Status:
UNKNOWN
The MONACO Cell Therapy Study: Monocytes as an Anti-fibrotic Treatment After COVID-19
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Collaborating Sponsors:
King's College London
Conditions:
Pulmonary Fibrosis
Interstitial Lung Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 infecti...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
March 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 5 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04805086
Start Date
March 8 2021
End Date
March 5 2023
Last Update
March 18 2021
Active Locations (1)
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1
Guy's & St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH