Safety and Effectiveness of EV-Pure + WJ-Pure Treatment on Pulmonary Fibrosis Secondary to Covid-19

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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 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 WJPure and EVPure in Covid-19 patients exhibiting pulmonary fibrosis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vitti Labs, LLC

Criteria

Inclusion Criteria:

• Subjects will be eligible for enrollment in the study only if they meet the following criteria:

1. Male or female, aged between 25 years (including) to 90 years old

2. Confirmed and documented COVID-19 infection history with confirmed diagnosis of Pulmonary Fibrosis

3. Negative to current Covid-19 infection as tested by RT-PCR tests

4. Able to perform a 6-minute walk test

5. Blood routine, liver and kidney functions test values are within controllable range

1. Adequate hepatic function as evidenced by ALT, AST and LDH < 2X ULN and bilirubin < 1.5X ULN for the reference lab

2. 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

3. Adequate hematopoietic function as evidenced by white blood cells ≥ 3x109 / L and platelets ≥ 100x109 / L

6. If childbearing age: agree to practice effective birth control from screening until 12 weeks after the last study treatment.

Exclusion Criteria:

• Subjects will be ineligible for enrollment in the study if they meet any of the following criteria:

1. Clinically relevant heart condition such as, but not limited to, uncontrolled heart failure, severe pulmonary hypertension, atrial fibrillation or significant congenital heart disease

2. Severe asthma on chronic therapy with biologics or steroids

3. 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)

4. Evidence of active malignancy, or prior history of active malignancy not in remission.

5. Life expectancy of < 6 months

6. Patient included in another ongoing interventional therapeutic trial.

7. Pregnant or Lactating.

8. 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.