).

Study groups in NCT05205759
Study group	Role	What they receive
Bamlanivimab Etesevimab	Experimental	Bamlanivimab 700 mg + Etesevimab 1400 mg administered in 250 mL prefilled 0.9% sodium chloride injection infusion solution over one hour Receives: Drug: Bamlanivimab Etesevimab
Sotrovimab	Experimental	Sotrovimab 500 mg administered in 100 mL prefilled 0.9% sodium chloride injection infusion solution over 1/2 hour Receives: Drug: Sotrovimab
Casirivimab Imdevimab	Active comparator	Casirivimab 600 mg + Imdevimab 600 mg administered in 250 mL prefilled 0.9% sodium chloride injection infusion solution over one hour Receives: Drug: Casirivimab-Imdevimab

What is being measured

The primary outcome is the main question the study is designed to answer.

COVID-19 progression
(1) hospitalization or (2) need of supplemental oxygen therapy at home or (3) death within 14 days of randomisation
Measured: 14 days

Secondary outcomes (9)

Visits to the Emergency Room
Number of visits to the Emergency Room without subsequent hospitalization within 28 days of randomization
Measured: 28 days
Duration of supplemental oxygen therapy
Days of supplemental oxygen therapy within 90 days of randomization
Measured: 90 days
Duration of hospitalization
Days of any hospitalization within 90 days of randomization
Measured: 90 days
Non-invasive ventilation
Rate of patients undergoing non-invasive ventilation within 28 days of randomization
Measured: 28 days
Duration of non-invasive ventilation
Days of non-invasive ventilation within 90 days of randomization
Measured: 90 days
Mechanical ventilation
Rate of patients undergoing mechanical ventilation within 28 of randomization
Measured: 28 days
Duration of mechanical ventilation
Days of mechanical ventilation within 90 days of randomization
Measured: 90 days
28-day mortality
Death rate at 28 days of randomization
Measured: 28 days
Duration of symptoms
Days of symptoms within 90 days of randomization
Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Dec 20215 Apr 2022

First posted25 Jan 2022
Study start9 Dec 2021
Primary completion5 Feb 2022
Study completion5 Apr 2022

Why it stopped: Stop for futility after the onset of the omicron wave

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 319 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05205759
Sponsor's protocol ID: MANTICO
Other IDs: 2021-002612-31
Acronym: MANTICO
Status last verified: Jul 2022
First submitted: 15 Jan 2022
Last updated: 26 Jul 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Gupta A, Gonzalez-Rojas Y, Juarez E, Crespo Casal M, Moya J, Falci DR, Sarkis E, Solis J, Zheng H, Scott N, Cathcart AL, Hebner CM, Sager J, Mogalian E, Tipple C, Peppercorn A, Alexander E, Pang PS, Free A, Brinson C, Aldinger M, Shapiro AE; COMET-ICE Investigators. Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab. N Engl J Med. 2021 Nov 18;385(21):1941-1950. doi: 10.1056/NEJMoa2107934. Epub 2021 Oct 27.
PubMed 34706189
Dougan M, Nirula A, Azizad M, Mocherla B, Gottlieb RL, Chen P, Hebert C, Perry R, Boscia J, Heller B, Morris J, Crystal C, Igbinadolor A, Huhn G, Cardona J, Shawa I, Kumar P, Adams AC, Van Naarden J, Custer KL, Durante M, Oakley G, Schade AE, Holzer TR, Ebert PJ, Higgs RE, Kallewaard NL, Sabo J, Patel DR, Dabora MC, Klekotka P, Shen L, Skovronsky DM; BLAZE-1 Investigators. Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19. N Engl J Med. 2021 Oct 7;385(15):1382-1392. doi: 10.1056/NEJMoa2102685. Epub 2021 Jul 14.
PubMed 34260849
Weinreich DM, Sivapalasingam S, Norton T, Ali S, Gao H, Bhore R, Xiao J, Hooper AT, Hamilton JD, Musser BJ, Rofail D, Hussein M, Im J, Atmodjo DY, Perry C, Pan C, Mahmood A, Hosain R, Davis JD, Turner KC, Baum A, Kyratsous CA, Kim Y, Cook A, Kampman W, Roque-Guerrero L, Acloque G, Aazami H, Cannon K, Simon-Campos JA, Bocchini JA, Kowal B, DiCioccio AT, Soo Y, Geba GP, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD; Trial Investigators. REGEN-COV Antibody Combination and Outcomes in Outpatients with Covid-19. N Engl J Med. 2021 Dec 2;385(23):e81. doi: 10.1056/NEJMoa2108163. Epub 2021 Sep 29.
PubMed 34587383
U.S. Department of Health and Human Services Food and Drug Administration. Assessing COVID19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-covid-19-related-symptoms-outpatient-adult-and-adolescent-subjects-clinical-trials-drugs. Accessed 30 March 2022.
Mazzaferri F, Mirandola M, Savoldi A, De Nardo P, Morra M, Tebon M, Armellini M, De Luca G, Calandrino L, Sasset L, D'Elia D, Sozio E, Danese E, Gibellini D, Monne I, Scroccaro G, Magrini N, Cattelan A, Tascini C; MANTICO Working Group; Tacconelli E. Exploratory data on the clinical efficacy of monoclonal antibodies against SARS-CoV-2 Omicron variant of concern. Elife. 2022 Nov 22;11:e79639. doi: 10.7554/eLife.79639.
PubMed 36413383

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adaptive, Randomized, Non-inferiority Trial to Evaluate the Efficacy of Monoclonal Antibodies in Outpatients With Mild or Moderate COVID-19
ClinicalTrials.gov ID: NCT05205759
Acronym / sponsor ID: MANTICO / MANTICO
Conditions: COVID-19
Keywords: Coronavirus Infections, Monoclonal antibodies, Bamlanivimab Etesevimab, Casirivimab Imdevimab, Sotrovimab
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Stop for futility after the onset of the omicron wave
Enrolment: 319 participants (actual)
Lead sponsor: Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
Collaborators: Agenzia Italiana del Farmaco, Azienda Sanitaria-Universitaria Integrata di Udine
Study start: 9 Dec 2021 (actual)
Primary completion: 5 Feb 2022 (actual)
Study completion: 5 Apr 2022 (actual)
First posted: 25 Jan 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Bamlanivimab Etesevimab	Experimental	Drug: Bamlanivimab EtesevimabBamlanivimab 700 mg + Etesevimab 1400 mg administered in 250 mL prefilled 0.9% sodium chloride injection infusion solution over one hour
Sotrovimab	Experimental	Drug: SotrovimabSotrovimab 500 mg administered in 100 mL prefilled 0.9% sodium chloride injection infusion solution over 1/2 hour
Casirivimab Imdevimab	Active comparator	Drug: Casirivimab-ImdevimabCasirivimab 600 mg + Imdevimab 600 mg administered in 250 mL prefilled 0.9% sodium chloride injection infusion solution over one hour

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age ≥ 50 years
Informed consent by the subject or legally authorized representative
Laboratory-confirmed SARS-CoV-2 infection, as determined by antigen or nucleic acid identification in any specimen, within 4 days of eligibility assessment
Peripheral oxygen saturation ≥ 94% on room air and not requiring supplemental oxygen
Onset of symptoms within 4 days of eligibility assessment. Onset time of symptoms is defined as the time when the patient experienced the presence of at least one of the following SARS-CoV-2 infection-associated symptoms for the first time [4]: cough, nasal congestion, sore throat, feeling hot or feverish, myalgia, fatigue, headache, anosmia/ageusia, nausea, vomiting, and/or diarrhoea

Key exclusion criteria (16 listed)

Previously or currently hospitalized or requiring hospitalization
Respiratory distress with respiratory rate ≥ 25 breaths/min
Heart rate ≥ 125 beats per minute
Peripheral oxygen saturation ≤ 93% on room air at sea level
Known allergies to any of the components used in the formulation of the trial drugs

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
Bamlanivimab EtesevimabSingle intravenous infusion of bamlanivimab 700 mg and etesevimab 1400 mg, administered together [1 bamlanivimab vial (700 mg/20 mL) and 2 etesevimab vials (700 mg/20 mL)] in a 250-mL prefilled 0.9% Sodium Chloride infusion bag over one hour.	Drug	Bamlanivimab Etesevimab
SotrovimabSingle intravenous infusion of sotrovimab 500 mg (500 mg/8 mL), administered in 100 mL prefilled 0.9% sodium chloride injection infusion solution over 1/2 hour.	Drug	Sotrovimab
Casirivimab-ImdevimabSingle intravenous infusion of casirivimab 600 mg + imdevimab 600 mg, administered together in 250 mL prefilled 0.9% sodium chloride injection infusion solution over one hour. Casirivimab and imdevimab are each supplied in individual single use vials. Casirivimab is available as 300 mg/2.5 mL (120 mg/mL) or 1332 mg/11.1 mL (120 mg/mL). Imdevimab is available as 300 mg/2.5 mL (120 mg/mL) or 1332 mg/11.1 mL (120 mg/mL).	Drug	Casirivimab Imdevimab

Primary outcome

COVID-19 progression
Time frame: 14 days
(1) hospitalization or (2) need of supplemental oxygen therapy at home or (3) death within 14 days of randomisation

9 secondary outcomes

Visits to the Emergency Room
Time frame: 28 days
Duration of supplemental oxygen therapy
Time frame: 90 days
Duration of hospitalization
Time frame: 90 days
Non-invasive ventilation
Time frame: 28 days
Duration of non-invasive ventilation
Time frame: 90 days
Mechanical ventilation
Time frame: 28 days
Duration of mechanical ventilation
Time frame: 90 days
28-day mortality
Time frame: 28 days
Duration of symptoms
Time frame: 90 days

Results and safety

The study was stopped early (reason given: Stop for futility after the onset of the omicron wave). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
Background: PubMed 34706189Gupta A, Gonzalez-Rojas Y, Juarez E, Crespo Casal M, Moya J, Falci DR, Sarkis E, Solis J, Zheng H, Scott N, Cathcart AL, Hebner CM, Sager J, Mogalian E, Tipple C, Peppercorn A, Alexander E, Pang PS, Free A, Brinson C, Aldinger M, Shapiro AE; COMET-ICE Investigators. Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab. N Engl J Med. 2021 Nov 18;385(21):1941-1950. doi: 10.1056/NEJMoa2107934. Epub 2021 Oct 27.
Background: PubMed 34260849Dougan M, Nirula A, Azizad M, Mocherla B, Gottlieb RL, Chen P, Hebert C, Perry R, Boscia J, Heller B, Morris J, Crystal C, Igbinadolor A, Huhn G, Cardona J, Shawa I, Kumar P, Adams AC, Van Naarden J, Custer KL, Durante M, Oakley G, Schade AE, Holzer TR, Ebert PJ, Higgs RE, Kallewaard NL, Sabo J, Patel DR, Dabora MC, Klekotka P, Shen L, Skovronsky DM; BLAZE-1 Investigators. Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19. N Engl J Med. 2021 Oct 7;385(15):1382-1392. doi: 10.1056/NEJMoa2102685. Epub 2021 Jul 14.
Background: PubMed 34587383Weinreich DM, Sivapalasingam S, Norton T, Ali S, Gao H, Bhore R, Xiao J, Hooper AT, Hamilton JD, Musser BJ, Rofail D, Hussein M, Im J, Atmodjo DY, Perry C, Pan C, Mahmood A, Hosain R, Davis JD, Turner KC, Baum A, Kyratsous CA, Kim Y, Cook A, Kampman W, Roque-Guerrero L, Acloque G, Aazami H, Cannon K, Simon-Campos JA, Bocchini JA, Kowal B, DiCioccio AT, Soo Y, Geba GP, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD; Trial Investigators. REGEN-COV Antibody Combination and Outcomes in Outpatients with Covid-19. N Engl J Med. 2021 Dec 2;385(23):e81. doi: 10.1056/NEJMoa2108163. Epub 2021 Sep 29.
BackgroundU.S. Department of Health and Human Services Food and Drug Administration. Assessing COVID19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-covid-19-related-symptoms-outpatient-adult-and-adolescent-subjects-clinical-trials-drugs. Accessed 30 March 2022.
Derived from this study: PubMed 36413383Mazzaferri F, Mirandola M, Savoldi A, De Nardo P, Morra M, Tebon M, Armellini M, De Luca G, Calandrino L, Sasset L, D'Elia D, Sozio E, Danese E, Gibellini D, Monne I, Scroccaro G, Magrini N, Cattelan A, Tascini C; MANTICO Working Group; Tacconelli E. Exploratory data on the clinical efficacy of monoclonal antibodies against SARS-CoV-2 Omicron variant of concern. Elife. 2022 Nov 22;11:e79639. doi: 10.7554/eLife.79639.

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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.

The record lists no contact. Use the official record to reach the sponsor.

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bamlanivimab Etesevimab, Sotrovimab and Casirivimab-Imdevimab in people with COVID-19, run by Azienda Ospedaliera Universitaria Integrata Verona at 20 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 16 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: stopped early, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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?

The study was stopped early (reason given: Stop for futility after the onset of the omicron wave). 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?

COVID-19 progression (time frame: 14 days). 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 NCT05205759, which also lists 5 linked publications.

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 26 Jul 2022.