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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04805086
Recruitment Status : Recruiting
First Posted : March 18, 2021
Last Update Posted : March 18, 2021
Sponsor:
Collaborator:
King's College London
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Pulmonary Fibrosis Interstitial Lung Disease Covid19 Biological: MON002 Phase 1 Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II MONACO Cell Therapy Study: Monocytes as an Anti-fibrotic Treatment After COVID-19
Estimated Study Start Date : March 8, 2021
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : March 5, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MON002
Minimum of 1x10~7 cells to maximum of 2x10~6 cells/kg. Single infusion.
Biological: MON002
Autologous monocytes




Primary Outcome Measures :
  1. Frequency of serious adverse events (SAE) related to the administration of the IMP [ Time Frame: Total number of SAEs at 12 months after administration ]
    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


Secondary Outcome Measures :
  1. Absolute change from baseline of predicted forced vital capacity (FVC) [ Time Frame: 3, 6 and 12 months ]
  2. Rate of decrease in FVC [ Time Frame: 3, 6 and 12 months ]
  3. Time to first occurrence of a ≥10% absolute decline in percentage of predicted FVC [ Time Frame: 3, 6 and 12 months ]
  4. Time to decrease from baseline (relative change) of ≥ 10% in FVC (mL/year) [ Time Frame: 3, 6 and 12 months ]
  5. Time from cell administration to first event of acute pulmonary fibrosis exacerbation [ Time Frame: 3, 6 and 12 months ]
    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

  6. Absolute change in transfer capacity of the lung (TLCO). [ Time Frame: 3, 6 and 12 months ]
  7. Improvement in quality of life as indicated by the King's Brief Interstitial Lung Disease (K-BILD) score [ Time Frame: 3, 6 and 12 months ]
    Score is transformed to range from 0-100. 100=best health status

  8. Improvement in quality of life as indicated by the 36-Item Short Form Survey (SF-36) score [ Time Frame: 3, 6 and 12 months ]
    Score is transformed to range from 0-100. 100=best health status

  9. Reduction in fibrosis score on high resolution lung CT [ Time Frame: 6 and 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04805086


Contacts
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Contact: Ashish Patel, PhD FRCS +442071880214 ashish.patel@kcl.ac.uk

Locations
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United Kingdom
Guy's & St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom, SE1 7EH
Contact: Ashish Patel, PhD FRCS    +442071880214    ashish.patel@kcl.ac.uk   
Contact: Bijan Modarai, PhD FRCS    +442071880214    bijan.modarai@kcl.ac.uk   
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
King's College London
Investigators
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Study Chair: Ashish Patel, PhD FRCS King's College London and Guy's & St Thomas' NHS Foundation Trust
Principal Investigator: Bijan Modarai, PhD FRCS King's College London and Guy's & St Thomas' NHS Foundation Trust
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04805086    
Other Study ID Numbers: 289624
First Posted: March 18, 2021    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Phase I/II
cell therapy
ATIMP
Additional relevant MeSH terms:
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COVID-19
Lung Diseases
Pulmonary Fibrosis
Lung Diseases, Interstitial
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Diseases