COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49593

Anant Mohan

anantmohan@yahoo.com

2021-03-22

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Long covid

1. History of COVID-19 illness diagnosed by RT-PCR/Rapid antigen/ Truenaat of throat or nasopharyngeal swab at least 8 weeks prior <br/ >2. Having persistent respiratory symptoms (cough and breathlessness) or persistent hypoxemia (SpO2 <94% on room air) or oxygen desaturation on exercise <br/ >AND <br/ >Has evidence of pulmonary fibrosis on HRCT thorax (at least 15% involvement by visual semi-quantitative assessment) performed at least 8 weeks after COVID-19 diagnosis <br/ >3. Provides written informed consent for evaluation and treatment as per study protocol <br/ >

1. Patients not providing consent for participation in the study <br/ >2. FEV1/FVC ratio < 0.80 <br/ >3. Active smokers <br/ >4. Any active malignancy/ malignancy within past 2 years <br/ >5. Severe hepatic impairment <br/ >6. Use of immunosuppressant drugs (except corticosteroids and tocilizumab) within last 6 weeks <br/ >

2

Anant Mohan

18

80

India

Patients recovered from covid

N/A

60

The change in Forced Vital Capacity (FVC) (% predicted) at 6 months following treatment initiation with oral Pirfenidone versus placebo in patients with COVID-19 associated pulmonary fibrosisTimepoint: at 6 months

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "", "treatment_id": 995, "treatment_name": "Pirfenidone", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]