Covid19NCT04729153
Impact of Previous Treatment of HCV Patients by DAADs on Covid-19 Disease Frequency and Severity
An observational study of Covid19, run by Assiut University.
Trial summary
Evaluate effect of DAADs on covid-19 disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Covid19
- What is being tested?
- DAAD Compound
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2021to Mar 2022
- Phase
- Observational
- 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 to 70 years
- All sexes
- Adult, Older adult
Study population: Retrospective study
Who may be able to join
- HCV patient with or without LC.
- >18 years old.
- Received DAADs at 2019.
Who cannot join
- Combined HCV and HIV infected patients.
- Combined HCV and HBV infected patients.
- < 18 years old.
- Pregnant or breast-feeding patients.
- Patients with autoimmune disease.
- Patients with multiorgan failure, active cancer, renal insufficiency.
Show all 9Show fewer
- Patients received immunosuppressive drugs.
- Immune compromised patients.
- Previous confirmed diagnosis of SARS-CoV-2 before starting DAAs.
Trial locations and contacts
No sites are listed yet.
About this study
Evaluate effect of DAADs on covid-19 disease.
Read the detailed description
If Chronic HCV patients who already received DAADs are protected against covid 19 and considered to be immune or not And if DAADS can be used in ttt of covid 19
- Conditions
- Covid19
- Being tested
- DAAD Compound
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAAD CompoundDrug
Sofosbuvir , Daclatasvir and ribavirin
| Study group | Role | What they receive |
|---|---|---|
| Chronic HCV patients previously treated by DAADs. | Not described Receives: Drug: DAAD Compound | |
| Chronic HCV patients not treated by DAADs yet. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of DAADs on covid -19
If chronic HCV patients who received DAADs suspected to be infected by covid-19 by having findings suggest covid 19 infection in MSCT chest or clinically symptoms or confirmed by nasopharyngeal swab . And if infected what about severity , if they need hospital admission or oxygen therapy or mechanical ventilation ,if they still alive or died
Measured: 12 months (from 1/2/2021 to 1/2/2022)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study startFeb 2021 (estimated)
- Primary completionFeb 2022 (estimated)
- Study completionMar 2022 (estimated)
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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Adel Zareh, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729153
- Sponsor's protocol ID
- DAADs and covid-19
- Status last verified
- Jan 2021
- First submitted
- 23 Jan 2021
- Last updated
- 3 Feb 2021
- Results posted
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Previous Treatment of HCV Patients by DAADs on Covid-19 Disease Frequency and Severity
- ClinicalTrials.gov ID
- NCT04729153
- Acronym / sponsor ID
- DAADs and covid-19
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 28 Jan 2021 (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.
Evaluate effect of DAADs on covid-19 disease.
Detailed description
If Chronic HCV patients who already received DAADs are protected against covid 19 and considered to be immune or not And if DAADS can be used in ttt of covid 19
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic HCV patients previously treated by DAADs. | – | Drug: DAAD Compound |
| Chronic HCV patients not treated by DAADs yet. | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Retrospective study
Key inclusion criteria (3 listed)
- HCV patient with or without LC.
- >18 years old.
- Received DAADs at 2019.
Key exclusion criteria (9 listed)
- Combined HCV and HIV infected patients.
- Combined HCV and HBV infected patients.
- < 18 years old.
- Pregnant or breast-feeding patients.
- Patients with autoimmune disease.
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 |
|---|---|---|
| DAAD CompoundSofosbuvir , Daclatasvir and ribavirin | Drug | Chronic HCV patients previously treated by DAADs. |
Primary outcome
Evaluate the effect of DAADs on covid -19
Time frame: 12 months (from 1/2/2021 to 1/2/2022)
If chronic HCV patients who received DAADs suspected to be infected by covid-19 by having findings suggest covid 19 infection in MSCT chest or clinically symptoms or confirmed by nasopharyngeal swab . And if infected what about severity , if they need hospital admission or oxygen therapy or mechanical ventilation ,if they still alive or died
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Assiut University.
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 3 inclusion and 9 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 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Contact Eman Adel (01096883754, emanadel9594@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effect of DAADs on covid -19 (time frame: 12 months (from 1/2/2021 to 1/2/2022)). 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 3 Feb 2021.