Covid19Phase 4NCT04530409
Timing of Corticosteroids in COVID-19, II. Post COVID-19 Follow-up
A Phase 4 study testing Early-Corticosteroids in people with Covid19 and Corticosteroids, run by ClinAmygate at 1 site in Egypt.
Trial summary
Timing of of corticosteroids administration is very important in COVID19 cases for the recovery and decrease the mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Corticosteroids
- What is being tested?
- Early-Corticosteroids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 752 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2021to 15 Oct 2023
- Phase
- Phase 4
- 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
- any case with COVID-19 more than or equal to 18 years
- mild and moderate severity
Who cannot join
- Severe to critical COVID-19
- Any contra-indication for the interventional drug
- Mentally disabled cases
Trial locations and contacts
1 site in 1 country.
About this study
Timing of of corticosteroids administration is very important in COVID19 cases for the recovery and decrease the mortality.
Read the detailed description
The sickest patients with COVID-19 suffer a hyperinflammatory state-a cytokine storm-that has features in common with a rare haematological condition called haemophagocytic lymphohistiocytosis. Immune suppression should help such patients. By contrast, immune suppression during the early phase of the viral infection might allow increased viral replication and aggravate the disease.
The 3C-like proteinase on SARS-CoV-2 (nsp5) inhibits HDAC2 transport into the nucleus, and so impairs the way in which it mediates inflammation and cytokine responses, so activation of histone deacetylase by dexamethasone may directly oppose the action of SARS-CoV-2.
Timing of of corticosteroids administration is very important in COVID19 cases for the recovery and decrease the mortality.
- Conditions
- Covid19, Corticosteroids
- Being tested
- Early-Corticosteroids
- Keywords
- COVID19, dexamethazone, methylpredisolone, early recovery
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early-CorticosteroidsDrug
Also called Dexamethasone, Methylprednisolone
early use of dexamethasone/Methylprednisolone as early as laboratory evidence of high inflammatory markers
| Study group | Role | What they receive |
|---|---|---|
| Early CS | Experimental | early use of dexamethasone as early as the laboratory confirmation of inflammation. Receives: Drug: Early-Corticosteroids |
| Late CS | No intervention | Dexamethasone is to be used lately upon the deterioration of cases i.e. sPO2 < 92% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of cases that will need hospitalization
Deterioration in the clinical picture of cases that necessitate hospitalization
Measured: 10 days
Percentage of cases that will need oxygen supplementation
Percentage of cases whose clinical status deteriorate that their sPO2 become less than 92%
Measured: 10 days
28-days mortality
Percentage of cases who died within 28 days of presentation
Measured: 28 days
Secondary outcomes (6)
Percentages of COVID-19 Severity according to CDC 2020
Percentages of COVID-19 severity according to CDC 2020
Measured: 10 days
Time to return to daily activity
Time to return to daily activity level
Measured: 60 days
Percentage of cases with increased d-dimer
Percentage of cases with increased d-dimer from baseline
Measured: 10 days
Percentage reduction in CRP
Percentage reduction in CRP from baseline
Measured: 10 days
Percentage reduction in LDH
Percentage reduction in LDH from baseline
Measured: 10 days
Percentage reduction in Ferritin
Percentage reduction in Ferritin from baseline
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start20 Mar 2021
- Primary completion1 Nov 2021
- Study completion15 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 752 participants (actual)
Sponsor and investigators
- Lead sponsor
- ClinAmygate
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad R Issak, ClinAmygate
- Investigators
- Emad R Issak, Principal investigator, Assalam Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530409
- Sponsor's protocol ID
- PR0012
- Status last verified
- Sep 2023
- First submitted
- 24 Aug 2020
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Spoorenberg SM, Deneer VH, Grutters JC, Pulles AE, Voorn GP, Rijkers GT, Bos WJ, van de Garde EM. Pharmacokinetics of oral vs. intravenous dexamethasone in patients hospitalized with community-acquired pneumonia. Br J Clin Pharmacol. 2014 Jul;78(1):78-83. doi: 10.1111/bcp.12295.
PubMed 24400953
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Corticosteroids in COVID-19, II. Post COVID-19 Follow-up
- ClinicalTrials.gov ID
- NCT04530409
- Acronym / sponsor ID
- PR0012
- Conditions
- Covid19, Corticosteroids
- Keywords
- COVID19, dexamethazone, methylpredisolone, early recovery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 752 participants (actual)
- Lead sponsor
- ClinAmygateUniversity, hospital or other
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 15 Oct 2023 (estimated)
- First posted
- 28 Aug 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.
Timing of of corticosteroids administration is very important in COVID19 cases for the recovery and decrease the mortality.
Detailed description
The sickest patients with COVID-19 suffer a hyperinflammatory state-a cytokine storm-that has features in common with a rare haematological condition called haemophagocytic lymphohistiocytosis. Immune suppression should help such patients. By contrast, immune suppression during the early phase of the viral infection might allow increased viral replication and aggravate the disease.
The 3C-like proteinase on SARS-CoV-2 (nsp5) inhibits HDAC2 transport into the nucleus, and so impairs the way in which it mediates inflammation and cytokine responses, so activation of histone deacetylase by dexamethasone may directly oppose the action of SARS-CoV-2.
Timing of of corticosteroids administration is very important in COVID19 cases for the recovery and decrease the mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early CS | Experimental | Drug: Early-Corticosteroidsearly use of dexamethasone as early as the laboratory confirmation of inflammation. |
| Late CS | No intervention | –Dexamethasone is to be used lately upon the deterioration of cases i.e. sPO2 < 92% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- any case with COVID-19 more than or equal to 18 years
- mild and moderate severity
Key exclusion criteria (3 listed)
- Severe to critical COVID-19
- Any contra-indication for the interventional drug
- Mentally disabled cases
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 |
|---|---|---|
| Early-CorticosteroidsAlso: Dexamethasone, Methylprednisoloneearly use of dexamethasone/Methylprednisolone as early as laboratory evidence of high inflammatory markers | Drug | Early CS |
Primary outcome
Percentage of cases that will need hospitalization
Time frame: 10 days
Deterioration in the clinical picture of cases that necessitate hospitalization
Percentage of cases that will need oxygen supplementation
Time frame: 10 days
Percentage of cases whose clinical status deteriorate that their sPO2 become less than 92%
28-days mortality
Time frame: 28 days
Percentage of cases who died within 28 days of presentation
6 secondary outcomes
Percentages of COVID-19 Severity according to CDC 2020
Time frame: 10 days
Time to return to daily activity
Time frame: 60 days
Percentage of cases with increased d-dimer
Time frame: 10 days
Percentage reduction in CRP
Time frame: 10 days
Percentage reduction in LDH
Time frame: 10 days
Percentage reduction in Ferritin
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Background: PubMed 24400953Spoorenberg SM, Deneer VH, Grutters JC, Pulles AE, Voorn GP, Rijkers GT, Bos WJ, van de Garde EM. Pharmacokinetics of oral vs. intravenous dexamethasone in patients hospitalized with community-acquired pneumonia. Br J Clin Pharmacol. 2014 Jul;78(1):78-83. doi: 10.1111/bcp.12295.
- Individual participant dataSharing planned: No
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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.
Emad R Issak principal investigator
Assalam Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Early-Corticosteroids in people with Covid19 and Corticosteroids, run by ClinAmygate 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 6 Sep 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Percentage of cases that will need hospitalization (time frame: 10 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04530409, which also lists 1 linked publication.
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 6 Sep 2023.