Covid19Phase 2/3NCT04497649
Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients
A Phase 2/3 study testing Sofosbuvir and Daclatasvir in people with Covid19, run by Tanta University at 1 site in Egypt.
Trial summary
efficacy and safety of Sofosbuvir containing regimens in treatment of COVID-19 Egyptian patients, Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- What is being tested?
- Sofosbuvir and Daclatasvir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2020to 10 Apr 2021
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- COVID 19 positive patients
Who cannot join
- COVID-19 patients with critical manifestations.
- Sepsis.
- Acute respiratory distress syndrome (ARDS).
- Decompensated liver disease (Child-Pugh class B or C disease).
- Chronic renal impairment.
- Patients with blood diseases (severe anemia, thalassemia, ITP, leukemia ….).
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- Ischemic heart disease within the last 6 months.
- Chronic pulmonary disease.
- Malignancy.
- Pregnancy or breastfeeding.
- Hypersensitivity to sofosbuvir or ribavirin.
- Patients with organ transplant.
- Unwilling to participate in our study
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo and Tanta Universitities
Tanta
sherief abd-elsalam, ass. prof, 00201147773440, sheriefabdelsalam@yahoo.com
About this study
Official title: Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients: A Randomized Controlled Trial.
efficacy and safety of Sofosbuvir containing regimens in treatment of COVID-19 Egyptian patients,
Read the detailed description
The study aims to assess Sofosbuvir containing regimens in treatment of COVID-19 Egyptian patients,
- Conditions
- Covid19
- Being tested
- Sofosbuvir, Daclatasvir
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SofosbuvirDrug
Also called Mpiviropack, Sovaldy, soflanork
Sofosbuvir once daily
DaclatasvirDrug
Also called daklinza, daklanork
daclatasuvir once daily
| Study group | Role | What they receive |
|---|---|---|
| Sofosbuvir and Daklatasuvir | Experimental | Sofosbuvir and Daklatasuvir with standard of care treatment Receives: Drug: Sofosbuvir; Drug: Daclatasvir |
| Standard of care treatment | No intervention | Standard of care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with improvement or mortality
The number of patients with improvement or mortality
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start1 Jul 2020
- Primary completion1 Apr 2021 (estimated)
- Study completion10 Apr 2021 (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 Tanta 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Marwa Salama, Lecturer, Principal investigator, Tanta University - Faculty of Medicinesherief Abd-Elsalam, ass. Prof., Principal investigator, Tanta University Faculty of medicineAhmed Cordie, lecturer, Principal investigator, Cairo UniversityGamal Esmat, Professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497649
- Sponsor's protocol ID
- Tanta sofosbuvir covid
- Status last verified
- Dec 2020
- First submitted
- 1 Aug 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04497649
- Acronym / sponsor ID
- Tanta sofosbuvir covid
- Conditions
- Covid19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 10 Apr 2021 (estimated)
- First posted
- 4 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.
efficacy and safety of Sofosbuvir containing regimens in treatment of COVID-19 Egyptian patients,
Detailed description
The study aims to assess Sofosbuvir containing regimens in treatment of COVID-19 Egyptian patients,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sofosbuvir and Daklatasuvir | Experimental | Drug: Sofosbuvir, Drug: DaclatasvirSofosbuvir and Daklatasuvir with standard of care treatment |
| Standard of care treatment | No intervention | –Standard of care treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- COVID 19 positive patients
Key exclusion criteria (13 listed)
- COVID-19 patients with critical manifestations.
- Sepsis.
- Acute respiratory distress syndrome (ARDS).
- Decompensated liver disease (Child-Pugh class B or C disease).
- Chronic renal impairment.
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 |
|---|---|---|
| SofosbuvirAlso: Mpiviropack, Sovaldy, soflanorkSofosbuvir once daily | Drug | Sofosbuvir and Daklatasuvir |
| DaclatasvirAlso: daklinza, daklanorkdaclatasuvir once daily | Drug | Sofosbuvir and Daklatasuvir |
Primary outcome
Number of patients with improvement or mortality
Time frame: 1 month
The number of patients with improvement or mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- 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.
Marwa Salama, Lecturer principal investigator
Tanta University - Faculty of Medicine
sherief Abd-Elsalam, ass. Prof. principal investigator
Tanta University Faculty of medicine
Ahmed Cordie, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sofosbuvir and Daclatasvir in people with Covid19, run by Tanta 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 13 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 Dec 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Sherief Abd-Elsalam, ass. prof. (00201147773440, sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with improvement or mortality (time frame: 1 month). 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 Dec 2020.