COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05387239

Mukesh Kumar

mkumar@fdamap.com

2022-05-24

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Long covid

inclusion criteria: 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 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, ast and ldh < 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.

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.

2

Vitti Labs, LLC

25

90

United States

Patients recovered from covid

N/A

20

Evaluate incidences of Treatment-Emergent Adverse Events following following EV-Pure™ and WJ-Pure™ administeration to patients exhibiting Covid induced Pulmonary Fibrosis.;To evaluate the efficacy of EV-Pure™ and WJ-Pure™ administration in alleviating long term symptoms of Covid induced Pulmonary Fibrosis, compared to placebo

None

Phase 1

[{"arm_notes": "EV-Pure\u2122 and WJ-Pure\u2122", "treatment_id": 787, "treatment_name": "Mesenchymal stem cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]