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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT04657484 |
|
Full text link
Last imported at : Dec. 10, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : April 28, 2022, 3:30 a.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : April 28, 2022, 3:30 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Dec. 10, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
2020-12-08 |
|
Recruitment status
Last imported at : April 28, 2022, 3:30 a.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : Dec. 10, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Dec. 10, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Dec. 10, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Dec. 10, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Open label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : Dec. 10, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Long covid |
|
Inclusion criteria
Last imported at : Dec. 10, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - diagnosed to have covid-19 by means of a real-time reverse transcription polymerase chain reaction (rrt-pcr) test performed on a respiratory (upper or lower respiratory) sample or the detection of covid-19 antigen - having significant respiratory symptoms (cough and breathlessness) or persistent hypoxemia or oxygen desaturation on exercise and ct chest showing residual changes of post-covid parenchymal involvement of any extent or having ct chest showing residual changes of post-covid parenchymal involvement >20% of the lung parenchyma on visual inspection of the scans between 3-8 weeks of the onset of symptoms of covid-19 - willing to participate in the study |
|
Exclusion criteria
Last imported at : Dec. 10, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
- receiving ventilatory or respiratory support (invasive or non-invasive mechanical ventilation or high flow nasal cannula) or supplemental oxygen with fio2>0.35 - requiring intensive care due to acute covid-19 pneumonia or its complications - having a known lung parenchymal lung disease before the onset of covid-19 - pregnant or lactating women - having absolute contraindication for prednisolone in a dose of 40 mg/day (this includes untreated glaucoma, uncontrolled diabetes mellitus, signs of an uncontrolled or untreated infection or sepsis, pulmonary mycosis, untreated severe psychiatric disorders) - unwilling to provide informed consent |
|
Number of arms
Last imported at : Dec. 10, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : April 3, 2024, 8 a.m. Source : ClinicalTrials.gov |
Post Graduate Institute of Medical Education and Research, Chandigarh |
|
Inclusion age min
Last imported at : Dec. 10, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Dec. 10, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Dec. 10, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
India |
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Type of patients
Last imported at : Dec. 10, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Patients recovered from covid |
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Severity scale
Last imported at : Dec. 10, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : April 28, 2022, 3:30 a.m. Source : ClinicalTrials.gov |
130 |
|
primary outcome
Last imported at : Dec. 10, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Proportion of subjects with a complete radiologic response |
|
Notes
Last imported at : Dec. 10, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Arms
Last imported at : Dec. 10, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Low dose", "treatment_id": 1020, "treatment_name": "Prednisolone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Medium dose", "treatment_id": 1020, "treatment_name": "Prednisolone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}] |