NHS foundation trust conducts the MONACO Cell Therapy Study: Monocytes as an Anti-fibrotic Treatment After COVID-19

The Guy's and St Thomas' NHS Foundation Trust is enrolling patients into the clinical trial investigating The MONACO Cell Therapy Study: Monocytes as an Anti-fibrotic Treatment After COVID-19.

Up to a third of patients who recovered from SARS coronavirus (SARS-CoV) had a 20% decline in lung function with a long term reduction in exercise capacity and SF-36 health status a year after infection. Similar outcomes are now being reported in COVID-19 patients, with interstitial lung disease (fibrosis) and long term lung function decline being a common feature. Anti-fibrotic monocytes/macrophages are important for the clearance of partially degraded collagen fragments of fibrotic extracellular matrix, in particular fibrillary-type collagen.

MON002 is an autologous monocyte product, cultured in vitro prior to intravenous delivery into patients with post-COVID-19 lung fibrosis.

King's College London is the collaborator in this study.

The frequency of serious adverse events (SAE) related to the administration of the IMP is primary outcome measure.

The trial is designed to enroll male and female 18 years and older and is being conducted in the Guy's & St Thomas' NHS Foundation Trust, London, United Kingdom.

The study start date is March 8, 2021.

Among the inclusion criteria are:

• Clinical evidence/diagnosis of interstitial lung disease (fibrosis) following COVID-19 infection.
• Aged at least 18 years.
• Willing and able to participate in the MONACO Cell Therapy Study

There are a number of conditions that do not allow participation, such as:

• Participants who have had other investigational medicinal products within 90 days prior to screening or during the treatment phase.
• Malignant or premalignant haematological conditions.
• Serologically positive for antiHIV1,2; HBsAg; Anti-HBc; Anti-HCVab;Anti-HTLV1,2 or syphilis (Treponema palladium).
• Concomitant malignancy or history of malignancy within 5 years prior to planned study entry (excluding successfully treated non metastatic basal/squamous cell carcinoma of the skin).
• Evidence of significant local or systemic infection.
• Any uncontrolled medical condition or concurrent disease that could interfere with the study objectives.
• Clinical diagnosis of interstitial lung disease prior to the COVID-19 infection.

The full list can be viewed at the link below.

This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT04805086