Covid19NCT04551781
Short Term Low Dose Corticosteroids for Management of Post covid19 Pulmonary Fibrosis
A study testing 20 Mg Prednisone for 14 days in people with Covid19, run by South Valley University at 1 site in Egypt.
Trial summary
A randomized controlled trial to study the efficacy of low dose steroid for 14 days in the treatment of post-covid-19 lung infiltrates Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- 20 Mg Prednisone for 14 days
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to 30 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COVID-19 diagnosis with a positive nasopharyngeal swab, they were discharged from quarantine hospitals after 2 Polymerase chain reaction (PCR) swab negative for COVID-19, and have persistent radiological changes in follow-up chest computed tomography (CT) chest
Who cannot join
- patients with normal CT chest at discharge, patients on chemotherapy, patients <18years old, patients with known interstitial lung disease, and patients with rheumatoid arthritis or systemic lupus erythematosus
Trial locations and contacts
1 site in 1 country.
Egypt1 site
south-Vally University faculty of medicine
Qina, Qena Governorate, 868532
About this study
Official title: Short Term Low Dose Corticosteroids for Management of Post Covid-19 Pulmonary Fibrosis
A randomized controlled trial to study the efficacy of low dose steroid for 14 days in the treatment of post-covid-19 lung infiltrates
Read the detailed description
: the study included patients with COVID-19 diagnosis with a positive nasopharyngeal swab, they were discharged from quarantine hospitals after 2 Polymerase chain reaction (PCR) swab negative for COVID-19, and have persistent radiological changes in follow-up chest computed tomography (CT) chest, patients with normal CT chest at discharge, patients on chemotherapy, patients <18years old, patients with known interstitial lung disease and patients with rheumatoid arthritis or systemic lupus erythematosus were excluded from the study.
Study patients were randomly assigned to either steroid group or control group and were followed up for 14 days, and CT chest was done at end of 14 days and was evaluated by a radiologist how was blinded for study arm, Ct chest was graded either very minimal infiltrates including reticular shadows, hallow sign, and ground glass s (GGO), infiltrates <25%, and infiltrates >25%.
The steroid group received 20 mg/day prednisolone for 14 days in addition to symptomatic treatment; the control group received symptomatic treatment without steroids Data collected included patient demographics, symptoms, and its duration at baseline, CBC, Ferritin and D-dime, CT chest at discharge, and after 14 days of inclusions in the study.
- Conditions
- Covid19
- Being tested
- 20 Mg Prednisone for 14 days, control
- Keywords
- Covid-19, post covid-19 fibrosis, low dos steroids
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 Mg Prednisone for 14 daysDrug
Also called steroid
20 Mg Prednisone for 14 days
controlDrug
Also called symptomatic ttt
symptomatic ttt
| Study group | Role | What they receive |
|---|---|---|
| steroid | Experimental | 20 mg prednisolone for 14 days Receives: Drug: 20 Mg Prednisone for 14 days |
| control | Placebo comparator | controll Receives: Drug: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
improved
resolution of CT chest infiltrates as evaluated by radiologest on a score of no infiltrates, <5%, 5-25%and >25 % infiltrates
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 Apr 2020
- Primary completion30 Jul 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-blinded randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Rashad, South Valley University
- Investigators
- alaa DR Rashad, MD, Principal investigator, south-Vally Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551781
- Sponsor's protocol ID
- SVU-MED-CHT019420861
- Status last verified
- Sep 2020
- First submitted
- 13 Sep 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Low Dose Corticosteroids for Management of Post Covid-19 Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT04551781
- Acronym / sponsor ID
- SVU-MED-CHT019420861
- Conditions
- Covid19
- Keywords
- Covid-19, post covid-19 fibrosis, low dos steroids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized controlled trial to study the efficacy of low dose steroid for 14 days in the treatment of post-covid-19 lung infiltrates
Detailed description
: the study included patients with COVID-19 diagnosis with a positive nasopharyngeal swab, they were discharged from quarantine hospitals after 2 Polymerase chain reaction (PCR) swab negative for COVID-19, and have persistent radiological changes in follow-up chest computed tomography (CT) chest, patients with normal CT chest at discharge, patients on chemotherapy, patients <18years old, patients with known interstitial lung disease and patients with rheumatoid arthritis or systemic lupus erythematosus were excluded from the study.
Study patients were randomly assigned to either steroid group or control group and were followed up for 14 days, and CT chest was done at end of 14 days and was evaluated by a radiologist how was blinded for study arm, Ct chest was graded either very minimal infiltrates including reticular shadows, hallow sign, and ground glass s (GGO), infiltrates <25%, and infiltrates >25%.
The steroid group received 20 mg/day prednisolone for 14 days in addition to symptomatic treatment; the control group received symptomatic treatment without steroids Data collected included patient demographics, symptoms, and its duration at baseline, CBC, Ferritin and D-dime, CT chest at discharge, and after 14 days of inclusions in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- single-blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| steroid | Experimental | Drug: 20 Mg Prednisone for 14 days20 mg prednisolone for 14 days |
| control | Placebo comparator | Drug: controlcontroll |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COVID-19 diagnosis with a positive nasopharyngeal swab, they were discharged from quarantine hospitals after 2 Polymerase chain reaction (PCR) swab negative for COVID-19, and have persistent radiological changes in follow-up chest computed tomography (CT) chest
Key exclusion criteria (1 listed)
- patients with normal CT chest at discharge, patients on chemotherapy, patients <18years old, patients with known interstitial lung disease, and patients with rheumatoid arthritis or systemic lupus erythematosus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20 Mg Prednisone for 14 daysAlso: steroid20 Mg Prednisone for 14 days | Drug | steroid |
| controlAlso: symptomatic tttsymptomatic ttt | Drug | control |
Primary outcome
improved
Time frame: 14 days
resolution of CT chest infiltrates as evaluated by radiologest on a score of no infiltrates, <5%, 5-25%and >25 % infiltrates
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
alaa DR Rashad, MD principal investigator
south-Vally Universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20 Mg Prednisone for 14 days in people with Covid19, run by South Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improved (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.