Study on COVID-19 Prevention Using Sipavibart and Cilgavimab for Patients with Weakened Immune Systems

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What is this study about?

This clinical trial is focused on studying the prevention of COVID-19, a disease caused by the SARS-CoV-2 virus, in people with weakened immune systems. The study will test a new treatment called Sipavibart (also known by its code name AZD3152), which is a type of protein designed to help the body fight off the virus. Another treatment being studied is EVUSHELD, which contains a protein called cilgavimab. Both treatments are given as injections. The study will also use a substance called sodium chloride as a comparison.

The purpose of the study is to evaluate the safety and effectiveness of these treatments in preventing symptoms of COVID-19. Participants will receive either Sipavibart, EVUSHELD, or a placebo. The study will monitor participants over a period of time to see if they develop symptoms of COVID-19 and to assess any side effects from the treatments. The study will also look at how well the treatments work against different variants of the virus.

Participants in the study will be monitored for any side effects and the occurrence of COVID-19 symptoms. The study will also measure the levels of the treatments in the body over time. This research aims to provide valuable information on how these treatments can help protect people with immune system challenges from COVID-19.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, a rapid antigen test will be conducted to ensure you are negative for COVID-19. This is a necessary step before receiving any study medication.

You will be asked to provide written informed consent, confirming your understanding of the study and your willingness to participate. If you are between 12 and 18 years old, your parent or legal guardian will also need to provide consent, and you will sign an assent form.

2 medication administration

You will receive an injection of the study medication. The medication options include AZD3152, EVUSHELD, or a placebo. The injection is given intramuscularly, which means it is administered into a muscle.

The dosage for EVUSHELD is 150 mg of each component, cilgavimab, and tixagevimab, in a solution for injection. The frequency and duration of administration will be determined by the study protocol.

3 monitoring and follow-up

After receiving the medication, you will be monitored for any side effects or adverse events. This monitoring will continue for approximately 90 days after each administration of the study medication.

You will have follow-up visits to assess your health and the effectiveness of the medication in preventing symptomatic COVID-19. These visits will include evaluations of any symptoms you may experience and additional tests as required by the study.

4 completion of study participation

Your participation in the study will continue until the study’s estimated end date, which is February 7, 2025, unless you choose to withdraw earlier.

At the end of your participation, you will have a final visit to review your health status and any outcomes related to the study.

Who Can Join the Study?

Sentinel Safety Cohort: Must be healthy based on medical history, physical exam, and lab tests, with no other diseases or medications unless allowed by the study.
Main Cohort: Must weigh at least 40 kg (about 88 pounds) at screening.
Main Cohort: Must have at least one of the following risk factors:
- Have solid tumor cancer and be on active treatment that weakens the immune system.
- Have blood cancer.
- Have had a solid organ transplant or stem cell transplant within the last 2 years, or have chronic graft-versus-host disease.
- Be taking medicines that weaken the immune system, such as certain steroids or cancer treatments.
- Have received CAR T cell therapy, a type of treatment that uses modified immune cells.
- Have received B-cell depleting therapies within the last year, which are treatments that reduce certain immune cells.
- Have a moderate or severe immune deficiency, either from birth or due to another condition like dialysis.
- Have advanced or untreated HIV infection with low CD4 cell counts or symptoms.
Main Cohort: Must be medically stable, meaning no major changes in treatment or hospital visits for worsening conditions in the last month, and no expected changes at the time of joining the study.
Main Cohort: Must be able to understand and follow all study requirements, with help if needed, as assessed by the study doctor.
Sentinel Safety Cohort: Must be between 18 and 55 years old at the time of signing the consent form.
Sentinel Safety Cohort: Must provide written consent and any required local authorization before any study procedures.
Sentinel Safety Cohort: Must have a negative rapid antigen test at the first visit.
Sentinel Safety Cohort: Must weigh between 45 kg (about 99 pounds) and 110 kg (about 243 pounds) at screening.
Sentinel Safety Cohort: Must be able to understand and follow all study requirements, with help if needed, as assessed by the study doctor.
Main Cohort: Must be 12 years or older at the time of signing the consent form.
Main Cohort: Must provide written consent and any required local authorization before any study procedures. For those aged 12 to under 18, a parent or guardian must also give consent, and the participant will sign an assent form.
Main Cohort: Must have a negative rapid antigen test before receiving the study treatment at the first visit.

Who Cannot Join the Study?

Patients who are currently infected with COVID-19 cannot participate.
Patients who have had a severe allergic reaction to similar medications in the past are not eligible.
Patients with a history of severe heart problems are excluded.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who are participating in another clinical trial at the same time are not allowed.
Patients with a weakened immune system, which means their body has trouble fighting infections, are excluded.
Patients who have received a COVID-19 vaccine within the last 30 days are not eligible.
Patients with any other medical condition that the study doctors think would make it unsafe for them to participate are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Hochschule Hannover	Hanover	Germany
Hopital Cardiologique	Lille	France
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Hospital Clinico San Carlos	Madrid	Spain
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nimes	Nimes	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre hospitalier universitaire de Liege	Liege	Belgium
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Ko-Med Centra Kliniczne Sp. z o.o.	Lublin	Poland
Hospital Universitario Infanta Leonor	Madrid	Spain
Hospital Quironsalud Marbella	Marbella	Spain
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH	Hamburg	Germany
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Hospital De Merida	Merida	Spain
Odense University Hospital	Odense	Denmark
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Aalborg University Hospital	Aalborg	Denmark
Pratia S.A.	Skorzewo	Poland
Centre Hospitalier Universitaire De Nantes	Nantes	France
Anima	Alken	Belgium
Hopital Beaujon	Clichy	France
Rheumazentrum Ratingen	Ratingen	Germany
Region Sjaelland	Holbæk	Denmark
Uwbvbghnzcbgdqkzpylib Efmhz Ayz	Essen	Germany
Hryoqelu Hyxunqne	Hvidovre	Denmark
Caivcnnc Hzeuuqnwigoy Uojxiojdzvxjy Dc Vvym	Vigo	Spain
Uwatxenyiz Hzpxcwyp Chvekik	Cologne	Germany
Cpozye Hkuxnrjqnor Ukdazgbqxjrhz De Dikkd	Dijon	France
Acoybjtzou Pfomftyq Hkatpgyl Dr Psmsf	Paris	France
Apuuyp Uoqtssyase Hnuggjmk	Aarhus	Denmark
Ciuaiw Hqfmoyiiymb Ryxppxqg Uiburhpzcpxso Dx Tfjyc	Tours	France
Hicycrgj Dh Lj Slvqm Cfqb I Soqk Pny	Barcelona	Spain
Htvuzenf Uwuyckjmpbvjp Hphdcsfk Tixjq y Plraou Iridmpug Cgbmpq dsbsnnwoqzykvnlbi (tphz	Badalona	Spain
Iqlifbvp dt Cyfslweyiooc Hegmbovatjk Uipbanzkhchlj di Squit Esibghf (wpmvped	Saint Priest En Jarez	France
Hqbmnalb Vwmg dpnaakga	Barcelona	Spain
Hdhafmrz Uzuthdvarslzzo Seyfvouhgw &jrhwmg Hbxqvob do Hqfyaccpugf	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	19.12.2022
Denmark	Not recruiting	19.12.2022
France	Not recruiting	19.12.2022
Germany	Not recruiting	19.12.2022
Poland	Not recruiting	19.12.2022
Spain	Not recruiting	19.12.2022

Trial locations

Investigated drugs:

AZD3152 is a medication being studied to see if it can help prevent COVID-19 in people who have weakened immune systems. This medication is being tested to understand how well it can stop the virus from causing symptoms, especially in people who might not respond well to vaccines.

EVUSHELD is a combination of two antibodies that are designed to help prevent COVID-19 infection. It works by giving your body extra help to fight off the virus, especially if your immune system is not strong enough to do it on its own. This medication is being compared to others to see how effective it is in preventing COVID-19 symptoms.

AZD5156 is another medication being tested in this study. It is being evaluated for its safety and how well it can prevent COVID-19 in people with immune system challenges. The goal is to see if it can be a safe option for protecting against the virus in those who are more vulnerable.

COVID-19 – COVID-19 is an infectious disease caused by the coronavirus SARS-CoV-2. It primarily affects the respiratory system, leading to symptoms such as fever, cough, and difficulty breathing. The disease can progress to more severe respiratory issues, including pneumonia and acute respiratory distress syndrome. COVID-19 spreads through respiratory droplets when an infected person coughs, sneezes, or talks. The virus can also spread by touching surfaces contaminated with the virus and then touching the face. The progression and severity of the disease can vary widely among individuals.

Trial ID:

2024-512554-15-00

Protocol code:

D7000C00001

NCT ID:

NCT05648110

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on COVID-19 Prevention Using Sipavibart and Cilgavimab for Patients with Weakened Immune Systems

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?