Safety and Effectiveness of VL-PX10 + VL-P22 Treatment on Pulmonary Fibrosis Secondary to Covid-19
Paused · Phase 2 · Has a placebo group
Conditions studied: Pulmonary Fibrosis, COVID-19 Respiratory Infection
In brief
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 patients who have recovered from severe COVID indicate that there is a 30% chance of developing a persistent respiratory system pathology and a 10% chance of developing a severe pathology. The symptoms of lung fibrosis include a severe disruption of respiration, reduction of exercise tolerance, and concomitant development of persistent fibrotic lung damage. This study intends to evaluate benefits of a combination of VL-P22 and VL-PX10 in Covid-19 patients exhibiting pulmonary fibrosis.
Key facts
- Study ID
- NCT05387239
- Run by
- Vitti Labs, LLC
- People needed
- 20
- Starts
- 2022-11-30
- Expected to finish
- 2024-12-01
- Last updated by the study team
- 2024-09-19
Who can join
Age: 25 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Kit Bartalos — Liberty, Missouri, United States
Full record on ClinicalTrials.gov
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