Nebulisation of lyophilised platelet-rich plasma to improve compromised lung health in patients

Nebulisation of lyophilised platelet-rich plasma to improve compromised lung health in patients caused by a mild-moderate COVID-19 infection - a Phase I/II, a randomised, placebo controlled, blinded study. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/072420

Enrollment

Registered

2024-08-12

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J418- Mixed simple and mucopurulent chronic bronchitis

Interventions

Intervention1: Lyophilized platelet-rich plasma: One vial of L-PRP, Duration 30 Days Control Intervention1: Placebo: One vial of Saline, Duration 30 Days

Eligibility

Inclusion criteria

Inclusion criteria: - Individuals who experience respiratory symptoms directly as a result of COVID-19 infection. - Patients with chest X-ray findings of peripheral ground glass opacities seen in the lower lobe and/or consolidation - Patients with fibrotic areas in the lung field on chest X-ray/CT scan Six-minute walk test distance less than 300 m - Individuals with associated systemic illnesses such as diabetes mellitus, renal disease, hypertension, liver disease, pulmonary disorders, among others - Individuals who can give informed consent

Exclusion criteria

Exclusion criteria: 1. Terminally ill COVID-19 patients/Patients not responding to conventional treatment/Patients with rapidly-progressing infection 2. Patients on OR those requiring ventilator support 3. Presence of active malignancy 4. Immunodeficient conditions 5. Hypercoagulation conditions 6. Any other associated medical condition requiring immediate attention or uncontrolled status. 7. 10.Patients who have recently undergone organ transplantation, heartpacemaker implantation (within 6 months) 8. Patients with other infectious/communicable disease. 9. Pregnant and lactating women

Design outcomes

Primary

Measure	Time frame
Reduction in general weakness Improvement in symptoms such as breathlessness upon exertion and at rest, dry cough, rapid shallow breathing, etc. Reduction in general weakness 6 minute walk testTimepoint: At the time of visits	—

Secondary

Measure	Time frame
Spirometry, Forced expiratory volume in 1 sec (FEV1), Forced vital capacity (FVC), FEV1/FVC ratio, and single- breath diffusing capacity for carbonmonoxide (DLCO)Timepoint: At the time of visits	—

Countries

India

Contacts

Public ContactDr Sayali Sadgune

Mudra Clincare

mahajanhospital21@gmail.com8291745386

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026