Status:
SUSPENDED
Safety and Effectiveness of VL-PX10 + VL-P22 Treatment on Pulmonary Fibrosis Secondary to Covid-19
Lead Sponsor:
Vitti Labs, LLC
Conditions:
Pulmonary Fibrosis
COVID-19 Respiratory Infection
Eligibility:
All Genders
25-90 years
Phase:
PHASE2
Brief Summary
The COVID-induced fibrotic lung damage continues long after viral infection has subsided and is exhibited by severe respiratory pathology and concomitant symptoms. The long-lasting sequelae in patient...
Detailed Description
Multiple clinical trials are underway to explore options for treatment of pulmonary fibrosis in patients with history of COVID. Mesenchymal stem cell (MSC)-based therapies have been used worldwide for...
Eligibility Criteria
Inclusion
- Subjects will be eligible for enrollment in the study only if they meet the following criteria:
- Male or female, aged between 25 years (including) to 90 years old
- Confirmed and documented COVID-19 infection history with confirmed diagnosis of Pulmonary Fibrosis
- Negative to current Covid-19 infection as tested by RT-PCR/rapid antigen tests
- Able to perform a 6-minute walk test
- Blood routine, liver and kidney functions test values are within controllable range
- Adequate hepatic function as evidenced by ALT and AST \< 2X ULN and bilirubin \< 1.5X ULN for the reference lab
- Adequate renal function as evidenced by a serum creatinine ≤ 1.5 X ULN for the reference laboratory OR a calculated creatinine clearance of ≥ 60 mL/min by the Cockcroft-Gault Equation
- Adequate hematopoietic function as evidenced by white blood cells ≥ 3x109 / L and platelets ≥ 100x109 / L
- If childbearing age: agree to practice effective birth control from screening until 12 weeks after the last study treatment.
Exclusion
- Subjects will be ineligible for enrollment in the study if they meet any of the following criteria:
- Clinically relevant heart condition such as, but not limited to, uncontrolled heart failure, severe pulmonary hypertension, atrial fibrillation or significant congenital heart disease
- Severe asthma on chronic therapy with biologics or steroids
- Active smokers as defined as individuals who currently smokes at least one cigarette or equivalent product a day. (Ex-smokers who had regularly smoked but who had not smoked the previous month are eligible)
- Evidence of active malignancy, or prior history of active malignancy not in remission.
- Life expectancy of \< 6 months
- Patient included in another ongoing interventional therapeutic trial.
- Pregnant or Lactating.
- Serious or life-threatening co-morbidities, that in the opinion of the investigators, may compromise the safety or compliance with the study guidelines and tracking.
Key Trial Info
Start Date :
November 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05387239
Start Date
November 30 2022
End Date
December 1 2024
Last Update
September 19 2024
Active Locations (1)
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1
Kit Bartalos
Liberty, Missouri, United States, 64068