EV-Pure™ + WJ-Pure™ for Pulmonary Fibrosis

Overseen By Mukesh Kumar

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Vitti Labs, LLC

Must not be taking: Biologics, Steroids

Disqualifiers: Heart condition, Severe asthma, Active smokers, Active malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a combination of two substances, VL-P22 and VL-PX10, given to Covid-19 patients with lung fibrosis. These patients have lung damage and severe breathing issues. The treatment aims to repair lung tissue and improve breathing by reducing lung scarring.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Eligibility Criteria

This trial is for adults aged 25-90 with a history of COVID-19 and confirmed pulmonary fibrosis. They must have good kidney, liver, and blood cell function, not be currently infected with COVID-19, able to walk for six minutes unaided, and if of childbearing age, agree to use birth control. Excluded are those with severe heart conditions or other serious illnesses that could affect safety or compliance.

Inclusion Criteria

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

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

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

Exclusion Criteria

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.

Life expectancy of < 6 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive intravenous infusion of VL-PX10 and VL-P22 or placebo for 5 days

5 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• EV-Pure™ and WJ-Pure™

Trial Overview The study tests the effectiveness of VL-PX10 combined with VL-P22 against lung damage from COVID-19 compared to a placebo group. Both groups receive standard care as well. The goal is to see if these treatments can improve breathing issues and exercise tolerance in patients who've developed pulmonary fibrosis after recovering from COVID-19.

Participant Groups

Group I: Experimental/treatment arm Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Vitti Labs, LLC

Lead Sponsor

Trials

3

Recruited

50+