The MONACO Cell Therapy Study: Monocytes as an Anti-fibrotic Treatment After COVID-19

Covid19 Clinical Trial

— MONACO  

Official title:

Phase I/II MONACO Cell Therapy Study: Monocytes as an Anti-fibrotic Treatment After COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04805086
• Other study ID #: 289624
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 8, 2021
• Est. completion date: March 5, 2023

Study information

• Verified date: March 2021
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Ashish Patel, PhD FRCS
• Phone: +442071880214
• Email: ashish.patel[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The MONACO Cell Therapy Study is a prospective, non-randomised, open label study phase I/II clinical trial with a key objective of evaluating safety of MON002 in 5 adults who have a clinical diagnosis of interstitial lung disease (pulmonary fibrosis) after recovery from acute COVID-19 infection. The main objectives of this study are to: (1) to determine the safety profile of MON002 by assessing clinical responses in adults with post-COVID-19 pulmonary fibrosis and (2) to assess its impact on reducing disease morbidity/severity in this population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: March 5, 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Clinical evidence/diagnosis of interstitial lung disease (fibrosis) following COVID-19 infection

2. Aged at least 18 years

3. Willing and able to participate in the MONACO Cell Therapy Study

4. Signed and dated written informed consent.

Exclusion Criteria:

1. Subjects who have had other investigational medicinal products within 90 days prior to screening or during the treatment phase.

2. Malignant or premalignant haematological conditions

3. Serologically positive for antiHIV1,2; HBsAg; Anti-HBc; Anti-HCVab;Anti-HTLV1,2 or syphilis (Treponema palladium)

4. 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)

5. Evidence of significant local or systemic infection

6. Any uncontrolled medical condition or concurrent disease that could interfere with the study objectives

7. Clinical diagnosis of interstitial lung disease prior to the COVID-19 infection

8. Any condition which, in the judgement of the Investigator, would place the subject at undue risk

9. Female patients of childbearing potential with a positive serum pregnancy test at enrolment

10. Sexually active Women of Childbearing Potential who do not agree continued abstinence from heterosexual intercourse or to use highly effective methods of birth control for the duration up to 4 weeks post IMP administration. Men who do not agree to use a condom if their partner is of child bearing potential, even if they have had a successful vasectomy after receiving the therapy

11. Female patients who are breastfeeding

12. Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow up visit schedule

13. Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel

14. Patients unable to freely give their informed consent (e.g. individuals under legal guardianship).

Related Conditions & MeSH terms

• Covid19
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Fibrosis

Intervention

Biological:
• MON002
Autologous monocytes

Locations

Country	Name	City	State
United Kingdom	Guy's & St Thomas' NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of serious adverse events (SAE) related to the administration of the IMP	Any SAEs that result in death, are life-threatening, require hospitalisation or prolonged or existing hospitalisation (that are not determined to be as a result of disease progression) or result in persistent or significant disability or incapacity	Total number of SAEs at 12 months after administration
Secondary	Absolute change from baseline of predicted forced vital capacity (FVC)		3, 6 and 12 months
Secondary	Rate of decrease in FVC		3, 6 and 12 months
Secondary	Time to first occurrence of a =10% absolute decline in percentage of predicted FVC		3, 6 and 12 months
Secondary	Time to decrease from baseline (relative change) of = 10% in FVC (mL/year)		3, 6 and 12 months
Secondary	Time from cell administration to first event of acute pulmonary fibrosis exacerbation	Defined by (a) worsening or development of dyspnoea and radiologic evidence of new bilateral ground-glass abnormality or consolidation superimposed on a reticular or honeycomb background pattern	3, 6 and 12 months
Secondary	Absolute change in transfer capacity of the lung (TLCO).		3, 6 and 12 months
Secondary	Improvement in quality of life as indicated by the King's Brief Interstitial Lung Disease (K-BILD) score	Score is transformed to range from 0-100. 100=best health status	3, 6 and 12 months
Secondary	Improvement in quality of life as indicated by the 36-Item Short Form Survey (SF-36) score	Score is transformed to range from 0-100. 100=best health status	3, 6 and 12 months
Secondary	Reduction in fibrosis score on high resolution lung CT		6 and 12 months