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

NCT04805086 | Unknown Phase 1 DMC

• 1 other identifier: 289624
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Fibrosis; Interstitial Lung Disease; Covid19

Keywords

Phase I/II; cell therapy; ATIMP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Absolute change from baseline of predicted forced vital capacity (FVC)

  3, 6 and 12 months

• Rate of decrease in FVC

  3, 6 and 12 months

• Time to first occurrence of a ≥10% absolute decline in percentage of predicted FVC

  3, 6 and 12 months

• Time to decrease from baseline (relative change) of ≥ 10% in FVC (mL/year)

  3, 6 and 12 months

• Time from cell administration to first event of acute pulmonary fibrosis exacerbation

  3, 6 and 12 months

Study Arms (1)

MON002

EXPERIMENTAL

Minimum of 1x10\~7 cells to maximum of 2x10\~6 cells/kg. Single infusion.

Biological: MON002

Interventions

MON002 BIOLOGICAL

Autologous monocytes

MON002

Eligibility Criteria

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

You may qualify if:

• 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
• Signed and dated written informed consent.

You may not qualify if:

• Subjects 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
• Any condition which, in the judgement of the Investigator, would place the subject at undue risk
• Female patients of childbearing potential with a positive serum pregnancy test at enrolment
• 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
• Female patients who are breastfeeding
• Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow up visit schedule
• 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
• Patients unable to freely give their informed consent (e.g. individuals under legal guardianship).

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator

Study Sites (1)

Guy's & St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Fibrosis; Lung Diseases, Interstitial; COVID-19

Interventions

MON002

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Ashish Patel, PhD FRCS

  King's College London and Guy's & St Thomas' NHS Foundation Trust

  STUDY CHAIR

• Bijan Modarai, PhD FRCS

  King's College London and Guy's & St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashish Patel, PhD FRCS

CONTACT

+442071880214; ashish.patel@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective trial

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 18, 2021
• Study Start: March 8, 2021
• Primary Completion: June 1, 2022
• Study Completion: March 5, 2023
• Last Updated: March 18, 2021

Record last verified: 2021-03

Locations

GB (1)