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COVID-19 – Trials in Disease

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Ongoing Clinical Trials for COVID-19

There are currently 34 ongoing clinical trials focused on COVID-19 (also known as: SARS-CoV-2 infection, coronavirus disease 2019). These trials are testing various vaccines, antiviral medications, immune-modulating therapies, and preventive treatments across multiple countries in Europe. The trials include studies in adults, children, and immunocompromised patients, examining both acute COVID-19 treatment and long-term effects such as Long COVID.

Clinical trial locations

Study comparing intranasal COVID-19 vaccine (LVT-001) with mRNA vaccine (bretovameran) as booster doses in healthy adults

This trial in France is comparing an innovative intranasal COVID-19 vaccine (LVT-001) with the injectable mRNA vaccine Comirnaty JN.1 as booster doses. The intranasal vaccine is administered as a nasal spray rather than an injection.

Inclusion criteria: Participants must be healthy adults aged 18-55 years (Phase I) or 18-60 years (Phase II) with a body mass index between 18.5 and 30 kg/m². They must have received at least three doses of COVID-19 mRNA vaccine, with the last dose given at least 6 months before the study, or two doses plus a confirmed COVID-19 infection at least 6 months before joining. Participants must provide written informed consent and follow protective measures including hand washing and mask wearing for 28 days after vaccination.

Exclusion criteria: The trial excludes individuals with severe allergic reactions or anaphylaxis to vaccine components, pregnant or breastfeeding women, and those with active COVID-19 infection or positive test within 30 days. People with chronic medical conditions that are not well-controlled, immunodeficiency disorders, or use of immune-suppressing medications cannot participate. Those with nasal conditions that could interfere with intranasal administration, fever or acute illness within 7 days before vaccination, or history of neurological conditions are also excluded.

Focus: The study evaluates the safety of different doses of the intranasal vaccine and compares immune responses in both nasal passages and blood between the two vaccine types. The trial is divided into two phases, with the first testing three different strengths of the nasal vaccine. Participants will be monitored for side effects and provide nasal swabs and blood samples to measure immune response over one year.

Investigational drugs: LVT-001 is an intranasal vaccine containing SARS-CoV-2 N/S recombinant proteins, administered as a nasal spray to stimulate immune responses in nasal passages. Pfizer-BioNTech COVID-19 vaccine (Comirnaty JN.1) is an mRNA vaccine injected into the muscle, teaching the body’s cells to make harmless virus pieces to help the immune system fight COVID-19.

Study of Baricitinib in Children Aged 1 to 17 Hospitalized with COVID-19

This trial in Spain and Belgium is studying baricitinib, an oral suspension medication, in children aged 1 to 17 who are hospitalized with COVID-19 and require oxygen therapy.

Inclusion criteria: Participants must be hospitalized with confirmed coronavirus infection and need oxygen therapy. Children must be at least 2 years old. Both male and female participants are eligible, including those who might be considered vulnerable.

Exclusion criteria: The trial does not provide specific exclusion criteria in the available data.

Focus: The study evaluates how baricitinib behaves in the body of pediatric patients, including how it is absorbed, distributed, and eliminated. Participants receive baricitinib for up to 14 days while researchers monitor the medication’s safety and movement through the body, with particular focus on pharmacokinetics including area under the concentration curve and maximum concentration.

Investigational drugs: Baricitinib is being studied for its effects in reducing inflammation and managing immune response in hospitalized children with COVID-19.

Study of ibuzatrelvir tablets in non-hospitalized adults and adolescents with COVID-19 who are at high risk of developing severe illness

This trial across Denmark, Germany, Slovakia, Finland, Czechia, Bulgaria, Spain, and Belgium is testing ibuzatrelvir tablets in non-hospitalized patients with COVID-19 who cannot or choose not to take other available treatments.

Inclusion criteria: Participants must be at least 12 years old weighing at least 40 kg, or 18 years or older of any weight. They must have risk factors for severe COVID-19 based on age, a positive rapid antigen test within 24 hours before starting, and be unable or unwilling to take nirmatrelvir/ritonavir treatment.

Exclusion criteria: Patients hospitalized for COVID-19, requiring supplemental oxygen, or who have received COVID-19 antiviral treatments for their current infection are excluded. Those with severe liver problems, known allergies to ibuzatrelvir, pregnant or breastfeeding women, patients taking medications that may interact with ibuzatrelvir, and those participating in another clinical trial within the past 30 days cannot join.

Focus: The study monitors participants for 28 days to assess emergency care needs, oxygen support requirements, additional treatments, hospitalizations, and health issues. It tracks symptom improvement speed and checks for lasting COVID-19 effects up to 24 weeks after treatment begins.

Investigational drugs: Ibuzatrelvir is an oral antiviral medication designed to reduce severity and prevent COVID-19 progression in high-risk individuals not receiving other specific treatments.

Study of nirmatrelvir and ritonavir (Paxlovid) for prevention of long COVID-19 in patients with acute COVID-19 infection in Norway

This Norwegian trial examines whether early treatment with Paxlovid (nirmatrelvir and ritonavir combination) can prevent long-term COVID-19 complications in recently infected individuals.

Inclusion criteria: Participants must have COVID-19 symptoms that started within the last 5 days and are still present, with a positive PCR or lateral flow test taken between 2 days before symptoms started and the day of joining. They must be between 18 and 65 years old, able to give informed consent, and willing to take a pregnancy test if able to become pregnant.

Exclusion criteria: People below 18 or above 65 years, those with previous Paxlovid treatment in the last 6 months, known allergies to nirmatrelvir or ritonavir, severe liver or kidney problems, currently taking medications that interact with Paxlovid, pregnancy or breastfeeding, no positive COVID-19 test, symptoms lasting more than 5 days, current participation in another clinical trial, inability to provide informed consent, history of organ transplantation, active cancer treatment, HIV infection with uncontrolled viral load, or severe heart conditions are excluded.

Focus: Participants report symptoms daily for the first 7 days, then weekly for 28 days, with additional reporting at 3 and 6 months. The study monitors hospital visits, health issues, and tracks participants’ healthcare service use through health registries.

Investigational drugs: Paxlovid contains nirmatrelvir (which blocks a key coronavirus enzyme) and ritonavir (which helps keep nirmatrelvir active longer in the body), taken orally to treat early COVID-19 and potentially reduce long COVID risk.

Study of Remdesivir to Prevent Severe COVID-19 in Kidney Transplant Recipients with No or Mild Symptoms

This Spanish trial evaluates remdesivir in preventing severe COVID-19 in kidney transplant recipients who have tested positive for SARS-CoV-2 but have no symptoms or only mild symptoms.

Inclusion criteria: Participants must be at least 18 years old, have end-stage kidney disease with a scheduled transplant within 12-36 hours or a living donor transplant within 5 days, tested positive for SARS-CoV-2 within 5 days before transplant, received at least three COVID-19 vaccine doses with the last dose at least 3 months ago, and be either without symptoms or having only mild symptoms without fever above 38°C or shortness of breath in the past 48 hours.

Exclusion criteria: Patients with severe COVID-19 symptoms requiring hospitalization, previous kidney transplant rejection, known allergies to remdesivir, those under 18 years, pregnant or breastfeeding women, severe liver dysfunction, kidney function below 30 mL/min, current participation in other trials, inability to provide informed consent, positive test more than 5 days before transplant, significant heart conditions, active cancer or ongoing treatment, and known drug resistance to antivirals are excluded.

Focus: Patients receive remdesivir through intravenous infusion for 10 days with a maximum total of 1100 mg and daily maximum of 200 mg. They are monitored for 90 days after transplant for severe COVID-19 development, including breathing difficulties or chest abnormalities on imaging tests.

Investigational drugs: Remdesivir is an antiviral medication given intravenously that stops the virus from spreading by interfering with its ability to replicate genetic material.

Study on Anti-COVID-19 Hyperimmune Globulin for Treating Adults with Early COVID-19 Symptoms

This trial in Denmark, Spain, and Greece tests Anti-COVID-19 Hyperimmune Globulin (COVID-HIGIV), a treatment made from antibodies, in adults with early-stage COVID-19.

Inclusion criteria: Participants must be at least 55 years old, or at least 18 with an immunosuppressed condition, have tested positive for SARS-CoV-2 within 5 days, and if symptomatic, symptoms must have started within 5 days. They must agree not to join another COVID-19 trial for 7 days or until hospitalized/condition worsens, and provide written consent.

Exclusion criteria: Patients who have received direct-acting antivirals or other anti-SARS-CoV-2 agents as standard care, those not within specified age range, vulnerable populations the study isn’t designed for, and those unable to provide informed consent are excluded.

Focus: Participants receive a single intravenous infusion of COVID-HIGIV or placebo alongside standard care. The study monitors health status over 28 days, assessing symptoms, activity limitations, and evaluating clinical status after 7 days, hospitalization rates, death, viral burden changes, antibody levels, and healthcare resource use.

Investigational drugs: Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin (hIVIG) provides concentrated antibodies to help the immune system fight coronavirus, potentially reducing disease severity and improving recovery times.

Study on Antiviral Therapy with Nirmatrelvir and Remdesivir for Immunocompromised COVID-19 Patients

This trial in France, Norway, and Italy tests whether combining Paxlovid (nirmatrelvir) and Veklury (remdesivir) or extending Paxlovid treatment from 5 to 10 days can reduce virus presence in immunocompromised patients.

Inclusion criteria: Participants must have laboratory-confirmed SARS-CoV-2 infection using RT-PCR, asymptomatic or mild to moderate COVID-19, be 16 years or older, weigh more than 40 kg, and be immunocompromised due to conditions like HIV with low CD4 cells, low white blood cell counts, hereditary immunodeficiencies, immune-suppressing medications, certain cancers, stem cell or bone marrow transplant, organ transplant or waiting list status.

Exclusion criteria: Those not diagnosed with COVID-19, outside the specified age range, or part of vulnerable populations like pregnant women or those with severe health issues cannot participate.

Focus: The study monitors virus levels in nasal swabs at days 5, 10, 14, and 21, and collects blood samples to assess virus presence and immune response. Treatment begins within 7 days of hospital admission, with participants followed until day 90.

Investigational drugs: Nirmatrelvir (Paxlovid) is an oral antiviral that stops virus multiplication by interfering with its replication ability. Remdesivir (Veklury) is administered intravenously and prevents virus spread by interfering with genetic material replication. Both are being tested in combination or with extended duration to improve viral clearance.

Study on Immune Responses to COVID-19 Vaccines: Raxtozinameran, Bretovameran, and Drug Combination for COVID-19 Patients

This Finnish trial studies immune responses after receiving different formulations of COVID-19 vaccines, including Comirnaty Omicron XBB.1.5, Comirnaty JN.1, COVID-19 Vaccine AstraZeneca, Spikevax bivalent Original/Omicron BA.1, and others.

Inclusion criteria: Participants must be at least 18 years old, received or planning to receive at least one COVID-19 vaccine dose per the national program, able to understand written and spoken information, and have given written informed consent.

Exclusion criteria: Those with current or recent COVID-19 infection, outside 18-65 age range, pregnant or breastfeeding, weakened immune system, history of severe allergic reactions to vaccines, participating in another trial simultaneously, or any medical condition making participation unsafe are excluded.

Focus: The study evaluates immune system response to vaccines by measuring antibody levels and other immune responses over time in people with different numbers of doses, vaccination intervals, age groups, and health conditions. The multi-year study aims to understand vaccine effectiveness against different virus variants.

Investigational drugs: Multiple COVID-19 vaccines are being studied, administered as intramuscular injections, to teach the body’s cells to produce harmless virus pieces that help the immune system recognize and fight COVID-19.

Study on Metformin and Colchicine for Patients with Long COVID Symptoms

This Dutch trial evaluates metformin and colchicine treatments for Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) – the long-term effects some experience after COVID-19 recovery.

Inclusion criteria: Participants must be adults aged 18 or older, living in the study area for the trial duration, having persistent PASC symptoms like fatigue or post-exertional malaise for at least 12 weeks after SARS-CoV-2 infection. Symptoms should not have been present before infection but may have improved and returned. Confirmation of previous infection through positive PCR, rapid test, or medical diagnosis is required, along with willingness to provide informed consent and follow trial procedures.

Exclusion criteria: Those without PASC experience, outside specified age range, not meeting gender requirements, unable to provide informed consent, pregnant or breastfeeding, participating in another trial, or having conditions that could interfere with the study are excluded.

Focus: Participants receive either metformin, colchicine, or placebo orally for 12 weeks with maximum daily doses of 1500 mg (metformin) or 1 mg (colchicine). The study monitors health changes throughout this period and assesses physical health using standardized questionnaires at the end, also examining mental well-being and daily activity ability.

Investigational drugs: Metformin, commonly used for blood sugar management, and colchicine, often used for inflammation reduction in conditions like gout, are being tested for their effects on long COVID symptoms and quality of life improvement.

Study on COVID-19 Immunity in Immunocompromised Adults Using Raxtozinameran and Bretovameran in Belgium

This Belgian trial studies immune response to SARS-CoV-2 in immunocompromised individuals including nursing home residents, dialysis patients, and kidney and lung transplant patients aged 18-105, using Comirnaty Omicron XBB.1.5 and Comirnaty JN.1 mRNA vaccines.

Inclusion criteria: Participants must be healthy or immunocompromised patients (nursing home residents, dialysis patients, or kidney/lung transplant recipients), aged 18-105, and previously participated in PICOV-VAC, REDUVAC, Lung-VAC, or Nephro-VAC studies. Both males and females are eligible.

Exclusion criteria: Those not between 18-105 years, not healthy or immunocompromised, or not meeting specific patient population criteria are excluded.

Focus: The study assesses antibody levels against the most common virus variant three times yearly, examining both antibody response quality and cellular immune response. Participants receive vaccines through injection with blood tests conducted throughout the multi-year study from 2023-2026.

Investigational drugs: Comirnaty Omicron XBB.1.5 and Comirnaty JN.1 are COVID-19 mRNA vaccines with 30 micrograms per dose, administered as intramuscular injections to help protect against specific virus variants.

Study on Immune Response in COVID-19 Recovered Patients Treated with Monoclonal Antibodies: Effects of Revaccination with Elasomeran, Tozinameran, and Cilgavimab

This Italian trial studies immune response in COVID-19 recovered patients who received monoclonal antibodies, examining revaccination effects with Spikevax, Nuvaxovid, EVUSHELD, Xevudy, and Comirnaty vaccines.

Inclusion criteria: Participants must be 12 years or older with laboratory-confirmed SARS-CoV-2 infection, mild or moderate COVID-19 symptoms starting within 7 days of evaluation, and at high risk for severe infection due to factors like high BMI (30 or above, or above 95th percentile for age/gender), chronic renal failure, uncontrolled diabetes, immunodeficiency, age over 65, cardiovascular disease, chronic lung disease, chronic liver disease, blood disorders, or neurological conditions.

Exclusion criteria: Those without COVID-19 infection, not receiving monoclonal antibodies after infection, outside specified age ranges, not in designated clinical trial groups, unwilling to follow revaccination schedule, not in vulnerable populations, or unable to provide informed consent are excluded.

Focus: Participants receive monoclonal antibody treatment followed by revaccination at either 4 or 12 months. The study monitors immune responses at 0, 1, 4, 6, 9, and 12 months after treatment, measuring antibody levels and cellular immunity to determine optimal revaccination timing for maintaining strong immune defense.

Investigational drugs: Monoclonal antibodies are laboratory-made proteins that mimic immune system ability to fight pathogens, used to help understand immune system response over time and effects on future vaccinations.

Summary

The 34 ongoing clinical trials for COVID-19 demonstrate a diverse research landscape spanning prevention, treatment, and management of both acute infection and long-term complications. Geographically, trials show significant concentration in Western European countries, with Germany, Spain, France, and the Netherlands hosting multiple studies. Belgium stands out with seven trials, suggesting it as a major research hub.

Research approaches vary considerably, including novel intranasal vaccines, oral antivirals, intravenous immunoglobulins, and monoclonal antibodies. Several trials focus on vulnerable populations such as immunocompromised patients, kidney transplant recipients, elderly individuals, and children. Notably, multiple studies examine treatments for Long COVID or Post-Acute Sequelae of SARS-CoV-2 Infection, reflecting growing recognition of this condition’s significance.

Vaccine research extends beyond initial immunization to booster doses, variant-specific formulations (particularly Omicron variants), and co-administration with influenza vaccines. Drug repurposing appears in trials testing metformin, colchicine, and other existing medications for COVID-19 applications. The pediatric population receives special attention with dedicated trials for children and adolescents, addressing an important gap in COVID-19 treatment options.

These trials collectively represent comprehensive efforts to improve COVID-19 prevention, treatment across disease stages, and management of long-term effects, with particular emphasis on protecting vulnerable populations and developing more convenient administration methods like intranasal delivery.

Ongoing Clinical Trials on COVID-19

  • Study on Montelukast for COVID-19 Patients at Higher Risk in Primary Care

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on Everolimus and Mycophenolate Mofetil for Improving COVID-19 Vaccine Response in Kidney Transplant Patients

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on the Effectiveness and Safety of Bemnifosbuvir for High-Risk COVID-19 Patients

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Latvia The Netherlands Romania Spain Sweden

  • Study of Prednisolone and Losartan in patients with heart inflammation after COVID-19 infection

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany

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