TURN-COVID Biobank: The Dutch Cohort Study for the Evaluation of the Use of Neutralizing Monoclonal Antibodies and Other Antiviral Agents Against SARS-CoV-2

NCT05195060 | Completed

• 1 other identifier: NL78705.018.21
• Study Type: observational
• Target: 1,178
• Locations: 1 country
• Sites: 4

Brief Summary

Novel antiviral drugs can mark a turning point in the prevention and treatment of patients with Covid-19. Recently, several independent large phase-III RCTs have shown that the intravenous administration of one gift of neutralizing SARS-CoV-2 monoclonal antibodies can reduce the relative risk of hospital admission and/or death with 70-85% in seronegative patients with SARS-CoV-2 infection when given within 3 to 7 days after state of symptoms. Moreover, novel oral anti-viral compunds such as molnupiravir and nirmatrelvir/ritonavir could reduce the risk of hospitalisation or death by 30% to89% in at-risk adults with Covid-19. These are potential breakthroughs in the treatment of SARS-CoV-2 infection and can be of special importantance for immunocompromised patients who have a diminished or complete lack of an effective humoral response towards Covid-19 vaccination. Monoclonal SARS-CoV-2 antibodies and antivirals have been given an emergency use authorization by regulatory authorities and are or will become available in the Netherlands to treat SARS-CoV-2 infected patients who are at high risk of developing severe disease. Now, urgent key questions need to be addressed: Which patient categories will benefit most from these new drugs? What are the SARS-CoV-2 viral load as well as inflammatory response kinetics during and after treatment with the new SARS-CoV-2 therapies? What is the safety profile in () patients; do new SARS-CoV-2 variants occur during treatment? This study aims to establish a prospective cohort together with a biobank of patients treated with new SARS-CoV-2 therapies to evaluate its real world effect and safety. Primary Objectives:

• A. What are the SARS-CoV-2 viral load kinetics during and after treatment withneutralizing monoclonal antibodies and other antiviral agents against SARS-CoV-2?
• B. Do viralvariants, spike mutations and immune escape occur during treatment with neutralizing monoclonal antibodies and other antiviral agents against SARS-CoV-2?new SARS-CoV-2 therapies?
• C. What are the viral antibody and inflammatory response kinetics during and after treatment with neutralizing monoclonal antibodies and other antiviral agents against SARS-CoV-2?
• D. To create a biobank to address future questions regarding the current use of neutralizing monoclonal antibodies and other antiviral agents against SARS-CoV-2compared to novel COVID-19 treatments which are in development. Study design: Establishment of an observational cohort study including a biobank of patients who receive neutralizing monoclonal antibodies and other novel antiviral agents against SARS-CoV-2. Study population: All patients above 18 years of age treated with neutralizing monoclonal antibodies and other novel antiviral agents against SARS-CoV-2. Intervention (if applicable): None Main study parameters/endpoints: Viral load kinetics during treatment. Viral mutations during and after treatment. Presence of monoclonal antibody during treatment and host antibody production and inflammatory responses during treatment. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participating in this observational study will not directly benefit the participants and healthy volunteers. The study will provide information about the effect, host response and safety of thse new anti-SARS-CoV-2 therapies during Covid-19. Clinical data will be obtained through the electronic patient dossier. The knowledge obtained can potentially benefit Covid-19 patients in the future by optimizing treatment strategies. The burden and risks for patients participating in the TURN-COVID biobank study is minimal. Patients will be visited by a research physician or research nurse during or within three days after receiving neutralizing monoclonal antibodies and other antiviral agents against SARS-CoV-2. Baseline data regarding medical history, admission and vital parameters will be collected through the electronic patient dossier. At the follow-up visits we will draw a total of (3x 43 ML and 1x16 ml = 145 ml of venous blood) and obtain 4 oro-/nasopharyngeal swabs divided over four time-points (day of treatment and day 7, 28 and 90 post treatment).

Conditions

COVID-19

Outcome Measures

Primary Outcomes (3)

• Therapeutic effect of treatment with monoclonal antibodies and antiviral agents

  At day 90

• Incidence of Treatment-Emergent Adverse Events of treatment with monoclonal antibodies and antiviral agents

  At day 90

• Cost-effectiveness of treatment with monoclonal antibodies and antiviral agents

  At day 90

Secondary Outcomes (1)

• Change of serologic response during treatment with monoclonal antibodies and antiviral agents

  At baseline, day 7, day 28 and day 90

Study Arms (1)

COVID-19

Patients diagnosed with COVID-19

Drug: casirivimab with imdevimab; Drug: sotrovimab; Drug: molnupiravir

Interventions

sotrovimab DRUG

Monoclonal antibody

Also known as: Xevudy

COVID-19

casirivimab with imdevimab DRUG

Monoclonal antibody

Also known as: REGEN-COV

COVID-19

molnupiravir DRUG

antiviral agent

Also known as: Lagevrio

COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients that are treated with neutralizing monoclonal SARS-CoV-2 antibodies and with small drug molecules as standard of care for SARS-CoV-2 infection. Patients can receive the intervention in an outpatient setting, ward or ICU. Woman with child bearing potential are included in the study if the treating physician deemed the treatment safe. We will not determine whether or not a a patient receives a treatment as this is the choice of the treating physician.

You may qualify if:

• All patients that are treated with neutralizing monoclonal SARS-CoV-2 antibodies or with small-molecules for Covid-19 as standard of care.
• Patients have to be aged ≥ 18 y.

You may not qualify if:

• No informed consent is provided by the patient or by his/her legal representative
• Patients not suitable to fulfil study procedures

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (4)

Amsterdam University Medical centre - VUMC

Amsterdam, North Holland, 1081 HV, Netherlands

Location

Amsterdam University Medical Centre

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Leiden universitair medisch centrum

Leiden, 2333ZA, Netherlands

Location

Radboud Universitair Medisch Centrum

Nijmegen, 6525GA, Netherlands

Location

Related Publications (5)

• Birnie E, Vergouwe M, Appelman B, Biemond JJ, Heijmans J, Nichols BE, Wiersinga WJ, Popping S; TURN-COVID studygroup. Cost-effectiveness Analysis of Nirmatrelvir/Ritonavir for COVID-19 Among Individuals at High Risk: A Modeling Study. Open Forum Infect Dis. 2025 Mar 26;12(4):ofaf187. doi: 10.1093/ofid/ofaf187. eCollection 2025 Apr.

  PMID: 40256045 RESULT

• Vergouwe M, Birnie E, van Veelen S, Biemond JJ, Appelman B, Peters-Sengers H, de Bree GJ, Popping S, Wiersinga WJ; TURN-COVID Study Group. A Longitudinal Description of the Health-Related Quality of Life Among Individuals at High Risk After SARS-CoV-2 Infection: A Dutch Multicenter Observational Cohort Study. Open Forum Infect Dis. 2025 Jan 30;12(2):ofaf055. doi: 10.1093/ofid/ofaf055. eCollection 2025 Feb.

  PMID: 39974282 RESULT

• Vergouwe M, Biemond JJ, van der Straten K, van Pul L, Kerster G, Claireaux M, Burger JA, van Dort KA, Kootstra NA, Jonges M, Welkers MRA, Hazenberg MD, Peters-Sengers H, van Gils MJ, Wiersinga WJ, Birnie E, de Bree GJ; TURN-COVID study group. A Robust Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)-Specific T- and B-Cell Response Is Associated With Early Viral Clearance in SARS-CoV-2 Omicron-Infected Immunocompromised Individuals. J Infect Dis. 2024 Oct 16;230(4):e860-e871. doi: 10.1093/infdis/jiae306.

  PMID: 38843052 RESULT

• Popping S, Nichols BE, Appelman B, Biemond JJ, Vergouwe M, Rosendaal FR, van der Valk M, de Bree GJ, Wiersinga WJ, Birnie E; TURN-COVID study group. Health Outcomes and Cost-effectiveness of Monoclonal SARS-CoV-2 Antibodies as Pre-exposure Prophylaxis. JAMA Netw Open. 2023 Jul 3;6(7):e2321985. doi: 10.1001/jamanetworkopen.2023.21985.

  PMID: 37410460 RESULT

• Birnie E, Biemond JJ, Appelman B, de Bree GJ, Jonges M, Welkers MRA, Wiersinga WJ. Development of Resistance-Associated Mutations After Sotrovimab Administration in High-risk Individuals Infected With the SARS-CoV-2 Omicron Variant. JAMA. 2022 Sep 20;328(11):1104-1107. doi: 10.1001/jama.2022.13854.

  PMID: 35913747 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

EDTA plasma, serum, PBMC's

MeSH Terms

Conditions

COVID-19

Interventions

casirivimab; imdevimab; casirivimab and imdevimab drug combination; sotrovimab; molnupiravir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: January 18, 2022
• Study Start: December 14, 2021
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

NL (4)